[Fwd: FDA MedWatch - Cymbalta (duloxetine hydrochloride) associated wit h increased risk of liver injury in patients with chronic liver disease]

[Guest guest]

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

Eli Lilly and FDA notified healthcare professionals of revision to the

PRECAUTIONS/Hepatotoxicity section of the prescribing information for

Cymbalta (duloxetine hydrochloride), 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.

Read the complete MedWatch 2005 Safety Summary, including links to the

Dear Healthcare Professional letter and revised label, at:

http://www.fda.gov/medwatch/safety/2005/safety05.htm#Cymbalta

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