Yaz / Yasmin Label Updated By FDA To Further Warn Of Blood Clots And Venous Thromboembolism (VTE)

Over the past few years, more than 11,300 Yaz / Yasmin / Beyaz patients have filed product liability lawsuits against Bayer, the drugs’ manufacturer, typically alleging the drugs caused blood clots in legs or arms (deep vein thrombosis), blood clots in lungs (pulmonary embolism), or a stroke involving venous thrombotic event. Only 500 of those cases – fewer than five percent – have been settled so far (according to this Bloomberg report), for an average settlement amount of $220,000 per case. The courts presiding over the consolidated “Yasmin and YAZ (Drospirenone) Marketing, Sales Practices and Products Liability Litigation” (most of which is in federal court in Illinois) have ordered the parties to sit down for mediation and more rounds of settlement talks.

In the meantime, as scientific studies continue to demonstrate additional risks of progesterone and progestin birth control pills that were not disclosed by Bayer, the FDA has again updated the warning labels for four pills that contain a particular form of synthetic progesterone, drospirenone:

The revised drug labels (Beyaz, Safyral, Yasmin and Yaz) will report that some epidemiologic studies reported as high as a three-fold increase in the risk of blood clots for drospirenone-containing products when compared to products containing levonorgestrel or some other progestins, whereas other epidemiological studies found no additional risk of blood clots with drospirenone-containing products. The labels also will include a summary of the previously released results of an FDA-funded study of the blood clot risk.

To put the risk of developing a blood clot from a birth control pill into perspective: The risk of blood clots is higher when using any birth control pills than not using them, but still remains lower than the risk of developing blood clots in pregnancy and in the postpartum period.

The action follows a meeting of the FDA’s advisory panel back in December 2011, which produced this thorough report on the studies linking blood cots like deep vein thrombosis (DVT) to synthetic progesterone pills, with new data on drospirenone.

As attorney Max Kennerly discussed on his blog, Bayer tried to prevent the plaintiffs in the consolidated Yaz / Yasmin litigation from calling as expert witnesses:

• the former head of the FDA,
• a lecturer at Harvard Medical School who has written books and peer-reviewed articles about about the influence of the pharmaceutical industry on the practice of medicine,
• a former commissioned officer in the United States Public Health Service who was one of the first clinical instructors in FDA’s Center for Devices and Radiological Health Staff College, and
• the CEO of a pharmaceutical development consulting company.

The judge correctly ruled against Bayer, and that’s part of why the parties are sitting back down for settlement talks – the case isn’t looking good for Bayer.

If you suffered a blood clot injury, like venous thrombosis (whether deep vein thrombosis (DVT) or pulmonary embolism (PE)), contact our dangerous drug lawyers for a free, no-obligation consultation. We’ve been representing injured patients for over 60 years, recovering over $2 billion in jury verdicts and settlements.