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FDA Scheduled to Review Safety Regulations for Newer Oral Contraceptives

Originally introduced as revolutionary oral contraceptives, fourth-generation birth control pills have become the subject of a heated debate. Birth control drugs that were once believed to have fewer side effects, and the ability to alleviate hormonal complications, are now facing an onslaught of scrutiny from healthcare officials. According to several studies, newer birth control formulations may significantly increase the risk of a patient suffering from a severe, life-threatening blood clot. Subsequently, the U.S. Food and Drug Administration (FDA), in light of these recent findings, will determine future safety measures in a meeting later this week.

Fourth generation contraceptives, those containing drospirenone, consist of Yaz,Yasmin, Beyaz, Ocella, and several others. According to a recent study funded by the FDA, these birth control pills may demonstrate a propensity for the development of adverse cardiac events. More specifically, complaints have been filed on behalf of women who have suffered heart attacks, strokes, pulmonary embolism, deep vein thrombosis and other serious blood clot-related injuries.

According to the FDA analysis, fourth generation contraceptives with drospirenone are responsible for a 1.5-fold higher risk of blood clots than their predecessors. That translates into an estimated 10 in 10,000 women on the newer drugs experiencing a blood clot, compared with 6 in 10,000 women on older contraceptives.

According to Dr. Jennifer Wu, of Lenox Hill Hospital in New York, “it’s a very small percentage of patients that develop these, but it’s such a serious side effect that I think doctors have to use a lot of caution.”

After having been on the U.S. market for nearly a decade, millions of women have transitioned from older counterparts to newer oral contraceptives. However, recent studies comparing the medical histories of women taking the newer drugs, with drospirenone, to older ones suggest a slightly higher risk of blood clots in the legs and lungs.

In a meeting scheduled for Thursday of this week, healthcare officials will discuss the safety and effectiveness of drospirenone-containing contraceptives such as Yaz, Yasmin, Beyaz, and Ocella. Cindy Rippee, a representative scheduled to speak at the meeting, will tell the FDA panel about her 20-year-old daughter, Elizabeth, who died Christmas Eve 2008 when a blood clot traveled to her lung after taking Yasmin for approximately two months. “I really feel that if my daughter had been told about the increased risk she would have made a different decision,” said the distraught mother.

Contradictory to the FDA analysis, Bayor released a statement acknowledging that there is no difference in blood clot risk between its drugs and the older hormone-based contraceptives.

Regardless of what representatives have acknowledged about the controversial issue, the FDA still plans to meet this week in an attempt to determine the future of such products. The meeting will discuss the safety and effectiveness of newer contraceptives and determine if future regulations are required. The results of the meeting may have a significant impact on product sales in the future.

Do I Have a Drospirenone Lawsuit?

The trial lawyers at The Senators (Ret.) Firm, LLP have decades of experience navigating through complex legislative and regulatory issues and litigating high stakes cases all over the nation. Our law firm focuses on the representation of plaintiffs in drospirenone birth control lawsuits. We are currently accepting new cases in all 50 states.

If you or a loved one has been injured by an oral contraceptive containing drospirenone, you may be entitled to financial compensation. For a free case review, please click the link below or call toll free 24 hrs/day 1-800-773-0849.

Categories: Product Liability
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