Since diet drug Acomplia (rimonabant) first went on sale in Europe in mid-summer, European regulators have had reports of a dozen cases of psychiatric disorders in Acomplia patients, including six incidences of major depression, according to a report in the news magazine Business Week.

The magazine, in a report headlined "Can Sanofi's Wonder Drug Save the Day," again raises questions as to on whether the holdup of the drug at the U.S. Food and Drug Administration -- where action on approval has been stalled since February -- is based on concern about Acomplia's side effects.

Noting that Acomplia is the first weight-loss drug that works blocking the CB-1 receptors in the brain, the magazine points out that "there are no long-term studies yet of the effects of interfering with this part of the brain."

"I'm not convinced the side effects, especially the psychiatric ones, are as minor as the company claims," Navid Malik, a pharmaceutical analyst with London-based brokerage Collins Stewart, told Business Week.

The magazine reports that most analysts -- including Malik -- anticipate that Acomplia eventually will be approved by U.S. regulators.

But with concerns mounting over Sanofi's antibiotic Ketek -- which is the subject of new safety concerns that will be the subject of a special hearing in December -- Malik speculated that any approval of Acomplia may come with conditions.

"The FDA may take a tough line and restrict the way and to whom the drug is marketed," Malik said.