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Potential Side Effects
Ortho McNeil has been accused of failing to adequately warn consumers about life threatening Ortho Evra side effects, such as deep vein thrombosis and pulmonary embolism.
Ortho Evra defects have received widespread consumer concern since the publication of a study indicating birth control patch users are three times more likely to suffer fatal vascular side effects than women taking oral contraceptives.
Patients who experience any unusual or unexplained Ortho Evra symptoms may wish to speak with their physician in greater detail to ensure that these symptoms do not indicate a more serious health condition. Ortho Evra is a birth control patch that was approved by the FDA in 2001. Like all hormonal contraceptives, there are some common Ortho Evra symptoms that, though they may cause some discomfort, do not indicate a more serious problem.
In clinical trials, between nine and twenty-two percent of all patch users experienced one or more of the following Ortho Evra symptoms: breast changes, headache, skin patch site reaction, nausea, menstrual cramps, abdominal pain, and upper respiratory infection. Ortho Evra symptoms may also include significant emotional lability. Generally speaking, these Ortho Evra symptoms should be discussed with your health care professional but typically do not indicate more serious health problems.
There are however, Ortho Evra symptoms that may indicate a more serious complication. Studies have found the Ortho Evra patch may triple a user’s risk of developing serious and potentially fatal cardiovascular complications. The following serious and life threatening conditions have been associated with use of hormonal contraceptives: deep vein thrombosis, pulmonary embolism, heart attack, high blood pressure, and more.
A slight increase in blood clot and related risks has long been associated with use of oral contraceptives, but recent studies have suggested that these risks may be drastically increased for patients using the Ortho Evra birth control patch. The exact link between Ortho Evra use and blood clot and related complications remains unclear.
The deaths of at least 23 women have been linked to Ortho Evra risks, 17 of which were caused by blood clot complications. Most of these Ortho Evra users were young and healthy with no history of cardiovascular conditions or risk factors. The Ortho Evra symptoms these women reported, if able, before dying included: severe headache, blurry vision, vomiting, and nausea.
Ortho McNeil, the makers of Ortho Evra, state they are currently investigating the link between Ortho Evra and serious life threatening side effects. Some experts believe Ortho McNeil discovered Ortho Evra symptoms associated with serious cardiovascular complications before the drug was approved. These critics allege that Ortho McNeil failed to adequately warn consumers about serious potential risks associated with their product.
While the exact link between Ortho Evra and serious injury and death remains unknown, some medical experts speculate that the patch’s delivery system is responsible for these increased risks. With oral contraceptives, hormones are processed through the digestive system before entering the bloodstream, but with Ortho Evra, estrogen and progestin are absorbed directly into the blood stream. Because the patch’s delivery system is so new, safety experts believe higher reports of Ortho Evra symptoms are the result of the device’s widespread use. If you would like to learn more about Ortho Evra symptoms and side effects, please contact us to speak with a qualified and experienced attorney.