https://www.trafford.nhs.uk/.../ALERT%2 ... ramine.pdf
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http://www.nelm.nhs.uk/en/NeLM-Area/New ... 80/484688/
Summaryby: Devika Sennik Reuters reports that the U.S. Food and Drug Administration has rejected a consumer group's petition to withdraw Abbott Laboratories obesity drug sibutramine in the United States. However, the FDA has said that it would continue to watch for safety problems. Consumer group Public Citizen had twice called on the FDA to withdraw the drug from the market, mentioning deaths from cardiovascular problems in people using the drug. According to Reuters, the head of the FDA?s drug division concluded "Sibutramine's overall risk-benefit profile supports it remaining available as a prescription drug for the treatment of appropriately selected obese patients". He added that the agency had worked with Abbott to educate doctors about appropriate patients and to change the drug's label, adding the need to monitor patients' blood pressure. The Health Research Group Director for Public Citizen said the 50 heart-related deaths reported since the drug's approval still warrant its removal.
In a statement, Abbott criticised Public Citizen's analysis and said sibutramine had repeatedly been proven safe and effective. According to the drug?s label the long term effects of the drug on obesity-related death is still unknown. Sibutramine is one of the five approved drugs that last year FDA scientist David Graham said should be scrutinised. He said the FDA and the company were "relying on statistics" to keep the drug on the market. Because of the side effects, he said a study he did three years ago showed most patients stayed
