A new study found that Ortho Evra, which has been called the 'The most dangerous contraceptive on the market', carries a higher risk for blood clots than oral contraceptives.
As a result of the new study, Ortho-McNeil, the manufacturers of Ortho Evra, sought and gained FDA approval to update the warning label.
(For some background, see my article on the numerous lawsuits and claims against Ortho-McNeil, manufacturers of the patch. )
This isn't the first study which found an increased risk of VTE among patch users. The study "Venous Thromboembolism, Myocardial Infarction, and Stroke Among Transdermal Contraceptive System Users," (PDF) published in the February 2007 issue of Obstetrics & Gynecology, found more than a two-fold increase in the venous thromboembolism rate among patch users compared with norgestimate-containing oral contraceptives
It will be interesting to see if Public Citizen petitions the FDA to ban the patch, as they previously did with third generation oral contraceptives (OCs).
After the 2007 study was released, I contacted Frits Rosendaal, MD, co-signer of Public Citizen's petition and an internationally known expert on Venous Thromboembolism (VTE), to get his opinion on it. His reply to my inquiry:
"I am not convinced that the patch is in fact less safe than oral contraceptives with a similar dose of oestrogen"
I wonder if the new study will convince him that the patch is not safer than OCs, and that it should be banned along with third generation pills?
Finally, it's time for the FDA to step in and request a recall or demand a withdrawal of Ortho Evra. A possible reason why this hasn't been happened yet is that the FDA considers blood clots to be 'acceptable risks' of hormonal contraception. I'm not sure the parents of 14 year old Alicya Brown, who is alleged to have died as a result of using Ortho Evra, agree that the risk is acceptable.
More Resources:
Read the Ortho-McNeil-Jannssen Pharmaceuticals Inc. press release on the updated Ortho Evra prescribing information here.
Ortho Evra is Harmful website
http://www.ortho-evra-deaths.com
Jill Stanek - BC patch prey
h/t: Jill Stanek
