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.
First published July 19 2012, 7:51 AM