February 11, 2009

Bayer runs corrective ads on Yaz

The U.S. Food and Drug Administration is requiring Bayer HealthCare Pharmaceuticals to run ads correcting claims about a popular birth control pill.

Federal health officials said previous ads overstated the ability of the birth control pill Yaz to cure acne or reduce premenstrual mood swings and played down potential health risks, The New York Times reported Wednesday.

Bayer agreed last week to spend at least $20 million on corrective ads during the next six years, the report said.

The FDA warned Bayer in a letter last October that two television ads gave consumers the impression Yaz is effective in ''a broader range of patients and conditions than has been demonstrated by substantial evidence or substantial clinical experience."

The warning letter said the ads violated federal laws against promoting the unapproved uses of a drug.

Yaz is approved for use in women with premenstrual dysphoric disorder but has not been evaluated as a treatment for premenstrual syndrome, the FDA's warning letter said. The agency also said the drug is indicated for treatment of moderate acne rather than all severities of acne.