(2003; 58 pages)
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