The FDA hasn't approved a new weight loss drug in 13 years. Now, an advisory panel is endorsing a previously rejected diet pill. What changed?
In a 20 to 2 ruling, an advisory panel overwhelmingly recommended the anti-obesity drug, Qnexa, for approval by the Food and Drug Administration. The FDA has not approved a weight loss drug in the past 13 years, and has removed similar diet pills from the market over concerns about heart risks and other adverse side effects. What makes Qnexa any different? Is it an important step forward in the fight against obesity, or another "quick fix" for Americans who refuse to make healthier lifestyle choices? Here's what you should know:
What is Qnexa?
It's a prescription medication for weight loss. It helps users shed pounds by suppressing appetite and speeding up metabolism. If approved by the FDA, it would be the first anti-obesity drug to be approved for medical use since 1999. When Qnexa's manufacturer, Vivus, first presented it before the agency in 2010, the FDA denied approval in a 10 to 6 vote.
Why was it rejected previously?
For weight loss drugs, side effects are a major issue. "Several potential medications for obesity and other metabolic diseases have floundered because they raise the risk of heart problems [palpitations, increased heart rate] even while causing weight loss," says Shari Roan at the Los Angeles Times. Qnexa posed many of the same risks for patients, but was also found to be linked to birth defects. ("An FDA expert on birth defects estimated there would be five babies born with a cleft lip defect for every 1,000 women who became pregnant while taking Qnexa," says the Associated Press.)
Why is the panel recommending it this time?
With so few weight loss medications on the market and obesity at epidemic levels in America, the panel agreed that the risks posed by obesity outweighed the drug's side effects. "This is far from a great drug," Dr. David Katz of the Yale Prevention Research Center tells ABC News. "The FDA panel recommended approval of Qnexa only because the ranks of useful weight loss drugs are so thin, and desperate times call for desperate measures."
Will it be approved?
Though the FDA isn't required to follow the recommendations of its special panels, it often does. If Qnexa ends up being approved, "FDA scientists said they would require Vivus to train prescribers to educate patients on the pregnancy risks of Qnexa," says the AP, and only 10 mail-order pharmacies would be permitted to sell the drug.
If it is approved, is that a good thing?
Qnexa "could re-energize the pharmaceutical industry after several years of disappointment in trying to develop anti-obesity drugs," says Roan. One analyst thinks it could very well be the next Lipitor, says Melanie Halken at Forbes, "resulting in millions of prescriptions." Critics of the drug argue that Qnexa is nothing more than a "magic bullet," and the search for an anti-obesity drug shouldn't replace "the need to make difficult lifestyle changes," says Carrie Gann at ABC News. A final decision is expected to be made by the FDA by mid-April.
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