The U.S. Food & Drug Administration (FDA) has sent Bayer three warning letters over its Yaz & Yasmin birth control pill advertisements – basically telling the German-based drug manufacturer to stop misleading consumers. Here's what each letter said:
The FDA notified Berlex Laboratories, a Bayer subsidiary, that its advertisement entitled “Goodbye Kiss” was not only misleading because it “makes implied clinical superiority claims to other combination oral contraceptives and minimizes the important risk information that distinguishes Yasmin from other combination oral contraceptives,” but that it also violated the Federal Food, Drug and Cosmetic Act.
The FDA notified Bayer that its Yaz “Not Gonna Take It” and “Balloons” advertisements are “misleading because they broaden the drug's indication, overstate the efficacy of [the drug], and minimize serious risks associated with the use of the drug. Thus, the TV Ads misbrand the drug in violation of the Federal Food, Drug and Cosmetic Act.”
The FDA notified Bayer again that its Yaz advertisements are “incomplete and misleading, suggesting that YAZ is useful in a broader range of conditions or patients than has been demonstrated by substantial evidence or substantial clinical experience.”
The FDA also warned Bayer that its claims that all patients with moderate acne are candidates for Yaz is simply not true. It said, “...Yaz's indication is limited to the treatment of moderate acne vulgaris in women at least 14 years of age who have achieved menarche (their first menstrual cycle), and it should be used for the treatment of acne only if the patient desires an oral contraceptive for birth control.”
Misleading ads prompt Yaz / Yasmin lawsuits
Yaz and Yasmin lawyers say that thousands of product liability lawsuits are expected to be filed against Bayer by injured women who have suffered blood clots, heart attacks, strokes, liver damage, depression, hyperkalemia (too much potassium in the blood that can disrupt heart rhythms, slow the flow of blood and create clotting) and others – because they relied upon Bayer's misleading statements about these drugs.
Hundreds of Yaz and Yasmin product liability lawsuits have already been filed – the latest two in Pennsylvania which, like the others, claim that Bayer concealed the health risks associated with the pills and failed to warn consumers about the drugs' dangers.