Birth Control Patch May Up Clot Risk
Finding Is Preliminary and Needs More Study, Experts Caution
'Fairly Unusual Events'
All hormonal contraceptives carry some degree of clotting risk, Shames says. He calls blood clots "fairly unusual events."
The FDA currently isn't seeking any changes in the patch's labeling, Shames says. He adds that last November, the patch's labeling was updated to note that its total estrogen exposure is about 60% higher than with oral contraceptives.
The clinical importance of higher estrogen exposure with the patch isn't known yet, Shames says.
"For some people, the patch may be better because some people don't reliably take the pill or they don't want to take the pill, or they forget the pill," he says. "The patch does offer them some alternative for contraception." On the other hand, Shames says the new findings need to be interpreted.
It's important to share new information on drug safety quickly, but that may mean releasing information before final analysis is done, Shames notes. "If there is a downside to being more transparent, this may be it," he says.
WebMD spoke with Sutel Pardanani, MD, of the obstetrics, gynecology, and women's health department at New York's Montefiore Medical Center.
"I think this data is very new," Pardanani says. "It's important to take this information in its context and really follow up the information in the next few months to see if this truly is a concern."
Pardanani encourages women using or considering the patch to talk to their doctors.
"I would actually have these women who are on the Ortho Evra patch to contact their physicians before this turns into a panic of sorts, just to discuss this risk," Pardanani says, stressing that women should remember that the facts aren't final yet, that all hormonal contraceptives carry clotting risk, and that no one is certain yet how the patch rates in that regard.
Discuss Risk Factors
Before using any hormonal contraceptive, women should discuss their risk factors with their doctors, Pardanani says. Those risk factors include smoking -- especially for women age 35 and older -- and family history of recurrent clots.
Pardanani also suggests that women report symptoms such as leg pain, chest pain, shortness of breath, or swelling or redness in either leg to their doctors. However, she cautions that clotting symptoms "may be even more subtle than that, so I would actually have the patient contact her physician to go through the whole list of things."