Ortho Evra Timeline

Ortho Evra Timeline Provided by the Birth Control Patch Law Firm
The timeline below includes major Ortho Evra® events, from FDA approval to the announcement of a new label that states the elevated risks of blood clots with the Ortho Evra® Patch.

November 20, 2001 – Ortho Evra® Birth Control Patch Receives FDA Approval

The FDA approves Ortho Evra®, the first birth control patch.

April 30, 2002 – Ortho Evra® Available by Prescription

The Ortho Evra® patch is offered by prescription as an alternative to the Pill. The patch is aggressively marketed toward younger women.

April 2002 – December 2004: Ortho-McNeil Receives 500 Reports of Serious Health Problems with the Birth Control Patch

Ortho-McNeil Pharmaceutical’s records reflect 500 separate incidents of serious health problems linked to the birth control patch reported directly to the company. During this period women suffer serious health problems associated with the birth control patch.

April 2004 – First Death Publicly Linked to the Ortho Evra® Birth Control Patch

An 18-year-old fashion student collapses in a New York subway station and dies on the way to the hospital after complaining of a headache and dizziness. An autopsy shows that she died from a blood. The medical examiner determined that the clot was a side effect of Ortho Evra®.

July 18, 2005: AP Report Shows Ortho Patch May Pose Health Risk

The Associated Press (AP) releases an investigative report that links the Ortho Evra® patch with an increased risk of blood clots and death. The news story also notes that Ortho-McNeil Pharmaceutical had been analyzing the FDA’s death and injury reports. It further cited a memo in which the manufacturer refused to fund a study in 2003 comparing the birth control patch with the pill because there was “too high a chance” that it “may not produce a positive result.”

November 10, 2005 – FDA Updates Labeling for Ortho Evra Contraceptive Patch

The Food and Drug Administration revises the Ortho Evra® label in order to highlight potential problems with the Ortho Evra® Patch. The new label warns that women who use Ortho Evra® are exposed to 60 percent more estrogen than women who take a typical birth control pill containing 35 micrograms of estrogen. An FDA press release notes that, in general, increased exposure to estrogen can raise a woman’s risk for blood clots.