Ortho Evra and Blood Clots: consumer group urges Ortho Evra ban

consumer group urges Ortho Evra ban

October 2nd, 2008 by Kurt Niland

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.

Ortho Evra lawsuit settled for $1.25m as J&J tries to avoid public trials

Tags: birth control, estrogen, johnson and johnson, ortho evra

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