Cymbalta Promotion Halted by FDA

Scott Kappes

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Eli Lilly and Co., the manufacturer of the fast-selling dug Cymbalta has been issued a letter by the FDA ordering them to immediately stop promoting the drug. The FDA claims that a mailer sent out by the company greatly overstates the effectiveness of Cymbalta and conveniently leave out the most serious risks associated with using the drug. Eli Lilly was asked to "immediately cease" dissemination.

The mailer promotes the drug's use for diabetic nerve pain and states that those patients experienced "significantly less pain interference with overall functioning" when using the drug. The FDA letter noted that this "has not been demonstrated by substantial evidence or ... clinical experience."

The mailer also does not include liver toxicity precautions and other dangerous concerns. Cymbalta was approved in 2004 and has been selling strong ever since. Last year in particular was a break through with a sales increase of almost 95 percent from the previous year, to about $1.3 billion. This year was looking to be off for a repeat performance but this news could hinder sales.

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