The Food and Drug Administration (FDA) and Eli Lilly have notified healthcare professionals of a significant revision to the PRECAUTIONS/Hepatotoxicity section of the prescribing information for Cymbalta (duloxetine hydrochloride); Lilly’s antidepressant indicated for treatment of major depressive disorder and diabetic peripheral neuropathic pain.
Cymbalta, which already carries a Black Box Warning regarding “Suicidality in Children and Adolescents,” is now linked to post-marketing reports of hepatic injury (including hepatitis and cholestatic jaundice) that suggest “patients with preexisting liver disease who take duloxetine may have an increased risk for further liver damage.”
The FDA’s letter and the new Cymbalta label are posted online at http://www.fda.gov/medwatch/safety/2005/safety05.htm#Cymbalta.
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.
"Some of these reports indicate that patients with preexisting liver disease who take duloxetine may have an increased risk for further liver damage," Lilly said in its letter to doctors dated October 5.