Late last year, FDA advisory committees reviewed studies which suggested that birth control pills containing the hormone drospirenone put women at greater risk for blood clots than pills made with older-generation hormones. Blood clots are serious health problems because they can break loose and travel to the heart, lungs or brain causing serious complications or death.

Oral contraceptives that contain drospirenone are the top selling Yaz and Yasmin, as well as Safyral, Beyaz (all made by Bayer) and generics Gianvi, Loryna, Ocella, Syeda, and Zarah.

These claims have resulted in thousands of lawsuits against Bayer by women who say they were not adequately warned that using drospirenone-containing pills could put their life at risk.

The FDA committee fell short of recommending that the pills be banned, instead advising that stronger labels be placed on the pills.

The committee also recommended that stronger warnings be placed on the Ortho Evra birth control patch, made by Johnson & Johnson. Studies have linked the patch to high numbers of blood clots.

While many otherwise healthy women have suffered health problems as result of these contraceptives, experts say women with specific risk factors should probably avoid them altogether. This includes women with blood clotting disorders or a family history of blood clotting, smokers, and women over the age of 35.

Perhaps the best advice is to consider alternatives to birth control pills and patches. Options include the hormone shots and the increasingly popular intrauterine devices (IUDs), which are made in both hormone and non-hormone forms. And there are always more traditional methods, such as condoms, contraceptives sponges and diaphragms.

Source: Everyday Health

SOURCE: Yaz Lawsuit › Women should be aware of blood clot risk with birth control pills, patches

Confused by her daughter’s sudden illness, Rebecca’s parents ordered an autopsy. The primary cause of death was a blood clot in her heart. “The secondary cause of death was her oral contraceptive,” her mother, April Bapp, told the Barton Chronicle.

Rebecca was taking Ocella, a generic version of the top-selling Yaz birth control pill. The pills are in a newer class of oral contraceptives that contain the hormone drospirenone.

The Food and Drug Administration (FDA) advisory panel recently reviewed studies that indicate the pills put users at greater risk for blood clots than pills containing older hormones, and recommended that stronger warnings be placed on the pills’ packages. Other pills that contain drospirenone include Yasmin, Safyral and Beyaz.

April says her daughter was aware that birth control pills could increase the risk of blood clots, but said both she and her daughter were swayed by the ads for Yaz, which touted the pill for the treatment of PMS and acne. The FDA since ordered Bayer, makers of Yaz, to redo the ads, clearly explaining its approved indications (the drug is approved for the treatment of the more severe PMDD, not PMS) and the risks associated with the pills.

The potential benefits aside, studies have begun to show that the blood clot risk with drospirenone-containing pills is greater than with other types of oral contraceptives. And now Rebecca’s mother April wants to warn others in hopes no more mothers have to experience the same devastating loss she did.

Source: VT Digger

SOURCE: Yaz Lawsuit › Birth control called ‘secondary cause of death’ in young woman taking Yaz

While the drug has yet to be approved for use in the United States, the possibility of a male birth control medication is creating a buzz. Researchers are already testing various contraceptive pills, patches, creams, and implants on men, and it is strongly believed that a male birth control pill could be available in the United States within 5 to 7 years, and implants could hit the market even sooner.

Researchers say data shows that contraceptives that combine progestin and androgen are safe, effective, inexpensive and reversible. However, proof of the drugs’ initial safety profile will be determined when clinical trials are completed.

Hormone birth control for women is known to slightly increase the risk for blood clots, which can lead to more serious problems such as heart attacks, strokes, and even death. Some studies suggest that a newer generation of pills – those that contain the hormone drospirenone – put women at even greater risk for blood clots. Those pills include the brands Yaz, Yasmin, Ocella, Beyaz, and Safyral, as well as their generic equivalents.

The male contraceptives are currently being tested in China, but researchers say they hope to conduct clinical trials in the United States within the next two years.

Sources:
Smart About Health
MSNBC

SOURCE: Yaz Lawsuit › Male birth control drugs may soon reach U.S. market

Generic drugs are what the Food and Drug Administration calls “copies of brand name drugs that have exactly the same dose, intended use, side effects, route of administration, risks, safety, and strength as the original drug.” However, the generic version, by law, is not entirely the same. It may have different colors or inactive ingredients. About half of all generic drugs are produced in the same plants used to manufacture the brand name drugs.

Yaz contains 3mg drospirenone and 20 mcg of ethinyl estradiol. Bayer offers the same formulation in Beyaz, a birth control pill that also contains the B vitamin folic acid. Generic versions of Yaz made by other manufacturers include Gianvi and Loryna.

Yasmin contains 3mg drospirenone and 30 mcg of ethinyl estradiol. Bayer also offers a folic acid-fortified version of Yasmin known by the brand name Safyral. Bayer also offers a generic Yasmin by the name of Ocella. Syeda and Zarah are more generic brands of Yasmin sold by other companies.

While all birth control pills put women at risk for blood clots, new studies show that drospirenone-containing pills put women at even greater risk. This includes Yaz and Yasmin, but also the numerous generic brands. Using a generic version of a medication does not mean, if you have been injured, that you are not eligible for compensation.

However,  a recent Supreme Court ruling determined makers of generic drugs are not required to warn patients if they receive reports of new side effects from the drugs. This ruling can protect generic drug makers from being sued under state liability laws for failing to warn patients of these new dangers. If you have been injured by a generic drug, it is important to talk to your lawyer about how this ruling may affect your rights to justice.

Beasley Allen Law Firm is currently investigating cases of women who have suffered blood clots, heart attacks, strokes or gallbladder damage after using any drospirenone-containing birth control pill.

Source: WebMD

SOURCE: Yaz Lawsuit › Generic versions of Yaz, Yasmin just as dangerous as brand name pills

The girl was prescribed Yasmin, manufactured by Bayer,  when she was 13 by her dermatologist to help clear up her acne. Her prescription was later changed to the generic Ocella, also manufactured by Bayer but marketed by Teva Pharmaceuticals. Yasmin and Ocella are part of a family of birth control pills that contain the hormone drospirenone. Other brands include Yaz, Yasminella, and Beyaz. Only Yaz and its generic equivalent Gianvi are FDA-approved for the treatment of acne in girls 14 and older.

The lawsuit alleges that Bayer heavily marketed the drugs to appeal to young women by highlighting its pills as a treatment for acne, and by downplaying the serious risks associated with the drugs.

All birth control pills carry a slight risk for blood clots, but recent studies suggest the risk with drospirenone-containing pills is even greater. Blood clots can cause strokes, heart attacks and sudden death. Pills containing drospirenone have also been linked to gallbladder damage.

Bayer faces about 7,000 lawsuits filed on behalf of women who allege they were not adequately warned that taking the pills could seriously injure or kill them.

SOURCE: Yaz Lawsuit › Family of deceased 15-year-old girl files Yasmin lawsuit

All birth control pills carry a slight risk for blood clots, but critics have long argued that Yaz and Yasmin put women at even greater risk. Both Yaz and Yasmin are made by Bayer Healthcare and contain the hormone drospirenone.

Health Canada’s announcement comes just days after the U.S. Food and Drug Administration (FDA) said it was keeping a watchful eye on two recent studies published in the British Medical Journal that compared the blood clot risks with drospirenone-containing birth control pills to pills that contained another popular birth control hormone known as levonorgestrel.

Birth control pills that contain drospirenone include Bayer’s Yaz, Yasmin, Beyaz and Safyral, as well as generics Ocella, Gianvi, Loryna, Syeda, and Zarah. Bayer has maintained that its pills are no more dangerous than other birth control pills; however, the pharmaceutical company faces thousands of lawsuits from women or their families who say that their drospirenone-containing pills caused them serious injuries such as blood clots, strokes, heart attacks, gallbladder damage, and even death.

Both Health Canada and the FDA say they will review all available information to fully assess the risk of blood clots with drospirenone-containing pills and will take appropriate action as necessary once the review is complete.

Sources:
680 News
FDA

SOURCE: Yaz Lawsuit › Health Canada reviewing data linking Yaz to greater risk of blood clots

Birth control pills with the hormone drospirenone include Bayer’s Yaz, Yasmin, Beyaz and Safyral, as well as generics Ocella, Gianvi, Loryna, Syeda, and Zarah. The FDA says it hopes to have data later this summer from an 800,000-person study it commissioned to examine the risks.

While all birth control pills carry a risk for blood clots, the new studies indicate what many have feared over the years – that pills containing drospirenone were more dangerous. Not only had they become the most prescribed birth control pills in the country with more than 1.47 billion in sales, more and more reports of serious injuries and deaths were being reported in women who used the pills. Blood clots are serious health consequences that can lead to strokes, heart attacks, and sudden death.

Bayer has long defended its family of drospirenone-containing birth control pills, arguing that they are no more dangerous than other pills. Thousands of lawsuits have already been filed against Bayer by women or their family members who say they were not adequately warned of the risks.

The FDA says it will wait on more data to decide if more action should be taken. Until then, women who are using Yaz or other drospirenone-containing pills to seek immediate medical attention if they experience symptoms of blood clots, such as persistent leg pain, severe chest pain, or sudden shortness of breath.

Sources:
FDA
New York Times

SOURCE: Yaz Lawsuit › FDA keeping a watchful eye on studies on dangers of Yaz

The studies referenced by the FDA looked at VTE rates in women using birth control pills containing drospirenone compared with women taking pills containing levonorgestrel. Data showed that the risk for venous thromboembolism, or pulmonary embolism, is as much as two to three times greater with drospirenone-containing pills than with levonorgestrel-containing pills.

Bayer launched its blockbuster birth control pill Yaz with a huge marketing campaign that claimed it could conquer symptoms of premenstrual syndrome and clear up acne. The FDA fined Bayer for overstating the benefits of the drug and downplaying the risks, including the risk for blood clots.

Women began asking their doctors for Yaz by name, making it the most prescribed birth control pill in the country. The success of Yaz was only slightly hampered by a series of ads Bayer was forced by the FDA to run that clearly stated the risks associated with the pill. It wasn’t until reports of deaths and serious injuries in women who used Yaz that the public began to take notice.

Bayer has defended its oral contraceptives, arguing they are no more dangerous than other birth control pills. The new studies suggest otherwise. Bayer now faces thousands of lawsuits from women and their families who say they were not adequately warned of the risks associated with the pills, including blood clots (including VTE), heart attacks, strokes and sudden death.

The FDA recommends women who have questions about their oral contraception contact their doctors. If they experience any of the following symptoms of VTE to seek medical help immediately – persistent leg pain, severe chest pain, sudden shortness of breath.

Women who smoke and are older than 35 years of age should not take combination birth control pills because they increase the risk of serious cardiovascular events, including blood clots.

Source: FDA

SOURCE: Yaz Lawsuit › FDA warns of elevated blood clot risk in Yaz birth control pills

Bayer

Levonorgestrel is a progestogen that is used in both combination hormone pills and progestogen-only formulations. It is known by the brand names Escapelle, Plan B, Levonelle, NorLevo, Postinor-2, i-pill, Next Choice, and 72-HOURS. It is also the active ingredient in the Mirena-brand intrauterine device (IUD).

Blood clots have always been a risk factor with birth control pills, but mounting lawsuits against Bayer argue that Bayer’s formulation of drospirenone and ethinyl estradiol in Yaz and Yasmin puts women at greater risk. The same formulation of hormones is also in the generic oral contraceptive Ocella, as well as Bayer’s newly introduced folic acid-fortified pills Bayaz and Safyral.

Researchers from the Boston Collaborative Drug Surveillance Program at Boston University School of Medicine studied about 900 women on birth control since 2002. The blood clot risk for women taking Yaz or Yasmin was 30.8 per 100,000 person-years. Women on pills containing levonorgestrel had a rate of only 12.5 per 100,000 person-years.

Most alarming, researchers also found that women younger than 30 who used Yaz or Yasmin were at even greater risk for blood clots than women on second-generation pills. These young women had an incidence rate of 24.8 per 100,000 compared to only 5.39 per 100,000 if they took pills containing levonorgestrel.

SOURCE: Yaz Lawsuit › Young women at even greater risk for blood clots with Yaz, Yasmin

About 7,000 lawsuits have been filed against Bayer by women or their family members who allege that they were not warned by Bayer that company’s birth control pills Yaz and Yasmin could put them at serious risk of life-threatening blood clots, heart attacks, strokes, and gallbladder damage. More plaintiffs are joining the lawsuit and some estimate that there could be as many as 14,000 plaintiffs in all.

While the documents are stored at a St. Louis-based law firm and are managed by one attorney with a full-time IT employee for technical support, firms across the country are helping review the documents and can access the database remotely. To date, about 150 attorneys have been trained how to use the data base, and up to 50 people review the documents as much as five days a week.

The paperwork not only includes documents related to Bayer’s Yaz and Yasmin, but also to generic versions of the drugs, including Ocella and Gianvi.

The first bellwether case trial is set for September. Aside from the federal litigation in southern Illinois, consolidated lawsuits are pending in Pennsylvania, California and New Jersey state courts.

SOURCE: Yaz Lawsuit › Bayer generates millions of pages for Yaz, Yasmin lawsuits

Yasmin is part of Bayer’s “four sisters” of oral contraceptives that include Yaz and Yasmin as well as the recently introduced folic acid-fortified pills Beyaz and Safyral. All four use a combination of the hormones ethinyl estradiol and drospirenone. The pills brought in more than $1.5 billion, a 13 percent drop from 2009.

Yaz was approved by the Food and Drug Administration (FDA) in 2006, and was marketed as a new kind of birth control pill that not only prevented pregnancy but also tackled PMS symptoms such as irritability and helped clear up acne. The marketing campaign launched Yaz into the best-seller category among birth control pills, with many women asking their doctors for it by name.

The FDA soon penalized Bayer for running ads that overstated the drug’s benefits and downplayed the serious risks, including the risk of blood clots, heart attack and strokes. The FDA also ordered the drug company to run a series of clarification ads.

Soon after, Bayer was hit with thousands of lawsuits from women who claim they suffered serious health problems from the pills and that Bayer knew the risks but did not adequately warn consumers.

The bad press surrounding Yaz and Yasmin have contributed to the drugs’ lagging sales over the past year, which may explain why the company is fighting generic competition that would devour more of its waning profits.

SOURCE: Yaz Lawsuit › UK blocks sales of generic Yasmin

“Sadly, she was a normal, healthy young woman before this,” she told the CBCNews Facebook community. “Now she will never be able to take birth control again and will forever be worried about blood clots and what the long term effects are from this drug.”

Several community members expressed concern over Yasmin, an oral contraceptive made by Bayer HealthCare that combines the hormones ethinyl estradiol and drospirenone. Bayer also makes Yaz, Beyaz and Safral with a similar combination of hormones. The pill is also known by the generic ocella. All have a similar side effect profile.

All oral contraceptives carry a risk for blood clots, but some say Bayer’s pills put women at even greater risk. CBC News recently covered a story saying Canadian doctors don’t think Yasmin is more dangerous than other pills, but that notion was squashed by numerous commenters to the CBC story. The sad truth is that thousands of women have experienced blood clots, heart attacks, strokes, and gallbladder damage.

More than 800 Canadian women and 4,000 American women have filed lawsuits against Bayer looking for compensation for their pain and suffering.

SOURCE: Yaz Lawsuit › Facebook community speaks out about dangers of Yasmin

Birth control pills contain a combination of estrogen and progestin, which can trigger clotting in the blood and lead to strokes, heart attacks and blood clots. Yaz and similar Bayer pills (Yasmin, Beyaz, Natazia, Angeliq and Teva’s Ocella generic) also contain drospirenone, a diuretic, that some say can cause an increase in potassium levels in the blood and lead to hyperkalemia, which causes heart rhythm disturbances that can cause blood clots and lead to sudden cardiac death or pulmonary embolism or strokes. Diuretics have also been associated with gallbladder problems.

Claims of venus thromboembolisms (including pulmonary embolisms and deep vein thromboses) make up 40-41 percent of the lawsuits, and strokes and heart attacks make up 9-10 percent of the claims. The remaining 43 percent involve gallbladder injuries, a problem not typically associated with blood clotting, nor with oral contraceptives. But few can deny the fact that numerous young women and teenagers taking Yaz have suffered from gallbladder problems, a condition that usually affects women in their 40s.

The first lawsuits against Bayer are scheduled to face juries in September 2011. Meanwhile, Bayer is fighting back with denials as well as a lineup of new similar birth control pills such as Natazia, Angeliq and Beyaz.

SOURCE: Yaz Lawsuit › Gallbladder damage most reported problem with Yaz birth control pill

Acne spurred by hormone changes usually occurs the week before the period and often springs up on the chin. “In that situation, you might prescribe a birth control pill along with their standard regimen,” Dr. Berson told Modern Medicine. Oral contraceptives shouldn’t be looked at as the lone cure-all for acne. “It is something that is given to prevent further breakouts. … You would still give it along with the traditional therapies, whether they are topical or oral.”

But birth control pills are not without risks. “Most of the side effects are due to the estrogen component,” Dr. Berson says, adding that the most common problems associated with the pill include nausea, headaches and breast swelling. But, she adds, “there is still potential for deep vein thrombosis and vascular events.”

Yaz (as well as Yasmin and the generic ocella) is one type of birth control pill that has been singled out for its indication for treating acne as well as taming the symptoms of premenstrual dysphoric disorder (PMDD). Because it has multiple indications, more prescriptions are written for Yaz in the United States than any other birth control pill. But, there have also been more lawsuits filed against Yaz from women who say they suffered serious health problems from the pill, including blood clots, heart attacks, strokes, deep vein thrombosis, pulmonary embolism and even gallbladder problems.

Women who have a history of blood clotting disorders, migraines, high blood pressure, smoking or heart disease should not take oral contraceptives because they are at greater risk for blood clots. But even women who had no prior health problems that would make them a bad candidate for the birth control pills still became ill after taking Yaz.

“You want to make sure that (women) understand the potential risks, such as blood clots,” Dr. Berson says.

SOURCE: Yaz Lawsuit › Should you use the pill to treat acne?

“I used to take Yaz until it mess up my gallbladder and I had to get surgery to have it removed. Thank you, Yaz!”

“I have heard bad things about this brand of contraception so I will not use it.”

“Don’t take Yaz. *personal experience*”

Yaz, also known as Yasmin and by the generic ocella, was introduced in the United States as a new type of birth control pill that not only prevented unwanted pregnancies but also helped curb the symptoms of premenstrual dysphoric disorder (PMDD) and treat moderate acne.

The pills were marketed by a massive adverting campaign, but the Food and Drug Administration (FDA) slapped Bayer, the makers of Yaz and Yasmin, with a huge penalty saying its ads didn’t adequately warn women of the risks associated with the pills, such as blood clots that could lead to pulmonary embolism, heart attacks and strokes, as well as gallbladder problems. The drug company was forced to run more ads clearly stating its approved uses and possible risks.

When Bayer began running the disclaimer ads, the pills were already the top selling oral contraceptives in the country, bringing in billions of dollars annually to Bayer. Meanwhile, thousands of otherwise healthy women were beginning to fall ill and even die from blood clots and other health problems. Bayer now faces more than 1,000 lawsuits from women injured by the pills.

Is it any wonder Yaz has a bad reputation on YouTube?

SOURCE: Yaz Lawsuit › Bad press catches up with top selling Yaz, Yasmin

Rebecca Anderson-Hull

How could an otherwise healthy woman suffer from life-threatening blood clots? Her doctors said it was likely caused by her oral contraceptives. Rebecca had been taking Yaz, the country’s most widely used birth control pill, for two years.

“Do you think the company knew,” asked CBS 11’s Ginger Allen.
“Yes,” she replied.
“Do you blame the company?” the reporter asked.
“Yes,” Rebecca replied.

Rebecca is just one of thousands of women across the country who have filed lawsuits against Bayer, the makers of Yaz, also known as Yasmin and by the generic ocella. The lawsuits allege that Bayer was aware that its blockbuster birth control pills put women at greater risk of blood clots that could lead to heart attacks, pulmonary embolisms and strokes but failed to adequately warn them that their lives were at risk.

The lawsuits reflect a concern raised not long after the revolutionary birth control pills were introduced to the market. Bayer launched the pills with a huge advertising campaign touting the drug’s benefits for everything from premenstrual syndrome to acne. The Food and Drug Administration barked back at Bayer saying its ads were misleading, that they overstated the benefits of Yaz and minimized the serious risks associated with the pills. Bayer was fined and was ordered to launch a new ad campaign, this time clearly stating the approved uses for the pills and explaining the risk.

But it was too little, too late for many women, including Rebecca. Now Rebecca, and thousands of other victims of Yaz side effects, are demanding justice.

SOURCE: Yaz Lawsuit › Texas woman says Yaz caused brain damage

“Our goal is to evaluate objectively the risks and benefits of demedicalizing contraceptive care, with an eye toward improving access to OCs (oral contraceptives) and potentially other hormonal contraceptive methods by making them available without a prescription,” a statement from the nonprofit advocacy group reads.

The group says there is substantial literature available on oral contraceptives that show birth control pills meet most of the Food and Drug Administration’s criteria for OTC status. “The drug’s benefits outweigh the risk for women of reproductive age; the potential for misuse or abuse is low; a consumer can easily self-diagnose the condition for which the pills are indicated; and directions for use are straightforward.”

Birth control pills have a host of minor side effects including vision changes, breast tenderness, fluid retention, weight gain, acne, headaches, depression and anxiety. But women who use estrogen-containing birth control pills are at a 3- to 6-fold increased risk of developing blood clots. Blood clots may lead to deep vein thrombosis, heart attack or stroke.

Some studies suggest that different types of birth control pills can put women at an even greater risk of blood clots. Most notably is Bayer HealthCare’s blockbuster birth control pill Yaz, also known as Yasmin and by the generic ocella. Yaz is the top-selling birth control pill in the country, yet few women realize they are at risk of blood clots until it is too late. To date, more than 1,100 lawsuits have been filed against Bayer by women who allege they were not adequately warned by the drug company that taking Yaz put them at greater risk of serious injury.

Making oral contraceptives available OTC does have benefits. It will give women greater control over their birth control choices, and that could lead to easier access to higher rates of initiation, continuation and fewer gaps in use, thereby “potentially leading to an overall decrease in rates of unintended pregnancy and abortion,” the organization’s statement reads.

For now, the Working Group on Oral Contraceptives Over-the-Counter will carry out several activities, including research, engaging in public education and discussion, and building consensus on key issues. “We will initiate dialogue with professional medical organizations, host a meeting to gauge support for this issue among organizations representing diverse groups of women, and create informational materials on the safety of OCs.”

SOURCE: Yaz Lawsuit › Group advocates to make birth control pills available OTC

High blood pressure is known as the silent killer because most often there are no symptoms. The symptoms that do occur include chest pain, confusion, ear noise or buzzing, irregular heartbeat, nosebleed, tiredness, and vision changes. Complications from high blood pressure include aortic dissection, blood vessel damage, brain damage, congestive heart failure, kidney damage, kidney failure, heart attack, hypertensive heart disease, stroke and vision loss.

There are many different medications that are used to treat high blood pressure. You can lower your risk by making lifestyle changes, including exercising, losing weight and following a healthier diet. You may also be advised to stop taking other medications, such as birth control pills.

Oral contraceptives can increase blood pressure and carry a slight risk of blood clots that can lead to heart attacks and strokes as well as other life-threatening problems. Recent studies suggest that some pills are more dangerous than others, such as the country’s most popular birth control pill, Yaz, also known as Yasmin and by the generic ocella. Bayer, the maker of Yaz and Yasmin, currently faces more than 1,100 lawsuits from women who say the pills caused them to suffer from blood clots, heart attacks, strokes, gallbladder damage and other serious health problems.

SOURCE: Yaz Lawsuit › Women with high blood pressure should use caution with ‘the pill’

“Defendants have been issued warnings by the FDA at least three times – in 2003, 2008 and 2009 – for misleading the public through the use of ads which overstate the efficacy of YAZ/Yasmin and minimize serious risks associated with the drug,” the lawsuit reads.

Heather was prescribed and took Yaz/Yasmin beginning in October 2008 through July 2009 and during that time suffered multiple pulmonary emboli. She believes her birth control pill put her at greater risk for developing the serious side effects and blames Bayer for ignoring the link between the use of the pills and the increased risk of serious and life threatening side effects. Heather’s is one of more than a thousand lawsuits filed against Bayer for inadequately warning women of the risks of blood clots, strokes, heart attacks, gallbladder problems and other serious health issues, including death.

Heather’s lawsuit was filed against Bayer Corporation as well as Bayer Healthcare, Bayer Pharmaceuticals, Berlex, Berlex Laboratories, Bayer Schering Pharma AG, and Bayer Healthcare AG under the Louisiana Products Liability Act. She is seeking damages for medical expenses, physical pain and suffering, mental anguish, physical disfigurement, physical impairment, loss of earnings, loss of earning capacity, interest, and court costs.

SOURCE: Yaz Lawsuit › Another woman files lawsuit against makers of Yaz

Stewart was prescribed Yaz by her gynecologist in September 2007 to treat cramps associated with her period. Yaz is marketed as a contraceptive that also treats premenstrual dysphoric disorder (PMDD), premenstrual syndrome, as well as moderate acne. It also is the only birth control pill to contain ethinyl estradiol and drospirenone, a diuretic.

In June 2008, Stewart began to feel pain in her abdomen and learned that her gallbladder was not functioning properly. Two months later her gallbladder was removed. Stewart took a short break from Yaz until April 2009, when she resumed treatment only to go off of it again when she says the pills made her feel queasy. Severe cramping a few months later led her to go back on Yaz. Within days of resuming treatment, Stewart’s lawsuit claims she began suffering severe depression and suicidal thoughts that led her to attempt suicide on two separate occasions.

Stewart’s lawsuit names Bayer, Bayer HealthCare Pharmaceuticals, Bayer HealthCare AG, Bayer HealthCare LLC, Bayer HealthCare Corporation, Berlex Inc., and Berlex Laboratories Inc. The plaintiff seeks unspecified damages, court costs, and attorney fees.

SOURCE: Yaz Lawsuit › Woman blames Yaz for gallbladder damage, severe depression

Herndon was appointed to preside over numerous lawsuits from across the country from women who claim they were seriously injured by the unique birth control pills. The women say the drugs’ safety labels did not adequately warn them of an increased risk of health problems such as blood clots, strokes, heart attacks, gallbladder damage and sudden death.

Bayer’s Yasmin and Yaz, and the generic versions Ocella and Gianvi, are marketed not only for their contraceptive but also as a treatment for premenstrual dysphoric disorder (PMDD) and for the treatment of moderate acne. The pills are also the only ones sold in the U.S. that contain drospirenone, a diuretic, which can cause an increase of potassium levels in the blood. This imbalance can lead to heart rhythm disturbances that can trigger blood clots and other serious injuries.

Source: Madison/St. Clair Record

SOURCE: Yaz Lawsuit › Judge orders birth control pill makers to turn over files for litigation

Kathy Perea

Kathy says the attacks began shortly after she started taking the Yasmin birth control pill. “I would wake up in the middle of the night and it would feel like someone had hit me with a baseball bat in my rib,” she said. So she stopped taking the pill. Her symptoms did not go away. That’s when her doctor told her the damage had already been done. Her gallbladder was damaged and had to be removed.

Yasmin, also known by the brand name Yaz and the generic Ocella, is one of the top selling birth control pills in the country. It is the only one that combines a hormone with a diuretic. While Bayer HealthCare, the maker of Yasmin, says the pill carries the same risks as other birth control pills, women like Kathy say they believe Yasmin is more dangerous and that they were not adequately warned by the drug company of the serious side effects that could occur with taking the once-daily pill.

To date, Bayer faces more than 1,100 lawsuits from women who allege they were harmed by the drugs. Many claim to have suffered damage to their gallbladder. Others claim the pills caused them to develop life-threatening blood clots and other serious medical conditions.

Though Kathy is feeling better she says she still suffers from occasional pain after eating. She blames Yasmin for threatening her life, and she wants justice. “I have five kids I have to support financially and I had to miss days of work. I had to have surgery,” Kathy said through tears. “That’s money coming out of my pocket for something they didn’t tell me was going to happen to me.”

SOURCE: Yaz Lawsuit › Woman blames Yasmin for damaging her gallbladder

Dawn Varrechio

Like many women, Dawn was taking Yaz birth control pills, the most popular oral contraceptive in America. What she didn’t realize is that by taking Yaz she was putting herself at greater risk for life-threatening blood clots. Last year, two studies published in the British Medical Journal found women on Yaz to be at greater risk of developing blood clots than on other forms of birth control. Bayer HealthCare, makers of Yaz, sponsored two previous studies that discount those claims, arguing that Yaz doesn’t increase blood clot risk any more than other brands of birth control pills.

Yaz, also known by the brand name Yasmin and the generic Ocella, is the only birth control pill that contains drospirenone, a diuretic, and ethinyl estradiol. The pills were touted not only for pregnancy prevention but also for the treatment of severe acne and premenstrual dysphoric disorder, or PMDD. Yaz soared in popularity, becoming a blockbuster money maker for Bayer.

But as Bayer began collecting its profits, reports of serious injuries and deaths in women who took the drug began pouring in. Bayer now faces more than a thousand lawsuits from women who say Yaz caused them to suffer from health problems such as heart attacks, strokes, pulmonary embolisms, blood clots, deep vein thrombosis, and gallbladder disease.

Survivors can only hope their problems don’t return. “It’s scary,” said Dawn, who says she now worries about the long-term effects Yaz will have on her. “It’s really scary.”

SOURCE: Yaz Lawsuit › Woman worries about long-term effects of Yaz

Irina Shiryaeva

Blood clots are one of the most common causes of death in the United States, second only to cancer. Despite their prevalence, only six percent of Americans know the symptoms and risk factors of blood clots – including pulmonary embolism and deep vein thrombosis, or blood clots that commonly affect the leg veins.

According to the National Alliance for Thrombosis and Thrombophilia, there are many known causes for blood clots to form. Those factors include prolonged bed rest or inactivity, such as long plane rides. The lack of movement can cause reduced circulation in the legs. Most surgical procedures or physical trauma can also increase one’s risk. Other situations that increase one’s risk of blood clots includes pregnancy, oral contraceptives and hormone replacement therapy.

Estrogen does not cause blood clots, but it does dramatically increase a woman’s risk. Most birth control pills, which include an estrogen and progestin, increase a woman’s risk of blood clots by as much as three- to four-fold. About one woman out of 300 taking oral contraceptives will develop a blood clot. Women on birth control pills who have additional risk factors – such as taking a long-distance trip or flight – are at even greater risk of developing potentially life threatening blood clots.

While manufacturers of birth control pills and even birth control patches have warnings on their label of the increased risk of blood clots, many women who have been harmed by them say the warnings weren’t adequate enough. Several lawsuits have been filed against the makers of Yaz, Yasmin and its generic, Ocella; and Johnson & Johnson, maker of the Ortho Evra birth control patch, has paid millions to settle lawsuits from women who have suffered blood clots after using the patches.

Unfortunately, it’s too late for Irina, who leaves behind a husband and 3-year-old son.

Source: News Observer

SOURCE: Yaz Lawsuit › Birth control pills, long plane flights increase risk of blood clots

“I hate the pill. Hormonal contraception, which covers birth control pills and nearly every other highly effective method on the market, murders my libido. I say that with as much certainty as I can, given the murky, multi-variate thing that is the human sex drive,” she writes in a post titled Why I hate the pill. “I’ve experimented with several pills, hoping that any slight variation in hormonal ingredients would yield a contraceptive that worked without neutering me. Each doused my interest in sex as completely as the other. Although a libido-destroying pill does wonders to lower your pregnancy risk, it’s also done a number on my relationships, self-esteem and emotional well-being.”

Sealey says she didn’t find relief from her problem when switching to other forms of birth control. Nothing seemed to be the right “fit.” But she makes a good point. “If you’re like me, you assume that someone, somewhere is figuring all of this out — that there will be a new kind birth control discovered or invented at some point because that’s just how human progress rolls on. I mean, they’re already working on another iPad. Surely, some lab rat is putting the finishing touches on the next breakthrough in contraception.”

Unfortunately, Sealey says, any prospect for the development of innovative birth control methods have stopped dead in their tracks. “According to a 2008 report by Harper and several colleagues, public and private funds for contraceptive research have dried up in recent years. Most pharmaceutical companies have withdrawn from investing in contraceptive R&D, perhaps due to fears of costly personal injury litigation. And those fears aren’t necessarily unfounded. A reported 1,100 lawsuits have been filed in the United States against Bayer HealthCare alone, mostly by women claiming health problems such as blood clots, strokes, heart attacks and gall bladder disease after taking the popular pills Yaz and Yasmin.”

Perhaps the key is not finding new methods, but making the ones currently marketed to women safer to use.

SOURCE: Yaz Lawsuit › Women deserve safer options in birth control

The news story focused on lawsuits filed against Bayer Healthcare over its birth control pills Yaz and Yasmin (ocella) and claims that the pill caused women, including young and otherwise healthy women, to suffer from serious and sometimes fatal blood clots.

“The studies don’t give a clear answer if Yaz and Yasmin are ‘the cause of health problems, including deep vein thrombosis (blood clots in the deep veins), strokes, heart attacks and gallbladder disease’ as they’re being accused of doing,” Garcia writes.

But Hull countered with a personal story. “It (Yaz) should scare the heck out of women! My wife began taking Yaz shortly after it hit the market in 2006, and a little over a year later she suffered a bilateral pulmonary embolism that devastated her. It caused a cascade of injuries that culminated in pulmonary arrest, multiple cardiac arrests, multiple strokes and ultimately an anoxic brain injury. At 46 years old she went from being vibrant and active to lying flat on her back and being unable to do anything for herself,” he responded. “Not worth it.”

SOURCE: Yaz Lawsuit › Husband of Yaz victim says pills were ‘catastrophic in our lives’

Yaz, and Bayer’s equivalent Yasmin, as well as the generic Ocella, are considered fourth-generation birth control pills. They contain a new type of synthetic progestin, drospirenone, that acts as a diuretic. The pills are promoted to not only prevent pregnancies but to also treat severe acne and premenstrual dysphoric disorder, or PMDD.

As of November, the Food and Drug Administration had received 993 reports of pulmonary embolism (blood clots in the lungs), 487 reports of deep vein thrombosis (blood clots in the deep veins), and 229 reports of other blood clots from birth control pills containing drospirenone.

Bayer stands by the safety of its blockbuster birth control pill, saying the pills carry the same health risk as any other type of oral contraceptive. However, two separate studies in the British Medical Journal claimed women were at as much as 6.3 times higher risk of developing blood clots when taking Yaz, Yasmin or Ocella. Recently, Bayer updated the labels of Yaz and Yasmin to include a risk of developing life-threatening blood clots.

SOURCE: Yaz Lawsuit › Yaz, Yasmin can be dangerous to your health

Research on the safety of the active ingredients in Yaz and Yasmin has offered mixed results. Some studies found drospirenone to be no more dangerous than other birth control pills, while other tests put the risk of getting blood clots – even in young, healthy women – as high as six times greater.

“There is reason to be concerned, I believe, about both of them [Yaz and Yasmin],” Dr. Sidney Wolfe, founder and director of Public Citizen’s Health Research Group, a nonprofit advocacy organization based in Washington, D.C., told the Los Angeles Times. “When evidence like that comes up, people should pay attention to it.”

Bayer Healthcare response? To keep mum. In statements to the press, Bayer still stands by its oral contraceptives saying they are no more dangerous than other birth control pills.

SOURCE: Yaz Lawsuit › Bayer Healthcare still stands behind safety of Yaz, Yasmin

The first birth control pills approved for use in the 1960s contained high amounts of hormones, resulting in bothersome and sometimes dangerous side effects including mood swings, weight gain and blood clots. Since then, hormone levels in pills have dropped to as low as one-tenth of what they were 50 years ago. The side effects waned and benefits, such as regulated periods, less acne and bloating, and lighter flows, began to win over skeptics. Long term studies identified even greater benefits – a lower risk of ovarian and endometrial cancers.

But what also began to surface most recently were lawsuits aimed at the manufacturers of birth control products. For example, Johnson & Johnson recently settled thousands of lawsuits from women who suffered blood clots and strokes from the company’s Ortho Evra birth control patch. Similar lawsuits are mounting against Bayer Pharmaceuticals’ blockbuster oral contraceptive, Yaz. And most recently, lawsuits have been filed against the makers of the NuvaRing birth control device, all from women who say they were not adequately warned of their risk of serious and life-threatening injury.

“There are terrible misperceptions about these methods— and about all forms of contraception,” James Trussell, director of the Office of Population Research at Princeton University, told the Wall Street Journal. Given the women who have suffered needlessly, perhaps those misconceptions are with merit.

SOURCE: Yaz Lawsuit › Birth control pills celebrate 50th birthday, but safety still in question

Bayer HealthCare

Yaz and Yasmin, as well as the generic Ocella, contain drospirenone, a diuretic that the plaintiffs claim elevated potassium in their bloodstream, which put them at greater risk for serious and sometimes fatal complications from blood clots, such as heart attack, pulmonary embolism, deep vein thrombosis and stroke. Diuretics can also cause significant problems with the gallbladder and may lead to gallbladder removal.

The lawsuits allege Bayer’s birth control pills put users at greater risk for serious adverse events; however, the company maintains that a woman’s risk of developing blood clots while taking Yaz or Yasmin is similar to other oral contraceptives.

Yaz and Yasmin were Bayer’s top-selling pharmaceutical last year, ringing in sales of $1.64 billion.

SOURCE: Yaz Lawsuit › Bayer adds new information about blood clot risk to Yaz, Yasmin labels

Despina Papparis

The Papparises are among 800 Canadians taking part in a $15 million class-action lawsuit against Bayer Healthcare, the manufacturer of the popular Yaz and Yasmin birth control pills claiming Bayer did not adequately warn women that taking the pills would put them at greater risk of serious health problems. According to the lawsuit, seven Canadian women and more than 50 American women have died while taking Yaz, Yasmin, or its generic Ocella.

Yaz, Yasmin and Ocella have been touted for benefits beyond just birth control. The pill has been marketed as an effective treatment for moderate acne as well as premenstrual dysphoric disorder (PMDD), a condition of severe emotional and physical premenstrual symptoms. The pills are formulated differently from other birth control pills because they contain drospirenone, a diuretic that can increase the potassium level in blood. This increase in potassium can cause heart rhythm disturbances that can cause blood clots as well as problems with the gallbladder.

Source: Calgary Herald

SOURCE: Yaz Lawsuit › 800 Canadians taking part in lawsuit against Yasmin, Yaz maker

According to the Southeastern Texas Record, three east Texas women filed lawsuits against Merck & Co. Inc., alleging that they relied on misrepresentations of the device and as a result suffered injuries. All claim the manufacturers failed to warn them of the greater risk of venous thromboembolism, including deep vein thrombosis and pulmonary embolism.

The Nuvaring controversy is just another incident in which women claim that makers of contraceptives failed to adequately warn them of the increased risk of serious injury when using the birth control. Johnson & Johnson recently paid $68 million to settle thousands of cases against women who say they suffered from blood clots and other serious events after using the Ortho Evra birth control patch. As a result, the company no longer actively markets the patch.

Bayer Healthcare has found itself in a similar mess with its biggest money-maker, Yaz, a birth control pill also known by the brand name Yasmin. Plaintiffs claim the hormone-plus-diuretic formulation is more dangerous than other oral contraceptives, causing life-threatening blood clots and gallbladder problems.

SOURCE: Yaz Lawsuit › Lawsuits claim Nuvaring is just as dangerous as Ortho Evra patch, Yaz

Bayer has an obvious vested interest in the outcome of that survey. The drug company makes one of the nation’s most popular oral contraceptives, Yaz. It is also known by the brand name Yasmin and the generic brand Ocella. Bayer has hit snags over the years marketing its blockbuster birth control pill.

First, the Food and Drug Administration (FDA) fined the drug maker and ordered they spend millions on a revamped advertising campaign after the agency deemed its Yaz commercials were misleading and were not being forthright about the drug’s life-threatening side effects.

Next came the lawsuits – an estimated 1,100 to date – from women who say they were not adequately warned of the dangers in taking Yaz. These women suffered from serious health problems including blood clots, heart attacks, kidney failure, gallbladder disease and seizures. Some complications resulted in death or disability.

Bayer’s response to the mounting lawsuits has been unwavering. The company contends it will “defend itself vigorously against these lawsuits.”

Source: Daily Record

SOURCE: Yaz Lawsuit › Bayer has vested interest in survey results

Swissmedic

Birth control pills that contain drospirenone include the brand names Yaz and Yasmin as well as the generic Ocella. Drospirenone is a diuretic that can cause an increase in potassium in the blood that can lead to blood clots, strokes and sudden cardiac death. The drug has also been linked to significant problems with the gallbladder.

The most important updates of the product labeling for prescribers and patients concerns the frequency of venous thromboembolism, the presentation of the warning symptoms of venous thromboembolism, and the increased risk of venous thromboembolism after restarting oral contraception following a break of at least four weeks.

Yaz, manufactured by Bayer Healthcare Pharmaceuticals, Inc., is the only birth control pill sold in the U.S. that contains drospirenone. It is still prescribed by doctors despite numerous reports of serious injuries by women who took the oral contraceptives.

Source: World Radio Switzerland

SOURCE: Yaz Lawsuit › Yaz, Yasmin to stay on Swiss market despite risk of serious injury

Bayer Schering Pharma

“Yasmin’s positive benefit/risk profile remains unchanged. Our wealth of post-marketing safety data includes more than 42 million women with years of drospirenone use, as well as two epidemiological studies involving more than 120,000 oral contraceptive users. We are convinced that Yasmin is a good choice for women seeking convenient and reliable contraception if they use the product as directed. Bayer will continue to provide information which will support health care providers and their patients in taking informed decisions about appropriate treatment choices,” said Kemal Malik, MD, Chief Medical Officer at Bayer Schering Pharma, in a press release issued by the drug company.

The news is hardly reassuring for the hundreds of women who have been injured by Bayer’s Yasmin who have filed lawsuits in both the United States and Canada. They contend that flashy advertisements from the company downplayed the serious side effects of the drug, and that its formulation with the added diuretic made women more susceptible to suffering gallbladder problems, blood clots and other serious ailments. After strict orders and a stiff penalty by the Food and Drug Administration, Bayer has since bankrolled another advertising campaign aimed at clarifying its approved usages and explaining the serious side effects it may cause.

SOURCE: Yaz Lawsuit › Yasmin birth control pill to receive label changes

Monica Dakin

The 23-year-old Canadian was prescribed the popular oral contraceptive Yaz last May to treat her ovarian cysts. She believed the low-dose hormone carried fewer side effects than other birth control pills. But soon after starting the medication, she was doubled over with abdominal pain. Dakin was hospitalized six times in the first six months before surgeons finally removed her gallbladder in an emergency procedure.

Yaz, also known by the brand name as Yasmin and the generic version Ocella, was touted by its maker Bayer Healthcare for treating premenstrual dysphoric disorder (PMDD), premenstrual syndrome (PMS), and acne. This new type of contraceptive contains an added ingredient, a diuretic known as drospirenone. Dakin contends the diuretic caused the significant problems with her gallbladder and that she was never warned by Bayer that taking the pill could make her sick.

Dakin is one of hundreds of Canadian women suing Bayer Healthcare claiming they suffered severe adverse effects because of the popular birth control pill. The list of injuries includes everything from gallbladder problems to blood clots and even deaths. The lawsuits claim Yaz is more dangerous than other oral contraceptives and that Bayer knew this but failed to adequately warn consumers.

Dakin told Canadian news site HERE that the medical problems caused by Yaz have “ruined a year of my life.” Due to graduate from college in just a few months, she says she will have to sit out the ceremony because her illness set her too far behind.

SOURCE: Yaz Lawsuit › Canadian woman blames Yaz for year-long illness

Schwoob was one of two million Canadian women in 2009 prescribed Bayer Pharmaceutical’s blockbuster oral contraceptive Yasmin, according to TheSpec.com. Yasmin is also sold under the brand name Yaz and the generic brand ocella. Three months after starting on the meds, Schwoob suffered the chest pains. She says she was never warned that by taking Yasmin, she was at greater risk of suffering blood clots and other serious health problems. She is now a vocal representative of a class action lawsuit against Bayer filed by women, like her, who have been harmed by Yasmin. Bayer also faces hundreds of similar lawsuits in the United States.

Schwoob’s lawsuit claims Yasmin and Yaz carry a four times greater risk of deep vein thrombosis and pulmonary embolism compared to other contraceptives, yet the company failed to adequately warn the public of those risks. Bayer contests that notion, arguing that its birth control pills are safe and effective.

The class action lawsuit seeks damages of $500,000 for every woman who was prescribed Yasmin, as well as $20 million in punitive damages.

SOURCE: Yaz Lawsuit › Canadian women sue makers of Yasmin over health problems

Thanos is one of hundreds of women who have filed suit against Bayer, the makers of Yasmin, also known as Yaz and by the generic brand ocella. As the advertisements for the oral contraceptive say, Yasmin is a different type of birth control pill. The medication combines ethinyl estradiol with the diuretic drospirenone. The diuretic is considered the culprit, raising potassium levels in users’ blood, which can cause blood clots that can result in sudden cardiac death or pulmonary embolism or strokes. Diuretics also can cause significant problems with the gallbladder, leading to gallbladder removal.

But the advertisements for Yasmin focused on overstating the drug’s benefits as a treatment for premenstrual syndrome and acne control, and understating the serious risks associated with use of the drug. As a result, the FDA penalized Bayer, ordering it to spend $20 million on ads to clarify its use and the risks associated. The hundreds of plaintiffs in lawsuits against Bayer say it was too little too late.

Bayer released a statement to the San Mateo County Times stating it will “defend itself vigorously against these lawsuits.”

SOURCE: Yaz Lawsuit › California woman says Yasmin caused gallbladder failure

DVT is a common disorder, but it is highly preventable, says Gary Raskob, Ph.D. and lead author of the AJPM Paper. “That’s why spreading the word about who’s at risk and the steps one can take to prevent these dangerous clots is so important,” he said.

The paper recommends strengthening surveillance of DVT and PE, and increasing public awareness of risk factors through a national campaign. For example, recent studies have identified that people who travel by airplane are at three times greater risk of developing DVT or PE. The campaign would advise air travelers to reduce their risk by staying active on the plane and staying hydrated by drinking plenty of water and avoiding alcoholic beverages.

Other risk factors include surgery or trauma, hospitalization for medical illness, cancer, obesity, smoking, pregnancy, age over 60, and a family history of blood clots. Oral contraceptives can also put users at greater risk of blood clots. To date, 59 deaths have been linked to the popular birth control pill, Yaz, also known as Yasmin or Ocella.

Symptoms of DVT include sudden pain, swelling and tenderness. PE symptoms include chest pain, shortness of breath, and sweating. For more information about these blood clotting disorders, visit the American Society of Hematology Web site at www.BloodTheVitalConnection.org.

SOURCE: Yaz Lawsuit › Medical community wants to raise awareness of preventable blood clots

The gallbladder’s sole function is to store bile, a dark green to yellowish brown fluid produced by the liver to aid in the digestion of fats in the small intestine. When the gallbladder becomes diseased, it can become inflamed and produce gallstones. A gallbladder attack occurs when the stones block the flow of bile. These attacks can cause excruciating pain and oftentimes the only remedy is to have the gallbladder removed.

Common contributing factors include weight gain or loss, hypothyroidism or thyroid disease, high cholesterol, alcohol intake, family history of gallbladder disease, and diabetes. However, use of estrogen and birth control pills are also considered risk factors as estrogen increases the concentration of cholesterol in the bile.

Gallbladder disease is one of the many serious adverse events reported with use of one particular brand of birth control pill, Yaz, also known as Yasmin and Ocela. An estimated 1,100 lawsuits have been filed against Bayer, the makers of Yaz, by women who say the birth control pill caused them to develop gallbladder disease, blood clots, seizures, cardiac arrhythmias, heart attacks, or strokes. As many as 59 deaths to date have been linked to Yaz.

SOURCE: Yaz Lawsuit › Birth control pill Yaz linked to gallbladder disease

Yaz, also known by the brand name Yasmin and the generic brand Ocella, is Bayer’s top-selling oral contraceptive and one of the most popular choices among women and doctors for birth control. Last year, the company raked in more than a billion dollars from the sale of Yaz. The pill is different from other birth control pills because it contains a diuretic, drospirenone, that can raise the potassium in blood to dangerous levels and cause to blood clots that can lead to sudden cardiac death, pulmonary embolism or strokes.

The lawsuits allege that Bayer didn’t do enough to warn women about the serious health risks to women who take Yaz. Even the Food and Drug Administration (FDA) cracked down on the drug company, saying advertisements for the birth control pill were overstating its benefits and understating the risks involved. Yaz commercials touted added benefits such as treatment for symptoms of premenstrual syndrome and acne. Since the FDA crackdown, Yaz was forced to run a series of ads clarifying the use of Yaz and clearly stating the dangers of taking the drug.

Victims say it’s too little, too late.

Bayer’s 2009 annual report does not specify how many women have died from the drug, but the FDA puts the count as high as 59.

SOURCE: Yaz Lawsuit › Bayer facing more than 1,100 lawsuits from women injured by Yaz

Vicki Parsons

What Vicki didn’t know was that the Food and Drug Administration had linked more than 50 deaths to the use of Yaz, and that blood clots, stroke and other serious complications had been associated with the contraceptive.

Yaz, also known as Yasmin and the generic Ocella, are the only birth control pill that contains drospirenone, a diuretic. While it helps to flush out excess fluid in the body, it can cause a build up of potassium in the blood, which can cause heart rhythm disturbances that can lead to blood clots that can cause sudden cardiac death, pulmonary embolism or strokes.

Vicki is now one of numerous women who are suing Bayer Pharmaceuticals claiming they were not sufficiently warned by the drug company of the dangers of taking Yaz. Yaz denies the claim. “The company is in the process of gathering information on these cases, but the complaints we have review so far pertain to side effects that are warned about in the labeling of all oral contraceptives,” according to a statement Bayer gave to WERG-TV.

SOURCE: Yaz Lawsuit › Woman says Yaz caused blood clots that nearly killed her

Yaz, also known by the brand name Yasmin and the generic brand Ocella, is a different type of oral contraceptive that combines ethinyl estradiol with the diuretic drospirenone. Some health professionals say that the addition of drospirenone in birth control raised the potassium level in users’ blood. This increase in potassium can lead to hyperkalemia and cause heart rhythm disturbances that can cause blood clots that can cause sudden cardiac death or pulmonary embolism or strokes. At least 50 women and their family members have filed suit against the Bayer claiming the drug manufacturer knew of the potential risks but did not properly warn women.

Bayer has argued that it sufficiently warned women that Yaz, like all birth control pills, carries a risk of life-threatening side effects.

Last year, Bayer, after getting its hand slapped by the Food and Drug Administration (FDA), shelled out $20 million to air advertisements to clarify the drug’s use. The FDA argued the company’s previous ads misled consumers by broadening the drug’s indication. The commercials promoted Yaz as a treatment for PMS, a condition for which it was not indicated, and acne, a condition in which Yaz has a limited indication. The FDA also said that the drug’s risk information was not stated clearly and was clouded with distracting visuals, background music and other “competing modalities.”

Meanwhile, Yaz remains on the market and continues to rake in money for Bayer. Yaz scored $9 billion in the first nine months of 2009, a sizable increase over the $600 million it made in 2008.

SOURCE: Yaz Lawsuit › Bayer pockets billions from dangerous birth control pill Yaz

The Tennessee Tech student had been taking the drug for about six months when she suddenly passed out in the shower. Her roommate called 911, and when Leah briefly regained consciousness, her roommate got her mother, Traci, on the phone. “Leah told me that she was scared, and that she was tingling all over,” Traci tells WREG-TV. “I told her it was going to be OK, that me and daddy was coming.”

But they arrived too late. Leah died less than an hour after she collapsed. Doctors say what killed her was a blood clot in her lung, also known as a pulmonary embolism. “How does this happen to a healthy 20-year-old lady?” Traci asks. The answer may be in the birth control pill she was taking.

The diuretic drospirenone that is in Yaz can cause an increase in potassium levels in the blood, which can lead to hyperkalemia, a condition that causes heart rhythm disturbances that can cause blood clots that can trigger cardiac death or pulmonary embolism or strokes. Diuretics also can cause significant problems with the gallbladder, leading to gallbladder removal.

The Mayfields have joined at least 50 other women injured by Yaz and filed a lawsuit against Bayer. The lawsuit alleges that the drug maker ignored the increased risks of Yaz and kept it on the market to enjoy mounting profits. Now Traci wants to warn others of the dangers of Yaz.

“(Leah) didn’t have to die,” Traci says. “She didn’t have to die because of a pill.

SOURCE: Yaz Lawsuit › Mother warns others of the dangers of Yaz

But a group of 50 women in Indianapolis say Bayer is wrong. They are the latest victims to file lawsuits against the drug company, alleging the new formulation of birth control pills caused heart attacks, strokes, blood clots and other health problems.

Yaz and Yasmin, also known by the generic brand Ocella, is as the company’s ads claim – different than other birth control pills. Bayer’s top-selling contraceptive drugs contain ethinyl estradiol plus drospirenone. Drospirenone is a diuretic, which the lawsuits argue can lead to dangerously high levels of potassium, which can lead to hyperkalema. Hyperkalema is a condition that can cause heart rhythm disturbances, which can trigger blood clots and sudden cardiac death or pulmonary embolism or strokes.

The lawsuits allege that Yaz and Yasmin are more aggressive than other oral contraceptives and have left plaintiffs with blood clots and pulmonary embolisms in their legs and lungs. Many had to have their gallbladders removed. Others suffered strokes.

Yet, Bayer, which reaped more than $600 million in sales in 2008, says it is not at fault. “The complaints we have reviewed so far pertain to side effects that are warned about in the labeling of all oral contraceptives, including ours,” according to a statement from Bayer spokeswoman Rose Talarie.

Sources:
UPI
Fox59
Indy Star

SOURCE: Yaz Lawsuit › Bayer claims no fault in Yaz, Yasmin injuries, deaths

What the Food and Drug Administration (FDA) wanted Bayer to clarify are what the agency considers misleading statements about the drug’s ability to improve women’s moods and clear up acne while downplaying the drug’s potential health risks. Yaz, also known as Yasmin or the generic Ocella, is currently being blamed for increasing women’s risk of serious adverse events such as heart attack, stroke, pulmonary embolism and death.

The warning the FDA issued to Bayer is one of 41 enforcement notices sent to drug companies by the agency’s Division of Drug Marketing, Advertising and Communication (DDMAC) in 2009. The company issued 21 in 2008. DDMAC head Thomas Abrams says the increased number of warning letters is a direct result of FDA chief Dr. Margaret Hamburg’s pledge to crack down on makers of drugs and medical devices for questionable promotional messages.

“We’re trying to get the point across to industry that we want them to comply with the law because it affects public health,” Abrams said. “If you don’t comply with the law, we are going to take action. We are not going to tolerate having consumers or health care professionals misled.”

As part of a settlement on the charges of deceptive consumer advertising, Bayer agreed to run the clarification ads, and for the next six years submit all ads for Yaz to the FDA for screening before they appear.

Sources:
New York Times
Reuters

SOURCE: Yaz Lawsuit › FDA cracks down on deceptive advertising of drugs

Even the commercials for Yaz point out that it is a different type of birth control pill, specially designed to treat premenstrual dysphoric disorder (PMDD), a severe form of PMS, as well as moderate acne. Yaz is the only birth control pill to contain drospirenone, a diuretic that can increase potassium levels in the blood and lead to serious health problems such as heart attack, cardiac arrhythmias, stroke, pulmonary embolism, blood clots, kidney failure, seizures, deep vein thrombosis, gallbladder disease, hepaic adenomas and sudden death.

Nearly 30 percent of women who take oral contraceptives take Yaz or Yasmin. Bayer claims that the oral contraceptives are safe, but that women with a family history of blood clots shouldn’t take them. The company also claims that the drugs’ labels warn consumers of the possible risks.

But the women who suffered from serious adverse events after using Yaz say the warnings were not adequate enough. An attorney representing some of the women injured by Yaz says he expects the lawsuits to become part of a class-action lawsuit that could take years to litigate.

SOURCE: Yaz Lawsuit › Indiana women sue makers of Yaz after suffering serious side effects

What Adrienne didn’t know was that while the combination birth control pill had benefits, it also increased users’ risk of serious side effects such as heart attack, cardiac arrhythmias, stroke, pulmonary embolism, blood clots, kidney failure, seizures, deep vein thrombosis, gallbladder disease, hepaic adenomas and sudden death. Adrienne believes Ocella caused her to suffer from a stroke and other serious side effects. She claims it also left her at an increased risk of developing additional side effects such as blood clots in the deep veins and lungs.

On December 28, 2009, Adrienne and her husband Kenneth, filed a lawsuit against Bayer HealthCare, the manufacturer of Yaz, and other manufacturers and distributors, seeking $75,000 from each defendant, as well as punitive damages and compensation for medical care, pain, suffering, and mental anguish.

Adrienne’s lawsuit is one of hundreds from women who say they have suffered serious side effects from Yaz, Yasmin and Ocella. The Food and Drug Administration (FDA) reports that between 2004 and 2008, more than 50 deaths have been attributed to the drugs.

SOURCE: Yaz Lawsuit › Woman claims Yaz/Yasmin/Ocella caused her stroke

Yaz incorporates a unique progestin, drospirenone, with ethinyl estradiol, a more common ingredient used in birth control drugs. Many women who have been injured after starting a Yaz regimen allege that the drug poses a multitude of serious risks, which Bayer downplayed in its Yaz marketing campaigns.

The U.S. Food and Drug Administration admonished Bayer in October 2008, citing the company for “significant deviations” in its promotion of Yaz. The complaint largely centered on the understatement of the drug’s risks and the overstatement of its benefits, including the treatment of conditions for which the drug was not approved. The misleading marketing campaign is frequently cited in lawsuits brought against Bayer by former Yaz users.

Some of the most serious side effects associated with Yaz include stroke, heart arrhythmia cardiac arrest, deep vein thrombosis and other forms of blood clotting, pulmonary embolism, gallbladder disease, kidney damage or failure, and sudden death.

Judge Herndon told Southwestern Illinois’ Belleville News-Democrat that he may also conduct bellwether trials, a cluster of cases selected because they reflect the charges and allegations of the other lawsuits. The outcome of bellwether trials helps establish guidelines for other cases.

When a significant number of similar lawsuits, such as those being brought against Bayer over Yaz injuries, accumulate in federal courts, the Judicial Panel on Multidistrict Litigation normally moves to consolidate them in one U.S. District Court to avoid redundant efforts and inconsistent pre-trial rulings. The dynamics of these representative trials will then be considered in the evaluation of other cases.

SOURCE: Yaz Lawsuit › Southern Illinois district court to handle Yaz lawsuits

The plaintiff, who resides in Belpre, Ohio, had been taking Yaz for about a year when she developed deep vein thrombosis in her leg. She spent three days in the hospital, where like many other women who use Yaz, she was put on a regimen of blood thinners to dissolve the clot and reduce the swelling in her leg.

Deep vein thrombosis (DVT) is a very serious type of blood clot that can lead to serious complications and death if not treated properly. Clots that form a DVT can become dislodged, traveling through the bloodstream to the lungs and causing a pulmonary embolism, resulting in permanent damage to the lung. DVT can also cause stroke, cardiac arrest, and other potentially deadly conditions.

Yaz contains drospirenone, a synthetic progestin used in Yaz, Yasmin, and Ocella, which is a generic form of Yasmin. Drospirenone has been shown to increase potassium levels in some women who take the drug, which can lead to DVT and affect the function of several organs, including the heart.

The Ohio plaintiff’s lawsuit was filed in New Jersey Superior Court. The suit alleges that the plaintiff’s injuries were the result of Bayer’s failure to adequately warn consumers of the drug’s risks. Her attorney claims that Bayer knew Yaz to be more dangerous than other birth-control pills, but chose to downplay the drug’s hazards.

SOURCE: Yaz Lawsuit › Ohio mother sues Bayer, alleging Yaz caused blood clot