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FDA Advisory Panel: No Yaz Recall, Just Stronger Warning

By January 2, 2012July 10th, 2019Uncategorized

At the FDA’s Yaz Advisory Panel Meeting that took place December 8, regulators decided against recalling the controversial birth control pill and opted instead to strengthen the warnings on the drug’s label.

The meeting was initially designed to examine the real dangers associated with Yaz and Yasmin which are both made with drospirenone, namely blood clots. The panel voted 15-11 that the benefits outweighed the risks involved in taking the pills. This was enough for the regulators to keep the drug on the market despite the calls by consumers and medical professionals for the pills’ removal.

The panel did, however, vote 21-5 to have Yaz and Yasmin (along with other drospirenone-based pills) make changes to their labels. The goal here is to make the labels less confusing to read and less vague so that the real risks can be found easier. The panel already has analyzed research and determined that Yaz and Yasmin can increase consumer risk of developing blood clots by as much as 74 percent in comparison to non drospirenone-based pills.

What is interesting is how many independent studies show this increased risk of patients developing blood clots while using Yaz, even though Bayer’s studies find that there are no increased health risks linked to the drug. In fact, documents that have just been unsealed as part of the discovery process in Yaz lawsuits against Bayer show that even former FDA Commissioner David Kessler is convinced that Bayer hid safety information from the FDA. He even testified that Bayer purposefully mislead the FDA about how safe Yaz and Yasmin are by selectively choosing only blood clot data that made the pills look less dangerous than they actually are. This is nothing new, since Bayer refuses to listen to the warnings given about the pills, even in the face of thousands of lawsuits against the company.