Sibutramine
International Safety Reviews
Meridia, commonly known as sibutramine, has been making news in
the U.S. after consumer advocacy group Public Citizen lobbied for
the U.S. government to remove the drug from the market. The FDAs
response to the life threatening adverse
effects came after other countries began their own safety investigations
of sibutramine. Italy first suspended the sales of sibutramine after
reports of health problems, including two deaths, were received.
Italys suspension of sibutramine was the first move by any
country since its 1997 approval. Italys Pharmaceutical Commission
had decided that the beneficial effects of the weight loss pill
sibutramine had to be re-evaluated.
In Britain there have been two deaths and more than 200 other adverse
reactions to sibutramine, and in France drug regulators reported
that they had received 99 reports of sibutramine side effects. The
British Department of Health stated that the Medicines Control Agency
and Committee on Safety of Medicines are intensively monitoring
the safety of sibutramine. A Europe wide review by the European
Medicines Evaluation Agency is also now examining sibutramine. Britains
Drug and Therapeutics Bulletin that is published by the Consumers
Association warned sibutramine had limited benefits and unwanted
side effects last December.
Health Canada has also launched an investigation of Meridia, used
by 9,000 Canadians. The Canadian government has received 28 reports
of adverse sibutramine effects within the last year, including blood
pressure increases, chest pain, stroke, and vision disturbances.
Health Canada is reviewing the national and international safety
information regarding sibutramine and will then determine the weight
loss pills status.
Abbott Laboratories, Meridias manufacturer, has estimated
that 8.6 million people have used sibutramine since 1997.
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