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: Tennessee Law BlogOrtho Evra Injuries ? Dangerous Drug Warning
Ortho Evra contraceptive patch users should be aware of injuries caused by the transdermal (skin) birth control patch. FDA investigations have revealed Ortha Evra contraceptive users have a significantly higher risk of developing serious blood clots (aka ?venous thromboembolism? or VTE) than women taking oral contraceptives. Ortha Evra patch-caused VTE can lead to serious injury or sudden death from pulmonary embolism.
FDA has modified the prescription information for Ortho Evra after the release of the independent study of women ages 15-44. This drug safety study confirmed earlier safety studies showing the VTE dangerous side effect of Ortho Evra contraceptive patches.
Ortho Evra contraceptive patches have been under safety investigation for VTE and other side effects since the patch?s approval in 2001. Previous studies have shown women taking the contraceptive patch have twice the risk of developing VTE than women using birth control pills. This dangerous side effect appears to be caused by the patch?s birth control hormones which expose patch users to about 60 percent more estrogen than those who take oral birth control pills.
FDA officials have taken no other action than this label change announcing the results of this study.
If you or a loved one has suffered an Ortho Evra side effect injury, contact Nashville?s esteemed drug injury attorney Jim Higgins for a free consultation. Call toll free 1.800.705.2121 or fill out HHP's contraceptive patch injury form.
Full post as published by Tennessee Law Blog on January 25, 2008 (boomark / email).
Public Citizen Wants Ortho-Evra GONE…
Washington, DC: The push to get what many believe is a dangerous product off the market got a helping hand yesterday when Public Citizen petitioned the US Food and Drug Administration (FDA) to pull the Ortho-Evra contraceptive patch off the market.
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The Ortho Evra contraceptive patch has been used by many young women who unfortunately have developed clot related injuries. Some users have had strokes, heart attacks, pulmonary embolisms or deep vein thrombosis as a result of using this product...
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Amarillo, TX: In yet another example of a drug earning approval in the face of dissenters, the Ortho Evra birth control patch was approved by the US Food and Drug Administration (FDA) in 2001 despite strong opposition from one of the agency's own medical reviewers.
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Just recently, the FDA changed the warnings on the Ortho Evra birth control patch yet again. This time the agency updated the warnings to include the results of a new study. This new study showed that users of the Ortho Evra patch are twice as likely to develop blood clots known as thromboembolism (VTE)...
Mother warns daughter Never to Use the Ortho Evra Patch
Chandler, AZ: Tania used the Ortho Evra birth control patch for 9 months without incident—the only complaint she had was "unusual bleeding" but her doctor said that was normal. But then her knee started to hurt and during the next few months, Tania saw 3 doctors, none of whom made the link between the Ortho Evra patch and deep vein thrombosis (DVT).
Doctor Blamed Ortho Evra Patch for Aneurysm
Queensbury, NY: Brenda S. started using the Ortho Evra patch in March 2005 and she had an aneurysm in January 2007. Now she wants to know how the manufacturer--Johnson and Johnson subsidiary Ortho McNeil-- can say that Ortho Evra's benefits outweigh the dangers? "Why would anything be marketed that could possibly be a risk to someone's health, or even kill them," says Brenda, "and where is the FDA?
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