Mark & Associates, P.C. Attorneys At Law

Ortho Evra Timeline

Pre-approval

The FDA medical review expressed concerns about Ortho Evra causing venous thromboembolisms and noted the need for post-marketing surveillance for Deep Venous Thrombosis and Pulmonary Embolism.  There were two blood clot-related deaths in Phase III clinical trials for Ortho Evra that were submitted to the FDA in 2000.

November 20, 2001

Ortho Evra is the first adhesive transdermal birth control patch approved by the FDA.

April 2002

Ortho Evra goes on the market.

November 10, 2005

The Food and Drug Administration approved updated labeling for Ortho Evra to warn that the patch exposes women to higher levels of estrogen than most birth control pills. Ortho Evra was the first skin patch approved for birth control.

April 2005

A New York student collapsed and died in a subway station due to a clot blamed on Ortho Evra.  

July 2005

Data obtained by the Associated Press under the Freedom of Information Act is released in an investigative report that, for the first time, notifies the public of Ortho Evra’s risks.  The AP noted that before Ortho Evra’s approval, the FDA had already noticed nonfatal blood clots from the patch were three times that of the pill. The AP also found that deaths since the patch came on the market also appeared to be at least three times as high.  For young nonsmokers, the chance of developing nonfatal blood clots on oral contraceptives is 1 to 3 in 10,000, and the chance of dying from a blood clot on oral contraceptives is 1 in 200,000.  But the AP found that with the patch, nonfatal blood clot risk was 12 in 10,000, and the death rate 3 in 200,000.  Ortho McNeil said that the AP misinterpreted the clinical and adverse event data.

September 20, 2006

The results of a new study are released confirming previous data showing an increased risk of blood clots associated with Ortho Evra versus oral contraceptives.  The study found that women using Ortho Evra were twice as likely to develop blood clots.

September 23, 2006

As a result of a new study, the FDA warns women about the higher risk of developing blood clots associated with Ortho Evra versus oral contraceptives.

February 2007

A study published in Obstetrics & Gynecology found that women who use transdermal contraceptive patches such as Ortho Evra may be more than twice as likely to develop blood clots / thromboembolism as those taking oral contraceptives. The i3 Drug Safety Group / Ingenix study compared 98,000 women who used transdermal contraceptives to 250,000 who used oral contraceptives.