US FDA today on 4 March 2011 announced in their press release that drug topiramate increases the risk of developing birth defects cleft lip and cleft palate in babies born to woman who has taken topiramate. There are chances of high risk of cleft lip and palate in babies even if the mother discontinue the drug immediately after knowing about the pregnancy as these defect develop in early pregnancy in first trimester even before a women knows about her pregnancy.Therefore it is required to use drug carefully , the use of drug in topiramate very carefully in women in childbearing age. The risk of developing clift lip and palate in babies born to mothers taking drug topiramate is equal in both brand name as well as generic drugs of topiramate.
Topiramate is an antiepileptic drug its IUPAC name is 2,3:4,5-Bis-O-(1-methylethylidene)-beta-D-fructopyranose sulfamate , it is a sulfamate containing fructose , certain types of seizures and recurrence of migraine are treated with drug topiramate , but not the migraine pain , it is not approved by FDA for migraine pain.
It is believed that the anticonvalsant property of the drug topiramate may be because of blocking of voltage dependant sodium channel and augmentation of activity of gamma-aminobutyrate acid and inhibition of carbonic anhydrase enzyme, carbonic anhydrase enzyme play an important role in respiration and body fluid formation most important are aqueous humor and cerebrospinal fluid .
Cleft lip and palate can be corrected effectively with a surgery, such surgery may be conducted soon after the birth and further few more corrective surgeries may be required to correct the defect completely.
Cleft lip and palate leads to problem in speech and misaligned teeth and frequent ear infections.
FDA stated in their press release that risks and gains or benefits of drug topiramate should be considered while prescribing the drug to a women and a alternative drug which has similar beneficial effects and do not lead to any birth defect risk may be opted instead of topiramate.
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