其 他 安 全 警 示
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| European Union: COVID-19: reminder of the risks of chloroquine and hydroxychloroquine (English only) |
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European Medicines Agency (EMA) is reminding healthcare professionals to closely monitor patients with COVID-19 who are receiving chloroquine or hydroxychloroquine, given the serious side effects that can result from treatment with these medicines.
Several observational studies in COVID-19 have reported that chloroquine and hydroxychloroquine are associated with an increased risk of heart problems, a well-known side effect of such treatments, including cardiac arrhythmias and cardiac arrest.
When prescribing these medicines, healthcare professionals should take into account pre-existing heart conditions, uncorrected potassium or magnesium imbalance, and concomitant use with medicines that prolong the QT interval as these factors may make patients more prone to heart rhythm disorders.
Healthcare professionals should also note that heart rhythm disorders may be more likely or be more severe if chloroquine or hydroxychloroquine are used at higher doses than those recommended for their authorised indications or if they are combined with certain antibiotics such as azithromycin.
In addition to their effects on the heart, these medicines may cause neuropsychiatric disorders, including agitation, insomnia, confusion, psychosis and suicidal ideation. These medicines are also known to affect the liver, cause neuronal damage that can lead to seizures (fits), and lower blood sugar.
EMA reiterates that while further analyses of available data are being carried out, chloroquine and hydroxychloroquine should only be used in clinical trials for treatment or prophylaxis of COVID-19 or in national emergency use programmes in hospitalised patients under close supervision. It is important that properly designed, randomised clinical trials can be completed, with adjustments as needed, to generate the necessary evidence on benefits and risks of these medicines in COVID-19.
Patients who have been prescribed chloroquine or hydroxychloroquine for authorised indications (malaria and certain autoimmune diseases such as rheumatoid arthritis and lupus) should continue to take their medicines as advised by their doctor. Patients who have any questions about their treatment should talk to their doctor or pharmacist.
Please refer to the following website in EMA for details:
http://www.ema.europa.eu/en/news/covid-19-reminder-risks-chloroquine-hydroxychloroquine
In Hong Kong, there are 5 registered pharmaceutical products containing hydroxychloroquine, and all products are prescription-only medicines. There is no registered pharmaceutical product containing chloroquine. So far, the Department of Health (DH) has received 4 cases of adverse drug reaction related to hydroxychloroquine, but these cases are not related to heart rhythm problems, seizures or hypoglycaemia. The DH has not received any case of adverse drug reaction related to chloroquine.
Related news on the risk of serious side effects (such as heart rhythm problems, seizures, hypoglycaemia, liver and kidney problems) associated with the use of chloroquine and hydroxychloroquine was previously issued by various overseas drug regulatory authorities, and was posted on the Drug Office website since 27 Dec 2014, with the latest update posted on 27 Apr 2020. Letters to inform local healthcare professionals of the risk of hypoglycaemia were issued by the DH on 29 Dec 2014. In Feb 2015, the Registration Committee of the Pharmacy and Poisons Board discussed the matter, and decided that the sales pack labels or package inserts of chloroquine and hydroxychloroquine products should include the relevant risk of hypoglycaemia. Adverse effects and precautions about heart rhythm problems, seizures, hypoglycaemia, neuropsychiatric disorders, hepatic and renal impairment associated with the use of chloroquine and hydroxychloroquine are documented in overseas reputable drug references such as the “Martindale: The Complete Drug Reference”. The DH will remain vigilant on safety update of the drugs issued by other overseas drug regulatory authorities.
Ends/ Saturday, May 30, 2020
Issued at HKT 13:00
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