Washington, July 17, 2003 ( – The FDA has told Berlex Laboratories, a unit of pharmaceutical company Schering AG, that a television advertisement for its oral contraceptive Yasmin is “misleading” because it overstates the product’s efficacy and minimizes the health risks of the drug. The FDA has ordered the company to immediately discontinue running the ad.

On July 12, the FDA sent a warning letter to Nancy Konnerth, associate director for advertising and labelling for Berlex, addressing concerns that its ads falsely lead the public to believe that Yasmin is better than other birth control pills because it contains the hormone progestin drospirenone.

The FDA disagreed with their claims saying that, “On the contrary, FDA is aware of the added clinical risks associated with drospirenone.” While drospirenone, a synthetic version of the hormone progesterone, can reduce bloating and acne in users, at least 40 European users of the drug have experienced major blood clots—two of them fatal—since starting on the pill, according to a study published in the Feb. 1 issue of the journal BMJ.  See Kaiser Network: