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2003-83 AdvisoryHealth Canada is overseeing the market withdrawal of the antidepressant drug nefazodoneOTTAWA -Health Canada is overseeing the market withdrawal of the antidepressant drug called nefazodone. This action is in response to a Health Canada safety evaluation that found nefazodone poses a risk of causing serious liver-related adverse effects. This risk, while very remote, poses a greater risk than other similar antidepressants currently available 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 drug is also sold under the following generic names: Lin-Nefazodone (Linson Pharma); Apo-Nefazodone (Apotex Inc.); Nefazodone (Pharmel Inc.); Dom-Nefazodone (Dominion Pharmacal); Novo-Nefazodone-5HT2 (Novopharm Limited); PMS-Nefazodone (Pharmascience Inc.); and Gen-Nefazodone (Genpharm Inc.). Health Canada is aware of 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. Earlier this year, Health Canada requested that manufacturers of nefazodone products submit the latest scientific information available to support the safety of the drug. Health Canada evaluated this data, along with the latest information from the scientific literature, and concluded that, given there are other similar antidepressants available that pose less of a risk, the sale of nefazodone in Canada should be stopped. Bristol-Myers Squibb and Linson Pharma have agreed to have their nefazodone products withdrawn by November 27, 2003. Health Canada is working with other manufacturers of nefazodone to ensure the products are withdrawn from the Canadian market in a timely manner. A transition period has been established to allow time for patients taking nefazodone products to consult with their health care professionals about appropriate alternative treatments. This time is important for patients due to the risks associated with patients who abruptly stop taking their antidepressant medication. Health Canada advises patients on nefazodone to consult with their health care professional as soon as possible to make arrangements for alternative therapies. Health Canada also advises patients to contact their health care professionals if they have experienced any of the following adverse effects from taking products containing nefazodone:
Health Canada issued an advisory regarding nefazodone in July, 2001, to inform Canadians about the latest information available at that time. Health Canada also oversaw the issuance of a letter from the manufacturers of nefazodone to health care professionals in June, 2001, and published two articles in the Canadian Adverse Reaction Newsletter, one in 1999 and the other this year, to keep the medical community informed about the drug. These documents are available on the Health Canada web site at the addresses listed below. Nefazodone has been available internationally since 1993. Earlier this year, Bristol-Myers Squibb removed SERZONE® from the market in Europe, while Spain and Turkey both suspended its sale. While nefazodone is still sold in the U.S., the FDA in 2002 required Bristol-Myers Squibb to issue a letter to health care professionals advising them of the latest risk information about the drug and informing them of changes made to the drug's prescribing information. Health Canada is asking consumers and health care professionals to report any suspected adverse effects associated with the use of nefazodone products to Health Canada using the following contact information: Toll free phone: 1-866-234-2345
-30- Media Inquiries: Public Inquiries:
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Last Updated: 2003-11-10 |
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