This site is intended for health professionals only

FDA setback for weight-loss drug

teaser

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.”

Article continues below this sponsored advert
Featured Image
Explore the latest advances in cardiovascular care delivered by renowned experts from recognised Centres of Excellence and other NHS trusts around the UK. Gain CPD, put your burning questions to the experts, and boost your confidence when it comes to care for your patients.
Advertisement

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

Vivus






Be in the know
Subscribe to Hospital Pharmacy Europe newsletter and magazine

x