Ortho Evra Recall Urged by Public Citizen

Public Citizen, a national consumer advocacy group, filed a petition with the FDA today on behalf of more than 80,000 individuals throughout the United States. They are asking the FDA to recall the Ortho Evra birth control patch within six months due unreasonable risks of blood clots and other serious injuries.

Ortho Evra is a birth control patch manufactured by Johnson & Johnson. The consumer group has pointed out to the FDA that when it is compared with birth control pills, Ortho Evra side effects result in:

• 60% more estrogen on average exposure;
• Greater variability in estrogen levels
• A possible two fold increased risk of venous thrombosis, such as blood clots of the leg which can travel to the leg and cause death (pulmonary embolism)
• Increased risk of side effects such as breast discomfort, severe menstrual pain, nausea and vomiting
• A 50% increased likelihood of discontinuing the contraceptive therapy
• No improvement in birth control outcomes.

The petition points out that during pre-trial discovery in Ortho Evra lawsuits being pursued by women who were injured or killed after using the birth control patch, information has been released that shows Johnson & Johnson knew about problems with the patch before it was ever approved by the FDA. Previously unpublished studies have been turned over during the Ortho Evra litigation which indicate that the manufacturer was aware that higher levels of estrogen could be provided and that there was a greater variability in estrogen delivery.

Johnson & Johnson argues that the patch is a more convenient method of delivering birth control and results in better compliance, since daily pills can be missed. However, data indicates that there is no difference in the number of patients who end up getting pregnant while on the patch as compared to the pill.