USA. Eli Lilly and Company has received post-marketing reports of hepatic injury (including hepatitis and jaundice) associated with duloxetine (Cymbalta) use. Some of these reports indicate that patients with pre-existing liver disease who take duloxetine (Cymbalta) may be at increased risk for further liver damage. In view of these reports, the product label which cautioned against using duloxetine (Cymbalta) in patients with substantial alcohol use, has now been revised to extend the caution to include also those patients with chronic liver disease.

Reference:

'Dear Health-care Professional' letter from Eli Lilly and Company, 5 October 2005 (http://www.fda.gov).