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publicado em 27/03/2013 às 11h51:00
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Sibutramine should continue to be sold in Brazil, says director of ANVISA

Regulatory agency did a study on the drug and the report should be voted on next week by the board

 
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Foto: Fabio Rodrigues Pozzebom/ABr
Committee hearing on Social Security and Family PL 2431/11, which prohibits Anvisa to veto the sale of appetite suppressants
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Committee hearing on Social Security and Family PL 2431/11, which prohibits Anvisa to veto the sale of appetite suppressants

Sibutramine, a drug used in diet for weight loss, should continue to be sold in the Brazilian market, said Dirceu Barbano, chief executive of the National Health Surveillance Agency (ANVISA). The regulatory agency did a study on the drug and the report should be voted on next week by the board, but for Barbano, there is no reason to have a different outcome.

In October 2011, ANVISA has suspended the registration of amfepramone, the femproporex and mazindol and restricted the use of sibutramine, all drugs used for weight reduction. According Barbano, in this period there was no increase in the use of sibutramine with the suspension of the other inhibitors.

The agency report also noted that there was a decrease in the number of adverse event reports, and charts hypertensions arrhythmia, related to the use of sibutramine in proportion to the number of prescriptions.

There's been a greater vigilance on the part of the professional. The goal to reduce the period for revenues is to get the doctor to monitor the patient. As we observe that the number of notifications does not change much, we may revise this process, he said.

Barbano explained that while sibutramine was recorded based on studies that prove its effectiveness, amfepramone the femproporex and mazindol have nothing stating that work, and he said there are still consistent data that demonstrate the precariousness of the security of products.

On Tuesday (26), the Commission on Social Security and Family of the House of Representatives returned to discuss the bill (PL) 2.431/2011 that would prohibit Anvisa to veto the production and marketing of four drugs.

Barbano defended the commission that the drugs were withdrawn from the market to protect the health of people. He pointed out that on the day that some laboratory studies provide adequate showing the effectiveness of these inhibitors, the product can again be sold in the country.

The director of the Department of Obesity Brazilian Society of Endocrinology and Metabolism, Rosana Radominski, stressed that all drugs have side effects. What we need is to balance the risks and benefits. For Rosana, appropriate use of medicines help obese patients manage the disease, "he said.

She said that after the suspension of the inhibitors were many patients without treatment option. How to treat patients who can not only lose weight with lifestyle changes and has no indication for surgery? He asked. According to an endocrinologist, over 70% of patients undergoing treatment for obesity can not lose weight only with the change of lifestyle.

Source: AGÊNCIA BRASIL
   Palavras-chave:   Sibutramine    ANVISA    The National Agency for Sanitary Vigilance    Dirceu Barbano   
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