If you were looking to start a new birth control pill in or around 2008, your OB-GYN probably suggested Yaz, by Bayer, which was that year’s most popular pill. If, in 2011, you’re still on it, you may soon be seeing new warning labels, courtesy of the FDA, who are meeting this week to revisit the safety of Yaz and similar drugs. The reason for the meeting? Concern over conflicting safety studies, some of which show a higher-than-average risk of blood clots–just three years after copious lawsuits and oodles of bad press.
Yaz gained popularity, mostly because it was aggressively marketed, boasting that it could not only keep you from getting pregnant, but also that it could also clear up your skin, and came with fewer side-effects than other drugs. Unfortunately, Yaz and similar pills, which contain an ingredient called drospirenone, quickly became something of a birth control pariah when young, healthy women began developing blood clots. Researchers immediately began studying the safety of the pill…a process which takes a painfully long time.
While it was being studied, Yaz has remained cooperative and helpful, posting information from he FDA on their site. They’ve also remained on the market, much to the delight of lawyers, who began buying up domains (like yazlawsuit.com and yazattorney.net, just to name a few) and opening special practices, just to handle the landslide of lawsuits coming from women who’d experienced blood clots. But the wheels of research move more slowly than legal proceedings, and, as a result, it has taken the FDA years to have enough information to revisit the safety of drospirenon-containing contraceptives. But at least they’re coming back to it, now, armed with research and data–which may help many, many women make a more informed contraceptive decision.
In September, the government health and safety department announced that they were concerned about drospirenone-containing drugs, as studies commissioned in light of initial safety concerns began to emerge. The studies offered conflicting, inconclusive safety information, the FDA said, which necessitates a new examination. They’ll be meeting on Thursday to discuss the risks of Yaz and similar pills, and will likely decide on new labels (which will make lawsuits against the drug more difficult, as they’ll display the risks in plain print), but not a recall or removal of the drug.
Drospirenone-containing drugs aren’t merciless killers. Many women have stayed on Yaz and its counterparts, and have enjoyed the reduced side-effects, and have experienced no health complications at all. Still, the lack of safety information surrounding the drug is concerning, as is the lag between the pill’s legal troubles and the FDA’s reconsideration of its safety. How many women may have been harmed while studies were being conducted?
It’s important for the FDA to stay up-to-date about the safety of oral contraceptives, and it’s good to see them taking an interest in women’s health. Birth control pills are widely used, and prescribed to a broad range of women–many of whom may not have health care, and visit a doctor just once per year–which makes their safety a huge concern to a large section of the population. Meetings like the one planned by the FDA for this week are necessary–even if they come a little late.
If you’re currently taking a drospirenone-containing drug and are concerned, speak with your health care provider or clinic the next time you visit. Of course, by then, your pill may have a new warning prominently displayed on the front.