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The officials of the Food and Drug Administration are now looking into the possibility of Vivus’s newest weight loss drug, Qnexa as a stimulator of birth defects in pregnant patients. They want additional information about this experimental obesity drug and its possible association with congenital malformations.  As a result, there will be a delay in the approval of this medication.

Topimarate, a component of this new weight loss drug, was noted to cause oral cleft in the offsprings of patients who take this medication.

Qnexa is a combination of two drugs. Topimarate, a medication used to control seizure and relieve migraines and phentermine, a drug used to suppress appetite.

Vivus argued that Qnexa was given to 15 pregnant women without apparent occurrence of birth defects. However, the FDA still insisted that the manufacturer of Qnexa must resubmit their proposal together with the studies regarding birth defects and Qnexa use.

Qnexa was first disapproved in October after having the evidence of heart problems associated with the intake of this obesity drug.

Category : News

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