Healthy Skepticism Library item: 17510

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

Richwine L, Kerr T
UPDATE 1-U.S. FDA says Takeda sleep drug promotion misleads
Reuters 2010 Mar 19
http://www.reuters.com/article/idUSN1912681720100319

Abstract:

• Rozerem sales material minimized risks – FDA
• Company says working with FDA

Full text:

Japan’s Takeda Pharmaceutical Co (4502.T) used a misleading promotion for its insomnia drug Rozerem, U.S. regulators said in a letter released on Friday.

The Food and Drug Administration said it had reviewed company sales material that “makes unsubstantiated superiority presentations, omits and minimizes the risks associated with the use of Rozerem, omits material facts, and makes a misleading claim about Rozerem.”

In a letter, the FDA said Takeda’s promotion “suggests that Rozerem has no likelihood of abuse and no toxicity, in contrast to the other 18 sedatives/hypnotics presented.”

The agency said it was not aware of substantial evidence to support that claim. Takeda spokeswoman Jocelyn Gerst said the company was working with the FDA on the matter.

The company is “working very closely with them to understand what they have raised,” she said.

The FDA posted the letter here.