Yasmin and Yaz (drospirenone): Updated information on increased risk of blood clots

Starting date:
December 5, 2011
Posting date:
December 5, 2011
Type of communication:
Information Update
Subcategory:
Drugs
Source of recall:
Health Canada
Issue:
Important Safety Information
Audience:
General Public
Identification number:
RA-110004731

Health Canada has completed a safety review of drospirenone-containing oral contraceptives (marketed under the brand names Yasmin and Yaz) with respect to the risk of blood clots (venous thromboembolism, or VTE). The review determined that drospirenone-containing birth control pills may be associated with a risk of blood clots that is 1.5 to 3 times higher than other birth control pills.

Blood clots are a rare but well known side effect associated with all birth control pills. The risks of blood clots are higher with pregnancy and childbirth than with oral contraceptives.

As part of its review, Health Canada considered several recent observational studies evaluating the risk of blood clots with drospirenone-containing oral contraceptives versus other oral contraceptives. Overall, the body of current evidence suggests that the risk of blood clots is 1.5 to 3 times higher with oral contraceptives that contain drospirenone relative to those that contain levonorgestrel, a different hormone.

Overall the risk of blood clots with any oral contraceptive (including Yasmin and Yaz) is very small.

To put this into perspective, if the estimated risk of developing a blood clot among women taking a levonorgestrel-containing birth control pill is 1 in 10,000 women per year, as some studies have estimated, then the risk in women taking a drospirenone birth control pill is about 1.5 to 3 women in 10,000 per year.

The drug labels for Yasmin and Yaz have been updated to include information on the studies and the recommendation that, when prescribing an oral contraceptive, health professionals consider the risks and benefits of drospirenone-containing oral contraceptives for a specific patient in light of her risk for developing blood clots, and relative to the risks and benefits of other birth control pills on the market.

Women with questions or concerns about their birth control pill should talk to their healthcare professional. When choosing an oral contraceptive, women should talk to their health professional about their risk for blood clots. Known factors that increase the risk of blood clots include smoking, being overweight (obesity), and a family history of blood clots.

Canadians are reminded that birth control pills of any type should not be used by women who have had a blood clot or who have certain risk factors. This includes women over the age of 35 who smoke heavily (more than 15 cigarettes/day), 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 pain, or sudden shortness of breath or difficulty breathing.

Drug labels, or "Product Monographs," contain important prescribing and safety information for health professionals and patients, and are available by search of Health Canada's Drug Product Database.

How to report side effects to health products

To report suspected adverse reaction to these or other health products, please contact Health Canada's Canada Vigilance Program toll-free at 1-866-234-2345, or complete a Canada Vigilance Reporting Form and send to us using one of these methods:


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