In an update, the FDA advisory panel reviewing the weight-loss drug Qnexa has voted to reject it.
The final FDA decision will not be issued until October, but the advisory panel’s decision is usually key to their decision.
In a 10-6 vote, a Food and Drug Administration advisory panel said they were concerned that Qnexa was too experimental. […] Approving the drug would be “a huge public health experiment,” said panelist Elaine Morrato of University of Colorado.
[…] Vivus is seeking FDA’s green light to sell Qnexa to adults to use once a day to slim down in it hopes could become the first prescription diet drug in a decade. The company told advisers its pill offers a safe option for shedding pounds and improving their health.
There is little doubt the drug works, but panelists said potential side effects such as depression, memory loss, increased heart rate and birth defects are a worry.
Panelists were also concerned since patients may take Qnexa for years but Vivus only studied it for about 12 months.