FDA Advisers Want Straight Talk About Risks on Labels for Birth Control Pills

After weighing the benefits of a new generation of birth control pills against potentially fatal blood clot risks associated with the drugs, federal scientific advisers have called for a regulatory compromise.

Their recommendation to the Food and Drug Administration: Let the pills stay on the market, but require straight talk about the risks on the products’ labels.

The decision focused on contraceptive drugs containing a hormone called drospirenone. They include Bayer AG products Yasmin and Yaz, which in 2008 became the nation’s top-selling  birth control pill and remains one of the top-selling contraceptives.

As The Associated Press reports, the FDA advisers came to their decision Thursday following a recent agency review that found that women taking Yasmin had roughly a 75 percent higher chance of suffering a blood clot than patients taking older drugs. Even so, the risk from the drugs of a blood clot is slim, far less than 1 percent.

Earlier research provided conflicting data on the blood clot hazards, and Bayer has conducted studies that found no elevated risk from its products. Meanwhile, thousands of personal injury lawsuits have been filed in this country against Bayer, a German company.

The panelists brought together by the FDA decided in a 15-to-11 vote to recommend keeping the drug on the market. As Reuters reports, however, in a separate 21-to-5 vote the panelists called for more explicit warnings on the labels, after concluding that the current ones don’t adequately explain to patients and doctors the risks of the pills.

According to the AP, many doctors say they don’t expect to stop prescribing the drugs anytime soon. They say the risk of blood clots with any birth control pill remains far lower than it is with pregnancy and birth, when surging hormone levels and reduced blood flow dramatically increase the danger.

The FDA isn’t obligated to follow the recommendations of its expert panels, but it normally does. Earlier this week Canadian health officials took a similar step, asking Bayer to revise the warning label on its Yaz and Yasmin pills.

ROBERT T. NELSON

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