New research shows that drug major Abbott Laboratories Meridia (sibutramine), a popular weight-loss drug, has caused a significantly increased number of heart attacks, strokes, resuscitated cardiac arrests or deaths in obese patients getting the drug and should, therefore, be pulled from the market immediately, claims the US advocacy group Public Citizen, in a petition to the Food and Drug Administration yesterday.
This is Public Citizen's second appeal to have Meridia banned; the FDA rejected the first four years ago, saying it was awaiting results of an ongoing trial. The results are in, and they show that the drug's dangers significantly outweigh its benefits.
'If the FDA truly intends to operate as a public health agency, then it should acknowledge that the continued approval of this drug cannot be justified based on science,' said Sidney Wolfe, director of Public Citizen's Health Research Group, adding: 'The FDA should therefore tell Abbott to pull Meridia from the market immediately.'
In responding to Public Citizen's 2002 petition, the FDA said that until a large, randomized study could provide more conclusive results, Meridia ' which was approved in the USA in 1997 - would continue to be sold. Now, says the advocacy group, the early results are in from a 'persuasive study' called SCOUT (Sibutramine Cardiovascular OUTcome Trial), in which 10,000 people across Europe participated. The recently-released results of this study reveal a significant increase in heart attacks, strokes, resuscitated cardiac arrests or deaths in obese patients 55 or older with known or undetected cardiovascular disease who used sibutramine, compared with those given a placebo, says Public Citizen.
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