FDA Wants Contraceptive Labels to Be More Detailed

Federal Agency Targets Yaz and Yasmin

As questions linger about the risks of some widely used contraceptives, a Food and Drug Administration (FDA) advisory committee recently recommended adding more information about potential risks and defects to their safety labels.

The panel, which included 26 experts from outside the agency, convened to evaluate recent studies of the manmade hormone drospirenone, which is found in popular birth control pills such as Yaz and Yasmin. These contraceptives have often been advertised as being safer and having fewer side effects than their predecessors.

The "New" Form of Contraception

The release of the birth control pill Yasmin in 2001 by drug manufacturer Bayer marked the introduction of drospirenone, a synthetic hormone that took the place of progestin used in earlier birth control pills. The new drug was advertised as having fewer side effects than its predecessors. The 2006 release of Yaz, another Bayer product, further touted that drug's ability to decrease acne and treat a severe mood disorder. By 2009, Yaz was the highest-selling oral contraceptive in the U.S., earning $781 million.

Sales took a hit, however, when Bayer was forced to correct advertisements for misleading information, including many that promoted it as a treatment for symptoms of premenstrual syndrome (PMS). In addition, thousands of lawsuits filed against Bayer by users of Yaz or Yasmin claim harm due to use of the drugs, including about 100 deaths.

Multiple Studies, Conflicting Results

The call for input from the advisory panel came after recent studies seemed to indicate an increased rate of blood clots in drugs using drospirenone when compared with other hormone-based birth control. The most recent, a study published in the British Medical Journal in October 2011, raises serious concerns about user safety. The research involved 1.3 million Danish women and found that those taking the Bayer-produced contraceptive carried twice the risk of blood clots as women using older forms of oral contraception.

Additionally, the most recent analysis performed by the FDA discovered that users of drugs containing drospirenone reported a higher number of blood clots or venous thromboembolism in a year than those taking previous versions of the pill. These, along with a few other independent studies, suggest a higher risk of blood clots for users of drugs containing drospirenone.

Using its own research, Bayer disputed these findings. Studies performed by the manufacturer found that use did not result in increased risk of blood clots. Bayer also noted the difficulty of linking use of the drug to the occurrence of blood clots, particularly when all hormone-based drugs heighten the risk of blood clots. There are also many lifestyle factors that play a role in developing blood clots, such as obesity, family history and smoking.

Advisory Board Recommends Changes

After reviewing the information presented, which included the conflicting studies and statistics, the panel voted 21 to 5 to recommend that the FDA require Bayer to change the labels to increase the amount of information about blood clots. The panel further found, by a 15-11 vote, that the benefits of the drospirenone pills still outweigh the risks. However, the panel did not recommend that the labels include a warning about an increased risk of blood clots.

While the FDA is not required to follow the recommendations of the panel, the results of the review and recommendations seem to indicate a change may be forthcoming. For its part, Bayer has emphasized that it will cooperate with the FDA and follow any new directive on labeling. In time, the FDA hopes further research will clarify the safety of the pills to ensure its users are properly informed and protected.

If you or someone you know has experienced serious side effects when using Yaz or Yasmin, you may wish to discuss the situation with an attorney.