Hillard’s apparent conflict of interest on the federal agency panel was noted by former FDA Commissioner Dr. David Kessler, who recently offered expert witness testimony as part of an ongoing class-action lawsuit against the pharmaceutical company claiming that Bayer over-promoted the benefits and understated the risks of Yaz. Kessler also said that Bayer had plans to talk with Hillard about the risk of blood clots.

Hillard was also featured in a 2010 Bayer Tactical Brief video designed “to illustrate patient counseling techniques on the safety of Yaz.”

Blood clots are potentially deadly medical problems that can lead to strokes, heart attacks or pulmonary embolism. All birth control pills carry a slight risk for blood clots, which is noted on the drugs’ safety packaging. However, recent studies show that pills containing the hormone drospirenone put women at greater risk for developing blood clots. Bayer’s Yaz and Yasmin contain drospirenone. Bayer also makes versions of the pills with folic acid, known by the brand names Beyaz and Sayfral. Generic versions are also available.

The recent studies prompted the FDA to undergo a review of the safety of drospirenone-containing pills. The agency’s advisory panel voted to recommend that stronger warnings be put on the pills’ packages. Hilliard and at least three other members of the 26-member panel were later found to have research or financial ties to Bayer or companies that make generic versions of the pills.

In light of panel members’ possible conflict of interest in the Yaz case, citizen watchdog group POGO (Project On Government Oversight) is calling for a revote.

Source: California Watch

SOURCE: Yaz Lawsuit › FDA panel member ‘well utilized’ by Yaz maker

The FDA panel was charged with reviewing studies that showed a newer generation of birth control pills containing the hormone drospirenone put women at greater risk for life threatening blood clots than other oral contraceptives with other hormones. Drospirenone-containing pills include Yaz and Yasmin, made by Bayer. The drug company also sells versions of the pills containing folic acid under the brand names Beyaz and Safyral. Generic versions are also available.

While all birth control pills carry a risk for blood clots, new studies have shown drospirenone-containing pills to be more dangerous. Blood clots are a serious and potentially deadly medical condition. If the clots break free, they can travel to the heart and cause heart attack, travel to the brain and cause stroke, or travel to the lungs and cause pulmonary embolism.

The FDA ordered a review of the pills based on these new studies. The panel fell short of recommending banning the pills, opting instead to put stronger warnings on the drug’s safety label.

Following the vote, POGO (Project on Government Oversight) discovered that three of the panel’s advisers had research or financial ties to Bayer. A fourth adviser had a connection to Teva Pharmaceuticals, maker of generic versions of the pills. All four of those advisers voted to keep the drugs on the market, noting that the benefits of the pills outweighed the risks.

“The American public must be able to trust that the FDA and its advisory committees are making decisions based on science, not industry influence,” POGO Executive Director Danielle Brian told Huffington Post. The organization argues that a revote on the panel’s recommendation is in the best interest of the consumer.

Source: Huffington Post

SOURCE: Yaz Lawsuit › Watchdog group pushes FDA panel to revote on Yaz safety

What he has yet to accomplish is the removal of the birth control pill Yaz. The newer generation oral contraceptive contains the hormone drospirenone, and recent studies show the pill may put women at even greater risk for developing deadly blood clots than pills with older hormones.

Blood clots can be deadly and can lead to serious complications such as heart attack, stroke and pulmonary embolism.

An FDA advisory panel recently reviewed the blood clot risk with drospirenone-containing pills and fell short of recommending the drug’s removal from the market. Instead, the panel supported placing stronger warnings on the pills’ packages. It was a tremendous disservice to the public, Wolfe asserts.

Bayer, maker of Yaz and its sister contraceptive Yasmin, launched advertising campaigns when the pills hit the market that made the birth control pills the top-selling brands in the country. The company has made billions on the sales of the pills. Yet, when questioned about mounting reports of serious injuries associated with the pills, Bayer continues to insist Yaz and Yasmin are no more dangerous than other birth control pills.

Bayer currently faces thousands of lawsuits from women who say they were not adequately warned by the drug company that the pills could make them seriously ill.

When the FDA panel voted last month whether to keep Yaz on the market, Wolfe had already waged a war against Yaz. In his “Worst Pills, Best Pills” newsletter, Yaz was listed as a “Do Not Use” drug. Instead of allowing Wolfe to stand up against the birth control pills, the committee pulled his right to vote, citing an “intellectual conflict of interest.”

Source: Salem-News

SOURCE: Yaz Lawsuit › FDA advisor warns ‘do not use’ Yaz, Yasmin

U.S. District Judge David Herndon ordered Bayer and lawyers for the defendant to meet with mediator Stephen Saltzburg, a Gerorge Washington University law professor, to explore a possible settlement.

Yaz and Yasmin are a newer generation of birth control pills that contain the hormone drospirenone. New studies have indicated that the pills may put women at greater risk for suffering blood clots than pills with older hormones. An advisory committee to the Food and Drug Administration (FDA) last month recommended that stronger warnings about the greater risk of blood clots be added to the drugs’ safety labels.

Blood clots are potentially life-threatening conditions. They can break free and travel through the bloodstream and lodge in the heart and cause heart attacks, in the brain and trigger a stroke, or in the lungs which can cause a pulmonary embolism. Thousands of women allege that Bayer did not adequately warn them that taking Yaz or Yasmin could be deadly.

Yaz and Yasmin became the top selling birth control pill in the United States, with $1.58 billion in sales in 2010 alone. Bayer issued a statement saying that while it continues to defend the litigation, the company is engaged in mediation and settlement discussion.

Source: Business Week

SOURCE: Yaz Lawsuit › First Yaz lawsuit ordered to mediation for potential settlement

By taking a vow of celibacy, nuns deny themselves pregnancy and lactation, which means they have more menstrual cycles. Statistically, women who have more periods tend to be at greater risk for breast, ovarian and uterine cancers.

Comparatively, women who have babies beginning at a young age, have several babies, and who breastfed are less likely to develop these cancers.

Further, the overall mortality rate among women who use birth control pills is 12 percent lower than those who have never been on oral contraception. Their risk of developing ovarian or endometrial cancers is also reduced by 50 to 60 percent.

While birth control pills may help prevent nuns from getting cancer, it could put them at risk for other deadly conditions, such as blood clots. All pills carry a slight risk for blood clots, but some, such as the top selling Yaz and Yasmin, put women at even greater risk for developing blood clots, which can lead to heart attacks, strokes, pulmonary embolisms, and even death.

Thus, researchers say, the risks for recommending oral contraceptives to nuns – or any woman – for the prevention of cancer should be weighed against the potential risks of developing other serious health conditions.

Source: Fox News

SOURCE: Yaz Lawsuit › Pros and cons of birth control pills for nuns

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

The Yasmin family of birth control pills include Yaz, Beyaz and Safyral. All of these “four sisters” of contraceptives contain a combination of the hormones drospirenone and ethinyl estradiol. The pills have come under fire in recent weeks after the Food and Drug Administration (FDA) announced that it was reviewing studies that linked drospirenone-containing pills to a greater risk for blood clots. Blood clots can cause heart attacks, strokes, pulmonary embolism, and even sudden death.

Following the announcement Friday that the European Patent Market had pulled the patent on Yasmin, Bayer released a statement: “A decision on possible next steps will be taken by the company after studying the reasons for the decision.”

While the patent revocation begins immediately, there is no word yet how soon competitors will seek to put copycat versions on the market.

Despite competition and bad press about Yaz and Yasmin lawsuits filed on behalf of women who have been injured by the pills, the drug company reported global annual sales of $1.1 billion in 2010.

Source: Reuters

SOURCE: Yaz Lawsuit › Bayer loses European patent for Yasmin

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

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

Blood clots can occur after some surgeries, when people travel long distances, or sit in cramped positions for long periods of time. It can also be caused by medications, especially birth control pills. Some oral contraceptives may carry a greater risk for blood clots. For example, Bayer, maker of the popular birth control pill Yaz, is facing more than 2,000 lawsuits from women who say the pills caused them to suffer blood clots that in some cases led to serious complications such as pulmonary embolism, heart attack and stroke.

At least 100,000 cases of pulmonary embolism occur in the United States each year, and it is the third most common cause of death in hospitalized patients. If left untreated, about one-third of victims die, which is why the National Heart Lung and Blood Institute urges the public to know the symptoms of pulmonary embolism. The most common ones include shortness of breath when not exerting yourself, chest pain and coughing up blood.

Often, the only symptoms are those associated with DVT, such as swelling of the leg or along the vein of the leg, pain or tenderness in the leg, a feeling of increased warmth in the area of the leg that is swollen and tender, and red or discolored skin on the affected leg. Other symptoms include excessive sweating, clammy or bluish skin, light-headedness, fast or irregular heartbeat, and weak pulse.

These symptoms should be considered serious, and anyone who experiences these should seek medical attention immediately.

SOURCE: Yaz Lawsuit › Tennis star’s blood clot scare helps raise awareness

The FDA does not regulate over-the-counter medications as it does prescription drugs, which raises safety concerns first and foremost. Birth control pills already carry risks that women should be aware of, including the formation of  blood clots. Women who smoke and those with a family history of blood clots are at an even greater risk for developing blood clots, which can lead to life threatening conditions such as heart attacks, strokes and pulmonary emboli.

There is also no word on which pills would be made available without prescription. Pills offer a variety of single or combination hormone options, and some even include diuretics or are fortified with vitamins. Some may put women at even greater risk for serious side effects, such as the blockbuster birth control Yaz, manufactured by Bayer. The company is currently facing more than 2,000 lawsuits from women who claim they were injured by Yaz.

The FDA says one of the biggest benefits to keeping oral contraception a prescribed product is that for many women getting a birth control prescription is the motivating factor in getting them to the doctor for their annual exam. If birth control pills suddenly became available over-the-counter, many woman may forego seeing their doctors altogether.

SOURCE: Yaz Lawsuit › DC considers making birth control pills available OTC

The study, published in the Journal of Clinical Endocrinology and Metabolism, included data from more than 1,800 women between the ages of 16 and 44 on birth control pills and summarizes six previous studies related to heart attack risk in women taking the so-called mini-pills. Brand name mini-pills include Micronor and Ovrette.

More women take the combined estrogen-and-progestin pills than the mini-pills, and that is where researchers say the results become more skewed. The combined pills carry an increased risk for blood clots, which can lead to heart attacks, strokes, pulmonary embolism (blood clot in the lungs), and deep vein thrombosis, all of which can be life threatening.

Some studies suggest that some varieties of combined oral contraceptives put women at greater risk for blood clots, such as Yaz, a fourth-generation pill that includes the hormones ethinyl estradiol and drospirenone.

Women who are high risk for heart disease, such as women who smoke or have high blood pressure or a family history of blood clots, may consider switching to progestin-only products, or going off birth control pills altogether.

SOURCE: Yaz Lawsuit › Mini-pill may be safer than combination birth control pills

Perhaps Lucy was fooled by the aggressive advertising campaign launched in early the 2000s by Bayer Healthcare, the makers of Yaz. The ads touted the birth control pill’s strengths, such as fighting irritability from premenstrual syndrome and clearing up troublesome acne, and downplayed the serious side effects associated with the drug. Those side effects include blood clots, such as pulmonary embolism and deep vein thrombosis, as well as heart attack, stroke, and gallbladder damage. The deceptive advertising for Yaz paid off for Bayer. The pills became the top selling oral contraceptive in America.

But soon Bayer couldn’t escape the bad press that was growing from reports of these serious side effects happening in women and in some cases resulting in death. Bayer, instead, claimed the pills were no more dangerous than other birth control pills. Meanwhile, the Food and Drug Administration (FDA) ordered Bayer to run a new set of ads for Yaz clearly stating the harm the drugs may cause. The information came too late for Lucy.

“I am at home right now with very low energy and barely able to care for my children. Ladies, it is not worth it. My children were almost without a mother. I am unable to take anything without hormones now for the rest of my life, not to mention the painful treatments and the prescriptions I have to use now,” Lucy warned. “Please do not risk your life!”

* Not her real name

SOURCE: Yaz Lawsuit › Doctors blame woman’s blood clots on Yaz birth control

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

Yaz was marketed heavily across the globe, making it one of the best selling birth control pills and earning it more than $600 in sales in 2008. It is a combination of the hormones drospirenone and ethinyl estradiol. Drospirenone also works as a diuretic. Yaz is also touted as a treatment for acne and PMDD.

Bayer also sells Yasmin, a birth control pill with the same combined hormones but in different doses.

In 2010, Bayer also launched two other oral contraceptives with the same formulation but with added folic acid, known by the brand names Beyaz and Safyral. All four pills are considered to have the same side effects.

Despite the mounting lawsuits, Bayer stands by its defense that Yaz and its sister pills are no more dangerous than other birth control pills. The women who have filed lawsuits against Bayer say that the notion that Yaz is safe is simply a hard pill to swallow.

SOURCE: Yaz Lawsuit › Blood clots a serious side effect of Yaz birth control pills

All oral contraceptives carry a slight risk for blood clots, which can lead to heart attack, stroke, deep vein thrombosis or pulmonary embolism. But two separate European studies that suggest Yaz and Yasmin, made by Bayer HealthCare, put users at greater risk for blood clots than other birth control pills.

The “fourth generation” pills were the first to contain two hormones, ethinyl estradiol and drospirenone, the latter active ingredient also acts as a diuretic. The Food and Drug Administration has since approved two other birth control pills with the same combination of hormones plus folic acid. Those pills are marketed as Bayaz and Safyral.

In an effort to quell public panic, the Society of Obstetricians and Gynaecologists of Canada issued a statement saying Bayer’s pills posed no greater risk than other birth control pills. But some medical experts say the European studies shouldn’t be dismissed. One of the studies, published last year in the British Medical Journal, showed a six times greater risk of blood clots in women using Yasmin versus other types of birth control pills.

The group cited a third study of nearly 60,00 users of various birth control pills, which showed no real difference in risk among the pills; however, that study was sponsored by Bayer, makers of Yaz and Yasmin. Critics say Bayer’s vested interest in the outcome of the study could have influenced the results.

SOURCE: Yaz Lawsuit › Yaz, Yasmin lawsuits could cause public panic, unwanted pregnancies

But the honeymoon would soon end for Bayer, as reports of potentially fatal side effects from Yaz and Yasmin began to surface. Bayer was also slapped by the Food and Drug Administration (FDA) with fines and ordered to spend millions on new ads to clarify its benefits (for example, the pills are approved for the treatment of premenstrual dysphoric disorder, PMDD, and not PMS) and clearly state the risk for side effects such as blood clots.

While Bayer contends that its pills are no more dangerous than other birth control pills, thousands of women have filed lawsuits against the company claiming the pills are far more dangerous than other pills and that Bayer failed to adequately warn them. Serious and life-threatening side effects associated with Yaz and Yasmin include blood clots, heart attacks, strokes, deep vein thrombosis, pulmonary embolism, and gallbladder damage.

Despite the reports of serious problems, Yaz and Yasmin remain on the market and are still being used by hundreds and thousands of women. Warn your friends and family members of the dangers associated with Yaz and Yasmin by using social media tools such as Facebook and Twitter. Your friends and followers may appreciate the warning.

SOURCE: Yaz Lawsuit › Alert your friends to the dangers of Yaz, Yasmin

The day before she died she was treated for a knee injury, but the injury wouldn’t have caused her death, her mother, Joan Cummins, told Lehigh Valley Life. “There’s just really no reason that a healthy young woman who had a knee injury would have developed this.” Cummins has another theory as to what caused her daughter’s death – her birth control pills. “She was on Yaz … for acne,” she said. “All you have to do is Google that and look at all the lawsuits.”

Now Cummins has joined thousands of other people affected by Yaz and filed a lawsuit of her own against Bayer Healthcare, the makers of Yaz. Cummins alleges that Bayer knew Yaz was more dangerous than other oral contraceptives and put women at greater risk for life-threatening blood clots but failed to adequately warn consumers. Bayer maintains that Yaz is no more dangerous than other birth control pills.

Last April, however, Bayer agreed to update the safety labels on Yaz and the birth control pill Yasmin to warn of “the relative risk of developing venous thrombosis.” Cummins said the warning is too little, too late. “(Michelle) was 18 years old, completely healthy, at college with the world at her fingertips,” she said. “Any medication we take, we’re so used to seeing may cause … all these side effects. You just think, ‘That won’t happen. My daughter will be fine…’”

SOURCE: Yaz Lawsuit › Mother sues Yaz maker for daughter’s untimely death

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

It’s the same question thousands of woman are asking after suffering serious health problems they say were caused by Yaz and Yasmine birth control pills. The pills are a unique formulation that combine a new hormone called ethinyl estradiol with the diuretic drospirenone. Bayer Healthcare, the company that produces the pills, claimed the formulation not only prevented unwanted pregnancies, but also helped curb symptoms of premenstrual dysphoric disorder (PMDD) and moderate acne.

However, experts say the diuretic causes an increase in potassium levels that can lead to blood clots, which puts women at an increased risk of heart attack, stroke, pulmonary embolism, deep vein thrombosis, and even death. More than 2,000 women have filed suit against Bayer claiming they were not adequately warned that taking Yaz or Yasmin put them at risk for serious and life threatening health problems.

“There are a bunch of people out there (who have fallen ill after taking Yaz),” Mollie writes. “Let’s hope we can find them and make other girls aware just how dangerous Yaz really is.”

SOURCE: Yaz Lawsuit › Yaz blood clot victim hopes to warn others

Instead of instant death, these blood clots slowly filled Jones’ lungs for an entire month before she started experiencing symptoms – difficulty breathing and pain in her side. Doctors said it was caused by her birth control pills and aggravated by a genetic blood disorder called factor V Leiden. “Factor V is hereditary and can be passed down from one or both parents,” she said. She first learned she had the condition while lying in the hospital bed fighting for her life.

All birth control pills carry a risk for blood clots, but some people argue that the one-time best-seller pills Yaz and Yasmin carry an even greater risk of serious side effects including pulmonary embolism, deep vein thrombosis, heart attack, stroke and even gallbladder problems. To date, more than 2,000 lawsuits have been filed against the makers of Yaz and Yasmin from women who say they were not adequately warned that by taking the pills their lives could be in danger.

“I’ve been given different reports from my doctors, but the truth is that there is a risk for getting blood clots from birth control pills,” Jones writes. “Those warning statements and fine lines after TV commercials are there for a reason. Blood clots can cause heart attacks, strokes, pulmonary embolisms, kidney problems and even death. I don’t have anything against birth control, but before going on it, be aware and recognize the possible side effects.”

SOURCE: Yaz Lawsuit › Woman blames birth control pills for nearly killing her

Birth control pills increase a woman’s risk of life-threatening blood clots, a condition obese women are already at greater risk for than normal-weight women. Birth control pills with higher estrogen levels put women at even greater risk for developing blood clots, which can lead to deep vein thrombosis, pulmonary embolism, heart attack, stroke and even death. Thus, prescribing high-dose birth control pills to obese women can be dangerous.

The clinical trial involved 226 normal-weight or obese women who were randomly assigned to take pills with either a lower or higher estrogen dosage. All women underwent blood tests to determine if they were using the pills consistently. After three or four cycles, the women received multiple ultrasounds and blood tests to determine if their ovaries were making eggs. About 90 percent of normal-weight women and 72 percent of obese women had hormone levels that indicated consistent use.

Of the remaining 150 women who used the oral contraceptives regularly, three out of the 96 normal weight women conceived compared to one out of the 54 obese women, leading researchers to determine that obese women were just as protected against unwanted pregnancies while on the pill as normal-weight women.

This fall, the National Institutes of Health will convene a group of experts to investigate whether further research is necessary on obesity and oral contraceptives. Meanwhile, the Food and Drug Administration plans to hear evidence that a new emergency contraceptive pill is less effective in obese women.

SOURCE: Yaz Lawsuit › Study: Birth control pills just as effective for obese women

Despite a court order for the pharmaceutical company to hand over some 10 million pages of documents related to the oral contraceptive and the marketing for it, Bayer is playing hardball. The company is reportedly delivering the documents out of order or without attachments as it issues statements to the media that Yaz and Yasmin are no more dangerous than other birth control pills.

Yet, if that were the case, why did Bayer promote its oral contraceptives with flashy ads that, the Food and Drug Administration (FDA) says, overstated the benefits of the pills and downplayed the risks? The federal agency fined Bayer and ordered the drug company to launch a second campaign that more clearly stated the approved uses for the pills and the risks associated with them.

It seems every week there is another news story about a woman who has died or suffered severe health consequences associated with use of Yaz and Yasmin. That, coupled with the arrival of generic competition from drug maker Teva, has resulted in a 15 percent drop of Yaz sales. One can only wonder how much the legal settlements with Yaz/Yasmin victims will cost Bayer.

SOURCE: Yaz Lawsuit › Lawsuits against Yaz, Yasmin double to 2,000

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

Brenda’s story is told far too often these days. She is one of more than 1,100 women suing the drug company alleging claims of serious health problems after taking Yasmin, also known as Yaz. The lawsuits claim Bayer was aware of the increased risk of life-threatening blood clots in women taking Yasmin but they failed to adequately warn consumers of that risk. Some studies have backed up those claims; however, Bayer contends the blood clot risk for Yasmin and Yaz is no greater than other oral contraceptives.

Bayer has a reason to contest the claims made by the defendants. Its popular birth control pills have brought in $1.5 billion since 2009, making Yaz and Yasmin the most popular birth control pills in America and a favorite in Canada and numerous European countries. Yasmin and Yaz are different from other birth control pills because they contain drospirenone, a diuretic, that can increase potassium levels in the blood. This imbalance can trigger heart rhythm disturbances that can cause blood clots that can lead to pulmonary embolism, strokes, or even sudden cardiac death. The pills have also been linked to gallbladder disease.

Source: WPIX

SOURCE: Yaz Lawsuit › ‘Wicked’ understudy suffers stroke, joins lawsuit against Yasmin

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

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

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

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

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

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 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

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

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

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

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