I’ve written a lot about the serious problems associated with use of Topamax during pregnancy. After all, the FDA ordered Topamax to be re-labelled and re-classified in March, 2011 in response to data suggesting a conclusive correlation between Topamax usage by pregnant woman and birth defects such as: cleft lip, cleft palate, Spina Bifida, facial defects and pediatric heart problems. The swift decision to change the classification / labelling of Topamax is mainly due to the data collected by the FDA. The FDA collects information about problems associated with all drugs in an Adverse Event Database. According to the FDA’s adverse Event Report database: There are 244 safety reports concerning Topamax users who believe their child was adversely affected by the drug 114 of the 244 safety reports (approximately 47%) are related to birth defects 12% of adverse complaints are related to cleft lip / cleft palate 12% of the… Continue Reading
Category Archives: Topamax
Subscribe to Topamax RSS FeedNew FDA Warnings Suggest Correlation Between Topomax And Birth Defects Including: Cleft Lip & Cleft Palate
Posted in Dangerous Drugs, TopamaxA new FDA warning was recently published which warns women of childbearing age that their use of Topomax (and other generic variations known as topiramate) significantly increases their chances of giving birth to a child with mouth-related birth defects. Topiramate is a widely used prescription medication used to control epilepsy and severe headaches. Women taking Topomax were more than three times more likely to give birth to a child with birth defects related to a child’s mouth such as: cleft lip or cleft palate compared with women taking other brands of epilepsy drugs. Researchers estimate that infants born to women taking Topomax have a 1.4% chance of a having a birth defect relating to their mouth. As a result of the new disclosures, the FDA is requiring Johnson & Johnson, the manufacturer of Topomax and other generic Topomax manufacturers to incorporate stronger warnings about use and pregnancy. Children born facial… Continue Reading