Healthy Skepticism Library item: 11648
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.
FDA says Lilly's Cymbalta promotion misleading
Reuters 2007 Oct 2
http://www.reuters.com/article/healthNews/idUSN0241655320071002
Notes:
Link to FDA Warning Letter:
http://www.fda.gov/CDER/warn/2007/Cymbalta_wl.pdf
Link to promotional material:
http://www.fda.gov/CDER/warn/2007/Cymbalta_promo.pdf
Full text:
Eli Lilly and Co made misleading claims about its Cymbalta drug in a promotion to doctors about its use in treating nerve-related pain, U.S. regulators said in a letter released on Tuesday.
The promotion “is 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 Food and Drug Administration said in a letter to the company.
The FDA asked Lilly to immediately stop using the material or any similar promotions, adding that the company made similar claims for the drug in other promotions.
A Lilly representative could not immediately be reached for comment.
Cymbalta, known generically as duloxetine, is approved for treating depression, neuropathic pain and anxiety.
The FDA said the Lilly promotion, which it called a “professional mailer,” recommended Cymbalta only for the use of managing pain associated with diabetic peripheral neuropathy.
The material overstated the drug’s effectiveness by suggesting that patients who took it experienced significantly less pain interference with overall functioning, the FDA said.
“This has not been demonstrated by substantial evidence or substantial clinical experience,” said the agency’s letter, which was dated September 21 and posted on the FDA Web site on Tuesday.
The FDA also said Lilly’s promotion left out some important risk information, including reports of sometimes-fatal reactions if drugs such as Cymbalta are combined with medicines known as monoamine oxidase inhibitors.
