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Nearly 40 percent of adults and approximately 17 percent of  children and adolescents aged 2-19 years are obese.

To help lower those numbers, the U.S. Food and Drug Administration has approved Qsymia to be taken in addition to a reduced-calorie diet and exercise for chronic weight management.

Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, said this new approval will help fights this major public health concern. 

"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," Woodcock said. 

Only people with a body mass index (BMI) of 30 or greater or adults with a BMI of 27 or greater (overweight) who have at least one weight-related condition such as high blood pressure (hypertension), type 2 diabetes, or high cholesterol should use the new drug. 

Qsymia must not be used during pregnancy because it can cause harm to a fetus. Females of reproductive potential should have a negative pregnancy test before starting Qsymia and every month while using the drug and should use effective contraception consistently while taking Qsymia. Qsymia must not be used in patients with glaucoma or hyperthyroidism. 

Researchers say the drug can increase heart rate, but it's effect on heart rate in patients at high risk for heart attack or stroke is not known. The use of Qsymia in patients who had a stroke or heart disease within the last six months is not recommended. Regular monitoring of heart rate is recommended for all patients taking Qsymia, especially when starting Qsymia or increasing the dose. The most common side effects of Qsymia are tingling of hands and feet (paresthesia), dizziness, altered taste sensation, insomnia, constipation, and dry mouth.

Researchers tested the drug on nearly 4,000 obese and overweight people in two studies. All patients received lifestyle modification that consisted of a reduced calorie diet and regular physical activity. 

According to researchers,  after one year of treatment with the recommended and highest daily dose of Qsymia, patients had an average weight loss of almost seven percent and nearly nine percent, respectively, over treatment with placebo. Approximately 62 percent and 69 percent of patients lost at least five percent of their body weight with the recommended dose and highest dose of Qsymia, respectively, compared with about 20 percent of patients treated with placebo.

Patients who did not lose at least three percent of their body weight by week 12 of treatment with Qsymia were unlikely to achieve and sustain weight loss with continued treatment at this dose. Therefore, response to therapy with the recommended daily dose of Qsymia should be evaluated by 12 weeks to determine, based on the amount of weight loss, whether to discontinue Qsymia or increase to the higher dose.  If after 12 weeks on the higher dose of Qsymia, a patient does not lose at least five percent of body weight, then Qsymia should be discontinued, as these patients are unlikely to achieve clinically meaningful weight loss with continued treatment.

The recommended daily dose of Qsymia contains 7.5 milligrams of phentermine and 46 mg of topiramate extended-release. Qsymia is also available at a higher dose (15 mg phentermine and 92 mg of topiramate extended-release) for select patients.

In June, the Food and Drug Administration approved Arena Pharmaceutical's anti-obesity pill Belviq, ignoring push back from doctors for new weight-loss treatments.
 Qsymia will only be dispensed through specially certified pharmacies. 

According to reports, the drug is expected to be on the market by the fourth quarter of this year, but the cost of the pills hasn't been decided.