Canada orders antidepressant off market|
Health Canada announced today 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 The drugs are being withdrawn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
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risk, the department concluded the drug should be withdrawn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have their nefazodone products withdrawn by Nov. 27, Health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ensure the products are withdrawn from the Canadian market in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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