Prompted By Investigation Into Death Of Young Woman Who Died While Using Yaz; Results Of Analysis Expected In Late October 2009

(Posted by Tom Lamb at DrugInjuryWatch.com)

In late September 2009 we learned that the Swiss drug safety oversight regulator, Swissmedic, was investigating a possible link between the use of Yaz and a fatal pulmonary embolism (PE) suffered by a young woman in Switzerland earlier that month.

From the September 25, 2009 Reuters article, "Bayer contraceptive probed over possible death link":

Swiss medical authority Swissmedic said on Friday it was investigating suspicions of a possible link between the death of a woman from a blood clot 10 months after she was prescribed Bayer's low-dose oral contraceptive, Yaz….

Nine deaths in Switzerland since 1990 have been connected with oral contraceptives, according to Swissmedic. The authority said it began investigating all birth control pills after a 16-year-old was disabled by a lung embolism in May after taking Yaz.

Bayer launched Yaz last year in Europe, two years after it began selling it in the United States.

The drug company confirmed that the Swissmedic agency and an investigative judge are looking into the case of this young woman in a statement posted on Bayer AG's Swiss health unit's German language web site on September 25, 2009.

That same day, Swissmedic also posted a statement about the unexpected death of this young woman while using on Yaz on its German language web site.

As part of its investigation into the circumstances of this young woman who died while using Yaz in Switzerland during September 2009, the Swiss regulators will do an analysis regarding the overall safety of drospirenone-containing contraceptives, i.e., Yaz, Yasmin, and Ocella.

In particular, according to the September 25, 2009 Swissmedic statement, the agency will consider two recent studies which suggested that Yaz may have a higher risk of blood-clot complications than older birth control pills.

Those two articles, which were published August 13, 2009 by the medical journal BMJ, are:

• "The venous thrombotic risk of oral contraceptives, effects of estrogen dose and progestogen type: results of the MEGA case-control study"; and,

• "Hormonal contraception and risk of venous thromboembolism: National follow-up study".

Lastly, the September 2009 Swissmedic statement concerning this possible Yaz-related death due to pulmonary embolism (PE) said that the results of its Yaz safety analysis is expected in late October 2009.

We will be watching for news of the Swissmedic findings about Yaz and will report it as soon as possible here at Drug Injury Watch.

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