The teratogenicity of anticonvulsant drugs. To avoid confounding by other antiepileptic drugs, the analysis was restricted to topiramate monotherapy, defined as no use of other antiepileptic drugs in the first trimester. Retrieved November 27, from www. Drug Saf. With treatment, most children with cleft lip or palate do well. Both data sources define major congenital malformations as structural malformations with medical, surgical or cosmetic relevance.
March 4, -- Taking the epilepsy drug topiramate (Topamax) during pregnancy raises the risk of oral cleft birth defects such as cleft lip and cleft palate, according to a new warning issued by the FDA. Topiramate is approved by the FDA for treating seizures associated with. In a study published in the latest issue of the journal Neurology, taking Topamax (topiramate) during pregnancy was associated with a birth. However, because of new human data that show an increased risk for oral clefts, If you take topiramate during pregnancy, there is a higher risk that your baby You should report any side effects you experience to the FDA.
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Starting insubjects also included a random sample of all births without congenital malformations in Massachusetts as controls.
Use of topiramate in pregnancy and risk of oral clefts
Ann Pharmacother. The teratogenicity of anticonvulsant drugs.
Alternative medications that have a lower risk of oral clefts and other adverse birth outcomes should be considered for these patients.
Topiramate and Risk of Birth Defects New Data for Women with Epilepsy Epilepsy Foundation
Recent studies have shown that Topamax may also cause acute myopia, and. If you are a woman with epilepsy who is taking topiramate and considering pregnancy, read and discuss this study with your health care team.
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Use of topiramate during the first trimester of pregnancy was associated with an increased risk of oral clefts (i.e., cleft lip with or without cleft palate) in the.
Appropriate alternative treatment should be considered.
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Assessment of the teratogenic risk in fetuses exposed to topiramate in utero. Matched sets contained as many cases and controls as were available per stratum. Topiramate in early pregnancy increases risk of oral clefts: Study finds that taking a higher dose of the drug in the first trimester increases risk of cleft lip or cleft palate more than taking a lower dose.
In this study, epilepsy was reported by less than half of topiramate users. Use of topiramate in pregnancy and risk of oral clefts.