• E-mail
• Print
• RSS

Takeda gets FDA warning for "inappropriate" Rozerem ad

Pharma Compliance Alert, March 14, 2007

A 10-second TV ad for Rozerem is "concerning" because it suggests that the sleep aid is safe for children, although a precaution in its prescribing information says pediatric safety has not been established. That's according to an FDA warning letter requesting that Takeda stop running the ad.

The ad uses imagery such as a chalkboard, school bus, and school-aged children with backpacks, as well as the tagline, "Back to School." In addition to the suggestion of safety for children, the warning letter says that the ad is an "inappropriate reminder ad" and therefore should contain indication and risk information. Reminder ads are exempt from the requirement of disclosing risks and effectiveness. However, according to the FDA, the Rozerem ad in question is not actually a reminder ad because its statements and imagery suggests that Rozerem is indicated for children. Reminder ads "do not include indications," according to the FDA. The FDA says that since the ad is not a reminder ad, it must present the indication and major side effect information.

In addition, the FDA says Takeda did not submit the TV ad to the FDA as required. A Takeda spokesperson said that the company's preliminary review "indicates that no one internal to Takeda was involved in the approval, release, or broadcast of the advertisement in question," reports Bloomberg News. Takeda's outside ad agency couldn't immediately comment, according to the report.

Go to the FDA Web site to read the warning letter and see the promotional material.

• E-mail to a Colleague
• Print
• RSS
• Archive