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.

Other News

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  • Metal Hip Manufactures Asked to Provide Patient Data

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  • Jury Orders Allergan to Pay $212 Million in Botox Case

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  • Drug Manufacturers to Discontinue Infant Drops of Key Medicine

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  • Bisphosphonates Linked to Bone Fractures: Study

    Findings from a new Swedish study reveal that osteoporosis drugs known as bisphosphonates increase the risk of getting unusual thigh bone fractures, as experts have suspected, according to a recent WebMD news article. But these fractures are infrequent and the risk is small the study shows. When correctly prescribed, the overall benefit of the drugs preventing all types of fractures outweighs the risk of getting the unusual fractures, says study researcher Per Aspenberg, MD, PhD, a professor of orthopaedic surgery [...]

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  • Babies Heart Defect linked to Crude Oil Chemical Exposure

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  • Toyota Announces New Floor Mat Interference Recall

    Once again, Toyota owners are being affected by a new recall due to floor mat interference. Presently, Toyota Motor Corp. is facing hundreds of lawsuits in the United States form vehicle owners or families who suffered personal injuries, wrongful deaths, or suffered financial losses, as a result of sticky gas pedals and floor mat interference, which may causes sudden unexpected acceleration. Since the end of 2009, Toyota has recalled nearly 4 million vehicles in the United States due to sticky [...]

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  • Lawsuit over Seat Belts Can Proceed

    According to a recent Reuters news report, The U.S. Supreme Court ruled that federal regulations setting vehicle safety standards do not bar lawsuits seeking damages from automakers for installing lap-only seat belts. The unanimous ruling held that a California lawsuit against Mazda Motor Corp over a fatal 2002 collision involving a 1993 Mazda minivan can proceed. A passenger sitting in a rear seat and wearing a lap-only seat belt was killed. The lawsuit by the family of the passenger claimed [...]

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