WHO Drug Information Vol. 17, No. 4, 2003
(2003; 58 pages) View the PDF document
Table of Contents
Open this folder and view contentsRegulatory Challenges
Open this folder and view contentsSafety and Efficacy Issues
Open this folder and view contentsAspects of Quality Assurance
Close this folderRegulatory and Safety Action
View the documentRecommended influenza vaccine for 2004 (Southern hemisphere)
View the documentDaclizumab: safety alert
View the documentNefazodone discontinued
View the documentLevomethadyl discontinued
View the documentDaptomycin: new class of antibiotic approved
View the documentTetrahydrogestrinone: grave risks to health
View the documentCoronary stents and thrombosis
View the documentBicalutamide: do not use in localized prostate cancer
View the documentRecombinant antihaemophilic factor: dose monitoring required
View the documentNimesulide-containing products re-evaluated
View the documentMemantine approved for Alzheimer disease
View the documentVirologic non-response in more HIV combinations
Open this folder and view contentsPersonal Perspectives
Open this folder and view contentsCurrent Topics
Open this folder and view contentsEssential Medicines
View the documentRecommended International Nonproprietary Names: List 50
View the documentSelected WHO Publications of Related Interest
 

Nefazodone discontinued

Canada - In consultation with Health Canada, the manufacturer of nefazodone (Serzone-5HT2®) has decided to discontinue sales of the product from the market in Canada effective 27 November 2003. Nefazodone has been associated with adverse hepatic events including liver failure requiring transplantation.

Nefazodone is indicated for the symptomatic relief of depressive illness. Since introduction in 1994, nefazodone has been temporally associated with hepatic adverse events such as jaundice, hepatitis and hepatocellular necrosis in patients receiving therapeutic doses. As of December 2002, there were 51 Canadian reports of hepatotoxicity, ranging from no symptoms to transplantation, suspected to be associated with nefazodone use. One of two transplant recipients subsequently died. Cases of liver injury have occurred as early as a few weeks after initiation of therapy or after continuous use for up to 3 years. To date, no risk factor to predict patients who will develop irreversible liver failure with nefazodone has been identified. Also, no clinical strategy, such as routine liver function tests, could be identified to reduce the risk of liver failure.

Reference: Communication from Bristol Myers Squibb, 2 October 2003 on www.hc-sc.gc.ca

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