-January 25, 2008
The FDA recently approved additional changes that were requested for the labels of the Ortho Evra Contraceptive Transdermal (Skin) Patch.
The new labels will include results from a recent epidemiology study, which revealed that those using the birth control patch are at higher risk of developing blood clots than those using birth control pills.
Study Conducted on Patch
The study which prompted the label change was conducted by the Boston Collaborative Drug Surveillance Program (BCDSP).
The study analyzed the effects of the patch on women ranging in age from 15-44.
In conclusion to the study, researchers found that women taking the Ortho Evra patch were at higher risk for developing serious blood clots, also known as venous thromboembolism (VTE).
“This is an example of FDA working in tandem with the drug manufacturer to keep the public informed of new safety data and epidemiology studies that may impact health decisions about the use of FDA approved products,” explains Janet Woodcock, the FDA’s deputy commissioner for scientific and medical programs.
Ortho Evra Risks
The FDA revised the label for Ortho Evra once before in September 2006 to warn women of the potential risk of VTE.
Ortho Evra is a birth control patch that releases hormones into the blood stream through the skin as opposed to being digested in pill form.
Since the hormones are processed differently when received through the skin, women using the patch are typically exposed to 60 percent more estrogen than if they were using other forms of birth control.
(Source: FDA)
Have you been harmed by using the Ortho Evra Patch? If so, please contact us to speak with an experienced attorney who will enable you to be compensated for any harm done.
