Drospirenone Birth Control Side Effects Being Reviewed in Canada and U.S.

Growing concerns over the risk of blood clots from side effects of drospirenone, the active ingredient in Yaz and Yasmin birth control, has led Canadian health officials to launch an investigation, just one week after U.S. regulators launched a similar safety review of the popular pills.

Health Canada announced their drospirenone safety review on Tuesday, indicating that they will evaluate the risk of blood clots associated with the Bayer Healthcare oral contraceptives.

The only birth control pills sold in Canada with drospirenone are Yaz and Yasmin. However, in the United States other formulations and generic versions are marketed as Beyaz, Safyral, Ocella, Syeda, Sarah, Gianvi and Loryna.

The announcement comes just a week after the FDA announced that it was evaluating the potential risk of blood clots from drospirenone birth control pills, and less than a month after the European Medicines Agency officially determined that the side effects of Yaz, Yasmin and similar pills were associated with a higher risk of venous thromboembolism (VTE) [PDF] when compared to older levonorgestrel-containing pills and recommended that the labels be updated. Both the FDA and its European counterparts note that the overall risk of a blood clot is still small.

The safety reviews come in the wake of two studies recently published in the British Medical Journal, which determined that women taking drospirenone-based birth control pills like Yaz and Yasmin were twice as likely to have a blood clot than women taking levonorgestrel-based pills.

Drospirenone is a newer type of progestin that is usually used in combination oral contraceptives that also include estrogen. It was originally introduced by Berlex Laboratories in Yasmin. Once Berlex was acquired by Bayer Healthcare an updated version of Yasmin was introduced called Yaz. More recently, Bayer introduced a third version, marketed as Beyaz, which includes a folate supplement.

Some experts say that drospirenone disrupts the body’s normal mechanism of regulating a balance between salt and water. This results in elevated potassium levels, known as hyperkalemia, which can cause potentially life-threatening heart problems and other health issues.

Bayer currently faces about 7,000 Yaz lawsuits, Yasmin lawsuits and Beyaz lawsuits, which allege that the drug maker has failed to adequately warn about the increased risk of health problems associated with the birth control pills. The complaints have been filed on behalf of women who have suffered heart attacks, strokes, pulmonary embolism, deep vein thrombosis, gallbladder disease and other serious injuries after using Yaz, Yasmin, Beyaz or other drospirenone birth control pills.