Vivus Inc. to Present Study Results of Topamax Links to Birth Defects By Month’s End

Vivus Inc. announced in July that it will be presenting data from a study looking at the linkages between Topiramate (Topamax) and birth defects on August 31, 2011. Vivus officials say there is no significantly higher risk of babies exposed to Topamax during gestation being born with birth defects like oral clefts (OC) or major congenital malformations (MCM). The announcement was made at the International Epilepsy Congress (IEC) in Rome.

Dr. Alison Pack, Associate Professor of Clinical Neurology, Department of Neurology, Columbia University Medical Center, will be presenting the study results.

The study that is being presented was conducted by researchers “using medical claims and pharmacy prescription data from the Wolters Kluwer Pharma Solutions Source Lx Patient Longitudinal Database,” which looked at 778 mothers and their babies who were exposed to Topamax within at least 10 months before the mother gave birth.

However, that is not all the study looked at. It also examined two control groups which weren’t exposed to the Topamax. One of the groups had 3,431 dyads that had been exposed to other anti-epileptic drugs (AEDs) used to treat epilepsy during pregnancy. The other group consisted of 2,307 dyads that were diagnosed with epilepsy but also didn’t take Topamax during pregnancy. Researchers monitored the risk of OC and MCM that was caused by exposure to Topamax and added it up. Then they compared that number to the other AED exposed and those that didn’t take Topamax.

According to information at Applied Clinical Trials Online, the results of the study show that while the risk is there, it’s no higher just because of the exposure to the Topamax. Try telling that to the mothers who have taken Topamax while pregnant and whose children were born suffering from OCs and MCMs.

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