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Cymbalta Diabetic Nerve Pain Claims Deceptive, FDA Says

Oct 3, 2007 | Parker Waichman LLP

A new Cymbalta marketing campaign makes deceptive claims about the anti-depressant’s benefits and downplays its dangers.   Now, the Food & Drug Administration (FDA) is telling Cymbalta’s maker, Eli Lilly, to end the promotion.

Cymbalta is used to treat depression, anxiety and diabetic nerve pain.   In 2005, new warnings were added to the Cymbalta label about its potential to cause liver problems.  Doctors were warned to avoid prescribing Cymbalta to patients with pre-existing liver disease.  That label update also included warnings about a variety of side effects linked to Cymbalta, including  hepatitis, jaundice and other liver-related problems in patients using Cymbalta.  The FDA also recently issued a new warning about the potential for suicidal thinking in adults taking antidepressants, but the agency specifically singled out Cymbalta because of a higher than expected rate of suicide attempts in recent studies.

Cymbalta, launched in 2004, has become a strong seller for Eli Lilly. It registered $1.3 billion in sales last year, an increase of 94%. In the second quarter this year, only top-seller Zyprexa brought in more revenue than Cymbalta's $519.5 million.   No doubt, these stellar figures can be attributed to the aggressive marketing of Cymbalta by Eli Lilly.

The promotional campaign that has drawn the FDA’s attention consists of a mailer that promotes Cymbalta as a treatment for diabetic nerve pain.  The promotional material says  Cymbalta helps patients "experience less pain interference with overall functioning." It uses a series of bar charts to show how Cymbalta could ease their  pain.  But the FDA letter says the mailer overstates the drug’s effectiveness in treating diabetic nerve pain.   The letter says these claims are " false or misleading in that it overstates the efficacy of Cymbalta and omits some of the most serious and important risk information associated with its use."  The FDA  said that the mailer downplayed Cymbalta’s risk for liver damage, and left out important information about dangerous interactions with other drugs.   The FDA asked Eli Lily to cease use of the mailer, as well as several other promotional materials that made the same claims about Cymbalta.

An Eli Lilly spokesperson told the Indianapolis Star that the company is working with the FDA "to gain a greater understanding of their concerns." He said the company will take action once it has "more clarity" on the agency's comments.

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