FDA cites safety concerns over specific class of oral contraceptives

Bayer’s Yaz and Yasmin, two popular brands of birth-control pills that contain drospirenone (a synthetic progestin), are currently under investigation by the FDA, the agency announced Tuesday. After two recently published studies found that drospirenone-containing oral contraceptives increase a woman’s risk of venous thromboembolism (VTE) by two- to three-fold, the FDA said they will initiate a safety review of the risks and benefits of these birth-control pills.

It should be noted, says ACSH’s Dr. Gilbert Ross, that all birth-control pills increase the risk for blood clots, but “this uptick in risk is minuscule in non-smoking, younger women. For women who are older, or for those who smoke or are hypertensive, there is a significantly increased risk of VTE while on the pill.”

As of last May, the European Medicines Agency already ruled that drospirenone-containing oral contraceptives carry a new label warning of their higher risk of VTE.