Following a study highlighting, for the first time, a risk of malformation for fetuses exposed to hydroxychloroquine during pregnancy, the ANSM is issuing the alert and recalling good practices for prescribers and information to be give to patients.
L’hydroxychloroquine (Plaquenil) is a synthetic antimalarial indicated in adults for the treatment of rheumatoid arthritis and subacute or discoid lupus erythematosus, as well as for the adjunctive treatment or the prevention of relapses of systemic lupus and the prevention of lucite.
Data available to date did not reveal a risk of malformation in the children exposed in utero to this molecule (cf. the CRAT): therefore, it is now recommended not to interrupt its intake during pregnancy in certain pathologies such as lupus, at the risk of compromising the balance of the maternal pathology.
However, an American study has recently showed a risk of malformation in children exposed during thefirst trimester of pregnancy. It compared 2,045 pregnancies exposed to 19,080 pregnancies not exposed to hydroxychloroquine: the malformation risk of exposed fetuses was multiplied by 1.33 compared to those not exposed, from a daily dose greater than or equal to 400 mg. These are serious malformations, without it being possible to highlight a particular type. Finally, although the study does not seem to show any risk for doses < 400 mg, the data remain too limited to date to exclude it.
Following these conclusions, assessed at European level, the SPC and the leaflet for Plaquenil are being updated.