Healthy Skepticism Library item: 14427

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: news

Silverman E.
FDA Warns Bayer Over Birth Control Pill TV Ads
Pharmalot 2008 Oct 8
http://www.pharmalot.com/2008/10/fda-warns-bayer-over-birth-control-pill-tv-ads/

Full text:

The two television commercials for the Yaz birth control pill overstated effectiveness, minimized risks and wrongly suggested the pill is approved for relieving premenstrual syndrome, according to an October 3 warning letter (http://www.fda.gov/cder/warn/2008/YAZ_wl.pdf) sent to the drugmaker and posted on the FDA web site (http://www.fda.gov/cder/warn/2008/YAZ_promol.pdf).
The FDA notes that one TV spot, which is no longer broadcast, featured women singing “We’re not gonna take it” and kicking, punching and pushing balloons with words such as “irritability,” “moodiness” and “bloating.” These symptoms are common with PMS, but Yaz is approved for premenstrual dysphoric disorder, a more serious condition that causes anxiety, tension, persistent anger and other symptoms.

A second ad features a song “Good Bye to You” with women releasing balloons labeled with symptoms. The commercial suggests “women are saying ‘goodbye’ to their symptoms and are now symptom-free, when such an elimination of symptoms has not been demonstrated by substantial evidence or substantial clinical experience,” the FDA wrote Bayer. The agency also wrote the commercials “suggest that Yaz is approved for acne of all severities when this is not the case.”
A Bayer spokeswoman tells Reuters the drugmaker will stop running the only one of the two ads currently in use.