FDA

The Food and Drug Administration has approved two new diet drugs, but both have restrictions about who can -- or should -- take them.

The Food and Drug Administration has approved two new diet pills in a week -- the first new obesity drugs to be approved in 13 years. The agency, usually dry about its approvals, practically gushed about the pent-up demand for new obesity treatments in a country where more than two-thirds of the population is overweight or obese and steadily getting fatter.

“These prescription medications would be taken for the rest of a person’s life,” the FDA says on its website. 

“For many people, obesity is a life-long condition, but we don’t always think of it -- or treat it -- as such,” said Dr. Amy Egan, deputy director for safety in FDA’s Division of Metabolism and Endocrinology Products

But don’t expect to be able to get either drug easily. Each of the new drugs -- Belviq and Qsymia -- is being restricted in a different way. And consumer advocates say dieters should think twice about taking either.

The FDA was so worried about Belviq, approved last week, that it has asked for the Drug Enforcement Administration to control its use, like it does opiate painkillers. The DEA must now decide what restrictions to put on the pills, a process Belviq’s maker, Arena, says could take several months.

Qsymia, approved on Tuesday, won’t have these restrictions. But the FDA and drugmaker Vivus have worked out a plan to try to ensure that doctors don’t start running diet pill-mills.

“The only way the doctors will be able to prescribe Qsymia is through a certified pharmacy,” Vivus vice president Dr. Barbara Troupin said in an interview. That means they won’t be able to stock it themselves -- and they’ll be barraged with educational materials, Troupin said.

Vivus will track which doctors are prescribing the drug, and which ones undergo training. “If a prescriber wants to write for (prescribe) the drug, they can write for the drug. But we will have their information and continue to inform them about the risks and who the appropriate patients are,” Troupin said. “Hopefully, they won’t view it as being tormented.”

But the FDA and Vivus understand that people are likely to be clamoring for the drug, and there are clear guidelines on who should take it. Women who might get pregnant shouldn’t, for one -- the drug causes birth defects including cleft palates. Nor should people with overactive thyroids or who have heart disease risks such as an irregular heartbeat.

Approved patients should be obese, meaning they have a body mass index -- a measure of height to weight -- of 30 or greater. The National Institutes of Health has a BMI calculator here. A person 5 feet 5 inches tall is considered overweight at 150 pounds and obese at 180 pounds. People with BMIs of 27 may be eligible if they have a weight-related condition such as high cholesterol.

Doctors will be asked to monitor patients closely, watching heart function and looking for signs that a patient may become suicidal --a side effect of drugs related to topiramate, the seizure drug included in the two-drug Qsymia cocktail.

These precautions do not satisfy Dr. Sid Wolfe of Public Citizen, who has campaigned against Qsymia and Belviq.

“I would be very surprised if either of these drugs stays on the market very long,” Wolfe said in an interview.

Food and Drug Administration officials approved the diet drug Qysmia this week.

He points to the long list of withdrawn diet drugs, from Dexatrim, which caused fatal strokes, to fenfluramine, withdrawn in 1997 because it could damage heart valves, and ephedra, banned in 2004 after it was found to cause deadly heart attacks, strokes and other ills. Wolfe was disappointed when Qsymia won approval.

“There are a bunch of problems with it,” he said. “One is there is not remotely any kind of failsafe way to keep pregnant women from using this drug.”

Americans and drug companies are looking for an easy way out, but study after study shows good, old-fashioned careful eating and exercise works better than any diet pill, Wolfe says. And healthy eating and exercise have the added bonus of lowering the risk of heart disease, cancer, diabetes, arthritis and even Alzheimer’s disease. Wolfe's group approves of carefully designed programs that help people do that.

“People are just so desperate to approve something because they haven’t done anything for 13 years,” Wolfe said. One of Qsymia’s components, phentermine, is on the market as a diet drug. The only other diet drug on the market is orlistat, which stops the body from absorbing fat. A low-dose version, Alli, is even available without a prescription. But that’s it. The only other option for severely obese people, besides diet and exercise, is surgery to limit how much they can eat.

It is possible to get a home-made version of Qsymia. Any licensed doctor can prescribe phentermine together with certain versions of topiramate, the epilepsy drug, although the FDA doesn’t recommend it.

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Federal Food and Drug Administration officials approved a new weight-loss pill Wednesday, giving the nod to Belviq used in combination with a reduced-calorie diet and exercise to combat obesity.

The Arena Pharmaceuticals drug, which also goes by the generic name lorcaserin, is one of three new potential weight-loss treatments the agency is considering and the first new weight-loss medication approved in 13 years. More than two-thirds of adult Americans are overweight or obese. 

"Obesity threatens the overall well-being of patients and is a major public health concern," said Dr. Janet Woodcock, the director of the FDA's Center for Drug Evaluation and Research.

Lorcaserin was initially rejected because of concerns about safety issues, particularly concerns about heart valve problems, but a panel this spring agreed that the drug from Arena in conjunction with the Japanese firm Eisai Inc. was now suitable for use. 

The drug works by activating a receptor in the brain that may help a person eat less and feel full after eating smaller amounts of food.

It is approved for use in obese adults with a body mass index or BMI of 30 or greater and in overweight adults with a BMI of 27 or greater if they have at least one weight-related condition such as high blood pressure, type 2 diabetes or high cholesterol. For example, a 5-foot-7 woman who weighed 192 pounds would have a BMI of 30.

The drug was tested in three randomized, placebo-controlled clinical trials involving nearly 8,000 obese and overweight patients, including those with and without type 2 diabetes. They were treated for 52 to 104 weeks. All participants agreed to diet and exercise regimens. Compared with use of a placebo, or sugar pill, patients treated with Belviq for up to one year lost an average of 3 percent to 3.7 percent of their body weight. 

Nearly half of patients without diabetes lost at least 5 percent of their body weight, compared with about a quarter of those who took placebos. In people with diabetes, about 38 percent treated with lorcaserin lost 5 percent of their body weight, compared with about 16 percent treated with placebos. 

The drug is recommended to be discontinued in patients who fail to lose 5 percent of body weight after 12 weeks of treatment because they appear to be unlikely to achieve "clinically meaningful" weight loss. 

Approving lorcaserin will offer big benefits to patients approaching the 30 BMI mark, which increases health risks and decreases the likelihood of future weight loss, said Dr. Jaime Ponce, the new president of the American Society for Metabolic & Bariatric Surgery. 

"I think this is great," he said. "Thirteen years without any other medical option."

Select patients treated in a program that includes diet, exercise and medication may be able to lose weight without resorting to surgery, he added.

Arena Pharmaceuticals will be required to conduct six post-marketing studies including a long-term trial to evaluate cardiovascular risks including heart attacks and stroke. 

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