Product Liability: Warning Labels, Clotting Risk and Yaz

Recently, the U.S. Food and Drug Administration warned that the Yaz birth-control pill produced by Bayer AG and similar birth-control pills based on the same hormone may carry a higher risk of creating blood clots than birth-control pills based on a different hormone. As a result, the FDA is requiring Yaz and similar birth-control pills to be produced with new labels that warn about the blood-clot risk. The FDA has not designated Yaz as a dangerous drug, however.

Last year two studies published in BMJ Online First showed that women who take birth-control pills with a newer hormone called drospirenone have a higher risk of developing potentially serious blood clots than women who take oral contraception based on an older hormone called levonorgestrel. Yaz as well as Yasmin, Ocella, Zarah and Gianvi are birth-control pills that contain drospirenone. Women who took drospirenone-based oral contraception had a twofold to threefold increased risk of nonfatal blood clots compared to women who took birth control based on the older hormone.

When the results of the studies were released, Bayer claimed that the methodology used in the two studies was flawed. Yaz and Yasmin, both produced by Bayer, were also the most widely used prescription drugs in the world last year.

In April, on the advice of an outside panel of medical experts, the FDA recommended new and clearer warning labels for drospirenone-based birth-control drugs. However, the medical panel concluded that the benefits of the pill outweighed the risks. In a statement regarding the change, Bayer agreed with the recommendation to change the labels, saying the company has always cooperated with regulatory agencies as new information has become available.

The FDA recommends that the update should be a starting point for women to have conversations with their health care professionals about their risk of blood clots before deciding which birth-control drug or method is appropriate for them. While drospirenone-based birth control pills do not reach the threshold, the FDA will remove a drug from the marketplace when potentially serious side effects of a drug are well documented and become unreasonably dangerous.

The FDA's requirement to update the warning labels of birth control drugs containing drospirenone should be understood in context. All birth-control pills increase the risk of blood clots and product labels of the drugs warn of the risk. While the risk of blood clots is low among women who take birth-control drugs, the risk is higher than the risk among women who do not take birth-control pills. The risk of blood clots during pregnancy and during the postpartum period is higher than the risk of women who take birth-control pills.

If you have been injured by a defective product or a dangerous drug, contact an experienced personal injury attorney to explore your legal options.