The FDA approved new changes to Ortho Evra Contraceptive Transdermal Patch’s label on Friday, January 18. The label will include the results of a study that found that users who use the birth control patch are at a higher risk of developing blood clots, or known as venous thromboembolism (VTE), than for women who use birth control pills.
The study was conducted on women from 15-44 and illustrated the same results as previous studies.
In September 2006, FDA revised the label for Ortho Evra to warn women of the risk of VTE based on two epidemiology studies. One study, conducted by i3 Ingenix, showed that some women using the patch were at a two-fold greater risk of developing VTE. The other study, conducted by BCDSP, showed they were not at increased risk compared to women using birth control pills containing 30-35 micrograms of estrogen and the progestin norgestimate.
Ortho Evra is a prescription patch that releases an estrogen hormone and a progestin hormone through the skin into the blood stream. Women using this product will be exposed to around 60% more estrogen than those who use regular birth control pills containing 35 micrograms of estrogen. Increased levels of estrogen can increase the risk of side effects such as VTE. The FDA believes that Ortho Evra is safe and effective when used according to the labeling, which states that women with concerns or risk factors for blood clots should talk with their doctor about using Ortho Evra.
For more information on this subject, please refer to our section on FDA and Prescription Drugs.