Yasmin Side Effects Led to Warning from FDA

Washington, DCA Food and Drug Administration (FDA) advisory committee reportedly recommended increasing the warning on birth control pills, as the Yasmin side effects prompted the agency to act, according to Consumer Reports.

The news outlet reported that this recommendation came on the heels of the agency's recently released analysis that showed the drugs pose a more significant risk of blood clots compared to older birth control pills.

The FDA acknowledged that other studies concerning the medication have not found such an increase in the chance of blood clots, but suggested continued research on the matter should be conducted.

According to Consumer Reports, most birth control pills combine two types of hormones: estrogen and a progestin. Newer drugs, however, pair estrogen with drospirenone, a synthetic hormone that may minimize the side effects such as fluid retention, breast tenderness, weight gain and increased blood pressure.

The news source reported that the use of any combination birth control pill increases the risk that a blood clot may form in a deep vein of the leg. But overall, the risk of this is relatively small, as between nine and 10 women in 10,000 per year are affected, compared to about 0.5 to three women who do not take any birth control pills.

Though these studies showed only a small increase in the risk of blood clots, the FDA and an analysis of the evidence conducted for Consumer Reports by the American Society of Health-System Pharmacists asserted that this research had problems.

According to the news source, most studies did not consider all risk factors that the subjects may have had for venous thromboembolism (VTE), and some failed to identify the types of pills used in the comparison group or confirm diagnoses of VTE.

Everyday Health reported that the studies also didn't take into account risk factors like smoking and family history.

"These drugs got our attention when they hit the market [in 2006]," said Marcelle Pick, RNC, an ob-gyn nurse practitioner at the Women to Women Clinic in Yarmouth, Maine. "We were all pretty excited about them. Now we need to step back and say, 'Wait a minute—they aren't quite what we thought they were.'"