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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The U.S. Food and Drug Administration approved the new weight loss pill Qsymia on Tuesday, adding to a very skimpy arsenal of drugs Americans can take to battle severe obesity -- and adding a last-minute name change after two years of wrangling over whether to approve the drug.

Qsymia  (pronounced kew-SIM-ee-ah) pairs an old stimulant drug with an epilepsy drug to try and bring some options to the two-thirds of Americans who are overweight or obese -- and who have higher rates of heart disease, diabetes, stroke and cancer as a result.

“Obesity threatens the overall wellbeing of patients and is a major public health concern,” Dr. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, said in a statement. “Qsymia, used responsibly in combination with a healthy lifestyle that includes a reduced-calorie diet and exercise, provides another treatment option for chronic weight management in Americans who are obese or are overweight and have at least one weight-related comorbid condition.”

It’s the second obesity drug to win FDA approval this summer. Last month, the agency OK'd Belviq, the first new weight loss drug approved in 13 years. Qsymia combines phentermine, a stimulant, with the anti-seizure drug topiramate.

The FDA took its time in reviewing Qsymia, formerly known as Qnexa, because of fears about the side-effects, which can include a fast heart rate and metabolic acidosis, a condition marked by highly acidic blood that can, in severe cases, put people into a coma and even kill them. Metabolic acidosis can also cause kidney stones and damage bones. There’s been a growing debate over whether it’s worth the risk of taking drugs that could damage the heart to battle the growing obesity epidemic.

Diet drugs have a sketchy history in the U.S. and the FDA worries about irresponsible doctors who dispense pills from their offices to just about all comers, whether they’re in the group that’s supposed to get the drug or not. The FDA approves drugs for certain uses in certain people, but once a drug is approved, a licensed doctor may prescribe it as he or she sees fit.

Vivus, the company that makes the drug, has said it’s aware of this and has said it would restrict who can prescribe Qsymia and how. The once-a-day pill will be available only through mail order so that doctors cannot dispense it from their offices. The company also plans to educate doctors about the drug's risks, which include birth defects, and to carefully watch users for any signs of heart damage.

The agency asked for a last-minute name change from Qnexa, however. "The FDA indicated concern about potential confusion regarding the name Qnexa and worked with Vivus during the final steps of the review process to identify Qsymia as an acceptable brand name," Vivus's Dr. Barbara Troupin said in a statement.

Qsymia is approved for use in obese adults, those with a body mass index of 30 or greater, and overweight adults, those with BMI of 27 or greater, who have at least one weight-related condition such as high-blood pressure, type 2 diabetes or high cholesterol. 

This doesn’t calm the fears of Dr. Michael Lauer, a cardiologist at the National Institutes of Health who was on the panel of experts that advised the FDA about the drug.  Lauer and one other panelist voted against approval, but 20 panelists endorsed the drug in February.

"I believe that if the public were to 'buy' (Qsymia) after FDA approval, it would run the risk of severe, even fatal, consequences from another diet lemon," Lauer writes in Tuesday's issue of the Annals of Internal Medicine.

“If we think about the history of obesity medications, we've seen plenty of lemons. Ephedra, fen-phen, phenylpropanolamine, and sibutramine had to be withdrawn from the market because of cardiovascular toxicity. Rimonabant was approved for sale in Europe, but was never approved in the United States because of severe psychiatric side effects,” he added.

Lauer is not the only opponent. Public Citizen, a consumer group, has been campaigning against the drug, too.

"As was the case for the diet drug lorcaserin (Belviq), approved last month despite concerns about heart valve damage, it was also reckless of the Food and Drug Administration to approve Qnexa. Research shows the medication increases heart rate, and four patients on the diet pill had non-fatal heart attacks during the clinical trials, while none of those on the placebo had heart attacks," Public Citizen's Dr. Sidney Wolfe said in a statement.

"It is magical and delusional thinking for anyone to believe that a drug will turn off hunger without hitting other targets where it will do harm, usually to the cardiovascular system."

Vivus hopes it will be a safer successor to the notorious and now banned “fen-phen” diet cocktail. Fen-phen combined fenfluramine and phentermine -- one of the two drugs in Qsymia -- but it damaged the heart in some cases and caused a condition in some patients called pulmonary hypertension, which causes fluid to build up in the chest, bringing a feeling of breathlessness.

Reviewers say the amount of the drug phentermine in Qsymia is safer. The two drugs together seem to lower appetite while keeping patients perky. Lauer said he would have liked to see more tests to specifically look for heart problems before the FDA approves the drug.

Doctors tested the pill in more than 4,430 overweight and obese patients. About half lost 10 percent  of their weight -- enough to lower cholesterol and blood pressure, reduce the risk of diabetes and early death.

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