12 June 2023
In November 2022, we published the updated guideline on prescribing drugs in pregnancy and breastfeeding: immunomodulatory anti-rheumatic drugs and corticosteroids.
The NICE-accredited guideline co-produced by a wide working group made up of rheumatologists, obstetricians, obstetric physicians, pharmacists, GPs and patients. The guideline follows strict and robust methods and processes laid out in Creating Clinical Guidelines: British Society for Rheumatology Protocol.
Hydroxychloroquine (HCQ) is the antimalarial drug most used to treat rheumatic diseases. It has been extensively studied in pregnancy and our guidelines on prescribing antirheumatic drugs in pregnancy recommend its use in pregnancy if required to treat disease at doses up to 400mg/day.
The European Medicines Agency (EMA) has since recommended that the product information for HCQ should be amended to include the potential risk of causing defects in a developing foetus. You can read the periodic safety update report follow-up from the EMA for more information. The EMA’s recommendation was based on a single paper by Huybrechts et al. (2021).
We included the Huybrechts study in the systematic literature review (SLR) that informed our pregnancy guideline. The SLR was based on 43 studies of 4701 pregnancy exposures to HCQ. We found there were no appreciable adverse effects overall of HCQ on pregnancy duration or birth weight, no increased risk of first-trimester miscarriages and no specific patterns of congenital malformations associated with HCQ exposure.
Professor Ian Giles, on behalf of the guideline working group, commented, “We would like to reassure healthcare professionals and patients that the evidence underpinning the EMA safety alert on the use of HCQ in pregnancy was considered and does not alter the BSR 2022 pregnancy recommendations.”
Prof Giles also suggested, “The benefits and risks of HCQ during pregnancy should be considered with your specialist before conception. Therefore, encouraging consultations with specialists to balance the benefits of HCQ to prevent maternal disease flare and harm to the baby that may occur if this drug is stopped in pregnancy against potential small risks of congenital malformations at high dose.”