Other safety alerts
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| Singapore: Plaquenil® (Hydroxychloroquine sulfate): Risk of major congenital malformations and new risks of phospholipidosis and aggravation of myasthenia gravis symptoms |
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Health Sciences Authority (HSA) announces that a Dear Healthcare Professional Letter has been issued by Sanofi-Aventis Pte Ltd to inform healthcare professionals that the Huybrechts study published in 2021 suggested a small increase in the relative risk of major congenital malformations associated with the use of hydroxychloroquine in the first trimester of pregnancy, especially when used at a high daily dosage (≥ 400mg daily).
Healthcare professionals are advised to avoid prescribing daily doses of ≥ 400mg in the first trimester of pregnancy except when, in the judgement of the healthcare professional, the individual’s benefits outweigh the risks. It is also advisable to closely monitor the pregnancy, especially during the first trimester, for early detection of major congenital malformations. If there is no alternative treatment to hydroxychloroquine, the lowest effective dose should be used.
In addition, new risks of phospholipidosis and aggravation of myasthenia gravis symptoms have been reported with the use of hydroxychloroquine. Healthcare professionals are advised to discontinue hydroxychloroquine in patients if cardiac, renal, muscular or nerve toxicity is suspected or if aggravation of myasthenia gravis symptoms is suspected. The local package insert of Plaquenil® is being updated to include these information.
Please refer to the following website in HSA for details:
http://www.hsa.gov.sg/announcements/dear-healthcare-professional-letter/plaquenil--(hydroxychloroquine-sulfate)---risk-of-major-congenital-malformations-and-new-risks-of-phospholipidosis-and-aggravation-of-myasthenia-gravis-symptoms
In Hong Kong, there are 5 registered pharmaceutical products containing hydroxychloroquine. All products are prescription-only medicines. So far, the Department of Health (DH) has received 9 cases of adverse drug reaction with regard to hydroxychloroquine, but these cases were not related to congenital malformations, phospholipidosis and aggravation of myasthenia gravis symptoms. Avoidance in pregnancy has already been included in the package insert of Hong Kong registered hydroxychloroquine products. Risk of aggravation of myasthenia gravis symptoms is documented in overseas reputable drug references such as the “Martindale: The Complete Drug Reference”. In light of the above HSA’s announcement, letters to inform local healthcare professionals will be issued. The DH will remain vigilant on safety update of the drug issued by other overseas drug regulatory authorities.
Ends/Friday, Sep 20, 2024
Issued at HKT 16:15
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