LOS ANGELES, CA (Catholic Online) - Qysmia will also be prescribed in combination with a reduced-calorie diet and exercise. Obesity is defined as having a body mass index of 30 or more, while overweight people are defined as having a BMI of 27 or higher. It's estimated that more than one-third of U.S. adults are obese.

"Obesity threatens the overall well being 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."

Qysmia's name was subject to review to determine if there was potential for confusion with other approved drugs. The company eventually went with Qsymia to reduce any potential for medication errors.

Qsymia is an extended-release combination of two older drugs, phentermine and topiramate. Phentermine is an amphetamine approved for short-term weight loss and topiramate is prescribed to prevent seizures and migraines, and is supposed to make pill-takers feel fuller after meals.
Phentermine was one-half of the popular Wyeth drug fenfluramine, or fen-phen, which was tied to heart valve damage and taken off the market in 1997, resulting in a $13 billion settlement over tens of thousands of lawsuits.

There are side effects to the drug. Qsymia has been linked to tingling of the hands and feet, dizziness, insomnia, constipation, a change in taste sensation and dry mouth.

Pregnant women should not take Qsymia as it may harm the fetus, the FDA said. The FDA also doesn't recommend the drug for patients with glaucoma and hyperthyroidism, or patients with recent heart disease or stroke, as Qysmia also elevates heart rate.

Two studies won approval for the drug. One showed that after a year of taking the drug, patients lost between 7 and 9 percent of their body weight, and between 62 and 69 percent of study participants lost 5 percent of their body weight, compared with 20 percent of patients taking a placebo.

The FDA said people who took Qsymia and didn't lose at least 3 percent of their body weight by the twelfth week of treatment were not likely to achieve weight loss with continued treatment, and may need a higher dose.

© 2012, Catholic Online. Distributed by NEWS CONSORTIUM.