Bayer Spending $20 Million on YAZ Correction Messages Ordered by FDA

By Jim Greene

Published on December 28, 2009

Bayer Health Care Pharmaceuticals, Inc., will spend $20 million dollars on media messages to correct claims for its YAZ® birth control pill, under orders from the U.S. Food and Drug Administration (FDA). The agency ruled that Bayer misled consumers by overstating the efficacy of the oral contraceptive in combating premenstrual symptoms and acne.

The YAZ® correction messages begin by saying that they are in response to an FDA request "to correct a few points" in the original messages. They go on to say that the product has helped some women with certain advanced premenstrual symptoms and moderate acne, but is not intended as a treatment for normal premenstrual symptoms or mild acne.

Possible Adverse Side Effects Prominent in New Messages

The new messages also mention the risk of blood clots, stroke, and heart attack, as well as the possibility that taking YAZ® might contribute to an excess of potassium, which can lead to heart disease in some people. A study published in the British Medical Journal said the progestin ingredient in YAZ® is more likely to cause blood clots than progestins used in other oral contraceptives.

While the original YAZ® advertising put more stress on the claimed beneficial side effects than on birth control, the corrective messages reverse the priorities.

FDA Official Calls for Comprehensive Plan from Bayer

Thomas Abrams, director of the FDA's Division of Drug Marketing, Advertising, and Communications, sent a warning letter to Reinhard Franzen, president and CEO of German-owned Bayer's American pharmaceutical division. The letter requested "a comprehensive plan of action to disseminate truthful, non-misleading, and complete corrective messages."

Have you or someone you know taken YAZ® oral contraceptives and suffered blood clots, stroke, heart attack, or other medical problems? Were you coerced by unsubstantiated advertising claims? Do you find Bayer's corrective messages as unclear as their original advertising? You may have a strong case for financial compensation to help you deal with the consequences. Contact an experienced personal injury attorney right away to learn more.

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