Federal Health Panel Votes To Strengthen Warning On Yaz Label
Federal health experts have recently sated that drug labeling for Yaz and other widely-used birth control pills should be updated to emphasize recent data suggesting a higher risk of blood clots with the newer birth control pills.
Approved in 2006, Yaz grew into the best-selling birth control pill in the U.S. by 2008, backed by hundreds of millions of dollars in TV and magazine advertising that emphasized its ability to clear up acne and other hormonal side effects. However, in the last several years the prescription success that the drug had once enjoyed as trailed off amid the safety concerns that have come to light.
"Clearly the wording is inadequate and incomplete," said Dr. Richard Bockman of New York's Hospital for Special Surgery. "Adverse events have to be made graphic so physicians and patients are aware of the consequences."
In an earlier vote, panelists voted 15-11 that the pills remain a beneficial option for preventing pregnancy. Realistically, the majority ruling amounts to a vote of confidence for keeping the drugs on the market, though well over a third of panelists voted against the drug's overall benefit, citing numerous alternatives available.
"I can see no real group of patients that this drug benefited over existing alternatives," said Mark Woods of New York University School of Medicine. "Without any clear benefit, and given the potentially catastrophic risk, I voted no."
Since 2009, five large studies have suggested drospirenone-containing pills carry a slightly higher risk of blood clots than older birth control pills, though events in both groups are very rare. Even a slightly higher risk can be critical because blood clots can trigger heart attacks, strokes and blockages in lungs or blood vessels.
