Health Canada, Mar 27, 2002
2002-02
March 27, 2002
Advisory
Health Canada investigates safety of MERIDIA® (Sibutramine)
OTTAWA - In light of recent international regulatory
action and numerous adverse reactions reported in Canada and
elsewhere, Health Canada is conducting a safety review of the
prescription drug MERIDIA® (sibutramine). Sibutramine was approved
for sale in Canada on December 28, 2000, as a prescription drug for
the treatment of obesity, under the trade name MERIDIA®. Sibutramine
is approved as an obesity treatment to be used in combination with
diet and exercise. Patients who are currently taking sibutramine are
advised to consult with their treating physician if they have any
questions or concerns regarding the treatment of their condition
with this drug. Patients should be monitored by their physician
while they are taking sibutramine.
Although no deaths have been reported, there have been 28
reported adverse reactions associated with the use of sibutramine in
Canada from December 28, 2000 to February 28, 2002. These reports
are consistent with the known adverse reactions of sibutramine,
which include cardiovascular reactions such as increased blood
pressure, chest pain, stroke, as well as disturbances of vision such
as eye pain and eye hemorrhage. Health Canada is contacting and
collaborating with foreign regulatory agencies in reviewing the
safety of sibutramine. Health Canada will communicate the results to
the public and take further action if required.
Internationally, Italian authorities temporarily suspended market
authorisation of all drugs containing sibutramine in that country on
March 6, 2002, and have referred the matter to the European
Medicines Evaluation Agency Secretariat for a comprehensive
assessment of the risk/benefit profile of sibutramine. Sibutramine
was approved for sale in Italy in April 2001, and since that time 50
adverse reactions have been reported to the Italian authorities.
Seven of these reactions are considered to be serious, and 2 deaths
have been reported. The most commonly reported reactions in Italy
were tachycardia (increased heart rate) and hypertension (increased
blood pressure); arrhythmia (irregular heart rate) and cardiac
arrest were reported to be associated with the 2 deaths.
Several European countries such as France, Germany, England, the
Netherlands, Denmark, Portugal, Sweden, Finland and Spain have
issued statements informing the public of the market suspension of
sibutramine in Italy. France, Germany and England have announced
that they are conducting reviews of sibutramine but have not
withdrawn the drug from the market.
The text in this article was prepared by Health Canada.