Cymbalta Side Effects

Cymbalta May Aggravate Preexisting Liver Disease

Yael Waknine
Information from Industry
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Oct. 18, 2005 — The U.S. Food and Drug Administration (FDA) and Eli Lilly & Co. have warned healthcare professionals regarding the increased risk of hepatotoxicity associated with use of duloxetine HCl (Cymbalta) in patients with preexisting liver disease, according to an alert sent yesterday from MedWatch, the FDA's safety information and adverse event reporting system.

The FDA has received several postmarketing reports of hepatic injury in patients receiving duloxetine therapy, including cases of abdominal pain, hepatomegaly, and elevation of transaminase levels to more than 20 times the upper limit of normal with or without jaundice. Cholestatic jaundice with minimal elevation of transaminase levels has also been reported.

Some of these events have occurred in patients with underlying liver disease, suggesting that duloxetine may aggravate the condition. During clinical trials, similar cases of severe hepatic injury were reported in duloxetine-treated patients who consumed large quantities of alcohol.

The FDA cautions against use of duloxetine in patients with substantial alcohol use, chronic liver disease, or any evidence of hepatic insufficiency.

Patients and prescribers should be aware of signs and symptoms of liver damage such as pruritis, dark urine, jaundice, right upper quadrant tenderness, or unexplained flu-like symptoms. Healthcare professionals are encouraged to investigate these promptly upon presentation.

Duloxetine HCl is indicated for the treatment of major depressive disorder and diabetic peripheral neuropathic pain.

Additional information regarding duloxetine-related adverse events may be obtained by calling a local Eli Lilly representative or contacting the company's medical department at 1-800-Lilly Rx (1-800-545-5979).

Adverse events related to the use of duloxetine HCl should be reported to the FDA's MedWatch program by phone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, online at http://www.fda.gov/medwatch, or by mail to 5600 Fishers Lane, Rockville, MD 20852-9787.

Reviewed by Gary D. Vogin, MD