FDA Broadens Liver Warning for Cymbalta

Oct. 17, 2005 -- The FDA and Eli Lilly and Co. have broadened a warning about possible liver problems with Cymbalta, a drug used to treat depression and pain associated with diabetic peripheral neuropathy.

"Postmarketing reports of liver injury (including hepatitis and cholestatic jaundice) suggest that patients with pre-existing liver disease who take [Cymbalta] may have an increased risk for further liver damage," says the FDA.

Cymbalta's labeling previously noted possible liver problems. The label had warned that "Cymbalta should ordinarily not be prescribed to patients with substantial alcohol use." Now, that warning will read, "Cymbalta should ordinarily not be prescribed to patients with substantial alcohol use or evidence of chronic liver disease," according to a letter to doctors sent by Lilly, Cymbalta's maker.

"It is recommended that Cymbalta not be administered to patients with any [liver] insufficiency," says the FDA.

Maker's Letter to Doctors

About a million people have taken Cymbalta since the drug's approval in 2004, according to Lilly's letter.

"Among these, several cases of [liver] injury have been spontaneously reported," states Lilly's letter.

"Some of these patients had underlying liver disease. Review of these cases suggests that patients with underlying chronic liver disease may be at increased risk of [liver] toxicity with [Cymbalta]," the letter continues.

Lilly is a WebMD sponsor.

Symptoms

Signs and symptoms of liver damage can include dark urine, jaundice (yellowing of the skin and eyes), itchiness, abdominal tenderness in the liver area, or unexplained flu-like symptoms. Elevations of liver enzymes may be found on blood tests.

Lilly asks that any questions about the warning be directed to Lilly's medical department at (800) Lilly-Rx ((800) 545-5979).

Report any Cymbalta side effects to Lilly at (800) Lilly-Rx ((800) 545-5979) or to the FDA's Medwatch program at (800) FDA-1088 ((800) 332-1088) or online at www.fda.gov/medwatch.