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FDA Expert Panel says Controversial Contraceptives Can Stay on the Market

Posted on December 14, 2011

An FDA expert panel considering the future of the Ortho Evra birth control patch recommended by a 19-5 vote Friday, December 9, that it should stay on the market provided the label more clearly states the risks. The patch contains norelgestromin/ethinyl estradiol which is worn for one week at a time, but carries with it a risk of blood clots. The patch is made by Johnson & Johnson’s Janssen division using a synthetic form of progesterone in an easy-to-use patch. Estimates inidcate there will be three venous thromboembolism (VTE) events for every 10,000 women using the patch.

This is the same panel that decided 15-11 the day before that the contraceptive pills Yaz and Yasmin should stay on the market because the benefits outweigh the risks of VTE. Those pills contain drospirenone, which the patch does not, but is also associated with VTE. Yaz and Yasmin are sold by Bayer AG and are top-selling contraceptives, reports Fair Warning, despite agency findings that women taking Yaz and Yasmin risk a 75 percent higher chance of suffering a blood clot.

Bayer denies there is any additional risk presented by the birth control pills, but Bloomberg reports that a former FDA commissioner, David Kessler, said in unsealed documents that Bayer withheld company findings of additional blood clots in users. Those documents were released by lawyers representing women harmed or killed after using Yaz and Yasmin who are suing Bayer.

The expert panel said the patch’s label needs to more clearly lay out the risks even though the label has been changed three times since 2005 to increase the warning. Earlier this year, the FDA added a black box warning, which is the strongest warning that can be added to a prescription medication in this case concerning an additional risk of blood clots.

The FDA does not have to follow the recommendation of its expert panels, but it generally does. If you have suffered adverse health problems due to a dangerous medical drug, the Florida dangerous drug lawyers of Farah & Farah can help. Please call (800) 670-1464 for a consultation with one of our experienced attorneys.

Source: http://www.medpagetoday.com/OBGYN/Pregnancy/30139?utm_content=&utm_medium=email&utm_campaign=DailyHeadlines&utm_source=WC&eun=g399493d0r&userid=399493&[email protected]&mu_id=’ ;http://www.fairwarning.org/2011/12/fda-advisers-want-straight-talk-about-risks-on-labels-for-birth-control-pills/