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Approval of antiobesity drug is “major regression for patients’ safety,” says health watchdog

BMJ 2014; 349 doi: https://doi.org/10.1136/bmj.g7805 (Published 24 December 2014) Cite this as: BMJ 2014;349:g7805
  1. Nigel Hawkes
  1. 1London

The decision by European regulators to approve an antiobesity drug has been criticised by Prescrire, a Paris based healthcare watchdog, as a backward step for patient safety.

Mysimba, a combination of naltrexone and slow release bupropion, was recommended for authorisation by the European Medicines Agency (EMA) on 19 December. Both of the component parts of Mysimba are already approved for other indications, and it is licensed for use in the United States under the name Contrave.

Prescrire denounced the decision as “a major regression for European patients’ safety,” saying that it was inconsistent with earlier decisions by the EMA to withdraw several appetite suppressants with a similar mechanism of action, including sibutramine (Sibutral) in 2009 and benfluorex (Mediator) in 2010.

“Health authorities should learn from past public health disasters,” Prescrire said in a press release. “A weight loss of a few kilograms achieved through drug therapy cannot in itself justify exposing obese or simply overweight people to a disproportionate risk of adverse drug reactions, especially since the weight lost is very often regained within months of discontinuing treatment.”

Mysimba was developed by a small company …

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