FDA asks Vivus to check on Qnexa's risk of birth defects

01/23/2011 | Wall Street Journal, The

The FDA has requested that Vivus evaluate the feasibility of reviewing databases to find out whether topiramate, an active ingredient in the company's weight-loss pill Qnexa, increases the risk of oral cleft in children whose mothers took the medicine during pregnancy. Vivus said it thinks the agency's request is based on published cases of birth defects linked to topiramate, which is used for migraine and epilepsy, in North America and the U.K.

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