FDA refuses to recall Meridia
When Dr. David Graham had mentioned the top five most dangerous drugs in America, apart from Vioxx and Bextra (both since recalled), he included Accutane and Meridia. In another instance of how FDA favors the industry over the health and safety of American people, the agency has refused to recall Meridia.
According to a statement circulated by Abbott, the FDA has concluded that "(Meridia) sibutramine's overall risk-benefit profile supports it remaining available as a prescription drug for the treatment of appropriately selected obese patients." The response came to a petition filed by a consumer rights group Public Citizen.
Approximately 15 million patients in more than 75 countries have used sibutramine for the treatment of obesity since it was approved in 1997.
In another statement by Sidney M. Wolfe, MD, Director of Public Citizen’s Health Research Group, he expressed shock at the FDA decision and Abbott's statement that is highly critical of his petition. "Once again, the FDA is siding with a large drug company, much as the agency did several years ago with Merck concerning Vioxx, when it failed to demand a black box warning on that drug. How many more dangerously flawed decisions will the FDA make before the Congress repeals the Prescription Drug User Fee Act, which brings the agency ever closer to – and makes the agency less vigilant over – the companies that give it almost $200 million a year in funding?" he asks.
According to a statement circulated by Abbott, the FDA has concluded that "(Meridia) sibutramine's overall risk-benefit profile supports it remaining available as a prescription drug for the treatment of appropriately selected obese patients." The response came to a petition filed by a consumer rights group Public Citizen.
Approximately 15 million patients in more than 75 countries have used sibutramine for the treatment of obesity since it was approved in 1997.
In another statement by Sidney M. Wolfe, MD, Director of Public Citizen’s Health Research Group, he expressed shock at the FDA decision and Abbott's statement that is highly critical of his petition. "Once again, the FDA is siding with a large drug company, much as the agency did several years ago with Merck concerning Vioxx, when it failed to demand a black box warning on that drug. How many more dangerously flawed decisions will the FDA make before the Congress repeals the Prescription Drug User Fee Act, which brings the agency ever closer to – and makes the agency less vigilant over – the companies that give it almost $200 million a year in funding?" he asks.





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