Beasley, Allen, Crow, Methvin, Portis & Miles, P.C.

Public Citizen, an 80,000-member nonprofit organization dedicated to consumer advocacy, petitioned the FDA to ban Johnson & Johnson’s contraceptive patch Ortho Evra (ethinyl estradiol/norelgestromin). The organization requested complete removal of the contraceptive within 6 months.

Clinical data show that the Ortho-Evra patch carries greater risks compared to standard contraception in pill form without providing any real benefits. Public Citizen’s petition listed several reasons why the patch should be banned, including:

• Potentially toxic levels of synthetic estrogen, up to 60% more on average
• Greater variability in estrogen levels than standard oral birth control / inconsistent dosages depending on where on the body the patch is applied
• A substantially higher risk of blood clots: studies indicate that Ortho Evra users were twice as likely to develop venuous thrombosis – life-threatening blood clots in the leg that are fatal if they migrate to the lungs
• Higher risk of side effects such as breast discomfort, severe menstrual pain, nausea, and vomiting
• Higher than usual discontinuation rates; chances of women discontinuing usage due to side effects and irritation caused by wearing the patch are estimated at 50%
• The same results as oral birth control but with harsher side effects and greater risks

The consumer group also argues that a ban on the patch would be environmentally sound. Discarded patches, it notes, contain 80% of the original estrogen dose that threaten to leak and contaminate the environment after disposal.

The group concludes that if Ortho Evra were a pill, its side effects and greater risks would not be tolerated by the FDA.

This entry was posted on Thursday, October 2nd, 2008 at 1:34 pm and is filed under News. You can follow any responses to this entry through the RSS 2.0 feed. You can leave a response, or trackback from your own site.