Ortho Evra Recall Requested By Public Citizen Due To Blood Clot Risks

Women Have Developed Serious Side Effects Like Deep Vein Thrombosis (DVT) and Pulmonary Embolism (PE) After Using This Birth Control Patch

(Posted by Tom Lamb at DrugInjuryWatch.com)

On May 8, 2008 Public Citizen's Health Research Group (HRG) sent its "Petition to the FDA to Ban Ortho-Evra" to Commissioner Andrew von Eschenbach.  In this 11-page letter, Sidney Wolfe, M.D., the Director of HRG, discusses the increased risk of blood clots and serious side effects associated with Johnson & Johnson's Ortho Evra birth control patch, sometimes referred to simply as "the Patch".  In summary, Dr. Wolfe points out:

Compared to standard 35 microgram estrogen/progestin oral contraceptives, Ortho-Evra results in:

• 60% more estrogen on average exposure;
• greater variability in estrogen levels;
• a possible two-fold increased risk of venous thrombosis (typically, painful blood clots of the leg which can travel to the lungs and cause death)....

This May 2008 Petition concludes with a request for a "gradual recall" of the Patch:

Public Citizen therefore requests a six-month transition period in which  Ortho-Evra will be available for refill prescriptions to allow women time to meet with their healthcare provider and seek an alternative contraceptive method.

A May 8, 2008 Reuters article, "US Group wants FDA to pull J&J birth control patch", summarily presents the long-standing FDA and drug company positions as regards this allegation by Public Citizen that Ortho Evra is unsafe and, therefore, the Patch should be removed from the market:

The FDA has said the chance of developing a clot is low. For every 10,000 women who use hormonal contraceptives for one year, some three to five of them will develop a clot, the agency has said.

Ortho Women's Health & Urology, the J&J division that makes the contraceptive patch, has said its patch has risks and benefits like all hormonal contraceptives.

We will look for what the FDA and J&J have to say, if anything, about this May 2008 Ortho Evra Petition from Public Citizen in the days to come.