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Stronger Warnings Added to Yaz Labels

By June 15, 2012July 16th, 2019Uncategorized

The FDA unveiled the new Yaz warnings labels in April 2012. The updated warnings contain stronger language when discussing the risks of Yaz and Yasmin causing blood clots. Unfortunately, the update is due to patient injuries that have been caused by the pills’ main ingredient, drospirenone.

Yaz and Yasmin are manufactured by Bayer, and research has shown that the pills can cause serious adverse side effects, including heart attacks, strokes, gallbladder disease and blood clots that can lead to deep vein thrombosis and pulmonary embolisms. The cause of these side effects is the pills’ main ingredient, drospirenone, which is a synthetic progestin. When the FDA announced that the new warnings were added to the labels, the agency stated, “The revised drug labels will report that some epidemiologic studies reported as high as a three-fold increase in the risk of blood clots for drospirenone-containing products… whereas other epidemiological studies found no additional risk.”

This update is the result of a panel vote that took place in December. At that time, the panel voted to keep Yaz and Yasmin on the market, but to institute a label update. The reason for the 15-11 vote in favor of the pills remaining on the market was based on the panel’s decision that the benefits outweighed the risks involved. That decision was met with a good deal of criticism when it was learned that at least four of the panel members had financial ties to Bayer.

The side effects linked to Yaz and other drospirenone-based pills have caused thousands of users to file lawsuits against Bayer for failure to warn them of the dangers beforehand. For a long time, Bayer refused to accept liability. In fact, the company insisted that the pills were no more dangerous than older birth control pills that didn’t contain drospirenone. The company has since seemingly conceded a little bit when it agreed to a settlement with as many as 500 plaintiffs to the tune of $110 million (about $220,000 per plaintiff).