Sanofi's Valproate Restricted for Some Women in the UK: Regulator
April 24 2018 - 5:49AM
Dow Jones News
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
donatopaolo.mancini@dowjones.com
(END) Dow Jones Newswires
April 24, 2018 05:34 ET (09:34 GMT)
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