Heart attacks, strokes and babies born with cleft lips did not stop the Food and Drug Administration from approving the weight loss drug Qnexa on Wednesday. It was a reversal from 2010 when the same panel decided that the adverse effects outweighed the potential weight-loss.
Obese people now will have an opportunity to get a prescription for the drug that in trials showed an average loss of 10% total body weight in the first year of use.
The manufacturer of Qnexa, Vivus Inc., is taking steps to control who is prescribed the drug, specifically when it comes to women. Female patients taking the drug will have monthly pregnancy tests and they will only distribute the drug to registered pharmacies. Trial date has shown that babies born from mothers who became pregnant while taking the anticonvulsant drug topiramate, the main ingredient in Qnexa, are two to five times more likely to have cleft lip.
“We will know who the prescribers are. We will know who has been trained,” Dr. Barbara Troupin, Vivus’ senior director of global medical affairs, told the advisory committee. “We are confident the Qnexa [risk management program] balances the safeguards while allowing access for appropriate patients.”
This will be the first FDA-approved prescription obesity pill since 1999. Xenical is the only prescription diet pill on the market in the United States but it only blocks the absorption of fat. Qnexa suppresses the appetite and gives patients a sense of fullness.
With almost 75 million people in the United States considered to be unhealthy and obese, why not give Qnexa a chance? The weight will probably kill people long before the pill. Just keep an eye out on those overweight mothers.
Note: Vivus shares climbed this morning from $12 to $22.50. The average trading price over the last year was between $6-$13.