Magazine article Clinical Psychiatry News

Rozerem Safety, Toxicity Claims Draw FDA Rebuke

Magazine article Clinical Psychiatry News

Rozerem Safety, Toxicity Claims Draw FDA Rebuke

Article excerpt

Takeda Pharmaceuticals misrepresents its sleep aid Rozerem (ramelteon) in sales materials aimed at physicians who treat substance abusers by claiming the product has "no likelihood of abuse and no detectable toxicity," the Food and Drug Administration's Division of Drug Marketing, Advertising, and Communications charges.

In a letter to Takeda's North American division, the DDMAC says the claims misbrand Rozerem and requests that the drug maker immediately cease dissemination of the materials and produce a plan for discontinuing their use.

The DDMAC says a sell sheet focused on substance abuse patients is false or misleading because it makes unsubstantiated superiority presentations and omits and minimizes risks. Rozerem was approved in 2005 for use by patients whose insomnia is characterized by trouble falling asleep. It is not a controlled substance, as are competitors in the sedative-hypnotics class, but that difference alone does not "confer added safety," the DDMAC states.

The premise of the sell sheet--that Rozerem is a superior insomnia treatment for substance abusers based on the fact benzodiazepine receptor agonists are controlled substances, and Rozerem is not--is misleading, regulators said. …

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