Eli Lilly Sends "Dear Doctor" Letter Regarding Cymbalta and Liver Injury

FDA Warning: Cymbalta May Cause Liver Damage For Patients With Chronic Liver Disease

On October 17, 2005 the FDA and Eli Lilly & Co. said in a MedWatch drug alert that the antidepressant Cymbalta (duloxetine hydrochloride) should not be used in patients with preexisting liver problems because Cymbalta might worsen the underlying liver condition.

The package insert, or label, for Cymbalta had already warned about the possibility of liver injury.  In an October 5, 2005 "Dear Doctor" letter, Lilly is informing prescribing doctors that patients with underlying liver disease should not be prescribed Cymbalta based on "several reports" of liver injury made to the FDA and Lilly.  There have also been reports of Cymbalta-induced jaundice, a liver disorder that can cause the yellowing of the skin and eyes. "Review of these cases suggests that patients with underlying chronic liver disease may be at increased risk" of liver damage with Cymbalta, Lilly said in the Dear Doctor letter.

This October 5 letter from Lilly also advises doctors not to prescribe Cymbalta to patients "with substantial alcohol use" because postmarketing drug-safety studies have shown that some patients experienced liver damage when they consumed Cymbalta and alcohol.

The FDA MedWatch safety alert for Cymbalta, which was posted on the FDA's web site on October 17, said that Cymbalta has been associated with increased risk of liver injury in patients with chronic liver disease.  In relevant part, the MedWatch alert stated:

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.

Cymbalta was first approved by the FDA in August 2004 to treat major depressive disorder. Since then the FDA has approved Cymbalta for treatment of diabetic peripheral neuropathic pain, or nerve pain associated with diabetes. More than one million patients have been prescribed Cymbalta, according to Lilly.

(Posted by: Tom Lamb)