You may have heard about the miracle "diet drug" that was recently recommended by an advisory panel for FDA approval. Qnexa is allegedly set to become the first anti-obesity drug for over a decade since the drug "fen-phen" was pulled from the market over serious safety concerns. Regulators and doctors are hoping they can limit the pill to only those patients with serious obesity problems, but may have a hard time stopping millions of other Americans from taking the drug in the hopes of a slimmer waistline.
Qnexa, if approved, is slated to achieve annual sales of $1 billion to $3 billion. The drug works by combining the appetite suppressant phentermine with the anti-seizure drug topiramate. In clinical trials, patients lost 10 percent of their body weight after a year, but the weight started to come back on after 12 months. The FDA reviewers noted safety problems with the drug including memory loss and higher heart rates, and a higher incidence of cleft palates in children born to mothers who had taken the drug during pregnancy.
The FDA has been under an immense amount of pressure from lawmakers and patient groups to approve the drug. These groups view Qnexa as an alternative method for patients who can't stick to strict diet and exercise regimens to lose weight, but who don't want to or can't undergo bariatric surgery as a weight loss solution. However, the FDA wants to restrict the use of the drug to those who have a BMI of 30 or above (obese) or those who have a BMI of 25 to 29 (overweight) and have weight-related health problems. Nevertheless, FDA experts also admit that it is likely that some doctors will prescribe the drug "off label" to patients who want to take it for vanity weight loss.
recently named in the 2009 edition of Best Lawyer's In America, David Mittleman has been representing seriously injured people since 1985. A partner with Church Wyble PC—a division of Grewal Law PLLC—Mr. Mittleman and his partners focus on medical malpractice, wrongful death, car accidents, slip and falls, nursing home injury, pharmacy/pharmacist negligence and disability claims.