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 Ortho Evra (ethinyl estradiol/norelgestromin). The organization requested complete removal of the contraceptive within 6 months.

Clinical data show that the Ortho- carries greater risks compared to standard contraception in pill form without providing any real benefits. Public Citizen’s petition listed several reasons why the 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 is applied
  • A substantially higher risk of : studies indicate that users were twice as likely to develop venuous thrombosis – life-threatening 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 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 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 were a pill, its side effects and greater risks would not be tolerated by the FDA.

blog comments powered by Disqus

Comments are moderated and generally will be posted if they are on-topic and not abusive.