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Drug Maker Withdraws Generic Nefazodone Products Over Liver-Damage Fears

Nov 10, 2003 | Canadian Press

Health Canada announced Monday that generic versions of the antidepressant Serzone are also being pulled from the market.

The department will oversee the withdrawal of all generic drugs containing nefazodone, the generic name for the drug marketed as Serzone. The drugs are being withdrawn because of concerns that nefazodone may cause severe liver-related adverse effects in some users. "This risk, while very remote, poses a greater risk than other similar antidepressants currently available in Canada," Health Canada explained in a statement.

There have been at least 38 reported cases in Canada of liver-related adverse effects including one death suspected to be associated with nefazodone products between 1994 and the end of last year.

Last month a Quebec man announced he has launched a $200-million class action suit against the makers of Serzone and those who produce its generic equivalents. Steve Ledyit, 36, of Gaspe, said months after beginning treatment on Serzone he developed symptoms that were eventually diagnosed as serious liver damage.

Earlier this year, Bristol-Myers Squibb pulled the drug from the European market and Spain and Turkey suspended its sale.

In the face of the growing concern over the drug, earlier this year Health Canada requested that manufacturers of nefazodone products submit the latest scientific information available to support the safety of the drug.

Based on the data, the available scientific literature and on the fact that other antidepressants pose less of a risk, the department concluded the drug should be withdrawn from sale in Canada.

Nefazodone is a prescription-only product approved for sale in 1994 and sold under the trade name Serzone by Bristol-Myers Squibb Canada Inc.

The generic versions of the drug are as follows: Lin-Nefazodone, sold by Linson Pharma; Apo-Nefazodone, by Apotex Inc.; Nefazodone, marketed by Pharmel Inc.; Dom-Nefazodone, from Dominion Pharmacal; Novo-Nefazodone-5HT2, from Novopharm Limited; PMS-Nefazodone, made by Pharmascience Inc. and Gen-Nefazodone, from Genpharm Inc.

Bristol-Myers Squibb and Linson Pharma have agreed to have their nefazodone products withdrawn by Nov. 27, Health Canada said, adding it is working with other manufacturers to ensure the products are withdrawn from the Canadian market in a timely manner.

The department agreed to a transition period to allow patients using the medication time to consult with their doctors and to work out appropriate alternative treatment plans. "This time is important for patients due to the risks associated with patients who abruptly stop taking their antidepressant medication," Health Canada said.

The department also said that people who have been taking the drugs should contact their doctor if they have experienced any of the following adverse effects from taking products containing nefazodone: jaundice, brown urine, nausea, vomiting, unusual tiredness, weakness, stomach or abdominal pain or loss of appetite.

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