FDA to Discuss Safety of Newer Forms of Birth Control

FDA to Discuss Safety of Newer Forms of Birth ControlOn Thursday, December 8, two U.S. Food and Drug Administration advisory panels are set to meet to weigh whether to recommend warnings about newer forms of oral contraceptives that may be linked to an increased risk for blood clots.

Both the Reproductive Health Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee will listen to presentations given by experts and the public, and will then relay their decision to the full FDA, which has historically followed the advice of its advisory panels.

The FDA will be reviewing certain oral contraceptives after health officials announced that new forms of the birth control measure, such as Bayer's Yaz or Yasmin, contain a newer form of the progestin hormone drospirenone, which has been linked to a higher risk of potentially dangerous blood clots in the legs and lungs than other forms of oral contraceptives.

According to the American College of Obstetricians and Gynecologists, contraceptives have been linked to many adverse health conditions, including heart attacks and stroke, gallbladder disease, and liver disease.

The FDA will also be looking into Johnson and Johnson's weekly Ortho Evra patch, which uses another version of progestin that has lately been under fire.

Medical experts have asserted that while the risk for clot remains low, it is prevalent enough to not be ignored.

"It's a low risk but the risk exists," said Dr. Tara Narula, a cardiologist at Lenox Hill Hospital in New York City. "The idea of the FDA looking at this and potentially increasing the warning has no downside. If anything, it increases awareness and that can only be a good thing."

The FDA review that initially prompted the upcoming meeting was first issued in October, when the agency studied more than 800,000 American women who took some form of birth control between 2001 and 2008. The study concluded that those women taking new forms of oral contraceptives showed a higher rate of clots than others.

The review also suggested the Ortho Evra patch and Merck's NuvaRing vaginal ring were linked to higher rates of clots.

Compared with women who did not take any form of birth control the risk of clot was three times greater in those who took older forms of the pill, and six times higher among those who took newer forms of oral contraceptives.