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

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

By all accounts, Tania, who was studying to be a teacher, was the picture of health. She is now a statistic – a piece of data culled from research studies into the safety of birth control pills, like Yasmin, that contain the hormone drospirenone.

Yasmin is one of a family of birth control pills sold by Bayer. Other oral contraceptives that contain drospirenone include Yaz, Beyaz, and Safyral. The family of pills was Bayer’s top selling drug in 2010.

All birth control pills carry a slight risk for blood clots, but a new study suggests that pills that contain drospirenone may put women at even greater risk. The news has led the Food and Drug Administration (FDA) and Health Canada to undergo a safety review on the pills.

The study is based on about 300,000 women in the United Kingdom. Researchers found that women who were taking pills containing drospirenone were at about three times greater risk of developing blood clots in the lungs or legs than women taking oral contraceptives with an older hormone. Blood clots can cause heart attacks, strokes, and sudden death.

Bayer refuses to admit that its pills are more dangerous than others. The drug company also says its safety labeling includes a warning for blood clots. Genevieve finds this warning inadequate. “In the packet for Yasmin there’s a little booklet and it has 35 pages and on page 19 it lists the major side effects. I don’t believe Tania read it and I certainly didn’t. Because the pill is so widely accepted, you just don’t think that something might happen.”

Source: ABC

SOURCE: Yaz Lawsuit › Yasmin birth control pills claim another young life

The study is the first to provide a comprehensive review of diagnosing, imaging and treating CVT. Researchers found that CVT disproportionately affects pregnant women or women taking birth control pills, as well as people 45 years of age and younger. Oral contraceptives put women at an even greater risk, and researchers recommend that patients with suspected CVT undergo blood tests to determine if they have an inherited or acquired factor in the blood that predisposes them to blood clots.

The safety labels of all birth control pills warn users of a risk for blood clots. However, studies suggest that some birth control pills put users at an even greater risk. Yaz and Yasmin are a type of “fourth generation” birth control pill that combines the hormones ethinyl estradiol and drospirenone. Propelled by pricy marketing campaigns, the pills quickly became the most popular type of oral contraceptive in the country, with many women asking their doctors for the pills by name.

Since the pills were introduced, the Food and Drug Administration (FDA) has received hundreds of reports of women who have been seriously injured while using Yaz and Yasmin. Problems include blood clots, heart attacks, strokes and even gallbladder damage. Bayer HealthCare, makers of Yaz and Yasmin, now face thousands of lawsuits from women claiming they were not adequately warned that using the pills could put their lives in danger.

SOURCE: Yaz Lawsuit › Birth control pills can cause rare form of stroke

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

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

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

What doctors discovered on Rose’s arm was a 10-inch blood clot that stretched from the base of her upper arm to her chest. They say it was caused by Rose’s birth control pills. Large clots like Rose’s that form in the veins of the arms or legs are often caused by a condition known as deep vein thrombosis. If left untreated, the clots could break off and travel to the lungs, which can be fatal.

The standard treatment for blood clots is drugs known as blood thinners. However, there is no guarantee the clot will go away and there is always a risk of internal bleeding. In search of a more effective treatment, Portola Valley physician Dr. Thomas Fogarty invented the Trellis Peripheral Infusion System, designed to remove large clots in veins using balloons and blood thinners that are injected into the clot area.

Fogarty’s Trellis device was approved by the Food and Drug Administration (FDA) in 2005, and has since been used on patients at more than 600 hospitals nationwide. The process involves navigating a catheter through the vein and into the clot and then inflating a balloon on either side of the clot. Trapped between the balloons, the blood clot is then injected with a clot-dissolving drug. The clot usually breaks up within an hour and patients are usually able to go home within a day with little more than a centimeter-sized scar.

Rose turned out to be an ideal candidate for the procedure, and she said she is pleased the process went so smoothly. “My Trellis scar is one dot,” she said.

SOURCE: Yaz Lawsuit › Trellis device offers safer and more effective treatment for blood clots

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

But instead of seeking medical attention, Sara limped around in pain for three days as her leg began to swell from the knee down. “I should have listened to my gut and asked my father to take me to the doctor right then,” she said. “However, I felt silly about my worry because of my Achilles tendonitis and my young age.”

When her condition continued to worsen, Sara finally visited a doctor. The diagnosis surprised her. She had blood clot in her leg and needed immediate medical attention.

Blood clots can be deadly. What Sara learned is that despite her young age, she had common risk factors of blood clots – traveling in an airplane where she sat sedentary for hours, and using birth control pills. Oral contraceptives can increase the risk of blood clots due to the effect or dose of hormones, either estrogen or progestin. While the packaging on birth control pills may outline this risk, many lawsuits have been filed against makers of birth control pills by women who claim they were not adequately warned about the dangers in using the pills. To date, Bayer HealthCare faces more than 1,100 lawsuits for its oral contraceptives Yaz and Yasmin.

As part of her treatment, Sara had to discontinue use of her birth control. “I can never take birth control pills again and was told that if I get pregnant I will have to take a ‘blood thinner’ because changes during pregnancy make the blood clot more easily,” she said, adding a warning to other young women like her. “If you are contemplating use of birth control pills, make sure to discuss your family history (especially related to blood clots) as well as the adverse effects of birth control with your doctor.

“Take your life into your own hands.”

SOURCE: Yaz Lawsuit › Young woman warns others about birth control pills and blood clot risk

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

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