FDA Approves New Diet Drug Qsymia

The United States Food and Drug Administration (FDA) approved a new prescription drug called Qsymia (Kyoo-sim-ee-uh). It is the most effective weight loss pill that the FDA has considered in recent years.

The July 2012 approval came less than a month after the agency approved another drug called Belviq. Qsymia and Belviq are the first weight loss drugs approved by federal regulators in more than a decade.

Qsymia is manufactured by Vivus Inc., a California-based drug development company. Originally called Qnexa, Qsymia received overwhelming support from an FDA advisory panel in February 2012. The panel strongly recommended its approval for the treatment of obesity, one of the most important health concerns in America today.

Once merely an aesthetic issue, obesity is now recognized as a disease itself. It greatly increases the risk of serious health problems like diabetes, high cholesterol, high blood pressure, heart disease, and depression.

Qsymia combines two already approved prescription drugs: a stimulant called phentermine, the “phen” part of the controversial fen-phen diet drug, and an anti-seizure medication called topiramate. Qsymia is available as a controlled-release capsule that is taken once a day.

Diet pills cannot cure obesity, and they are not meant for long-term or rapid weight loss. However, they can be a valuable diet aid when combined with exercise and healthy eating.

Like many nutritional supplements that are formulated for weight loss, Qsymia works by curbing hunger, boosting metabolism, and creating a feeling of fullness. The FDA approved the drug for obese people with a body mass index (BMI) greater than 30.

Overweight people with a BMI greater than 27 can also take the drug if they have a weight-related problem, such as hypertension or high cholesterol. Qsymia is particularly useful for diabetics and those who may develop the disease.

Study participants who combined Qsymia with healthy lifestyle changes lost more than 10 percent of their body weight after using the drug for one year. While this may seem like a modest amount of weight loss, Qsymia is twice as effective as Belviq and other diet pills.

Like all drugs, Qsymia has the potential for unwanted side effects. Dry mouth, constipation, dizziness, insomnia, and taste disorders are the most common adverse effects.

Qsymia is not approved for pregnant women, and it is not recommended for people who have glaucoma, thyroid problems, or heart disease.

The FDA approved Qsymia with a Risk Evaluation and Mitigation Strategy (REMS), which attempts to educate doctors and patients about the risks associated with using Qsymia. Due to government restrictions, the drug is only dispensed through special certified pharmacies.

• Boyles, Salynn. (July 17, 2012) "FDA Approves Diet Drug Qsymia." WebMD Medical Reference. Retrieved July 19, 2012.
• DeNoon, Daniel J. (July 18, 2012) "Belviq, Qsymia: New Weight Loss Drugs Compared." WebMD Medical Reference. Retrieved July 19, 2012.
• Park, Alice. (July 18, 2012) "Qsymia: What You Need to Know About the New Diet Pill." Time Healthland. Retrieved July 19, 2012.
• Vivus Inc. (July 2012) "About Qsymia." Qsymia Medication Guide. Retrieved July 19, 2012.

Copyright © 2012. Annette R. Smith. All rights reserved.

Published: July 19, 2012 / Modified April 4, 2013.

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