Wednesday, January 25, 2012

FDA Panel Acknowledges Yaz Problems, Stops Short of Recall


The FDA evaluated the risk of Yaz blood clots from the birth control, which some studies have shown to be 2 to 3 times greater than the risk associated with other birth control pills, leading to an ever-growing number of Yaz Lawsuits. In December of last year they held a nine-hour meeting to evaluate the drug’s warning label, eventually deciding, in a 21-5 vote, that Bayer, the drug’s manufacturer, must revise the labe to more clearly explain that the birth control pill comes with an increased risk of Yaz Blood clots. 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.
Now, the FDA is facing strong calls that it hold a new meeting to evaluate the safety of Yaz and Yasmin birth control pills, after issues involving a possible conflict of interest have been raised regarding some of its advisory committee members. It has now been discovered that at least four of the committee members had ties to Bayer prior to the committee hearing, but all four say that those ties had no effect on their final vote. Despite the potential increased risk of Yaz and Yasmin blood clots, Bayer has heavily marketed these drugs, particularly to younger women. The drugs currently account for approximately 30% of the birth control pill market, and many women could reduce the risk of blood clots by taking alternatives to Yaz and Yasmin for birth control.
A DVT or deep vein thrombosis is a type of blood clot that usually occurs in the legs or deep veins of the pelvis. While it is possible to have a DVT with minimal symptoms, they usually cause extreme pain and swelling in the affected limb. If the deep vein thrombosis dislodges, it could travel to other parts of the body and cause a pulmonary embolism, heart attack or stroke. Yasmin and Yaz DVT is considered a medical emergency which requires immediate medical treatment. Thousands of women who have suffered from Yaz pulmonary embolisms have found a Yaz lawyer to help them fight for their legal rights.

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