Yaz, Yasmin BCPs Linked to 23 Deaths in Canada

Shelley Wood

June 14, 2013

OTTAWA, Ontario — Health Canada records indicate that at least 23 deaths and 600 adverse reactions have been reported among women taking the birth-control pills (BCPs) Yaz and Yasmin (Bayer) in that country.

News of the reports was first reported by the Canadian Broadcasting Corporation (CBC) and has been widely picked up by Canadian media [1].

Adverse-reactions reports, reviewed by heartwire , show that a total of 333 distinct cases, including 15 deaths, were collected for Yasmin and 267 for Yaz, including eight deaths.

The Health Canada database includes adverse reports collected between 2007 and February 28, 2013.

The most common categories of adverse reports for both products are nervous system, vascular, and respiratory/thoracic/mediastinal disorders, but cardiac disorders were not infrequently listed. For Yasmin, cardiac disorders are listed as the primary system organ class in 4.1% of cases; for Yaz, that number was 6.6%.

The pills already carry a label warning that BCPs containing drospirenone--a synthetic progestin produced by Bayer--carry a risk of venous thromboembolism that is 1.5 to three times higher than seen with other birth-control pills. That estimate comes from a review Health Canada conducted in 2011; the agency issued a letter to physicians with its conclusions at the time.

The FDA added a warning to drospirenone BCP labels in 2012.

In response to media reports on these adverse-event reports, Health Canada has reiterated that adverse-reaction reports do not necessarily mean that the product caused the adverse event. The agency has issued a statement saying, "At this time, it is Health Canada's view that the benefits of Yaz and Yasmin continue to outweigh the risks, when used according to Health Canada's approved labeling instructions. Health Canada has been monitoring the safety of contraceptive pills on an ongoing basis, as it does for all drugs on the market, and is continuing to review the safety of all oral and non–oral hormonal contraceptives, including Yasmin and Yaz."

According to the Globe and Mail, the Society of Obstetricians and Gynaecologists of Canada is also urging against an overreaction [2]. "Adverse events are very different from attributable events, and [the latter] is the number you need," the Globe quotes Dr Jennifer Blake, the society's CEO. "We are advising that there are no new data and . . . that the pills are safe and effective."

In April, Canadian courts certified the first class-action lawsuit against Bayer on behalf of women taking Yaz and Yasmin; at least 13 other class-action suits are pending across the country. The Globe reports that Bayer's report to shareholders in 2012 indicated that it had paid out $1.2 billion in settlements in thousands of US lawsuits.

Bayer maintains the pills are safe and effective when used as directed.


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