Group wants Ortho patch withdrawn

We've all heard the safety warnings [1] about the Ortho-Evra birth control patch and its link to life-threatening blood clots. The FDA has updated the Johnson & Johnson drug's labeling three times to notify about the risks, including once early this year. And demand for the patch has dropped to 2.7 million prescriptions in 2007 from 9.9 million in 2004. But Public Citizen isn't satisfied. It wants the patch taken off the market completely.

In a petition to the FDA, the consumer advocacy group argued that the patch doesn't offer better contraception to outweigh the extra risk of blood clots. And it alleges that plaintiff's lawsuits have uncovered two unpublished studies by J&J researchers, who found higher estrogen exposure from the patch even before it won agency approval in 2001.

Johnson & Johnson defended its product, saying it's safe and effective when used according to its labeling. The agency had no comment because it hadn't yet reviewed the petition.

- read the New York Times article [2]

Related Articles:
If J&J misled FDA, can patients sue? [3]
FDA issues warning for Ortho Evra patch [1]
Patch delivers killer doses [4]