October 17, 2005

Eli Lilly expands Cymbalta liver warning: FDA

WASHINGTON (Reuters) - Eli Lilly and Co. has expanded its
warning about possible liver-related problems with its
depression drug, Cymbalta, and cautioned doctors against its
use in chronic liver disease patients, U.S. health regulators
said on Monday.

A new label for the antidepressant, known generically as
duloxetine, also includes reports of hepatitis, jaundice and
other liver-related problems in patients using the drug, the
U.S. Food and Drug Administration said on its Web site.

"Some of these reports indicate that patients with
preexisting liver disease who take duloxetine may have an
increased risk for further liver damage," the company said in
letter to doctors dated October 5.

Cymbalta, which is also approved to treat a type of nerve
damage caused by diabetes, has been known to cause liver
problems. The label earlier warned against using the drug with
alcohol.

"Cymbalta should ordinarily not be prescribed to patients
with substantial alcohol use or evidence of chronic liver
disease," according to the new label, which was also posted
online.

A spokeswoman for the drugmaker could not be immediately
reached for comment.

The letter and new label are posted online at
http://www.fda.gov/medwatch/safety/2005/safety05.htm#Cymbalta.

Lilly shares fell $1.04, or 2 percent, to $51.58 in
afternoon trade on the New York Stock Exchange. The American
Stock Exchange Pharmaceutical Index of large U.S. and European
drugmakers was off 1.1 percent.