Continuing Attacks on the Yaz/Yasmin FDA Advisory Panel
Written By: Rheingold, Valet, Rheingold, Ruffo & Giuffra LLP
As our Yaz/Yasmin clients know, we have reported that the recent FDA panel which determined that Yaz was unsafe without strengthened warnings. Yet, as we suggested, perhaps the warnings should have been stronger or that the drug pulled from the market outright. Doctors we have talked to in our litigation cases say they are discouraging Yaz use in their patients due to the dangers of third generation progestins (drospirenone) in increasing the risk of stroke, deep vein thrombosis, pulmonary embolism and gallbladder injuries. We are also spearheading litigation against NuvaRing in state and federal courts as that birth control contains a third generation progestin known as etonogestrel.
Women's health groups are now pointing out further problems with the January 2012 FDA Advisory Panel decisions. The latest problem is that wrong and inconsistent questions were asked. Instead of comparing Yaz to other birth control pills, the comparison was done to risks of pregnancy. Almost all of the 15 FDA panelists who voted "yes" indicated they voted on a comparison of risks and benefits compared to pregnancy, rather than on whether the risks and benefits of oral contraceptives containing drospirenone outweigh risks and benefits compared to other oral contraceptives. These are two different issues and befuddled some panelists.
This controversy is bound to continue. However, for our clients, we are awaiting news of further settlements based upon Bayer's desire to resolve the litigation before further damaging evidence comes to light in a trial scheduled to start in April.