Thursday, July 7, 2011

Despite Safety Concerns, Generic Forms of Yaz Birth Control Go Forward

Although Bayer has continued to maintain that there is no increased risk of blood clots fromYasmin and Yaz side effects, the FDA and European drug regulators forced the drug maker to update the blood clot warnings on Yaz and Yasmin labels last year. The FDA finally announced this week that they are evaluating the risk of blood clots from Yaz, Yasmin and Beyaz birth control, which some studies have shown to be 2 to 3 times greater than the risk associated with other birth control pills. The safety review was initiated based on two published studies that reported there is a greater risk of venous thromboembolism (VTE) among women taking Yaz, Yasmin or other drospirenone birth control pills.

Despite there being over 7,000 Yaz lawsuits alleging side effects, a slew of companies are pushing forward with generic Yaz releases. Thus far, Yaz, Yasmin and generic Ocella have been linked to an increased risk of potentially life-threatening blood clots, which could result in a heart attack, stroke, deep vein thrombosis, pulmonary embolism or sudden death. It is unclear if generic manufacturers will be added to the list of companies involved in these lawsuits. Ocella (drosperinone and ethinyl estradiol) is generic Yasmin, a once-a-day birth control pill that was first approved by FDA in 2001 to prevent unwanted pregnancy. Yasmin was originally developed by Berlex Laboratories. In August 2009, a federal court affirmed a lower court’s ruling that invalidated Bayer’s patent on Yasmin, allowing Barr Laboratories to begin manufacturing and distributing Ocella without licensing from Bayer.

Yaz and Yasmin are similar pills that are both manufactured by Bayer, containing a combination of ethinyl estradiol and drospirenone, a new type of progestin. Drospirenone, or DRSP, impacts the body’s normal mechanism of regulating a balance between salt and water, which could result in elevated potassium levels. This can cause a condition known as hyperkalemia, which is linked to potentially life-threatening heart problems and other health issues. In its press release, Bayer acknowledges that drospirenone can increase the amount of potassium in some women’s bodies too much and should be avoided by women over 35 that smoke. Victim suffering from the adverse effects of Yaz are advised to contact an experienced Yaz lawyer immediately.

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