FDA Warnings

Yasmin Warning

In July 2003, the FDA sent a warning letter to Berlex Laboratories. The warning came from the Division of Drug Marketing, Advertising, and Communications (DDMAC) which had identified a direct-to-consumer broadcast advertisement for Yasmin that was misleading and in violation of the FDA and applicable implementing regulations.

The warning specifically addressed a 60-second T.V. ad entitled "Goodbye Kiss". The FDA warned Berlex that the ad was misleading because it makes implied clinical superiority claims to other combination oral contraceptives and minimizes the important risk information that distinguishes Yasmin from other oral contraceptives. The FDA stated that the misleading nature of the ad raised "significant public health and safety concerns."

According to the FDA, the unifying theme of the offending ad, typified by the tagline "Ask about Yasmin and the difference a little chemistry can make", suggested that Yasmin is superior to other birth control pills because it uses the progestin, drospirenone, which is not used in other oral contraceptives. The FDA stated that the ad violated its rules because there was no substantial evidence or substantial clinical experience demonstrating that Yasmin is superior to other combination oral contraceptives. The FDA noted that in reality, Yasmin has added clinical risks due to drospirenone and these risks are downplayed in the ad.

The FDA concluded by requesting that Berlex immediately discontinue the TV ad and all other promotional materials and activities for Yasmin that contain the same or similar presentations. Berlex was also required to submit a written response within fourteen days of the warning letter.

Yaz Warning

In October 2008, the FDA's Division of Drug Marketing, Advertising, and Communications warned Bayer that two of its direct-to-consumer television advertisements violated the FDA. The FDA found that the T.V. ads were misleading because they broaden the drug's indication, overstate the efficacy of Yaz, and minimize the serious risks associated with the use of Yaz.

The warning specifically addressed two 60-second T.V. ads entitled "Not Gonna Take it" and "Balloons". The FDA warned that the ads minimized the risk of Yaz in the way it communicated those risks. Specifically, the FDA said:

The audio communication of serious risk disclosures during the "major statement" is minimized by distracting visuals, numerous scene changes, and other competing modalities such as the background music which combine to interfere with the presentation of the risk information. In 'Not Gonna Take It", the fast-paced visuals depict various women looking at pictures, trying on clothes, chatting at a cafe, stretching/exercising in a park, and walking down the street while the audio component describes the major risks associated with Yaz...

These complex presentations distract from and make it difficult for viewers to process and comprehend the important risks being conveyed. This is particularly troubling as some of the risks being conveyed are serious, even life-threatening. The overall effect of the distracting visuals, graphics, concurrent supers and background music is to undermine the communication of important risk information, minimizing these risks and misleadingly suggesting that Yaz is safer than has been demonstrated by substantial evidence or substantial clinical experience.

"Warning Letter" to Bayer HealthCare Pharmaceuticals, Inc. from FDA Division of Drug Marketing, Advertising, and Communications, October 3, 2008.

The FDA concluded by requesting that Bayer immediately discontinue the TV ads and activities for Yaz that contain the same or similar presentations. Bayer was also required to submit a written responses within fourteen days of the warning letter.

After Bayer received this letter and as part of a settlement with the FDA and 27 states, Bayer agreed to spend at least $20 million on an ad campaign to correct the deceptive ads it had been running. The new ads will warn that Yaz is not FDA approved to cure pimples or PMS. Many believe however that the new ads still do not adequately warn of the dangers of Yasmin due to the progestin, drospirenone.

If you or a loved one suffered a stroke, pulmonary embolism, deep vein thrombosis (DVT), heart attack, gallbladder remvoal or a loved one died after using Yaz, Yasmin, Ocella or Gianvi birth control pills, you may be entitled to financial compensation. Call now 888-345-5291 for a Free Yaz/Yasmin Lawsuit Evaluation.