(2003; 14 pages)
NEFAZODONE - Regulatory status update
Republic of Turkey1. The Directorate General of Pharmaceuticals and Pharmacy has decided to suspend the license for nefazodone hydrochloride preparations (Serzone) held by Bristol Myers Squibb Drugs Inc in Turkey. This decision has been taken in view of the latest data received by the Turkish Ministry of Health as well as worldwide developments that suggest acute hepatic failure associated with nefazodone use. A variety of other antidepressant agents are available in the market and can be used effectively in its place. Procedures to stop further prescription and withdrawal of nefazodone (Serzone) from the market have been initiated.
Singapore2. Since nefazodone, indicated for the treatment of depression, was licensed in Singapore in 1997, the Pharmacovigilance Unit has received one local adverse drug reaction (ADR) report of mildly elevated ALT levels associated with nefazodone. Up to December 2002, 28 reports of liver failure, including 15 which resulted in death, associated with nefazodone had been received worldwide. In Singapore the package insert for nefazodone (Serzone) has been amended to include warnings relating to the risk of hepatic adverse events and a ‘Dear Healthcare Professional’ letter was issued in February 2002 to inform physicians of these amendments.
Reports in WHO-file: Liver and biliary system disorders 474
1. Communication from the Division of Pharmacovigilance, Ministry of Health, Republic of Turkey, 21 March 2003
2. Adverse Drug Reaction News (Singapore), 5:1, Feb 2003.