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Reported October 26, 2012

FDA Approves Two Weight-Loss Drugs

(Ivanhoe Broadcast)— Obesity is considered an epidemic in the United States; the demand for safe, effective weight-loss drugs is higher than ever. When it comes to body weight, it’s all about calories in, calories out. But researchers know the simple equation conceals critical complexities like genetic, environmental and cultural factors. The Food and Drug Administration (FDA) has recently approved two drugs that may assist patients with chronic weight management.

Weight-loss drug development has been a research priority, however most of the products have been dismissed due to their inherent risks. Everything from stroke to suicidal behavior has kept these drugs out of pharmacies. Lorcaserin (Belgiv) and phenterime (Qsymia) lack common toxic side effects associated with weight-loss medication and may help alleviate health hazards associated with obesity.

Joining the only approved prescription drug approved on the market, orlistat, the promising newcomers must be used in combination with diet and exercise. Researchers caution that lorcaserin and phenterime are not intended for cosmetic weight-loss. They are to be prescribed to patients considered obese by medical metrics, or overweight with a weight-related coexisting condition.

Each drug met FDA criteria to effectively lower patient Body Mass Index (BMI). In addition to intended weight-loss, the prescriptions also lowered blood pressure, cholesterol and waist circumference. Participants with type 2 diabetes saw the additional benefit of improved glycated hemoglobin levels.

As expected, both drugs carry risks. Lorcaserin was found to increase the occurrence of mammary and brain tumors in rats. The concern was quelled when independent pathologists concluded that cancerous tumors were not likely in humans. Phenterime with extended-release topiramate raised the heart rate of participants while initial data suggests that pregnant women may become more likely to have a child born with an orofacial cleft. Researchers warn that women who are or may become pregnant should not take this drug. Patients with a history of cardiac or cerebrovascular disease are also discouraged from using lorcaserin and phenterime.

Ultimately, the FDA approved the drugs because they effective and the benefits trumped the risks. They stress that though approved, the drugs still may have serious side-effects. The FDA required manufacturers to continue to conduct post approval clinical trials as there still is much to be learned about the performance of the promising pharmaceuticals.

Source: New England Journal of Medicine

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