The Health Science Authority (HSA), Singapore, has announced that Sanofi-Aventis Pte Ltd has issued a “Dear Healthcare Professional Letter” to provide critical updates on the safety profile of Plaquenil® (Hydroxychloroquine sulphate). Healthcare professionals are urged to take note of these new findings, particularly in patients who are pregnant, those with myasthenia gravis, or individuals at risk of developing phospholipidosis.
Key Safety Update – Increased Risk of Major Congenital Malformations: A 2021 study by Huybrechts et al. has reported a small but significant increase in the relative risk of major congenital malformations linked to hydroxychloroquine when administered during the first trimester of pregnancy. The risk becomes more pronounced at higher daily dosages (≥ 400 mg/day).