Keywords: Abbott, Meridia, Public Citizen, USA, Obesity, Sibutramine

USA’s Public Citizen again calls for a ban on Abbott’s obesity drug Meridia

Article | 4 December 2009

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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.

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“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.

EMEA and FDA already reviewing sibutramine drugs

Last month, the European Medicines Agency (EMEA) said it has started a review of sibutramine-containing anti-obesity medicines (marketed in Europe under trade names such as Reductil, Zelium, Reduxade), because preliminary data suggest a possible increased risk of serious cardiovascular events (The Pharma Letter November23).

The data raising the concern about the anti-obesity drug come from the SCOUT study which investigated long-term cardiovascular effects of sibutramine treatment in a population with high cardiovascular risk. Meantime, the FDA also said it is reviewing the drug as a result of the SCOUT study.

Commenting on the situation, Abbott spokesman Kurt Ebenhoch said that “sibutramine is not recommended or approved for use in more than 90 % of the patients who participated in the SCOUT study." He added that "Abbott's assessment is that the data do not indicate a change in the safety profile of sibutramine when used in the approved patient population," noting that European regulators asked Abbott to perform the study. Mr Ebenhoch previously stated that sibutramine is approved for patients who are obese and have no history of cardiovascular disease.

Based on the new findings from the SCOUT study and Public Citizen’s updated figures based on an analysis of FDA data, Public Citizen calculates that there have been 84 post-approval cardiovascular deaths of patients taking Meridia. This includes 32 patients who were 50 or younger and 11 patients 30 or younger. Public Citizen urges the FDA to take immediate action to ban sibutramine. About 294,000 prescriptions for Meridia were filled in the past 12 months.