New warnings about Cymbalta (duloxetine)

October 18, 2005 - Eli Lilly and FDA notified health care professionals of a revision to the precautions section of the prescribing information for Cymbalta (duloxetine hydrochloride). Cymbalta has been indicated for treatment of major depressive disorder and diabetic peripheral neuropathic pain. Postmarketing reports of hepatic injury (including hepatitis and cholestatic jaundice) suggest that patients with preexisting liver disease who take duloxetine may have an increased risk for further liver damage. The new labeling extends the precaution against using Cymbalta in patients with substantial alcohol use to include those patients with chronic liver disease. It is recommended that Cymbalta not be administered to patients with any hepatic insufficiency.

Patients and prescribers should be aware of the signs and symptoms of liver damage (pruritis, dark urine, jaundice, right upper quadrant tenderness or unelplained "flu-like" symptoms) and health care professionals are encouraged to investigate such symptoms and signs promptly.

Questions or concerns regarding this important safety information can be directed to Eli Lilly medical department at 1-800-Lilly-Rx. As always, pharmacies and members can also contact the RxAmerica customer service desk at 1-800-770-8014 if they have any questions about this new product warning.