Source: MHRA 19.4.22
Advice for healthcare professionals:
- an observational study of more than 2,700 pregnancies exposed to pregabalin has shown use in the first trimester to be associated with a slightly increased risk of major congenital malformations compared with exposure to no antiepileptic drugs or to lamotrigine or to duloxetine – see details of the study data below
- continue to provide counselling to patients using pregabalin on:
- the potential risks to an unborn baby (see separate patient safety leaflet)
- the need to use effective contraception during treatment
- continue to avoid use of pregabalin during pregnancy unless clearly necessary and only if the benefit to the patient clearly outweighs the potential risk to the fetus – ensure the patient has a full understanding of the benefits, risks, and alternatives, and is part of the decision-making process
- advise patients planning a pregnancy or who become pregnant during treatment to make an appointment to discuss their health condition and any medicines they are taking
- in cases where the benefit outweighs the risk, and it is clearly necessary that pregabalin should be used during pregnancy, it is recommended to:
- use the lowest effective dose
- report any suspected adverse drug reactions, including for the baby, via the Yellow Card scheme
Reminder for prescribers of ANY antiepileptic drug:
- at initiation and as part of the recommended annual review for patients with epilepsy, discuss the risks associated with antiepileptic drugs and with untreated epilepsy during pregnancy and review their treatment according to clinical condition and circumstances – see advice for antiepileptic drugs in pregnancy
- urgently refer anyone planning a pregnancy or who is suspected to be pregnant for specialist advice on their antiepileptic treatment
- if a patient is planning to have a baby, offer 5mg per day of folic acid before any possibility of pregnancy
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