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The risks of Vivus’s anti-obesity drug Qnexa far outweigh its ability to help people lose weight, a Food and Drug Administration (FDA) panel has ruled.
Officials voted 10-6 against the product, saying they were worried that its long-term side effects could pose a danger to patient health.
While members agreed that the drug helped people lost up to 10% of their mass, trial reports of memory lapses, suicidal thoughts, heart palpitations and birth defects swung the decision against Vivus.
Panel chairman Kenneth Burman said: “Some of these side effects are serious and could be life-threatening and must be weighed against a relatively modest weight loss.”
The company said it was disappointed by the decision but would continue to work with the FDA prior to a final ruling on the drug, expected before October 28.
Two competitors – Arena Pharmaceuticals and Orexigen Therapeutics – are set to have rival weight-loss medications reviewed by the agency later this year.
Copyright Press Association 2010
