The new prescription medications are designed for people who are obese or for those who are overweight and have other weight-related medical problems.
With the arrival of a diet drug to pharmacies today, there are now two new prescription medications to treat obesity — the first new ones available to heavy patients in more than a decade. The drugs offer to boost weight loss a modest 5% to 10%, but become another "tool in the toolbox" for physicians trying to help America out of its obesity crisis.
Beginning today, Belviq (pronounced bel-VEEK) sold by Eisai, will start arriving in pharmacies. It works on brain chemistry to create a feeling of fullness and can help obese patients lose an average of about 5% or so of their starting weight when used in combination with a reduced-calorie diet and exercise.
The wholesale cost of a month's supply of Belviq to pharmacies is just under $200, says Gary Palmer, chief medical officer for Eisai. The price that patients will pay depends on their insurance coverage and may vary between pharmacies, he says. "We are looking at a whole range of options for patients who don't have insurance (belviq.com) and need financial support for the medication."
Another new diet drug, Qsymia (pronounced kyoo-SIM-ee-uh), from Vivus, which came out in mid-September, helps heavy folks drop about 10% of their weight by suppressing appetite and increasing the feeling of fullness.
Both drugs are intended to provide treatment help for those who are obese, which is roughly 35 or more pounds over a healthy weight, or overweight patients who have one other weight-related condition, such as high blood pressure, type 2 diabetes or high cholesterol. About a third of people in this country are obese. The drugs are not meant for people who want to lose a few pounds for cosmetic reasons.
Initial sales of the Qsymia have been lower than the company expected, but the demand is continuing to grow and insurance coverage is improving, says Michael Miller, senior vice president at Vivus.
About 89,000 prescriptions were written for Qsymia from the launch through March, he says. The medicine costs about $150 a month for those who pay cash. About a third of the patients had their prescriptions covered by insurance companies with a $50 co-pay, Miller says. The company is offering the medication for no charge for the first two weeks, and a 50% discount for the first month of treatment, he says.
The new obesity drugs were approved last summer by the Food and Drug Administration. These medications are new "tools in the toolbox" for doctors who are treating obese patients, says Harvey Grill, president of the Obesity Society, and a professor of behavioral neuroscience at the University of Pennsylvania. There are several other new obesity drugs on the horizon, and many others being investigated now, he says.
Other diet medications available to treat obesity include phentermine, which suppresses appetite; and orlistat (Xenical), which keeps some dietary fat from being absorbed by the intestine. Orlistat is sold in a lower-dose, over-the-counter version as Alli.
Ben Yankowitz, 58, of Los Angeles, who has type 2 diabetes, has lost about 20 pounds since he started Qsymia several months ago. Six-foot-tall, he now weighs 185, down from 205. He says the medication really keeps hunger at bay. "During the day, I have to remind myself to eat lunch," says Yankowitz, who is the CEO of Proteus Energy, a California-based oil and gas company.
Yankowitz says he hasn't experienced any significant side effects from Qsymia, but he adds that it "is not a magic pill. You've got to exercise and follow a healthy diet too."
Patients also reported weight-loss success during the drug trials for Belviq, which works by activating a chemical receptor in the brain that can help people eat less and feel full after eating smaller amounts of food.
Lisa Sutter, 52, who works for the city government in Washington, D.C., lost weight on Belviq when she took it for two years during one of the drug's trials. At 5-foot-5, she dropped from 230 pounds to 190.
"Honestly it was effortless. ... I didn't feel hungry even though I was only eating 1,600 calories a day."
Sutter says she didn't experience any side effects from the drug, but when she went off the medicine after the drug trial ended, her hunger returned. She couldn't stick to a low-calorie diet and she regained the weight and then some. Now that Belviq is on the market, she plans to go back on it "because I know for me it worked really well."
Still, there are concerns about the side effects and risks of both drugs. Sidney Wolfe, founder and senior adviser of the health research group at Public Citizen, a consumer group, says, "We strongly oppose both of them. They both have serious dangers."
Belviq was rejected by an FDA advisory panel in 2010 over safety issues.The second time the advisory committee met, the members discussed heart-valve concerns but decided that the benefits of the drug outweighed the risks. The agency later approved the medication.
The product's label warns: "Some people taking medicines like Belviq have had problems with the valves in their heart. ... Before taking Belviq, tell your doctor if you have or have had any heart problems."
The drug's manufacturer (Arena Pharmaceuticals) and marketer (Eisai) are required to conduct a long-term cardiovascular trial to assess the effect of Belviq on the risk for major adverse cardiac events such as heart attacks and stroke, Palmer says.
Wolfe argues that Belviq "actually showed heart-valve damage prior to approval. The risks of this drug far outweigh any benefits."
He says it is "magical thinking to believe that you can turn off something as complex as hunger without affecting different systems, especially the cardiovascular system."
Palmer says, "We along with Arena Pharmaceuticals conducted a very long development program that included close to 8,000 patients studied for up to two years. In that program, we did not see a problem with heart valves when used in appropriate patients. But we will continue to monitor the efficacy and safety of the product."
Some experts are concerned that Qsymia raised the heart rates slightly in some patients. It is made up of two other older medications: the appetite-suppressant phentermine and the anti-seizure medication topiramate, which is sold under the brand name Topamax. The latter is used to treat epilepsy and migraines.
Wolfe is afraid history will repeat itself. In 1997, two diet drugs were pulled from the market — fenfluramine (part of the popular fen-phen combination) and dexfenfluramine (Redux) — because of evidence of heart-valve problems that arose only after approval, unlike Belviq.
In 2010, Abbott Laboratories removed sibutramine (Meridia) from the market because of evidence of an increased risk of heart attacks and strokes.