Rozerem DTC Ad Suggests Insomnia Drug Is Indicated In Children – FDA

Agency issues an "untitled" letter to Takeda citing the 10-second TV spot.

Takeda's direct-to-consumer TV ad for the insomnia drug Rozerem (ramelteon) fails to disclose the drug's indication, does not include information related to side effects and suggests through "back to school"-themed images and statements that the drug is indicated in children, FDA says in an "untitled" letter issued to the company March 5 and posted online March 8.

The letter relates to a 10-second reminder type ad that ran in September highlighting images of a chalkboard, school bus and children wearing knapsacks as a male announcer says, "Rozerem would like to remind you that it's back to school season."

"While reminder ads are exempt from the requirement to disclose information relating to risks and effectiveness ... we have determined that your TV ad is not an appropriate reminder ad," FDA's Division of Drug Marketing, Advertising and Communications says in the letter.

Labeling for ramelteon features several warnings, including those related to cognitive and behavior changes and driving. In addition, under the Precautions section, labeling addresses use in adolescents and children, stating, "Rozerem has been associated with an effect on reproductive hormones in adults, e.g. decreased testosterone levels and increased prolactin levels. It is not known what effect chronic or even chronic intermittent use of Rozerem may have on the reproductive axis in human development."

The Precautions section also notes that the safety and effectiveness of Rozerem in pediatric patients has not been established.

Despite these warnings and precautions, the TV ad suggests through statements and images that Rozerem is indicated for children, FDA says.

"The combination of these statements and images of school-aged children and school-related objects suggests that Rozerem is indicated for and can be safely used in the pediatric population," the agency notes. FDA adds that the TV ad is "especially concerning" given that the prescribing information for Rozerem includes a specific precaution that safety and efficacy has not been established in pediatric patients.

In addition, the ad is not considered an appropriate reminder ad because reminder ads should not contain any representation or suggestion relating to the advertised drug, according to the agency.

"Because the ad is not a reminder ad, it must present the indication and information relating to the major side effects, and must make adequate provision for dissemination of the FDA-approved labeling," FDA states.

Takeda also failed to submit the advertisement to DDMAC for review at the time of dissemination as required. The agency requests that the Japanese company immediately cease dissemination of the ad and respond to the warning letter by March 19.

The company told "The Pink Sheet" DAILY that it is currently conducting an internal investigation into the ad and preparing a response to FDA.

"To date, our preliminary review indicates that no one internal to Takeda was involved in the release, the approval or the broadcast of the advertisement in question," Takeda said.

The company has already stopped broadcasting the ad, which ran a total of four times in the month of September.

In comparison, a more frequently aired TV ad for Rozerem, featuring a beaver and an actor portraying Abraham Lincoln with the tagline, "Your dreams miss you," has been well received. That advertisement launched last July and has been suspected of playing a role in boosting new prescription share of the drug (¹ (Also see "Leave It To Beaver: Rozerem DTC Campaign Boosts New Rx Share" - Pink Sheet, 15 Sep, 2006.)).

The Pharmaceutical Research & Manufacturers of America's voluntary DTC guidelines, developed in 2005, ban reminder ads for drug products based on the principle that TV ads that identify products by name should clearly state the drug's indications and risks (² (Also see "PhRMA DTC Principles Call For End Of Reminder Ads" - Pink Sheet, 2 Aug, 2005.)).

-Jessica Merrill ([email protected])