New data indicates that children born to mothers taking Topamax (topiramate) or its generic versions during pregnancy have an increased risk of birth defects, according to the US Food and Drug Administration (FDA).
FDA has asked healthcare professionals to warn patients of a childbearing age about the potential hazard to the foetus if a woman becomes pregnant while taking the drug, used to treat epileptic seizures and prevent migraines.
Data from the North American Antiepileptic Drug Pregnancy Registry indicates that infants exposed to topiramate during the first trimester of pregnancy have an increased risk of oral clefts.
The data revealed that infants exposed to topiramate as a single therapy experienced a 1.4% prevalence of oral clefts, compared with a prevalence of 0.38-0.55% in infants exposed to other antiepileptic drugs.
The prevalence among infants of mothers who did not have epilepsy and were not being treated with other antiepileptic drugs was 0.07%.
Similar data from the UK Epilepsy and Pregnancy Register supported the data from its North American counterpart.
The FDA has said that topiramate will be given a stronger warning in its prescribing information based on this data.
The pregnancy category of the drug will also be changed to Pregnancy Category D, which indicates a positive evidence of human foetal risk based on human data, but the potential benefits of the drug in pregnant women may outweigh the risks in certain situations.
The FDA has recommended that before starting topiramate, pregnant women and women of childbearing potential should discuss other treatment options with their healthcare professional.
Russell Katz, director of the Division of Neurology Products at the FDA Center for Drug Evaluation and Research, said that healthcare professionals should carefully consider the benefits and risks of topiramate when prescribing it to women of childbearing age.
“Alternative medications that have a lower risk of birth defects should be considered,” Katz said.
