Acomplia Gets Rejected
The newer weight loss pill (prescription) that goes by the brand name of Acomplia but it’s drug name is Rimonabant, has been unanimously rejected for approval for use in the US by the panel the FDA uses to try to decide whether or not they want to approve a certain drug for sale and use here in the US. Although the FDA is not required to follow the advisory panel’s advice, it usually does, and in this case since the decision was unanimous that the panel’s participants didn’t like what they heard, the FDA rejected the drug for sale in the US.
The reason for the unanimous decision was that the drug was shown to almost double the risk of suicidal thoughts, depression, anxiety and sleeplessness in it’s subjects. Since the side effects are real and possible, the drug company recommende the way around such dangers was to screen potential patients of the drug for depression and anxiety prior to prescribing it.
The advisory panel decided this was not good enough though, and the potential for this serious side effect sounded too dangerous to allow for widespread sale here in the US.
The bigger problem was that most of the patients who reported the mental problems while on the drug had absolutely no history of depression or related mental health issues. Since the studies were done with half placebo and half on the drug, the findings were really significant, since these patients with no history of mental illness reported the issues.
The weight loss pill has been shown to be effective for weight loss though, but the findings suggest that much more research on the drug’s effect on the mind is needed before the FDA can conscienably approve a drug that can have a significant effect on one’s psyche.
