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by Robert MacKay, Thursday, 16 September 2010 | Categories: Reductil

The Endocrinologic and Metabolic Drugs Advisory Committee of the FDA yesterday considered clinical data on Sibutramine, marketed in the US as Meridia. 8 members voted to withdraw Sibutramine and the decision was split with six members in support of a thorough warning on the label with distribution limited to specially trained healthcare professionals and two members suggested a box warning only and follow up medicals on patients receiving the treatment with regular blood pressure, heart rate and body weight check- ups. Those panel members who were in support of rigorous patient monitoring with the limiting of the distribution of Sibutramine argued that its withdrawal would leave doctors and patients without much choice as the number of weight loss medications is severely limited. It was also argued that the moderate weight loss achieved in the clinical trial could translate into big overall health benefits.

Abbott, the manufacturer and patent holder, has long argued that the clinical data being considered was largely irrelevant given that most patients receiving the treatment were actually contraindicated in normal clinical practice, therefore nullifying the legitimacy of the outcomes observed in terms of application to the correct patient population. Having said this, Abbott has not been intransigent but has made a number of helpful proposals in terms of ensuring that the medication is used as intended.

We would not like to hazard a guess as to where the FDA will go with this one but we should know very soon. If the FDA does decide to keep Sibutramine on the shelves then we would expect Abbott to make approaches to the European Medicines Agency, which banned Sibutramine back in January.

The Endocrinologic and Metabolic Drugs Advisory Committee is considering Lorcaserin (a new weight loss medication) as I write, so we will bring more news on that as it comes through.





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