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Monday, September 30, 2013

YAZ CONTINUES TO SETTLE CASES DESPITE DENYING LIABILITY

Yaz Lawsuit Settlements Total $1.4 Billion

September 30, 2013:

As of July 2013, Bayer Healthcare Pharmaceuticals, makers of the Yasmin and Yaz birth control pills, have settled claims reaching up to  $1.4 billion dollars.  At least 6,760 plaintiffs have reached  Yaz lawsuit settlements in the United States – despite Bayer continuing to deny any wrongdoing.

These drugs, Yaz, Yasmin and other birth control pills, contain the hormone drospirenone are alleged to have caused thousands of deaths, strokes, pulmonary embolisms and dangerously elevated potassium levels, among other problems. Though all oral birth control pills carry an increased risk of blood clots in the legs and lungs, the newer generation of contraceptives is thought to pose a greater risk.

The extent and severity of Yaz and Yasmin side effects has prompted calls for the FDA to order Bayer to withdraw the products from the market. After reviewing research on the risk of blood clots associated with Yaz and Yasmin, the FDA demanded that Bayer alter the prescription information for both pills. The revised label explains that the risk of side effects such as blood clots may be greater than with other contraceptives.

In light of the number of settlements and emerging litigation, women’s health campaigners want to see more done to warn the public not to use these drugs. Oral contraceptives containing drospirenone “can cause increased blood levels of potassium and (are) no more effective than other oral contraceptives in preventing pregnancy.”

Bayer claims there is ‘no increased risk’

Bayer points to a number of industry-funded studies that indicate no greater risk of  Yaz blood clots or other side effects commonly associated with oral contraceptives. After reviewing the research, the FDA stated that the benefits of Yaz and Yasmin outweigh the risks.

Oral contraceptives are the most popular form of birth control in the U.S. Most use a combination of estrogen and progestin to prevent ovulation.

Common side effects include:

  • bloating
  • irregular bleeding
  • headaches
  • breast tenderness
  • nausea

Because estrogen can cause coagulation – leading to blood clots and strokes – the estrogen dose has been lowered since oral contraceptives were first introduced, and drug makers have looked for ways to favor progestin instead.

Yasmin was launched in 2001. It was the first birth control pill to use drospirenone, a new type of progestin. Yaz followed in 2006. Part of their appeal was that neither pill caused bloating or weight gain, a common side effect of first and second generation oral contraceptives. By 2008, Yaz was the best-selling birth control pill in the country.

FDA warning

The same year, the FDA warned Bayer about misleading advertising tactics after a series of Yaz and Yasmin commercials promised false benefits and minimal risk. The company denied any wrongdoing but did run a series of corrective television commercials. Sales fell by 60 percent during 2010.

More Yaz lawsuit settlements expected

More than 5,400  Yaz lawsuits are currently pending in the U.S. Bayer began settling claims for blood clot injuries, and has now set aside $24 million for nearly 9,000 lawsuits alleging gallbladder injuries.

Several studies suggest the risk of blood clots posed by Yaz and Yasmin is 1.5 times higher than with other hormone-based contraceptives.

 


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