FDA approves two life-long prescription diet drugs

bathroom scale iStock CROPPED FDA approves two life long prescription diet drugsTwo new medications are the first in 13 years to be approved by the Food and Drug Administration (FDA) for long-term weight management. Marketed as Belviq and Qsymia, the prescription drugs are designed to be taken for the rest of a person’s life – along with a healthy lifestyle – for obese and overweight people who have been unsuccessful in getting their weight under control with diet and exercise.

More than a third of adults in the United States are obese, and obesity contributes to a number of health conditions including high blood pressure, type 2 diabetes, and high cholesterol.

“For many people, obesity is a life-long condition, but we don’t always think of it – or treat it – as such,” says Amy Egan, M.D., M.P.H., deputy director for safety in the FDA Division of Metabolism and Endocrinology Products (DMEP). “Qsymia and Belviq are considered life-long therapies in patients who respond to and tolerate them.”

The drugs are eligible for people 18 years or older with a body max index (BMI) of 30 or greater or a BMI of 27 or greater with at least one other weight-related condition. People with BMIs of 27 or greater are considered overweight, and with a BMI of 30 or greater are considered obese.

Women who are pregnant or are thinking of becoming pregnant should not take either of these medications because the drug could cause harm to the fetus. Qsymia carries a risk for birth defects, such as cleft lip with or with out cleft palate, when taken by pregnant women during the first trimester of pregnancy.

Belviq contains the active ingredient lorcaserin. It comes in a 10 mg tablet taken twice a day that works by activating a part of the brain that controls hunger. It should be discontinued in patients who fail to lose 5 percent of their weight after 12 weeks of treatment, as it is unlikely that continued treatment will be successful.

Qsymia is a combination of two FDA-approved drugs – phentermine, an appetite suppressant, and topiramate, used to treat epilepsy and migraines. Qsymia is to be taken once daily with patients starting at the lowest dose (3.75 mg phentermine/23 mg topiramate extended-release), then increasing to the recommended dose (7.5 mg/46 mg). In some circumstances, patients may have their dose increased to the highest (15 mg/92 mg). If after 12 weeks the patient has not lost 3 percent of his body weight, the FDA recommends that treatment be discontinued or increased to the highest dose. If after an additional 12 weeks on the highest dose a patient dose not lose at least 5 percent of weight, the drug should be discontinued gradually.

It has been 13 years since the FDA has approved a drug for weight loss. The agency has been cautious about approving new diet drugs because of the potential for serious side effects. In 1997, two diet drugs were removed from the market because of concerns about damage to the heart valve. In 2010, the drug sibutramine (Meridia) was also removed because of concerns about the increased risk of heart attacks and strokes.

The makers of Belviq and Qsymia will be required to perform long-term trials to examine the effects of these products on the risk for heart attacks and strokes.

Source: FDA