UPDATE 1-US FDA objects to TV ad for Rozerem sleep drug

(Adds details from FDA letter paragraphs 3-6)

WASHINGTON, March 8 (Reuters) - A Takeda Pharmaceutical Co. (4502.T) television commercial for insomnia drug Rozerem should have included information about its risks, U.S. regulators said in a letter released on Thursday.

The Food and Drug Administration said the 10-second ad "was not an appropriate reminder ad." Reminder ads, which typically only mention a drug's name, do not need to balance benefit and risk information.

The letter said the Rozerem ad excluded FDA-approved instructions warning that patients who have trouble sleeping could have a psychiatric or medical illness that needs evaluation. The ad also failed to mention cautions against use with alcohol and other warnings.

The FDA also said the statements and images in the ad "suggest that Rozerem is indicated for children." The ad said "Rozerem would like to remind you that it's back to school season" and included images of a chalk board, a school bus, books, laptops and school-aged children.

The presentation is "especially concerning" because Rozerem's prescribing information states that safety and effectiveness in pediatric patients have not been established, the FDA said.

The FDA asked the company to stop running the ad or similar promotions. A Takeda spokeswoman could not immediately be reached for comment.

((Reporting by Lisa Richwine, editing by J.S. Benkoe and Jane Baird;Reuters Messaging: lisa.richwine.reuters.com@reuters.net; +1 202 310-5691)) Keywords: TAKEDA FDA/

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