Eight months after their counterparts in Europe told doctors to stop prescribing the Meridia diet pill, the FDA has finally scheduled an advisory committee meeting to review safety risks. A spokesman for Abbott Labs, which sells the drug, confirmed the Endocrinologic and Metabolic Drugs advisory committee will review Meridia on Sept. 15, a day before Arena Pharmaceuticals’ lorcaserin is reviewed.

The move comes in the wake of a trial known as SCOUT, which emerged last November and showed an increased risk of serious, non-fatal cardiovascular events, such as stroke or heart attack, when comparing the drug with a placebo among nearly 10,000 patients. The trial was designed to assess the impact of weight loss on cardiovascular problems in a large group of overweight people taking the pill.

However, the data prompted two different regulatory reactions. Last January, the European Medicines Agency told docs to stop prescribing Meridia, because the risks outweigh the benefits, and decided Abbott’s license to market the pill should be suspended (look here). For its part, the FDA added new warnings highlighting increased risks for patients with heart problems, but reserved further action until full results arrived in March and a committee meeting is held (see here).

Prescription diet pills have been something of a graveyard for drugmakers. More than a decade ago, the fen-phen weight-loss cocktail and a related diet pill called Redux made headlines after links to heart and lung troubles forced a recall, which eventually cost Pfizer’s Wyeth $21 billion in charges. Others - Abbott’s Meridia and Roche’s Xenical - never fared well at all due to side effects. And Sanofi-Aventis simply gave up in the US and never sold Acomplia due to psychiatric side effects.

Ironically, the Meridia review comes as diet pills become a hot topic again, although the first one to attempt to win over experts failed. Last month, an FDA advisory committee rejected the Qnexa pill being developed by Vivus. Clinical trials showed effectiveness, but panelists worried about usage by pregnant women and psychiatric side effects (back story). In addition to Arena, which just struck a deal with Eisai (see here), Orexigen Therapeutics is also developing a fat drug. Opinions, however, vary about their chances of winning regulatory approval, given ongoing scrutiny of side effect concerns in a population that is likely to use such drugs on an ongoing basis.

pic thx to alan cleaver on flickr