Ortho Evra
Ortho Evra Timeline
November 20, 2001—The Food and Drug Administration approves the Ortho Evra birth control patch, a 1 ¾-inch adhesive patch that releases estrogen and progestin into a woman’s body.
April 30, 2002—Ortho Evra, developed by Johnson & Johnson and made by Ortho-McNeil, goes on the market . It is the first birth control patch approved by the FDA.
April 2002-December 2004—About 28,000 reports of birth control patch side effects.
November 2003—A Las Vegas gynecologist reports that the Ortho Evra birth control patch is the most popular form of birth control among her patients.
October 2004—An investigation discovers that the FDA has logged more than 9,000 reports of adverse reactions to the Ortho Evra birth control patch in a 17-month period.
April 2005—An 18-year-old college student collapses and dies on her way to the hospital after suffering headache, dizziness and pain in her leg; an autopsy would show that a blood clot had moved to her lung, and the medical examiner determines that it is an Ortho Evra birth control patch side effect. This is the first death publicly linked to the Ortho Evra birth control patch.
July 16, 2005—The Associated Press publishes an article stating that women who use the Ortho Evra birth control patch are three times as likely to suffer blood clots as those using birth control pills. It indicates that 12 young women died in 2004 from blood clots linked to the Ortho Evra birth control patch.
August 2005—The first nationwide class action lawsuit is filed against Ortho-McNeil and Johnson & Johnson for injuries caused by the Ortho Evra birth control patch.
November 10, 2005—The FDA, noting that the Ortho Evra birth control patch gives women 60% more estrogen than do birth control pills, warns Ortho Evra users about risks of blood clots. A “black-box” warning is added to the Ortho Evra birth control patch label.
2005—More than 9.4 million prescriptions written for the Ortho Evra birth control patch.
January 2006—Seven Ortho Evra lawsuits filed against Johnson & Johnson in one day.
April 2006—The Ortho Evra birth control patch is still selling well despite FDA warnings and news reports about its increased dangers of blood clots, stroke and heart attack.
September 20, 2006—The FDA updates the Ortho Evra birth control patch warning label after a study shows that women using the patch are twice as likely to suffer serious blood clots.
February 2007—The i3 Drug Safety Group finishes its study involving 98,000 women who used transdermal contraception (such as Ortho Evra) and 250,000 who used the pill. The study, published in Obstetrics & Gynecology, confirms that those using the patch are more than twice as likely to suffer blood clots.
