WASHINGTON 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
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
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.
(Reporting by Lisa Richwine, editing by Gary Hill/Tim