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Group urges contraceptives ban

The consumer advocacy group Public Citizen has sent a petition to the Food and Drug Administration urging the agency to ban third-generation birth control pills

The consumer advocacy group Public Citizen has sent a petition to the Food and Drug Administration urging the agency to ban third-generation birth control pills, such as Barr's Mircette and Orgnanon's Cyclessa, and has also launched an online campaign aimed at getting consumers to stop using the pills.

Public Citizen believes that the newer birth control pills, which contain the ingredient desogestrel, carry too great a risk of dangerous blood clots.

The pills present an ìapproximately doubled risk of venous thrombosis (30 cases for every 100,000 users per year of third generation oral contraceptives compared to 15 cases for every 100,000 users of second generation oral contraceptives),î the group wrote in its petition. In addition, the petition points to a ìlack of evidence of clinical benefitî compared with older contraceptives.

Along with Mircette and Cyclessa, the list of desogestrel-containing pills includes Desogen (Organon), Velivet (Duramed), Apri-28 (Duramed/Barr), Kariva (Duramed/Barr), Ortho-Cept (Ortho-McNeil) and Reclipsen (Watson).  According to Public Citizen, about 7.5 million prescriptions for the pills are filled each year.

"By banning third-generation oral contraceptives, the FDA will potentially save hundreds of young women a year from developing venous thrombosis and its disabling and sometimes fatal consequences," according to the document, which is signed by Sidney M. Wolfe, MD, director of Public Citizen's Health Research Group; two of the group's research analysts; and Frits Rosendaal, MD, a  professor of clinical epidemiology at the University of Leiden Netherlands who has published papers on the link between the contraceptives and blood clots.

Public Citizen's grassroots campaign centers around a Web site, www.notmypill.org, that warns women about the risk of blood clots and urges them to spread the word to their friends and to contact the FDA to demand a ban.

One feature of the site asks visitors to create a YouTube video about why the issue is important to them and submit it to notmypill.org. Selected videos will be available for viewing on the site. Currently, the site highlights a video showing one young women stating that the newer pills offer ìa new, improved chance of death,î and another complaining that the healthcare industry does not adequately educate women about birth control pills.

The site also offers pre-worded e-mails that visitors can send to friends and to the FDA. The Tell-a-Friend e-mail states: ìApparently the FDA has known for 12 years that some kinds of birth control put women at twice the risk of blood clots and yet they still allow them to remain on the market.î

The pills' manufacturers did not return calls requesting comment by deadline. The FDA told Reuters that it has received the petition but had not yet reviewed it.

7th February 2007

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