FDA Action

Catchy Advertising Camouflages Dangers of Bayer Birth Control Drugs; Searcy Denney Attorneys Now Representing Women Who Have Been Harmed by Yaz

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Read More:

• Yaz, Yasmin and Ocella — New Studies Confirm Old Concerns
• What was Bayer thinking with “all that Yaz”?
• Drug Marketing Direct to Consumers
• Yaz Litigation in Mass Tort Coordination
• National Coordination of YAZ Litigation Requested
• The Show Must Go On and all that Yaz!

While evidence has been mounting against YAZ and Yasmin, the FDA has chastised Berlex and Bayer repeatedly for failing to warn consumers and for airing television ads that overstated efficacy, over-promised benefits, promoted for unapproved uses, and under-emphasized risks. Ultimately, the FDA forced Bayer to run a series of corrective TV commercials informing consumers that previous ads touting YAZ for prevention of PMS were improper and illegal.

• In a letter faxed in July 2003 to Berlex Laboratories, the makers of Yasmin before Bayer acquired the company in 2006, the FDA does not mince words in calling direct-to-consumer broadcast advertising for Yasmin misleading; in violation of the Federal Food, Drug, and Cosmetic Act; and raising “significant public health and safety concerns.” Challenging advertising claims that Yasmin’s chemistry offers unique product benefits, the letter says bluntly, “On the contrary, FDA is aware of the added clinical risks associated with drospirenone as communicated in the Warnings/Bolded Warning and Precautions/Drug Interactions sections of the PI (Prescribing Information).”

  This letter requests that Berlex immediately “discontinue the TV ad and all other promotional materials and activities for Yasmin that contain the same or similar violative presentations.”

• Nonetheless, buoyed by billions of dollars in sales in the ensuing five years, Bayer – the original manufacturer of YAZ and new owner of Yasmin-manufacturer Berlex – continued to violate the law and tantalize young women with exaggerations and empty promises. Another stern letter from the FDA in October 2008 not only warned against advertising over-stated benefits and minimizing risks associated with YAZ, but that “the TV ads misleadingly suggest that YAZ is appropriate for treating women with PMS, who may not be appropriate candidates for this drug.”

  The letter pointedly reminded Bayer that the drug’s Brief Summary Patient Package Insert and Detailed Patient Package Insert warn that women with PMS should only take YAZ to prevent pregnancy, not for the treatment of PMS. More important, the letter stated clearly:

  Additionally, there are numerous warnings associated with the use of YAZ, including, but not limited to, venous and arterial thrombotic and thromboembolic events (such as myocardial infarction, thromboembolism, and stroke), hepatic neoplasia, gallbladder disease, and hypertension.

  The FDA’s unusually comprehensive critique concludes by requiring Bayer to cease dissemination of its misleading promotional materials for YAZ – ads that appear to be deliberately deceptive.