As a breakthrough in fighting against obesity, Food and Drug Administration approved weight-loss drug Qsymia, is being manufactured by Vivius. Qsymia is the second anti-obesity drug that won the FDA approval in this summer. The company got the approval after it changed the name as Qsymia, from the name Qnexa, as directed by FDA due to pronunciation confusion.
According to Dr.Janet Woodcock, Director of Food and Drug Administration’s centre for drug evaluation and research, obesity is a major public health problem and rationale drug of Qsymia in conjunction with diet and exercise can modify the pathogenesis of obesity. FDA approved Qsymia for individuals, with BMI over 30 with any of the obesity-related complications such as dyslipidemia, elevated BP or Type-2 diabetes mellitus.
Qsymia is a once-a-day pill with the combination of two pharmaceutical agents, Phentermine and topimarate. In 2010, Vivius submitted the clinical trial data for FDA approval and it struggled for two years to get FDA nod, due to its potential adverse effects including serious cardiovascular events, metabolic acidosis, teratogenic effects and lack of co-ordination with delirium in the clinical study participants.
Due to its potential side-effects, many FDA panel members raise concern about this drug. Dr.Michael Lauer, a cardiologist at NIH and one of the panel members opposed its approval. According to him, “one has to buy Qsymia at their own risk that may cause coma or even death. But many similar drugs exist in market like ‘Fen-Phen’ has been withdrawn due to serious cardiotoxicity’. According to him, phentermine may adversely suppress the appetite with the risk of developing pulmonary hypertension. Not only Lauer, many public and independent pharmacologists suggested Vivius, to conduct further clinical studies before FDA approval.
Despite these concerns, 20 members of the FDA panel voted for approval recommended, just the change of name as Qsymia from Qnexa.
In the clinical trial study, Vivius reports that Qsymia causes no serious side effects, but less serious adverse events such as dry mouth, constipation and change in taste, sleep patterns. But these claims are not being accepted by many cardiologists and physicians. The irrational drug use can cause iatrogenic serious adverse events, including fatal complications.
In the press release, Vivius announced that, Qsymia will be available in market on or after October’ 2012.
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