L’hydroxychloroquine (Plaquenil®) is indicated in adults for rheumatoid arthritis, subacute or discoid lupus erythematosus, systemic lupus and lucite.
A teratogenic effect identified
A american study demonstrated a teratogenic effect of hydroxychloroquine with a risk of malformation multiplied by 1.33 compared to unexposed children. These are malformations classified as serious but no particular type of malformation has been demonstrated. The summary of product characteristics and package leaflet for Plaquenil® will be updated accordingly.
In this study, 2,045 pregnancies exposed to hydroxychloroquine in the first trimester were compared to 19,080 unexposed pregnancies. The increased malformation risk has been identified from a dose ≥ 400 mg/day but the data are too limited to exclude this risk at a lower dose.
Inform patients
It is important to inform patients of childbearing age taking hydroxychloroquine:
- In the absence of a pregnancy project, contraception is recommended.
- In the event of a pregnancy project, the patient must know that it is necessary to discuss it with her doctor to determine the appropriate treatment.
- In the event of pregnancy, it is important to notify your doctor immediately to assess the risk-benefit ratio of the treatment. If hydroxychloroquine is continued, the lowest effective dose should be prescribed. Reinforced obstetric monitoring must be put in place, as well as medical monitoring of the child after birth, in particular of his vision, given the ophthalmological adverse effects of the molecule.
In any case, patients should not stop their treatment without medical advice.
As a reminder: this is not a treatment for COVID-19!
The National Agency for the Safety of Medicines and Health Products (ANSM) would like to remind you that hydroxychloroquine is not a treatment for COVID-19 and that it is strongly discouraged in this indication. The data published to date do not support a clinical benefit of hydroxychloroquine, whether or not combined with azithromycin, in the treatment of this infection. They even show that this use is harmful due to increased exposure to adverse effects on cardiac function.