According to U.S. regulators, the label for the Johnson & Johnson contraceptive patch will be updated to better inform users of the risks associated with the drug.
The label update has been prompted by a recent study that showed a higher risk of blood clots linked with Ortho Evra in comparison to other forms of birth control.
Risks Associated with the Patch
The U.S. FDA recently found that those who use the patch may be at greater risk for blood clots and other ailments than those who take the pill.
“Even though the results of the three studies are conflicting, the results from two of the studies support the FDA's concerns regarding the potential for use of Ortho Evra to increase the risk of blood clots in some women,” explained a statement issued by the agency.
New Findings
The newest study conducted analyzing Ortho Evra's risks involved a group of women between the ages of 15 and 44.
In conclusion to this study, researchers discovered that blood clots known as venous thromboembolisms (VTE) were twice as likely in the women using the patch compared to the women taking birth control pill.
Label Revision
The new label strongly encourages women using the patch to talk about the risks and their concerns with their doctors beforehand.
“Women should discuss with their health-care provider the possible increased risk of VTE with Ortho Evra, which is applied once a week,” suggests the FDA.
(Source: Reuters)
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