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

Bayer

The claim was made by former FDA commissioner David Kessler, who claimed Bayer did not include an analysis that demonstrated an increase in the U.S. reporting rate for blood clots in a 2004 review of Yasmin’s safety to the federal agency. The report also didn’t include an earlier draft opinion by Bayer researchers that identified a difference in blood clot rates for Yasmin compared to other oral contraceptives. Instead, he claimed Bayer chose to market Yasmin for the treatment of premenstrual syndrome, a condition for which the drug was not approved.

The report was part of an expert panel’s analysis of data that suggested that Yasmin and other birth control pills containing the hormone drospirenone put women at greater risk for life threatening blood clots than older oral contraceptives. Other pills that contain drospirenone include Bayer’s Yaz, Beyaz and Safyral. Generic varieties are also marketed in the United States.

Bayer is currently embroiled in thousands of lawsuits from women who say they were not adequately warned that using drospirenone-containing birth control pills could put them at risk for blood clots, heart attacks, strokes and even death. The drug company has insisted its birth control pills are no more as dangerous as other oral contraceptives.

The expert panel pored over data for nine hours, eventually voting to recommend that the FDA place stronger warnings for the risk of blood clots on the drug’s packaging. The agency is not required to follow the advice of its expert panels, but it usually does.

Source: Bloomberg

SOURCE: Yaz Lawsuit › Report: Bayer withheld data on blood clot risk with Yasmin

While the new Health and Human Services guidelines will make contraception affordable for all insured women, it also raises the importance for women to understand the risks and benefits of using birth control. Pharmaceutical companies use advertising to promote the benefit of their drugs, and the Food and Drug Administration (FDA) requires those advertisements to include possible side effects.

This consumer-targeted marketing has resulted in patients asking their doctors for specific drugs by name. The tactic worked such wonders for Bayer when it launched its birth control pill Yaz that the pill became the most prescribed oral contraceptive in the county.

Unfortunately, the drug company was cited for running ads that overstated the benefits of Yaz and didn’t clearly explain the possible life threatening risks associated with the pills. Bayer was ordered to rerun a series of ads explaining that, like all forms of birth control, Yaz puts women at slight risk for blood clots that can lead to heart attack, stroke, and death.

As the top-selling birth control pill in the country, Yaz was also creating another stir. An unusually high number of blood clots in women who were using the pills were being reported, which lead researchers to conduct a study comparing the hormones in Yaz to those in older generation birth control pills. They found that Yaz put women at greater risk of developing blood clots.

The study has prompted the FDA to conduct an ongoing review of data. The agency says it will offer a recommendation once all information has been reviewed.

Source: CNN

SOURCE: Yaz Lawsuit › Birth control soon to be free to all insured women

Perhaps another attractive feature of IUDs and implants is that they may offer women a safer alternative to birth control pills. Most forms of birth control that use hormones carry a risk for blood clots, which can be life threatening. Birth control pills have blood clot warnings on their safety packaging. Recently, the Food and Drug Administration (FDA) issued a new warning that oral contraceptives containing drospirenone, such as the popular Yaz and Yasmin, may put women at even greater risk for blood clots, which can lead to heart attack, stroke and sudden death.

Studies have shown that Yaz and Yasmin are most popular among young women. However, the new study on contraceptive methods showed the biggest gains in recent years were among women younger than 24 and older than 35, as well as women in higher income brackets. Women who have already given birth were also more likely to choose IUDs and implants over birth control pills.

Source: Los Angeles Times

SOURCE: Yaz Lawsuit › More women choosing IUDs and implants over birth control pills

Most women who become pregnant are typically tested for gestational diabetes by their obstetricians. It is caused by high blood sugar (glucose) levels. Most women with gestational diabetes are able to control their blood sugar and avoid harm to themselves or their baby. Once the baby is delivered, the mother’s blood sugar usually goes back to normal. But these women are at risk for developing type 2 diabetes within five to 10 years of delivery. The new study suggests these women are at an even greater risk if they take the mini pill following pregnancy.

On a more positive note, another recent study found that women on mini-pills are at no greater risk for developing heart disease compared to women who were not taking oral contraceptives. The mini pills are also less likely to cause blood clots than the traditional estrogen-plus-progestin pills.

Some studies suggest that specific types of combination birth control pills, such as Yaz, which combines ethinyl estradiol and drospirenone, put women at an even greater risk for blood clots. To date, more than 2,000 lawsuits have been filed against Bayer, the makers of Yaz, from women who say they suffered heart attacks, strokes, blood clots and even gallbladder damage after taking Yaz.

SOURCE: Yaz Lawsuit › Mini pills may increase chances of developing type 2 diabetes

Chairman Andreas Fibig told reporters at a press conference in Sao Paulo that the company’s strong market position in Brazil, paired with new products that will be introduced to the Latin American market in the months and years to come will help drive that anticipated growth. Bayer is planning to introduce at least five new drugs in Brazil this year, including birth control pills, hypertension treatment, and a drug to treat erectile dysfunction.

Bayer’s birth control pill Yaz took off with a bang in the United States. Fronted by a strong marketing campaign that touted the pills as a cure-all for everything from acne to irritability, the drug soon became the No. 1 selling oral contraceptive in America with many women asking their doctors for it by name. But it wasn’t long before the Food and Drug Administration (FDA) cracked down on Bayer, saying the pricey ad campaign overstated the drug’s benefits and downplayed its risks. Bayer was ordered to run new ads that clearly warned women that the pill could cause life threatening blood clots.

But it was too little, too late. By then, thousands of women had already been sickened or had died from blood clots, heart attacks, strokes, and even gallbladder damage. The bad press led to a severe drop in Yaz sales, taking a bite out of the company’s profits.

Bayer currently faces more than 2,000 lawsuits from women who say they were not adequately warned that Yaz could make them seriously ill.

SOURCE: Yaz Lawsuit › Bayer targets Brazil for future sales of birth control pills

Yaz is considered a fourth-generation birth control pill and contains a combination of hormones known as ethinyl estradiol and drospirenone. Drospirenone also works as a diuretic.

Since Bayer Healthcare introduced Yaz to the market in the early 2000s, the company has launched three other birth control bills with similar formulations. The pills have become a favorite among young American and Canadian women, thanks to a massive marketing campaign claiming the pills help fight the symptoms of premenstrual syndrome and clear up acne.

The ads also effectively downplayed the serious side effects associated with the drug, which include blood clots, pulmonary embolism, deep vein thrombosis, heart attack, stroke and gallbladder damage. Soon after the commercials hit the airwaves, the Food and Drug Administration (FDA) ordered Bayer to rerun ads clearly stating the serious side effects that the drugs could cause.

Some experts question the use of drospirenone in the pills, claiming the diuretic can cause a condition that leads to irregular heart rhythms. Those arrhythmias can cause serious health problems, including blood clots, heart attacks and strokes.

The revision ads from Bayer came too late for thousands of women, including Amie and Lauren. Both women have joined the more than 2,000 other women who claim they were injured by Yaz and filed a lawsuit against Bayer.

SOURCE: Yaz Lawsuit › Deceptive ads lead to two more lawsuits against makers of Yaz

Carole Ann wasn’t the only woman swayed by the playful advertisements – Yaz soon became the best selling birth control pill in the nation. However, Carole Ann found out the hard way that women like her were being fooled by Bayer Healthcare, the makers of Yaz. She suffered a blood clot in her lungs, known as a pulmonary embolism.

Soon after the ads began, the Food and Drug Administration (FDA) slapped Bayer Healthcare with heavy fines and ordered the company to run a series of retraction ads that clearly stated the benefits of the pills as well as the risks involved.

“You may have seen some Yaz commercials recently that were not clear,” the revised ads say. “The FDA wants us to correct a few points in those ads.” Those corrections specify that the pills are not approved to tackle symptoms of PMS, but rather premenstrual dysphoric disorder, or PMDD, a condition with severe emotional and physical premenstrual symptoms. The ads also more clearly reported serious side effects, including blood clot conditions such as pulmonary embolism and deep vein thrombosis, heart attacks, stroke, and gallbladder damage.

The revision ads came too late for Carole Ann. She took the pills and suffered a life-threatening blood clot in her lungs. Carole Ann is one of thousands of women in the United States and Canada who has filed a lawsuit against Bayer Healthcare alleging that the pharmaceutical company did not adequately warn her of the dangers of taking the pill. She claims she would not have taken the pill had she known of the dangers. She is seeking compensatory and punitive damages including economic damages, economic damages and medical expenses, attorney’s fees, costs and other relief.

SOURCE: Yaz Lawsuit › NJ woman files lawsuit against makers of Yaz birth control

Let’s take a closer look at these “four sisters” of Bayer oral contraceptives:

• Yaz is a combination birth control pill containing the hormones drospirenone (3 mg) and ethinyl estradiol (20 mcg). Drospirenone also works as a diuretic. It was the first birth control pill approved to treat premenstrual dysphoric disorder (PMDD), a condition with severe emotional and physical premenstrual symptoms. It is also used to treat moderate acne.
• Yasmin is a similar formulation as Yaz but contains 3 mg drospirenone and 30 mcg of ethinyl estradiol. Yasmin is only approved for the prevention of pregnancy and not for treating the symptoms of PMDD nor the treatment of moderate acne.
• Beyaz was approved for sale in the United States in September 2010 and is essentially identical to Yaz but was the first birth control pill to include folic acid. Folic acid is the B vitamin that has been shown in pregnant women to reduce the occurrence of brain and spinal cord defects in their children if taken before and during the first three months of pregnancy. Like Yaz, Beyaz is approved for use as a form of birth control, for the treatment of PMDD symptoms, and for the treatment of moderate acne.
• Safyral is Bayer’s folate-added version of Yasmin. Formulated with the same types and doses of active ingredients as Yasmin, Safyral also adds folic acid as an added benefit.

All four Bayer birth control pills are surprisingly similar and, like Yaz, carry the same risk of serious health problems. While all oral contraceptives carry a risk of blood clots, heart attacks and strokes, some say Bayer’s pills put users at greater risk than other pills. An unusually large number of women who take Bayer’s pills have also reported gallbladder damage that in many cases has resulted in surgery to remove the gallbladder.

SOURCE: Yaz Lawsuit › Bayer’s ‘four sisters’ of birth control pills have same bad reputation

“SAFYRAL and Beyaz are part of Bayer’s growing women’s health franchise, and these new products reinforce our commitment to providing women with various contraceptive options,” said Leslie North, Vice President of Marketing, Women’s HealthCare, Bayer HealthCare Pharmaceuticals.

Bayer also offers the blockbuster birth control pills Yaz and Yasmin, both of which contain the diuretic drospirenone but no folic acid. The pills have come under fire in recent years because of mounting reports of serious side effects associated with the pills.

While all oral contraceptives put women at a slightly increased risk of developing blood clots, some studies show that the combination hormone with diuretic puts women at even greater risk. The pills also increase a woman’s risk of suffering from gallbladder problems that in many cases have resulted in surgery to remove the gallbladder.

Bayer faces thousands of lawsuits from women who have suffered serious health consequences – such as heart attacks, strokes, deep vein thrombosis, and gallbladder damage – while on Yaz and Yasmin. The company says that Beyaz and SAFYRAL have the same safety profile as Yaz and Yasmin.

SOURCE: Yaz Lawsuit › Bayer launches second birth control pill with folic acid

For the next three years, Katie took Yaz, but by the time she was ready to enter college, something changed. She felt constantly sick and spent much of her time in bed. “I didn’t go out. I didn’t see friends. I just laid in bed for the most part, and I was sick all the time,” she told KOKO News. “Eventually, I was vomiting bile.”

Doctors were baffled why such a healthy girl would turn so sick. They soon pinpointed the problem. Katie’s gallbladder was damaged. “I found out that my gallbladder function was at about 64 percent, and it should be between 98 and 100 percent,” she said. She was taken off Yaz and underwent surgery to remove her gallbladder.

Katie is one of thousands of women who are suing Bayer, makers of Yaz. They claim that the drug company was aware its top-selling pill was dangerous but failed to adequately warn women or their doctors of the risks. Bayer contends that Yaz carries the same risks as other oral contraceptives.

Just as the ads claimed, Yaz is different than other pills. It contains a diuretic that doctors say can raise potassium levels in the blood. This can cause the gallbladder to malfunction as well as cause blood clots that increase the risk of other serious problems such as heart attack and stroke.

As for those ads that sold women, like Katie, on the benefits of Yaz? Not long after they started running, the Food and Drug Administration (FDA) penalized Bayer, arguing that the ads for Yaz overstated the drug’s benefits and downplayed the risks. The company was ordered to run a series of ads clarifying its approved uses and clearly stating the risks, which include blood clots, heart attacks, strokes and gallbladder damage.

SOURCE: Yaz Lawsuit › Yaz likely cause of girl’s damaged gallbladder

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

But folic acid also offered other benefits, some experts claimed. Since folic acid lowers blood levels of the protein homocystine, which is linked to heart and blood vessel disease and other medical problems, some scientists suggested that the B vitamin could also lower the risk of heart disease, stroke or cancer.

However,  a new study published in the Oct. 11 issue of the Archives of Internal Medicine shows that even taken at high doses, folic acid supplements do not improve one’s risk of getting heart disease, a stroke or cancer.

To further complicate matters for Beyaz, the pill contains the same active ingredients as its sister product, Yaz – a hormone and a diuretic. Thus, Beyaz, like Yaz, is indicated not only for pregnancy prevention but also for the treatment of premenstrual dysphoric disorder (PMDD) and moderate acne. It also carries the same health risks, according to clinical studies conducted by Bayer.

Bayer contends that Yaz is no more harmful to women than other birth control pills, which carry a risk of life threatening blood clots. But more than 2,000 lawsuits by women who were seriously injured by Yaz beg to differ.

B vitamin-fortified or not, is Beyaz really a safe choice for women?

SOURCE: Yaz Lawsuit › New birth control pill contains folic acid, but is the B vitamin ‘all that’?

There are more than 2,000 women across the country who would tell Beth to get off the pills immediately. The women, like Gina Miller, suffered serious health problems such as heart attacks, strokes, blood clots and gallbladder problems after taking Yasmin and its similar oral contraceptive, Yaz. They have now filed suit against Bayer, makers of Yasmin and Yaz, claiming they were not adequately warned that the birth control pills they were taking could cause life-threatening health problems and death.

Bayer has done little to reassure women, arguing its pills are no more dangerous than other birth control pills. Some studies, however, suggest that there is a higher incidence of adverse events with Yasmin and Yaz than other oral contraceptives. The pills, and their generic equivalents, are the only ones sold in the U.S. that contain drospirenone, a diuretic, that can cause an increase in potassium levels in the blood, which can lead to heart rhythm disturbances that can cause blood clots and lead to sudden cardiac death, pulmonary embolism, DVT and other serious problems.

Doctors caution patients not to suddenly stop taking any medications, including birth control pills. However, the serious side effects associated with Yasmin would suggest women like Beth should definitely talk to their doctor as soon as possible about how to safely make a switch.

SOURCE: Yaz Lawsuit › ‘Should I still be on Yasmin?’

“My first symptoms were that my back was hurting,” Gina told WISH-TV. Her doctor diagnosed her with pneumonia. After treatment, she started running again, but she just couldn’t seem to get her stride back. “I was fatigued and short of breath,” she said. “I just didn’t feel like myself.”

Not long after that, Gina’s back pain came back and this time was so severe she was hospitalized. That’s when doctors discovered that Gina’s pain was caused by multiple pulmonary embolisms, or blood clots in her lungs.

How could such a young, healthy woman become so seriously ill? Doctors told Gina that her blood clots were likely caused by her birth control pills. Yaz, Gina soon discovered, had caused numerous women of all ages to suffer serious side effects from pulmonary embolism and deep vein thrombosis, to heart attack and stroke. Some women also reported gallbladder problems.

More than 2,000 women who became ill while taking Yaz and Bayer’s sister contraceptive, Yasmin, have filed suit against the drug maker claiming they were not adequately warned that taking Yaz or Yasmin could cause them serious illness and even sudden death.

Gina has filed a lawsuit against Bayer and is telling her story to warn other women of the dangers of Yaz and Yasmin. “I will be completely fine,” she said. “But for a lot of women, they weren’t so lucky.”

SOURCE: Yaz Lawsuit › CFO blames Yaz for her life-threatening blood clots

Watson Pharmaceuticals

Like Yasmin, Zarah is a combination of the diuretic drospirenone and the hormone ethinyl estradiol. While all birth control pills carry risks of blood clots and other serious injuries, some studies suggest that Yasmin and its sister contraceptive, Bayer’s Yaz, carry a greater risk than other pills. To date, more than 2,000 lawsuits have been filed against Bayer from women who claim they were harmed but not adequately warned by the drug company that by taking the pills they would be at greater risk of life threatening blood clots, strokes, heart attacks and even gallbladder problems.

The lawsuits don’t seem to sway drug makers from moving forward with generic versions of Yaz and Yasmin. Watson, too, is facing a lawsuit from Bayer, which claims  Zarah infringes on Bayer’s patent for Yasmin. The case is currently pending in the U.S. District Court for the Southern District of New York. Despite the lawsuit, Watson has begun shipping Zarah for distribution.

SOURCE: Yaz Lawsuit › Watson receives FDA approval for Zarah, generic version of Yasmin

Sure, the pharmaceutical company sells the top selling birth control pills in the nation – Yaz and Yasmin. The pills have earned the company a reported $1.5 billion in 2009 alone. Both Yaz and Yasmin contain drospirenone, a diuretic, which no other brand of oral contraceptive has. This special formulation, Bayer says, makes the pills an effective treatment for premenstrual dysphoric disorder (PMDD) and moderate acne. The company launched an advertising campaign for Yaz in 2007 and 2008 that resulted in skyrocketing sales.

It wasn’t long before the Food and Drug Administration (FDA) found those ads to be misleading. The agency accused Bayer of exaggerating the pills’ benefits and camouflaging the risks behind busy graphics. In February 2009, Bayer agreed to spend $20 million to run a series of corrective ads. They also agreed to submit future ads for the pills to the FDA for approval. But the damage had already been done. Thousands of women began suffering from blood clots, heart attacks and strokes, and soon after began filing lawsuits against Bayer saying they were not adequately warned of the risks.

Now, Bayer wants to assure us that they are a trusted source for women with questions about their contraception. I think I’ll leave the medical advice to my physician instead.

SOURCE: Yaz Lawsuit › Should you really trust Bayer for contraception advice?

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

“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

Now, Bayer has waged another fight against the rival drug company. Bayer filed suit against Teva claiming some information on Gianvi’s label was false. The drug’s safety label claimed the birth control pill contained the same technology as Yaz that extended its shelf life. According to Bayer, Teva will inform U.S. pharmacists on a weekly basis for three months about the corrected physician prescribing information on the label. Teva has already updated the information on its U.S. website and provided the Food and Drug Administration with the corrected information.

Yaz contains drospirenone and ethinyl estradiol that is enclosed within a beta-cyclodextrin (betadex) clathrate. A clathrate is a molecule that forms a “cage” around another molecule or molecules. The betadex clathrate in Yaz is a Bayer-patented technology that protects the enclosed ethinyl estradiol molecule and stabilizes the product against oxidation. This patented technology enhances the product’s shelf life.

Bayer also faces more than a thousand lawsuits from women who claim they have suffered serious injuries such as blood clots, strokes and gallbladder damage from Yaz but the drug’s safety label did not adequately warn them about the risks.

Yaz has earned Bayer more than $1.5 billion since 2009.

SOURCE: Yaz Lawsuit › Bayer, Teva rival birth control pills go head-to-head in court

Bayer has reason to want to protect its territory. Yaz, also known as Yasmin, brought in $782 million in sales in 2009, making it the top oral contraceptive in the nation. However, with popularity comes criticism. Bayer faces more than 1,100 lawsuits from women who allege that Yaz caused them to suffer serious health problems including heart attack, stroke, pulmonary embolism, blood clots, kidney failure, deep vein thrombosis, and gallbladder disease. Some fatalities have also been reported.

Yaz is marketed as an innovative new type of birth control pill containing drospirenone and ethinyl estradiol that not only serves as an effective contraceptive but also a proven treatment for premenstrual dysphoric disorder (PMDD) and severe acne. Drospirenone is a diuretic that can increase potassium levels in the blood and cause heart rhythm disturbances that can lead to blood clots and other serious problems.

The pills’ safety labels include a risk of potentially life threatening events, but women say Bayer downplayed those side effects even though it knew Yaz was just as, if not more, dangerous than other oral contraceptives. It is expected Gianvi will carry the same risks as its brand-name competitor.

Source: Globes

SOURCE: Yaz Lawsuit › Bayer sues Teva for prematurely marketing generic Yaz

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

“I’d been popping a drug every morning for years knowing only what my doctor had said: the Pill ‘regulated’ my periods. I had always backed it up with condoms. I had taken it through my teens when I wasn’t having sex. It was an unthinking habit. It took one last switch to another brand, an eye-opening two-month break, then six months back on the Pill to make me realize what it had been doing to my body and my mind throughout my adult life. I came to understand why I felt so very sick,” she writes in a recent column recognizing the Pill’s 50th anniversary.

Over the course of a decade, the writer took four different birth control pills, including Yasmin, a pill also marketed as Yaz in the United States and the UK. Made by Bayer HealthCare, the oral contraceptive has become one of the most widely used birth control pills in the world.

“I was taking the brand Yasmin, which I had requested from my doctor after reading in magazines about its amazing skin-clearing and weight-loss side effects. My sisters and many of my friends were also taking it. Yasmin was marketed aggressively in the US, and news of its supposed benefits spread quickly to young women in the UK. The New York Times recently described Yasmin as the ‘go-to drug brand for women,’ which has been sold as a ‘quality-of-life’ treatment,” Grigg-Spall wrote.

Last year, the Food and Drug Administration (FDA) penalized Bayer for overstating the benefits and covering up the risks of Yaz and Yasmin and ordered Bayer to produce commercials that clarified the uses and risks of the drugs. Bayer now faces more than 1,000 lawsuits from women who say they were harmed by the drugs but were not adequately warned of the risks involved. That information was enough to convince Grigg-Spall to look for other alternatives in contraception.

“The Pill is handed out to women with acne, PMS, irregular periods, heavy periods. The Pill has developed into a medication for the disease of being female. In place of changing society, society decided to fix women. On the 50th anniversary of the Pill we should stop celebrating the fictionalized revolution of the Sixties and turn our attention to the rebellion underway today. Young women are ditching the Pill in droves. They have come to see that the Pill can be harmful, as is the sugar coating used to make us swallow.”

SOURCE: Yaz Lawsuit › Columnist: 50th anniversary of The Pill nothing to celebrate

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

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

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

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

The plaintiff began taking Yaz after her gynecologist reassured her of the drug’s benefits and safety. After weeks of using Yaz, however, the woman began experiencing severe pain that sent her to the emergency room twice for general treatment and CT scans.

It took 13 hours for doctors to finally discover the problem. According to the Times, “In her left lung, the pulmonologist told her, was the largest blood clot they had ever seen and there were others in her right lung as well.”

The woman spent 6 days in the hospital as she was treated with 2 types of blood thinners to dissolve the clots in her lungs. Doctors expected a good recovery but told her that she might never be completely the same . Two weeks after the treatment, she told the Times that she is “incredibly tired most of the time.”

The plaintiff said that a couple of days after the treatment the severity of her situation suddenly hit her. “Wow, I almost died,” she told the Times. Now she strives to tell others about how Yaz affected her and has put the lives of so many other women in danger.

“It’s not just about women who are my age,” she told the Times, adding that lots of younger women are being seriously injured by the drug.

“There’s no reason for blood clots to be forming except for this pill and it’s a very scary situation,” she said.

Bayer has defended itself and Yaz against the allegations, pointing to the two Bayer-funded studies that showed the drug had a safety profile similar to other, more traditional oral contraceptives.

Another Yaz study, not funded by Bayer, found women who took Yaz to be more at risk for blood clots, heart attacks, and strokes. Those results were echoed by a more recent study published by the British Medical Journal in August.

SOURCE: Yaz Lawsuit › Recovering Maryland woman sues Bayer after Yaz nearly killed her

“She was short of breath. She was having severe chest pains and her face was changing colors,” Kraus told WTAE.

“She ended up going into cardiac arrest three times. One time it took 10 minutes to revive her. They eventually had to do emergency surgeries because they noticed there were two huge blood clots, one in each pulmonary artery,” Kraus said.

Kraus said that because of Yaz, her daughter now faces possibly lifelong struggles with pancreatitis, liver function problems, and acute kidney failure. Kraus and the other plaintiffs have requested a jury trial, more than $150,000 in compensation, attorney fees, court costs, and punitive damages.

Bayer Corporation, which is headquartered in Pittsburgh, defended itself from the allegations in a statement to WTAE.

“The complaints we have reviewed so far pertain to side effects that are warned about in the labeling of all contraceptives. Bayer will defend itself vigorously against these lawsuits,” a company spokesman said.

The lawsuit, however, alleges that Bayer grossly downplayed the risks of Yaz in its advertising campaigns and that the number of adverse events caused by Yaz is at least 10 times more than the number reported incidents, possibly 100 times more.

“I just don’t want anybody else to see their child go through anything like this ever again,” Kraus told WTAE.

Source: http://www.thepittsburghchannel.com/

SOURCE: Yaz Lawsuit › Mother says Yaz nearly killed her daughter

When customers go to Google’s search engine and perform a search for information on Yaz or “the pill,” they will see this simple new ad format appear in the search results. Some sponsored links will appear at the top of the results in a yellowish box. One of the links will lead to Bayer’s website for Yaz and will contain a gray-text notice: “Click to see full safety and prescribing information, including boxed warning.”

Why is Bayer using this new format for Yaz? Because the U.S. Food and Drug Administration has warned pharmaceutical companies about using the text promos for drug advertising since they do not contain any warnings or disclaimers to customers about possible side effects, health risks, and other drawbacks.

Bayer clashed with the FDA last year over its Yaz advertisements. The company aired a couple of television commercials titled “Not Gonna Take It” and “Balloons” that promoted the drug for unapproved uses, downplayed its risks and side effects, and used competing music and visual to draw the viewer’s attention away from the safety information. The FDA ordered the ads off the air and requested that Bayer spend a minimum of $20 million on a “corrective” ad campaign.

Other drug companies, anxious to promote their drugs through Google’s sponsored links without being called out by the FDA, will no doubt keep a watchful eye on the agency’s reaction to the new Yaz links.

SOURCE: Yaz Lawsuit › Bayer tests Google’s new ad format for Yaz promotion

Development of gall stones and gall bladder disease are among the serious risks associated with the oral contraceptive Yaz. The drug has also been blamed for elevating the risk of cardiac arrhythmias and heart attack, stroke, pulmonary embolism, blood clots, kidney failure, seizures, deep vein thrombosis, hepatic adenomas and sudden death.

According to the lawsuit, 50 deaths attributed to the use of Yaz and Yasmin were reported to the U.S. Food and Drug Administration between the first quarter of 2004 and the third quarter of 2008.

The lawsuit alleges that Bayer markets Yaz and Yasmin “as providing the same efficacy as other birth control pills in preventing pregnancy, but with additional benefits,” rather than the higher risks the drugs pose.

“The foreseeable risks of the product exceeded the benefits associated with its design or formulation. Or they were more dangerous than an ordinary consumer would expect,” the lawsuit states.

The plaintiff seeks compensatory and punitive damages, medical expenses and economic damages, and attorney’s fees. Because Bayer ran a deceptive ad campaign for Yaz, hailing the drug for uses unapproved by the FDA while downplaying its risks, the plaintiff also seeks an unspecified amount of punitive damages.

Source: http://www.chicagonow.com/

SOURCE: Yaz Lawsuit › Chicago woman sues Bayer over Yaz-related injuries

“Even though I’m old, I don’t want the horrifying side effects of aging to prevent me from doing what I love,” Haskins, who just turned 30, jokes. “I want to walk with canoes, peel oranges, play fetch with my pup, and do stuff with horses,” she says while a montage of images pulled from actual television drug ads plays. In one of the ads Haskins shows, anatomy takes the form of bouncing water balloons; in another, people are made of pipes. After all, cute, cartoon-like illustrations help lighten ads for drugs that pose very serious side effects for some people.

Amusing as Haskins’ Target episode is, it effectively illustrates just how outlandish and just plain silly some pharmaceutical advertising can be.

It’s also not the first time that Haskins has featured drug commercials on Target: Women. Last year, she spoofed big pharma television ads for birth control drugs, noting how they are touted as a way to have fewer periods more than anything else.

“Fewer periods! Yay! Now we don’t have to leave the tribe and go sit in that hut for a week. That was a bummer,” Haskins says.

Drugs developed for one thing but marketed as a treatment for something else is a common ruse employed by some pharmaceutical companies to make their products more enticing. Negative disclosures about the drugs, such as the legally required information about side effects, may be washed out with distracting music and visuals. That was how Bayer advertised Yaz last year, before the Food and Drug Administration cited the company for false and misleading advertising and ordered a redo.

“You may have seen some Yaz commercials recently that were not clear. The FDA wants us to correct a few points in those ads,” the presenter in the revised commercial says.

The Yaz advertisements spawned a number of video skits lampooning the drugmaker’s claims and the style in which they are presented: a group of girlfriends in a lively bar discussing side effects in a way that would never happen in real life. One woman, who says she “didn’t go to med school for nothing,” gives her friends an off the cuff and very clinical rundown of the drug’s risks while her friends listen intently.

Inserting herself into this scenario, Haskins asks “Does anyone think Stephanie is acting super weird right now?”

For all the risks attached to some blockbuster drugs, it’s good to see that the absurdity of drug advertising isn’t sliding by unnoticed.

SOURCE: Yaz Lawsuit › Comedian lampoons the absurdity of drug ads

The plaintiff claims that at the time, she was not aware the FDA had not approved Yaz for the treatment of skin conditions. In an extensive and aggressive marketing campaign, Bayer touted its birth control drug as an effective treatment for acne and symptoms associated with Premenstrual Syndrome (PMS) – conditions for which the FDA never tested or approved Yaz.

In October 2008, FDA officials warned Bayer that its Yaz ads intentionally mislead and confused viewers by overstating the drug’s effectiveness, overselling its benefits, and not adequately communicating the drug’s potential for serious side effects, including blood clots, cardiac arrest, and gallbladder disease. According to the FDA, the commercials used distracting visuals, multiple scene changes, and background music that effectively interfered with the audio presentation about the serious risks associated with the drug.

“Bayer promoted Yaz with the slogan ‘the difference a little chemistry can make,’” the plaintiff said. “What Bayer did not disclose was how negative that difference can be. Yaz gave me life-threatening injuries that have forever altered my life.”

After several months of Yaz therapy, the plaintiff developed an acute pain in her left shoulder and had difficulty breathing. A visit to the doctor revealed the plaintiff had developed blood clots in both her lungs. She was hospitalized immediately and treated successfully, but just one month later she developed gallstones and had to undergo surgery for their removal.

The plaintiff alleges that she “suffered months of anxiety and nausea related to (the) medical procedures and drugs given to treat the adverse side effects (she) developed from taking Yaz.”

The complaint charges that had Bayer properly warned patients about the dangers of using Yaz strictly as an acne treatment, the plaintiff could have avoided serious injury.

The lawsuit was filed in the Superior Court of New Jersey, where Bayer’s American operations are based. The plaintiff seeks an unspecified amount of compensatory damages.

SOURCE: Yaz Lawsuit › Injured by Yaz, SC nurse files lawsuit against Bayer

Pulmonary embolisms are blockages in one of the arteries leading to the lungs formed by a substance that has migrated through the bloodstream from another part of the body, commonly the legs. Clinical studies of Yaz conducted in Denmark and the Netherlands suggest a link between the Yaz ingredient drosperinone and a higher occurrence of blood clots than in women who took traditional contraceptives containing levonorgestrel.

A spokesperson for Bayer said that the company is cooperating with the investigation, but that it stood by the safety of its drug.

“A singular case, as tragic and sad as it is, does not indicate an increased risk for the whole group of women who take the pill,” Oliver Renner, a Bayer spokesman, told Bloomberg. “Studies have shown that the risk isn’t higher for Yaz than for other oral contraceptives.”

Of course, Bayer’s spokesperson dismisses the results of the two independent clinical trials and focuses on the more favorable outcome the Bayer-funded clinical test, which suggested the risks of Yaz were similar to those of traditional birth control therapies.

As the top selling oral contraceptive in the world, Yaz is big business for Bayer. The drug brought in $1.86 billion just in the first quarter of 2009.

SOURCE: Yaz Lawsuit › Switzerland investigates the death of young Yaz user

The New York Times recently published a report about the dangers frequently associated with Yaz and other oral contraceptives. The article observes that one Bayer-sponsored European study involving tens of thousands of women found no difference in the level of cardiovascular problems or death between women taking Yaz and women who took levonorgestrel, a much older progestin-based drug.

However, the results of two other studies conducted in Denmark and the Netherlands and published in the British Medical Journal last month, showed that women who took Yaz and other newer progestins had a higher risk of blood clots, which can adversely affect the heart.

One doctor quoted in the New York Times report theorized that Yaz and other newer forms of birth control may have a different affect in European populations versus the more racially diverse and genetically mixed American population.

However, Dr. Frits Rosendaal, a clinical epidemiologist at Leiden University Medical Center in the Netherlands, told the New York Times that patients taking Yaz should switch to birth control drugs containing levonorgestrel. “Even if the risk of thrombosis is low, why not choose the lowest risk, just in case?” he told the New York Times.

Both Bayer and the FDA are conducting ongoing studies designed to measure the safety risks of Yaz and Yasmin against drugs that do not contain drospirenone.

SOURCE: Yaz Lawsuit › Yaz health risks: better safe than sorry?

Earlier this year, the U.S. Food and Drug Administration sent a letter to Bayer Healthcare questioning the company’s ability to handle active pharmaceutical ingredients (API) testing. Bayer acknowledged the FDA’s concerns in an April response to the agency, but said that it had analyzed all relevant batches using its own testing standards and found that the quality of the U.S.-bound drugs was unaffected. Bayer stood by its quality control methods publicly as well.

Last month, the FDA sent another letter to Bayer, warning the company about “significant deviations” in its testing of key Yaz ingredients. “Your firm concluded that these … results were within the accepted variation of the analytical method and that the quality of these batches was not affected,” the FDA letter stated. “We disagree with your rationale and conclusion. An assay test is used to determine potency, not method variability.”

Rose Talarico, a spokeswoman for Bayer, told Reuters that the company was preparing a response to the FDA. “Based on our assessment at this point in time, we have identified no safety and efficacy impact on our products in relation to the [good manufacturing practice] issues as cited by the FDA,” she said.

The FDA warning to Bayer concerning its API testing wasn’t the first time the agency has found the company in violation of federal regulations. Last October, the FDA cited Bayer for false and misleading television advertisements that promoted Yaz for conditions for which it wasn’t approved, exaggerated its effectiveness, and downplayed the risks associated with the drug. FDA pressure prompted Bayer to launch another American ad campaign correcting the misrepresentations of the earlier ads.

Michael A. Santoro, an associate professor of ethics at the Rutgers Business School who studies pharmaceutical industry ethics, told the New York Times that the FDA warnings about quality control and advertising raise a red flag about Bayer’s attitude in complying with federal regulations. Santoro said that drug manufacturers ought to set higher standards for themselves than those established by the federal government.

“It tells me that [Bayer] is not understanding the business that it is in, that it is not understanding the health risks that it is posing to the public or the financial risk that it is creating for its shareholders,” Santoro told the New York Times.

His concerns seems to be bolstered by the growing number of Yaz lawsuits filed against Bayer in the U.S., which currently stand at 74. Some of the lawsuits have been filed by women allegedly harmed by Yaz who claim they were drawn to the drug because of Bayer’s misleading direct-to-consumer television ads.

SOURCE: Yaz Lawsuit › Yaz testing and marketing raises ethical red flag

All of the lawsuits allege that Yaz and Yasmin caused adverse events attributable to the ingredient drospirenone (DRSP), which has been linked to blood clots, strokes, heart attacks, gall bladder disease, deep vein thrombosis, pulmonary embolism, and other serious reactions, including sudden death. The suits assert that Bayer knew about the risks but failed to disclose them to consumers while at the same time aggressively marketing the drug.

Last year, the U.S. Food and Drug Administration warned Bayer that its television advertisements for Yaz were misleading and failed to disclose all of the drug’s risks.

Traditional birth control drugs do not contain DRSP, which is a new type of progestin that influences the body’s natural ability to balance salt and water, which could adversely lead to elevated potassium levels. Excessive potassium levels in the body may trigger fatal cardiac arrhythmia and other serious health problems.

The FDA received more than 50 reports of deaths linked to Yaz and Yasmin between 2004 and 2008. The fatalities involved heart attacks, pulmonary embolisms, and strokes. Excessive blood potassium levels were found in many of the cases.

A U.S. Judicial Panel on Multidistrict Litigation has scheduled a hearing for September 24 to decide if the Yaz and Yasmin lawsuits currently pending in federal courts are similar enough to be consolidated into an MDL (multi-district litigation).

SOURCE: Yaz Lawsuit › Yaz lawsuits consolidated in Pennsylvania

The “deviations,” as the FDA called them, were cited in a letter dated September 9th and sent to Dr. Franz-Josef Renneke, the Site Manager of Bayer’s plant in Bergkamen, Germany. The FDA published the letter on its website this week.

The FDA found that Bayer tested the quality of some drug ingredients, including drospirenone, a main ingredient in Yaz, using a method the U.S. does not accept. The method involves averaging a group of several samples, rather than providing test results for each ingredient batch. The U.S. requires foreign pharmaceutical manufacturers to conform to American standards when testing the quality of its U.S.-bound exports.

Earlier this year, the FDA warned Bayer that it exported ingredients to the U.S. between 2007 and 2009 yet failed to test them using U.S.-approved methods. Bayer responded in April that it had analyzed all relevant batches and concluded that their quality “was not affected.”

That’s beside the point, the FDA’s letter last week said.

“Your firm concluded that these … results were within the accepted variation of the analytical method and that the quality of these batches was not affected,” the FDA letter stated. “We disagree with your rationale and conclusion. An assay test is used to determine potency, not method variability.”

Yaz and Yasmin were Bayer HealthCare’s best-selling drugs last year, with sales reaching $1.8 billion worldwide.

The FDA has not discovered quality problems in the German imports and does not advise consumers taking Yaz to stop. The FDA’s warning is meant to prevent quality problems from occurring in the future.

According to the Associated Press, “The FDA regularly issues warning letters to companies that do not follow regulations for manufacturing and marketing. The letters are not legally binding, but the agency can take companies to court if they are ignored.”

SOURCE: Yaz Lawsuit › Yaz ingredient not properly tested, FDA warns Bayer

Yaz is a combination birth control pill containing drospirenone and ethinyl estradiol. It is marketed not only as a contraceptive pill, but as a treatment for premenstrual dysphoric disorder (PMDD), a condition with severe emotional and physical premenstrual symptoms, and as an effective treatment for moderate acne.

However, the FDA says the original television commercial implied Yaz could also treat Premenstrual Syndrome (PMS) and that it would keep a woman’s skin clear and/or treat more severe acne. Worse than this, the FDA says the commercials used distracting visuals, numerous scene changes, and competing background music that interfered with the audio presentation of the serious risks associated with the product.

“This is particularly troubling as some of the risks being conveyed are serious, even life-threatening,” the FDA letter states. The overall effect of the distractions adds up to “undermine the communication of important risk information, minimizing these risks and misleadingly suggesting that YAZ is safer than has been demonstrated by substantial evidence or substantial clinical experience.”

As a result of the FDA’s findings, the attorneys general of 27 states joined the federal agency in cracking down on misleading consumer advertising, and Bayer was required to create new ads to more clearly communicate the benefits and risks of its product, at a cost of $20 million.

But don’t feel too sorry for Bayer yet. Yaz is the best-selling oral contraceptive product in the United States, with sales in 2008 topping $600 million.

In the new campaign, a young woman seriously addresses the camera, while reminding viewers that they may have heard of Yaz on previous commercials, but that she’s here because “the FDA wants us to correct a few points in those ads.”

Source: New York Times

SOURCE: Yaz Lawsuit › Bayer creates new ad campaign for Yaz after FDA crackdown