NEWS - Diclofenac linked to liver failure, death

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Diclofenac Linked to Liver Failure, Death

December 5, 2009 — Treatment with all products containing diclofenac

sodium, including Voltaren Gel, may increase liver dysfunction,

resulting in severe hepatic reactions and liver transplantation or

death, the US Food and Drug Administration (FDA), Endo, and Novartis

announced late last night.

Cases of drug-induced hepatotoxicity have been reported within the

first month of treatment with diclofenac but can occur at any time

during treatment.

" Postmarketing surveillance has reported cases of severe hepatic

reactions, including liver necrosis, jaundice, fulminant hepatitis

with and without jaundice, and liver failure, " according to an alert

sent last night by MedWatch, the FDA's safety information and adverse

event reporting program. " Some of these reported cases resulted in

fatalities or liver transplantation. "

Physicians should discontinue diclofenac treatment immediately if

patients continue to have abnormal or worsening liver test results, if

liver disease symptoms develop, or if systemic manifestations occur,

such as eosinophilia, rash, abdominal pain, diarrhea, or dark urine,

according to a letter from Endo and Novartis to healthcare

professionals.

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Read the whole article here:

http://www.medscape.com/viewarticle/713451

Not an MD