The US drug regulator Food and Drug Administration (FDA)has approved weight-loss pill known as Qsymia. The drug is approved for obese adults, who have at least one weight related conditions such as high blood pressure, high cholesterol and diabetes. Qsymia is a combination of two approved drugs, phentermine and topiramate, in an extended-release formulation.
Phentermine is designated for instant weight loss in obese or overweight adults who do regular exercise and eat a less calorie diet. Topiramate is designated to treat certain types of seizures in patients of epilepsy and is also indicated to prevent migraine headaches. Experts assessed the safety and effectiveness of Qsymia in two randomized trials.
The study trails included more than thirty-seven hundred obese and overweight patients with and without significant weight-related conditions. All study participants were given lifestyle alteration that included less calorie diet and regular physical activity. They were also provided recommended daily dose of Qsymia.
The study showed that after one year of treatment with recommended dose of Qsymia, patients had weight loss by six and half to nearly nine percent, that treatment with placebo. About sixty to seventeen percent of patients lost five percent of their body weight with the recommended or highest dose of Qsymia.
Dr. Janet Woodcock, director of FDA`s Centre for Drug Evaluation and Research, explained. 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.
Obesity threatens the overall well being of patients and is a major public health concern. Qsymia should not be used during pregnancy because it can cause harm to an unborn baby. Patients having glaucoma or hyperthyroidism should also not be used Qsymia. It can increase hear rate and regular monitoring of heart rate is recommended for all patients taking Qsymia, particularly when starting Qsymia or increasing the dose.