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FDA: Yaz/Yasmin Blood Clot Warnings Should be Strengthened

An FDA advisory panel has recommended that labels of Bayer’s best-selling birth control products Yaz and Yasmin should be updated to include information about the increased risk of life-threatening blood clots associated with the products. The administration is not required to follow the committee’s recommendations, but inside sources believe it will. Bayer is currently facing more than 10,000 lawsuits filed on behalf of women who were allegedly harmed after taking Yaz and Yasmin.

Yaz / Yasmin Lawsuit Update 7/31/12: The number of lawsuits filed against pharmaceutical giant Bayer on behalf of women allegedly injured by Yaz and Yasmin continues to grow by leaps and bounds around the country, as the federal multidistrict litigation (MDL) for the cases recently surpassed asbestos as the largest in the nation. All of the complaints involve similar allegations which state that Bayer knew – or should have known – about the health risks involved with its blockbuster birth control pills, but that it failed to inform the public and medical communities about this risk.

Yasmin Blood Clot Lawsuit Update 7/23/12: Last week, a Florida man filed a medical malpractice lawsuit which claimed that his wife died following plastic surgery as the result of a Yasmin-induced pulmonary embolism that could have been prevented if her doctors had taken her off the drug prior to surgery. The complaint notes that proper standards of medical care outlined in the Physician’s Desk Reference indicate that “oral contraceptives should be discontinued at least four weeks prior to and for two weeks after elective surgery.”

Yaz / Yasmin Lawsuit Update 7/9/12: After nearly six months of settlement negotiations, Bayer has reportedly reached agreements with approximately 33 different law firms to resolve at least 1,444 Yaz and Yasmin lawsuits. All of the claims were filed on behalf of women who suffered blood clot-related injures after taking the company’s blockbuster birth control pills.

Yaz Lawsuit Update 6/18/12: Last month, a former Yaz user filed a lawsuit against pharmaceutical giant Bayer after she allegedly suffered blood clots leading to a life-threatening pulmonary embolism (PE) event. The plaintiff claims she began using Yaz in November 2006 and subsequently developed blood clots from the drug leading to the PE in December 2009.

Free Yaz Blood Clot Lawsuit Evaluation: If you or a loved one suffered a blood clot after taking Yaz, you should contact our law firm immediately. You may be entitled to compensation by filing a suit against the manufacturer and our lawyers can help.

What’s the problem?

December 8, 2011 – The question of whether Yaz and Yasmin can cause blood clots has been a hotly-debated issue as of late. Medical studies have yielded conflicting results. Bayer claims that its blockbuster contraceptives are no more dangerous than any other birth control pills, all of which come with a slight risk of blood clot side effects.

But other studies have found that the drugs may significantly increase the risk of potentially-fatal blood clots. An FDA analysis concluded that approximately 10 in 10,000 women taking birth control products containing drospirenone (the active ingredient found in both Yaz and Yasmin) will suffer a blood clot or venous thromboembolism (VTE), compared with about six in 10,000 women using older contraceptives containing levonorgestrel.

Another study published in the October 2011 edition of the British Medical Journal (BMJ) found that women taking drospirenone birth control pills had double the risk of blood clots compared to those using levonorgestrel contraceptives.

An FDA briefing document has acknowledged that research to date has yielded conflicting results regarding the safety and efficacy of Yaz and Yasmin, but concluded that labels on the pills should be updated to inform the public about this potential risk.

Despite the fact that the administration could not identify whether the increased blood clot risk resulted from use of the drugs or some other unknown cause, “we believe that, because of the consistency in recent reports for an increased risk, product labeling should reflect that very real possibility,” the scientists wrote.

According to newly released court documents, Bayer researchers found increased reports of blood clots in women using Yaz and Yasmin compared with those using other contraceptives, but failed to inform the FDA in a 2004 safety review.

“Bayer presented a selective view of the data, and that presentation obscured the potential risks associated with Yasmin,” said David Kessler, a former F.D.A. commissioner working as an expert witness for the plaintiffs.

Do I Have a Yaz Blood Clot Lawsuit?

The Product Liability & Defective Drug Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Yaz lawsuits. We are handling individual litigation nationwide and currently accepting new blood clot cases in all 50 states.

Free Confidential Case Evaluation: Again, if you developed a blood clot after using Yaz, you should contact our law firm immediately. You may be entitled to compensation by filing a lawsuit and our lawyers can help.

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