Canada Looking at Yaz, Yasmin Blood Clot Risk

The popular birth control pills <"">Yaz and Yasmin will undergo a safety review in Canada to investigate their risk of blood clots. The Health Canada review was prompted by the release of two studies which found that the danger of blood clots associated with Yaz, Yasmin and other drospirenone-based birth control pills may be two to three times greater compared to those that contain a different form of progestin.

Just last month, the U.S. Food & Drug Administration (FDA) announced it was conducting a Yaz and Yasmin safety review because of those same two studies, which were published in the British Medical Journal. Prior to the FDA announcement, the same studies prompted European regulators to order that the labels of drospirenone birth control pills be revised regarding the risk of blood clots.

Previous studies examining the risk of blood clots and drospirenone contraceptives have had conflicting results. Of four already noted in the “Warnings and Precautions” section of the U.S. labels for the medications, two indicated an increased risk, while two others did not.

According to an announcement from Health Canada, the agency is evaluating the recently published drospirenone studies and all other available information to fully assess the risk of blood clots. Health Canada will take appropriate action as necessary once the review is complete. This could include informing health professionals and Canadians of new safety information resulting from Health Canada’s review.

The agency also advised that patients who think they are experiencing symptoms of a blood clot should seek immediate medical attention and mention any medications they may be taking to their doctors, including birth control pills. Symptoms of a blood clot may include persistent leg swelling, leg pain or tenderness, chest (thoracic) pain, or sudden shortness of breath.

Women with questions or concerns about their oral contraceptive should talk to their healthcare professional, Health Canada said. Patients should be aware that stopping their birth control may result in unintended pregnancy.

Yaz and Yasmin, made by Bayer Corporation, are the only drospirenone birth control pills sold in Canada. However, in the U.S., these types of pills are also sold under the brand names rand names Beyaz and Safyral. The hormone is also an ingredient in generic forms of Yaz (Gianvi, Loryna) and Yasmin (Ocella, Syeda, and Zarah).

Drospirenone birth control pills, including Yaz, Yasmin and their generic counterparts, have been named in more than 6,000 U.S. lawsuits claiming the drugs caused users to suffer dangerous side effects, including blood clots, heart attacks, and strokes. Many of those lawsuits have been consolidated in a multidistrict litigation in federal court in the Southern District in Illinois.

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