The nation will have to wait another 90 days to learn if the United States will have its first new diet drug in more than a decade.
On April 9, The U.S. Food and Drug Administration (FDA), announced that it has delayed its decision on whether or not to approve a medication called Qnexa from April 17 to July 17.
Qnexa’s manufacturer, Vivus, describes the proposed drug as “an investigational, once-per-day, weight-loss therapy that combines low doses of two agents approved by the Food and Drug Administration (FDA), phentermine and topiramate, in a controlled-release formulation.”
An April 9 USA Today article on the FDA’s decision to delay approval included the following information:
Qnexa helps dieters lose 10% of their weight when used in combination with diet and exercise. Research shows it helps reduce diabetes and lowers blood pressure and other cardiovascular risk factors.Yet critics point out that Qnexa caused an increased heart rate in some patients who took a high dose, and increased the risk of cleft lip in the newborns of expectant mothers who took the drug.
According to Reuters, Qnexa is one of three weight loss drugs currently under FDA review for sale in the United States. The other two are Contrave (manufactured by Orexigen Therapeutics) and Lorcaserin (manufactured by Arena Pharmaceuticals, Inc.). Currently, Xenical (manufactured by Roche) is the only long-term prescription weight-loss drug currently approved for sale and use in the United States.
Of course, as Alexandra Sifferlin reported in “For Successful Weight Loss, Forget Fad Diets and Pills” on the TIME Healthland blog, the safest and most effective form of weight loss is a drug-free combination of healthy diet and appropriate exercise:
Researchers looked at data for 4,021 obese people ages 20 and older who participated in the government’s National Health and Nutrition Examination Survey. Between 2001 and 2006, about 63% of those participants were trying to lose weight, and 40% slimmed down — losing at least 5% of their body weight. Twenty percent of the participants lost 10% of their body weight or more.
The most popular strategies were eating less, exercising more, eating less fat and switching to lower-calorie foods. People who used commercial weight-loss programs and prescription weight-loss pills also saw success, but only a small portion of the study participants used them. Meanwhile, liquid diets, nonprescription diet pills and popular diets showed no association with weight loss.
“It’s reassuring that patients are using the less costly strategies that have been shown to be effective and the more ‘tried and true’ strategies,” Dr. Christina Wee, co-director of research at the Division of General Medicine and Primary Care at Beth Israel Medical Center, told Sifferlin “I think what is also reassuring is that when they try, in general, they lose weight.”