Sanofi's Valproate Restricted for Some Women in the UK: Regulator

   By Donato Paolo Mancini 
 

Valproate, an epilepsy and bipolar disorder drug made by Sanofi SA (SAN.FR) and others, has been restricted for women and girls of childbearing age unless they are participating in pregnancy-prevention programs, a U.K. regulator said Tuesday.

Valproate is sold by Sanofi as Depakine for epilepsy and Depakote and Depamide for bipolar disorders, and by other manufacturers as a generic.

The drug should not be used for epilepsy in pregnancy due to the high risk of birth and development defects unless there is no suitable alternative, the U.K.'s Medicines and Healthcare products Regulatory Agency said. For bipolar disorder, the ban during pregnancy is total.

The regulatory body said use in pregnancy leads to physical birth defects in 10 every 100 babies, compared with a background rate of between two and three in 100, and neurodevelopmental disorders in between 30 and 40 of every 100 children born to mothers taking the drugs.

The agency said previous communications about valproate-related risks had little impact on prescribing, with data showing that pregnancies continued to be exposed to the medicine. In addition, patients reported not receiving the necessary information to make informed decisions in many cases.

Write to Donato Paolo Mancini at [e-mail]

(END) Dow Jones Newswires

April 24, 2018 05:34 ET (09:34 GMT)

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