EMA re­views da­ta on risk of neu­rode­vel­op­men­tal dis­or­ders for chil­dren with fa­thers on val­proate drugs

The Eu­ro­pean Med­i­cines Agency said this week that it’s look­ing in­to da­ta — ret­ro­spec­tive ob­ser­va­tion­al da­ta that need to be cor­rect­ed by the com­pa­ny that ran the study, IQVIA — on the po­ten­tial risk of neu­rode­vel­op­men­tal dis­or­ders (NDDs) in chil­dren con­ceived by fa­thers tak­ing val­proate med­i­cines.

Val­proate-con­tain­ing med­i­cines, such as Ab­b­Vie’s De­pakote, have been ap­proved across the EU and US to treat epilep­sy, bipo­lar dis­or­der and in some coun­tries to pre­vent mi­graines.

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