FDA Issues Liver Warning for Cymbalta
Patients With Liver Disease May Risk Further Liver Damage, Says FDA
By Miranda Hitti
WebMD Medical News Reviewed By Louise Chang, MD
on Monday, October 17, 2005
Oct. 17, 2005 -- The FDA and Eli Lilly and Co. have issued a new warning about 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.
New labeling will extend the precaution against using Cymbalta in patients with substantial alcohol use to include those with chronic liver disease.
"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 a letter to doctors sent by Lilly, Cymbalta's maker.
"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.
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 http://www.fda.gov/medwatch
SOURCES: FDA Medwatch 2005 Medical Product Safety alerts: "Cymbalta." Eli Lilly and Company: "Dear Health Care Professional."