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FDA Endorses First Weight Loss Drug Since 1999

Posted 2/23/2012 6:30 am by

Possible candidates for Qnexa doing The Twist.

The last time the Food and Drug Administration approved a weight-loss drug was way back in 1999.  Since then, no new obesity medications have been approved or hit the market, and the obesity drug market has been rocked by multiple lawsuits.  However, medication to fight obesity is still big business, with 35 percent of Americans being classified as obese and 33 percent of Americans being overweight.  It is with the health risks of obesity in mind that the FDA has given approval to Qnexa, a weight loss drug from Vivus.

Qnexa, a combination of anticonvulsant topiramate and appetite suppressant phentermine was denied approval at first due to the health risks it posed, including birth defects and a risk in heart rate.  However, users in a controlled study lost an impressive 10 percent of their body weight during their first year on the drug and had lower blood pressure, which kind of balances out the increased risk of heart attack or stroke due to the elevated heart rate.  Vivus promises to carefully control who can prescribe and distribute Qnexa in order to keep side effects to a minimum.

“We will know who the prescribers are.  We will know who has been trained,” said Vivus senior director of global medical affairs Dr. Barbara Troupin.  “We are confident the Qnexa [risk management program] balances the safeguards while allowing access for appropriate patients.”

Qnexa is only for patients who have a BMI over 30; those with a BMI over 27 and who have weight-related health problems like diabetes or sleep apnea can also be prescribed the drug.

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