Medication safety

EMA sets out new measures to avoid risk from valproate in pregnancy

Both patient and prescriber will complete risk-acknowledgment form at the same time, confirming they understand the dangers associated with the drug.

All women of childbearing age prescribed the drug valproate — which has been linked to foetal abnormalities — must in future take part in a pregnancy prevention programme, according to tighter European drug safety recommendations published on Friday 9 February 2018.

The women should be assessed for their pregnancy risk when the drug is prescribed and should routinely be offered a pregnancy test before starting treatment, the new from the European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) proposes.

Treatment should be reviewed by a specialist at least once a year and both the patient and prescriber should complete a risk-acknowledgment form at the same time, which confirms they understand the dangers to an unborn child associated with the drug.

A visual warning — probably a symbol or pictogram — about the risks of the drug in pregnancy is also proposed for product packaging. A patient-reminder card should be attached to the outside of the package to remind pharmacists to discuss the risks each time the medicine is dispensed, PRAC recommends.

The proposed tighter controls around valproate — prescribed for the treatment of epilepsy, bipolar disease and migraine — follow the conclusions of the PRAC safety review published on February 9 2018. If agreed by the EMA’s Co-ordination Group for Mutual Recognition and Decentralised Procedures – Human, they will apply to all female patients of childbearing age in the European Union.

Announcing its recommendations, PRAC said in a statement that it “noted that women were still not always receiving the right information in a timely manner and that future measures were needed to help avoid use during pregnancy.”

The review was originally launched at the request of the French medicines regulator — the ANSM (Agence Nationale de Sécurité du Médicament et des Produits de Santé) — which had questioned the effectiveness of existing warnings and prescribing restrictions attached to valproate products.

The review, carried out last year, included the first EMA public hearing of its kind last September where patients who had been exposed to valproate products during pregnancy spoke about the impact they had on their, and their children’s lives.

The new proposals also reflect EMA current advice that valproate must not be prescribed during pregnancy to treat women for migraine or bipolar disease.

It acknowledges, however, that for some women with epilepsy, valproate may still be the only treatment option. In those cases the women should receive specialist care when pregnant.

In the UK, the risks associated with valproate were by the Medicines and Healthcare products Regulatory Agency (MHRA) in January 2015. It reiterated the then EMA advice that if valproate is the only treatment option, women of childbearing age should be given effective contraception.

According to the MHRA, sodium valproate carries a 10% risk of physical abnormalities in unborn babies. Babies exposed to the drug in the womb also have a 40% risk of developing autism, low IQ and learning disabilities, it says.

Citation: The Salvadore DOI: 10.1211/PJ.2018.20204386

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