FDA Endorses Prescription Obesity Medication Qnexa Despite Risks
A Federal Drug Administration (FDA) advisors committee voted 20 to 2 yesterday in favor of endorsing the prescription weight-loss drug Qnexa, reported The Los Angeles Times. Risks associated with taking the drug include heart problems and birth defects in babies of women who become pregnant while taking the pill.
Now the FDA will determine whether or not to approve Qnexa. If the obesity drug gets the green light, Qnexa will be the first new prescription obesity medication introduced in the United States since 1999. The only prescription diet drug currently available in the nation is orlistat, sold under the trade name Xenical. While orlistat blocks absorption of fat, the active drugs in Qnexa seemingly work by suppressing one's appetite and intensifying feelings of fullness.
In a clinical trial, 4,323 people took Qnexa and lost, on average, 10 percent of their total body weight in the first year. Many Qnexa users additionally lowered their blood pressure.
But the side effects are alarming: increase in heart rate, which augments one's risk of a heart attack or stroke, and a heightened risk of birth defects in babies born to mothers who took Qnexa during pregnancy—typically cleft lip. The drug's manufacturer Vivus Inc. dissuaded medical experts' concerns by proposing a tightly regulated system for prescribing it that includes monthly pregnancy tests. Healthcare providers would also receive special training on the medication's risks and benefits, amongst other measures. "We will know who the prescribers are. We will know who has been trained," Dr. Barbara Troupin, Vivus' senior director of global medical affairs, told the advisory committee. "We are confident the Qnexa [risk management program] balances the safeguards while allowing access for appropriate patients."
The benefits of treating obesity are many. Excess weight increases one's risk of diabetes, heart disease, stroke, osteoarthritis, certain cancers and possibly dementia, according to the Centers for Disease Control and Prevention. American Indians and Alaskan Natives are 1.6 times as likely to be obese than Non-Hispanic whites, according to the U.S. Department of Health and Human Service's Office of Minority Health.
If Qnexa gets FDA approval, the drug will be targeted at people with a body mass index of 30 or more, or a BMI of 27 or above for those who also suffer weight-related health problems, such as diabetes or sleep apnea. A BMI in the 25 to 29 range qualifies a person as overweight, and 30 or greater is indicative of obesity.