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Diet Drug Acomplia to Confront Tough EU Safety Analysis

Sanofi-Aventis’s obesity pill Acomplia will confront a tough review from European drug safety experts this week, with respect to data signifying concerns over the medicine's association with suicidal thoughts.

The drug is going to be reviewed by the European drug safety experts nearly a month after it failed to please the FDA’s advisory panel due to its connection with suicidal thoughts. The U.S. FDA’s advisory panel refused to support the drug approval for sale in the United States as it can augment depression and suicidal thinking when utilized.

In the reply, the French drug maker pulled its NDA in the United States, and thus gave a major blow to what had been touted as its landmark innovation for the treatment of obesity. In Europe, Acomplia, also recognized by the brand names Zimulti and rimonabant, has been marketed since last year.

The EMEA's Committee for Medicinal Products for Human Use is slated to take a decision on 19th July and has a variety of options available to choose from.

"They will advise whatever they believe is apposite. It may vary from nothing to addition of new safety warnings or other contraindications to suspension or withdrawal of the drug," said an agency spokeswoman.

Meanwhile, a U.S. consumer group and the Public Citizen's Health Research Group also requested the EMEA to pull out both Acomplia and another drug Arcoxia, which is intended to treat arthritis.

"These drugs are too unsafe and their benefits are extremely outweighed by the associated risks," opined the group's director, Dr. Sidney Wolfe.

Data gathered by the EMEA and proposed to the U.S. Food and Drug Administration advisory panel last month underlines the suspicions concerning Acomplia’s relation with psychiatric side effects.

With in just one year of its market launch, acomplia was found guilty of causing 208 psychiatric adverse events, together with 27 cases of suicidal thinking under the EMEA's post-marketing data.

Acomplia is the first in a novel class of medicines which work by switching off the same brain circuits that make people starve when they burn cannabis.