Healthy Skepticism Library item: 8815

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

Larkin C, Suzuki H.
Takeda Pulls Sleeping-Pill TV Ad After FDA Warning
Bloomberg.com 2007 Mar 9
http://www.bloomberg.com/apps/news?pid=20601080&sid=asfDbvde4aaA&refer=asia

Full text:

Takeda Pharmaceutical Co. pulled a commercial for the sleeping pill Rozerem after U.S. regulators said the ad improperly suggested the drug was safe for children.

The 10-second television ad showing a bus of school children was ``especially concerning’‘ because the drug hasn’t been proven safe for that age group, the Food and Drug Administration told the company in a warning letter posted online yesterday. Matt Kuhn, a spokesman for Takeda, Japan’s largest drugmaker, said the company has withdrawn the ad and is preparing a response to the FDA.

``To date our preliminary review of the situation indicates that no one internal to Takeda was involved in the approval, release or broadcast of the advertisement in question,’‘ Kuhn said in a telephone interview yesterday. The company’s outside advertising agency, Cramer-Krasselt of Chicago, couldn’t comment immediately on the commercial, said spokeswoman Susanna Homan.

Rozerem, whose other ads include a restless groundhog and Abraham Lincoln, competes against Sanofi-Aventis SA’s Ambien and Sepracor Inc.‘s Lunesta, the two most-heavily promoted drugs in 2006, according to Nielsen data. Some U.S. lawmakers argue that that rising spending on consumer advertising raises the risk that information will be misleading or wrong.

Shares of Osaka-based Takeda fell 60 yen, or 0.8 percent, to end trading at 7,930 yen on the Tokyo Stock Exchange. The stock has gained 18 percent in the past year.

Different Advertisements

Takeda will promote the drug in different, 75-second television advertisements that aren’t likely to raise concerns with the FDA, Toshiyuki Ikeuchi, a Tokyo-based spokesman for the company, said today.

Takeda introduced Rozerem in the U.S. in September 2005, and the drug had $26 million in sales as of March 2006, according to the company’s annual report. The product is the first drug developed by Takeda, the maker of the Actos diabetes medicine, sold in the U.S. in the last six years.

Rozerem, whose generic name is ramelteon, has not been studied in children or adolescents, according to drug-safety information posted on the Rozerem Web site.

``Safety and effectiveness of Rozerem in pediatric patients have not been established,’‘ it said. ``Further study is needed prior to determining that this product may be used safely in pre-pubescent and pubescent patients.’‘

The drug has been associated with an effect on reproductive hormones in adults, such as a drop in testosterone levels and higher prolactin levels, according to prescribing information. It isn’t known what effect chronic or even chronic intermittent use of Rozerem may have on fertility in children and adolescents, it said.

Rozerem is marketed in the U.S. by Deerfield, Illinois- based Takeda Pharmaceuticals America Inc. and manufactured by Takeda Pharmaceutical Co. in Kilruddery, Ireland.

To contact the reporters on this story: Catherine Larkin in Washington at clarkin4@bloomberg.net ; Hiroshi Suzuki in Tokyo at at hsuzuki5@bloomberg.net