After turning down its submission for approval two years ago, the Food and Drug Administration (FDA) is now concerned over associations of obesity drug Qnexa with birth defect risks and its incidence on the heart. Unlike last year when the agency had only 1 year’s data to study the FDA Advisory Panel (Endocrinology and Metabolic Drugs Advisory Committee) this time will look at clinical data of 2 years. To recommend or reject Qnexa, the experts of the panel will have to discuss and vote and the FDA has full authority to either accept or ignore the recommendations of the panel.
According to FDA the studies have shown that during the starting 12 months of treatment, Qnexa can help in reducing considerable amount of weight although some of the patients regained their lost weight during their second year. Qnexa which is a combination of Phentermine and Topiramate, can lead to birth defects such as babies with oral cleft can be delivered by pregnant women. Even augmented heartbeat can be a result of this obesity controlling drug.
Vivus Inc. which manufactures this drug was asked by the FDA to produce more data regarding the defective births as well as the major cardiovascular events in the light of this drug. Topiramate, which is the chief constituent of Qnexa, beckons towards a higher chance of babies with birth defects. The meeting of the panel will be held on 22 February and the panel will vote for the rejection or recommendation of Qnexa after discussing about it thoroughly. It has been reported that earlier the manufacturers of Qnexa had suggested limiting the use of the drug to adult males and females of specified age group (non-child bearing ages). The company also said that it was asked by the FDA to start a plan of limited usage of Qnexa by pregnant women.
The true study of the composition of Qnexa reveals the presence of Phetermine (C10H15N) which is presently used to curb appetite. It’s a psycho stimulant and its pharmacology resembles to amphetamine. Qnexa also contains Topiramate (C12H21NO8S) which is an anti epilepsy medication used to augment the feeling of fullness and it’s presently used for the correction of alcoholism as well as bipolar disorder. In 2010 a drug named Meridia was introduced to check obesity but it was soon called off because of its association to cardiovascular risks. Till now, the medications produced by numerous pharmaceutical companies to curb obesity have remained futile.