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

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

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

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

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

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

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 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