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Ortho Evra Side Effects

The Associated Press report concerning Ortho Evra side effects suggests that the birth control patch is riskier than an oral contraceptive. Using FDA data obtained under the Freedom of Information Act, the report indicates that in 2004 - when 800,000 women were on the patch-the risk of dying or suffering a survivable blood clot while using the device was about three times higher than while using birth control pills. Raw data indicated that about a dozen young women who used Ortho Evra in 2004 died from blood clots, and the FDA data showed that dozens of other young women survived strokes and other clot conditions after using the patch.

The women who suffered lethal Ortho Evra side effects were mostly in their teens and early 20's and apparently at low risk for blood clots. A women who is younger than 35 is very unlikely to get a blood clot, with her risk being between two and five in 100,000. While some doctors reviewing the FDA reports at the request of the AP were shocked with the results, other doctors said the Ortho Evra side effects are warranted considering the high use rate of the devices.

Ortho McNeil, the maker of Ortho Evra, said none of the deaths could be directly attributed to Ortho Evra. Women concerned with reports of Ortho Evra side effects risks were told not to overreact without first talking to their individual doctors, but other safety experts believed the Ortho Evra side effects were a consequence of the FDA approving drugs after trials with only a few thousand users and failing to require post approval studies to ensure safety.

The AP said an FDA medical reviewer recommended a post release study of Ortho Evra's safety at the time of its approval in November 2001, but the FDA did not mandate one. If there are serious Ortho Evra side effects, it should not be surprising that they are surfacing now, according to critics. Because the patch is a new delivery system, any potential Ortho Evra side effects will not emerge until the drug reaches the general market.

The FDA's reporting system is voluntary and has other deficiencies, so drawing reliable conclusions about Ortho Evra side effects risks is difficult. Ortho McNeil called the data quoted in the AP report as "misleading" because they are based on spontaneous reports that are called in voluntarily. The National Women's Health Network wrote to the FDA following news about possible increased Ortho Evra side effects risks, urging the agency to conduct a study to look at the risk of blood clots associated with the use of the birth control patch. Even if it failed to establish causality between side effects and the patch, the group believed the risk of blood clots associated with the use of Ortho Evra should be further investigated.

Ortho Evra has enjoyed booming sales ever since its arrival to the U.S. market, and is currently used by tens of thousands of American women. The Ortho Evra side effects concerns are the latest example of the FDA needing safety reforms to give greater authority, independence and resources to the agency's post-market safety monitoring system. The fact that an FDA medical reviewer recommended a study to better determine Ortho Evra side effects risks at the time of its approval but that this study was not required by the agency is, according to some critics, further evidence of pervasive deficiencies in drug safety.

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