Brazil approves obesity drug banned in US, Europe
October 5, 2011 in MedicationsBrazil on Tuesday approved the use of an anti-obesity medication, sibutramine, which has been banned in Europe and the United States, officials said.
The National Health Surveillance Agency (Anvisa) said it would halt sales of weight-loss medications which are based on amphetamines, but allow sibutramine under heightened surveillance.
The drug will be allowed to be prescribed to patients seeking to lose weight but only if they do not have cardiovascular problems, Anvisa director Dirceu Barbano told the state news agency Agencia Brasil.
But one Anvisa board member, former health minister Agenor Alvares, dissented.
"If a number of countries took this off the market based on scientific evidence, we cannot ignore that evidence," Alvares said.
According to Agencia Brasil, regulators in February proposed the withdrawal of sibutramine, following the lead of Europe and the United States.
The drug, sold in the United States under the name Meridia, was withdrawn in October 2010 after the European Medicines Agency suspended authorization for all anti-obesity medicines containing sibutramine in January that year amid concerns over the cardiovascular risks.
Barbano said however the evidence showed it is possible to use the medication to lose weight and that health risks can be minimized.
(c) 2011 AFP
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