Vivus Drugs May Cause Birth Defects, FDA Investigating

Vivus drugs may cause oral cleft, investigations ongoing

A new weight-loss drug may be linked to specific birth defects, United States officials discovered. The discovery caused the worst Vivus Inc. (alleged offending company) stock plummet in six months.

The Food and Drug Administration requested company information to examine potential birth defects of children after mothers took a drug the company created. The drug, topiramate, was taken by mothers to reduce and prevent migraine headaches, and it may increase the risk of children being born with oral cleft.

The company also formulated a diet pill. Qnexa is formulated with topiramate and phentermine, a drug used to suppress appetite.

A complete analysis of company data could last six months or longer as analysts look for potential links to birth defects that the company may have failed to mention.

The largest concern for analysts is that the company may have failed to accurately explain the resubmission time for those on medication.

The company did perform successful studies prior to releasing the drug, however. A total of 15 births from women taking one of the drugs Vivus produces resulted in no birth defects.

Vivus also explained that topiramate is marketed as Topamax by Johnson & Johnson. The drug is used as a seizure and migraine prevention, and reports show 2 cases of infants with oral cleft as a result from taking the medication.