Vivus has completed its analysis of past data relating to Topiramate, one of the ingredients in its proprietary weight loss medication, Qnexa. The study has shown that Topiramate can double the chances of a child being born with a cleft palate or cleft lip if the mother had taken Topiramate during the first trimester of pregnancy compared with mothers who had taken Topiramate in the past but not during pregnancy.
There was a suspicion that Topiramate was linked to this deformity so this is not a huge surprise. The incidence is quite low at 0.36 per cent compared with 0.16 per cent in the mothers who had taken Topiramate in the past but this is statistically significant and will weigh on the decision of regulators.
It seems likely that the FDA will approve Qnexa for patients who are male or who are not of child bearing age. If this does happen then it is entirely likely that Qnexa will be prescribed off-label for women of child bearing age so long as they take every precaution not to become pregnant.
Of all the new weight loss drugs currently being considered, Qnexa seems to have the most impressive weight loss record. If Qnexa gets the go-ahead from the European Medicines Agency then we would be very keen to prescribe it as there is a massive gap in the market for a medication that can suppress the appetite and prolong satiety (the feeling of being full).