Your blood needs to clot, but it is a delicate balance. Insufficient clotting leads to excessive bleeding and too much clotting leads to obstructed blood flow, pulmonary embolism and strokes. So, it is understandable that the Food & Drug Administration became worried about reports that birth control medications containing drospirenone were causing excessive clotting in women taking them. The FDA decided to conduct a review of literature and investigate the potential risks associated with birth control drugs such as, Yasmin, Zarah, Syeda, Safyral, Ocella, Yaz, Loryna, Gianvi, and Beyaz. The Food & Drug Administration has now reached some preliminary conclusions that would be disturbing to me if I were a woman taking these medications. The FDA believe s that the increased risk for blood clots, pulmonary embolism and stroke are around 1.5 times more in women taking the drugs than in women taking other types of similar medications for birth control. The manufacturer of Yaz and Yasmin agreed with the FDA in 2010 to amend its labeling to alert users of the potential for venous thromboembolism (VTE), but also indicated the risk was no greater than with other oral contraceptive preparations. There are really two central issues. The study and investigation being conducted by the Food & Drug Administration is exactly the same evaluation which should have been conducted by the manufacturers of these drugs BEFORE they were placed on the market. Where were the manufacturers when these drugs were being evaluated through clinical testing? Were risks of VTE suppressed during clinical trials? Were all the data of clinical trials provided to the FDA at the time the drug was submitted for final approval? When Bayer began producing its commercials for Yaz depicting young, successful, attractive women talking about the miracles of Yaz, did they know? When Bayer began pushing the envelope by trying to promote Yaz as a treatment for acne in young women, did they know about the increased risks of stroke? When Yaz commercials with their fun loving, balloon flying commercials tried to lure young women to Yaz, did Bayer know that each person faced a potential one and one half times greater risk they would develop a stroke or risk death as a result of a pulmonary embolus? So, it is great that the FDA is now evaluating these dangers of medications like Yaz, Yasmin and Beyaz; but where were these investigations and studies when manufacturers were making billions of dollars through the sale of them to young women? Click here to view the embedded video.
Read more detail on Recent Medical Malpractice Posts –