Warnings on Yasmin Blood Clot Side Effects Updated in Europe

Bayer has indicated that it will update its European warning label to provide additional information on the risk of blood clots from Yasmin side effects.

The label will be updated to include new information from four epidemiological studies, which provide conflicting information on the risk of 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 among users of Yasmin was comparable to the risk found in women who use levonorgestrel-containing combined oral contraceptives, such as Microgynon 30. However, two other recently published studies found that the risk of blood clots from side effects of Yasmin was higher than with levonorgestrel.

Yasmin is a newer type of birth control pill that contains a “fourth” generation progestin known as drospirenone. The progestin is only found in Yasmin, a newer formulation of the drug marketed as Yaz birth control, a generic Yasmin marketed as Ocella and a lower dose version marketed as Yasminelle. In recent months, concerns have increased about the risk of blood clots from Yaz and Yasmin, which can lead to potentially life-threatening injuries such as a stroke, heart attack, pulmonary embolism, deep vein thrombosis (DVT) or death.

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 known to cause serious heart problems and other health issues.

Shortly after Yasmin was introduced, the U.S. consumer advocacy group Public Citizen listed Yasmin on its list of “DO NOT USE” drugs because it contains drospirenone, which could increase the health risks and because there is no evidence that the drug is any better than older contraceptives that are available.

A number of Yaz blood clot lawsuits and Yasmin blood clot lawsuits have been filed throughout the United States alleging that the drug maker failed to adequately research their medications or adequately warn about the risks associated with the popular pills compared to other forms of birth control.

Last summer, an independent study published in the British Medical Journal found that women taking Yasmin, Yaz or other birth control pills containing drospirenone face a 6.3 times increased risk of blood clots when compared to women who were not on the pill. By comparison, women who took oral contraceptives containing levonorgestrel had the lowest risk of blood clots, with just below a fourfold increase over those not taking a birth control pill.

Despite mounting concerns about the risk of blood clots from Yasmin and Yaz, Bayer continues to stand behind their popular birth control pills. In a press release issued Friday to announce the new European warning label, Bayer indicated that they have identified “several methodological issues” in the two recently published retrospective studies that suggested the risk of blood clots with Yasmin may be higher. The drug maker indicated that these issues need to be clarified before a final conclusion on the Yasmin blood clot risk can be made.

“Yasmin’s positive benefit/risk profile remains unchanged,” said Kermal Malik, M.D., Chief Medical Officer at Bayer Schering Pharma in the press release. “We are convinced that Yasmin is a good choice for women seeking convenient and reliable contraception if they use the product as directed.”

The new European warnings come as Swissmedic, the medical agency for Switzerland, announced that Yasmin and Yaz will remain for sale in the country, despite the risk of blood clots. The Swiss agency began investigating the extent of Yaz and Yasmin side effects last year, after one young woman was killed and another was seriously injured from a pulmonary embolism on Yaz. World Radio Switzerland reports that while Swissmedic found that the risk of thrombosis is higher with Yaz and Yasmin, the risk remains “within reasonable limits.”