FDA approves anorectic Qnexa

 

         Qnexa was the first anti obesity drug approved by FDA in a decade. Last week expert advisory committee voted 20-2 in favour of Qnexa by Vivus as an antiobesity drug.This same drug was rejected by FDA in 2010 quoting the cardiac side effects and its teratogenic potential. But in a reversal it was accepted by majority of experts in the advisory committee.

    As the epidemic of obesity grows further the demand for approval of anti obesity drug was growing from all corners.In the last decade many antiobesity drugs were withdrawn from the market for their myriad no. of side effects. Even Qnexa had many issues.

      Qnexa is a combination of the anticonvulsant drug topiramate and the appetite suppressant phentermine.

    In a clinical trial involving 4,323 people, Qnexa  led to an average loss of about 10% of total body weight in the first year of use. Many users also saw improvements in blood pressure.
But the trials also found that that the drug caused a slight increase in heart rate, which can boost the odds of a heart attack or stroke. In addition, researchers detected an increased risk of birth defects — typically cleft lip — in women who became pregnant while taking the drug.

      Vivus Inc., the drug's manufacturer, addressed those concerns by proposing a tightly controlled system for prescribing Qnexa. To prevent birth defects, patients who take the drug will have to undergo monthly pregnancy testing and healthcare providers will get special training on the medication's risks and benefits. Vivus will also restrict distribution of the drug to registered pharmacies, among other measures.

Source:www.fda.gov/downloads/advisorycommittees/.../ucm218821.pdf