The use of the anti-obesity drug sibutramine, which has been banned in the US and Europe, has been permitted in Brazil.
According to Anvisa – the Brazilian National Health Surveillance Agency –strict regulations would need to be enforced to control its use.
The Agency has made something of a U-turn in its decision to approve the drug, as it had originally planned to ban obesity treatments containing amphetamines.
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Under the newly imposed regulations, the only patients who will be given access to sibutramine will be those with weight problems but who are without cardiovascular issues too.
These rules have been put in place after the European Medicines Agency voiced concerns that sibutramine heightened cardiovascular risks, which subsequently saw it removed from sale in the US and Europe last year.
This decision was followed in February by suggestions that the obesity treatment should also be banned in Brasil.
However, the Director of Anvisa, Dirceu Barbano, reportedly believes it is an effective anti-obesity medication and things can be done to minimise the associated health risks.
Despits the drug receiving an approval from the Brazilian regulators Anvisa, Agenor Alvares, a board member and former health minister, has disagreed with the move.
He said: “If a number of countries took this off the market based on scientific evidence, we cannot ignore that evidence.”
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