FDA Panel Recommends Approval of Diet Drug Qnexa
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| FDA Panel Recommends Approval of Diet Drug Qnexa |
In voting 20 to 2 for approval, the committee said today that Qnexa's weight reduction benefits for the chronically obese outweighed the risks of birth defects and cardiovascular problems which have been from the drug. An FDA advisory panel recommended against approval this year over concerns concerning the drug's unwanted effects, and the FDA rejected it briefly after that. Vivus, the drug's manufacturer, recently submitted additional research.
The committee today recommended that the manufacturer take an amount of steps to avoid the drug from causing birth defects like cleft palate, including a possible warning label targeted toward women of childbearing years.
The FDA has considered numerous anti-obesity drugs in the past twenty years, but most have didn't meet the agency's standards for safety and effectiveness. But up to now, data on Qnexa suggests that the drug may be the most effective in helping patients shed around 10 percent of their bodyweight. Those changes, along with diet and exercise modifications, could go quite a distance toward alleviating some of the health problems connected with obesity, such as diabetes and high blood pressure.
Critics say the chance of potentially dangerous unwanted effects of Qnexa, such as increased heartrate, heart attacks and arrhythmias, are too great to make the drug available to millions of people, especially because long-term effects of the drug remain largely unknown.
"Public health can't tolerate another diet drug approved which has not been accepted for cardiovascular risk especially in light of the suggested findings of Qnexa, " said Dr . Sidney Wolfe, director of the health research group at Public Citizen, an advocacy group.
Obesity currently plagues one-third of Americans and contains been associated with high blood pressure, diabetes and a selection of other chronic, expensive health problems. Doctors and dietitians routinely recommend changes in diet and exercise because the safest and most effective way to shed pounds. But some acknowledge that these strategies just don't work with a large number of obese patients. Bariatric surgery, though largely successful in producing weight reduction, is not a viable option for many individuals.
Dr . Melina Jampolis, an obesity specialist in San francisco bay area, said the existing options for treating obesity are "frustratingly limited, " and said it might be helpful if patients had additional tools to aid their weight reduction.
"I believe that combination therapy is vital as you'll find so many individual and overlapping mechanisms that make weight reduction difficult, " she said. "So the more of these you could address with medication therapy when necessary, the more effective a regimen will be. "
