US panel urges stronger labels on Yaz birth control

9th December 2011, Comments 0 comments

A panel of experts that advises the US Food and Drug Administration has urged stronger labeling on birth control pills such as Bayer's Yaz that have a shown a higher risk of blot clots.

Results of the 21-5 vote released late Thursday showed that most panel members found the current labels did not adequately reflect the risks and benefits.

The panel was divided on the question of whether the benefits of such pills outweigh the risks, with 15 saying "yes" and 11 saying "no."

At issue were pills that contain drospirenone, which studies have found carry a higher risk of blood clots than another type of progestin known as levonorgestrel.

Some brand names include Yaz, Yasmin, Beyaz, Ocella, Loryna, Gianvi, Safyral, Syeda and Zarah.

Many have been marketed on the basis they help alleviate premenstrual symptoms, reduce acne and cause less weight gain than competitors.

The pills have been the focus of numerous lawsuits, including one lodged earlier this year on behalf of a teenager who died from a blood clot allegedly linked to the German chemical and pharmaceutical company Bayer's Yaz contraceptive.

Two studies out this year in the British Medical Journal found that drugs like Yaz and Yasmin increase the risk of serious blood clots three-fold or two-fold compared to earlier-generation oral contraceptives.

The official Yaz website says the drug is associated with "increased risks of several serious side effects, including blood clots, stroke, and heart attack."

The European Medicines Agency concluded on May 27 that such birth control pills carry a higher risk of venous thromboembolism and that warning labels should be updated accordingly.

However, it noted the overall risk of blood clot from any birth control method remains small and stopped short of advising women to stop taking pills containing drospirenone.

Yaz is the second biggest selling product made by the German pharmaceutical giant Bayer, with $1.56 billion in global sales.

The FDA does not have to follow the advice of the advisory panel but it usually does.

© 2011 AFP

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