Yasmin, Yaz Side Effects Warning Updated For Blood Clot Risk in U.S.

Bayer is adding new information on blood clots to the warning section of the labels for Yaz and Yasmin birth control pills. The update comes as the drug maker faces thousands of Yasmin and Yaz blood clot lawsuits from women who allege that the company failed to adequately warn about the increased risk of serious and potentially life-threatening injuries. 

The label changes, which were approved on April 7 by FDA (pdf), are expected to be similar to updates made last month in the European Union about the potential risk of blood clots from side effects of Yaz and Yasmin, including new information from four epidemiological studies that provide conflicting information on the risk of Yaz and Yasmin blood clots compared to other birth control pills containing levonorgestrel.

Two of the studies, which were sponsored by Bayer, found that the risk of venous thromboembolism from Yasmin and Yaz was comparable to the risk found in women who use levonorgestrel-containing combined oral contraceptives, such as Microgynon 30. However, two independent studies found that the risk of blood clots from Yasmin and Yaz side effects was higher than with levonorgestrel.

One of those studies, conducted in the Netherlands and published in the British Medical Journal in August, determined that Yaz and Yasmin, both of which contain the progestin drospirenone, increased the risk of blood clots in women 6.3 times over those not on birth control, while levonorgestrel-based pills only increased the risk about 4 times.

Researchers determined that the benefits of Yaz and Yasmin, as well as some other newer forms of birth control pills, were no greater than the benefits of older birth control pills, and suggested women should use the pills with the least side effects. But Bayer has previously suggested that it has identified “several methodological issues” in the two independent studies that suggest Yaz and Yasmin carry higher blood clot risks.

Yaz and Yasmin are similar pills that are both manufactured by Bayer, containing a combination of ethinyl estradiol and drospirenone, a new type of progestin. Drospirenone, or drsp, impacts the body’s normal mechanism of regulating a balance between salt and water, which could result in elevated potassium levels. This can cause a condition known as hyperkalemia, which is linked to potentially life-threatening heart problems and other health issues.

About 1,100 Yaz lawsuits and Yasmin lawsuits have been filed in the U.S. on behalf of individual women who allege that they suffered injuries that were caused by the birth control pills, such as a stroke, heart attack, pulmonary embolism, deep vein thrombosis, gallbladder disease and other injuries.

All federal Yaz and Yasmin cases are consolidated in an MDL, or multidistrict litigation, centralized in the Southern District of Illinois for pretrial litigation. There are also state level Yaz and Yasmin lawsuits consolidated in Pennsylvania and New Jersey courts. As Yasmin and Yaz lawyers continue to investigate and review potential new cases, it is expected that the number of cases filed will increase dramatically over the next year.