• Home
• Defective Drug Index
• About A Drug Recall
• Contact A Defective Drug Lawyer

We Can Help.

FDA warning for Birth Control Patch

–November 14, 2005

On Thursday, 10 November 2005, the FDA announced that all information for the Ortho Evra birth control patch will now include a warning label about serious potential side effects. Ortho Evra, made by Ortho McNeil, is a contraceptive patch used by more than five million women since aggressive marketing of the drug began in 2001. Research indicates that women who use Ortho Evra are at a greater risk of developing blood clots and other serious side effects.

The new FDA-mandated Ortho Evra warning states women using the birth control patch receive 60 percent more estrogen than women taking the typical birth control pill containing 35 micrograms of estrogen. According to the FDA, higher levels of estrogen exposure increase the risk of developing blood clots. Prior to this announcement, the makers of Ortho Evra insisted that their product did not pose a greater risk of side effects than the pill.

Ortho McNeil adamantly denied claims of increased Ortho Evra risks after the Associated Press published information about injuries and deaths linked to Ortho Evra earlier this year. Four months ago, the Associated Press announced that women using Ortho Evra tripled their risk of developing blood clots and other serious side effects. The report disclosed information about dozens of women who developed blood clots and other complications while using the birth control patch. Many of these healthy women were in their 20s and 30s when they began using the patch. Tragically, at least a dozen women have died from serious Ortho Evra side effects.

Ortho McNeil says they have updated their website (operated by parent company Johnson & Johnson) to include Ortho Evra warning information. The company plans to disseminate this information to the medical community immediately. The company still maintains the patch is safe and effective when used appropriately, but may not be suitable for all women. Women who are using the Ortho Evra patch are urged to speak with their doctor about the new Ortho Evra warning before deciding to continue or terminate Ortho Evra use.

Lawsuits have already been filed on behalf of women who have been seriously injured by the Ortho Evra birth control patch. Attorneys say more Ortho Evra lawsuits will be filed in the near future. If you or a loved one has suffered serious side effects caused by Ortho Evra, you may wish to contact an experienced lawyer to learn more about your legal rights and options.

 More Recent Defective Drug News