FDA Broadens Liver Warning for Cymbalta

The Food and Drug Adminstration (FDA) and Eli Lilly have broadened a warning about possible liver problems with Cymbalta, a drug used to treat depression and pain associated with diabetic peripheral neuropathy. The FDA noted that post-marketing reports of liver injury suggest that patients with pre-existing liver disease who take Cymbalta may have an increased risk for futher liver damage. Nor should Cymbalta be prescribed to patients with substantial alcohol use.

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 go to www.fda.gov/medwatch.