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Health Canada reviewing safety of drospirenone-containing oral contraceptives (Yasmin and Yaz) and risk of venous thromboembolism

Starting date:
June 7, 2011
Posting date:
June 7, 2011
Type of communication:
Information Update
Subcategory:
Drugs
Source of recall:
Health Canada
Issue:
New safety information
Audience:
General Public, Healthcare Professionals
Identification number:
RA-110005091

Health Canada is informing health professionals and consumers, particularly women, that it is conducting an ongoing safety review of drospirenone-containing oral contraceptives to evaluate the potential for an increased risk of venous thromboembolism (VTE, which are blood clots) relative to other birth control pills. Blood clots are a rare but well known side effect associated with all birth control pills.

There are two drospirenone-containing birth control pills currently marketed in Canada: Yaz and Yasmin. Drospirenone is one type of female sex hormone known as progestin. Most birth control pills contain a combination of progestin and estrogen (another female sex hormone). Other birth control pills contain other types of progestin.

Health Canada is currently reviewing two new studies recently published in the British Medical Journal that suggest the risk of blood clots with drospirenone-containing birth control pills may be two to three times greater than with birth control pills containing another type of progestin (levonorgestrel).

Health Canada has reviewed other available studies regarding drospirenone-containing oral contraceptives and an increased risk of blood clots. Currently, Health Canada is evaluating the recently published studies and it is looking at all 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.

Health professionals are reminded that birth control pills are contraindicated (not to be used) in patients with a history that puts them at risk for blood clots. This includes women over the age of 35 who smoke, as they are at an increased risk.

Patients who think they are experiencing symptoms of a blood clot should seek immediate medical attention and mention any medications they may be taking, 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. Patients should be aware that stopping their birth control may result in unintended pregnancy.

The current Product Monographs for Yasmin and Yaz are available by searching Health Canada's Drug Product Database. Product Monographs provide detailed prescribing and safety information on a drug. Part III of the Product Monograph provides information specifically for consumers.

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