Where's the beef? FDA rejects Contrave combination of two FDA approved medicines

IN a suprise move, the FDA decided against the advice of its own expert panel and apparently has postponed approval of the new weight loss drug called Contrave. The shocking aspect of this action is that Contrave is a combination of two medicines WHICH ARE ALREADY APPROVED BY THE FDA.

A crucial question which arises is, " If the FDA has asked for more study and details on heart safety for a combination of naltrexone (Revia brand and others) and bupropion (Wellbutrin, others), should it ask for similar studies from the two medicines which are already approved? Combination therapy provides elegance in dosing (taking fewer pills), but may also have side effects which are different than a single medicine for a variety of reasons.

A closer look from clinicians, scientists and the press is warranted as to why the FDA came to this conclusion and at the time of this writing a stock report on the maker of the drug (Orexigen) on a business program is all that is available. It would be a usual course for the FDA to release details of the conclusion at www.fda.gov.

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