Other safety alerts
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| European Union: COVID-19: reminder of risk of serious side effects with chloroquine and hydroxychloroquine |
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European Medicines Agency (EMA) announces that chloroquine and hydroxychloroquine are known to potentially cause heart rhythm problems, and these could be exacerbated if treatment is combined with other medicines, such as the antibiotic azithromycin, that have similar effects on the heart.
Recent studies have reported serious, in some cases fatal, heart rhythm problems with chloroquine or hydroxychloroquine, particularly when taken at high doses or in combination with the antibiotic azithromycin.
Chloroquine and hydroxychloroquine are currently authorised for treating malaria and certain autoimmune diseases. In addition to side effects affecting the heart, they are known to potentially cause liver and kidney problems, nerve cell damage that can lead to seizures (fits) and low blood sugar (hypoglycaemia).
These medicines are being used in the context of the ongoing pandemic for treating patients with COVID-19 and investigated in clinical trials. However, clinical data are still very limited and inconclusive, and the beneficial effects of these medicines in COVID-19 have not been demonstrated. Results from large, well-designed studies are needed to make any conclusions.
Some clinical trials currently investigating the effectiveness of chloroquine or hydroxychloroquine in treating COVID-19 use higher doses than those recommended for the authorised indications. While serious side effects can occur with recommended doses, higher doses can increase the risk of these side effects, including abnormal electrical activity that affects the heart rhythm (QT-prolongation).
Healthcare professionals are recommended to closely monitor patients with COVID-19 receiving chloroquine or hydroxychloroquine and to take into account pre-existing heart problems that can make patients more prone to heart rhythm issues. They should carefully consider the possibility of side effects, particularly with higher doses, and exercise extra caution when combining treatment with other medicines such as azithromycin that may cause similar side effects on the heart. Patients and healthcare professionals are reminded to report any suspected side effects to their national regulatory authorities.
A number of large, randomised clinical trials are looking at the benefits and risks of chloroquine and hydroxychloroquine in patients with COVID-19. In the context of COVID-19, these medicines should only be used as part of clinical trials or in line with nationally agreed protocols. They must not be used without a prescription and without supervision by a doctor.
EMA and the national competent authorities are monitoring the situation closely and have enhanced their safety monitoring of medicines used in the treatment of COVID-19 in order to take timely action when necessary. This EMA public health statement has been issued by the COVID-19 EMA pandemic Task Force (COVID-ETF) in consultation with EMA’s safety Committee (PRAC), in light of the ongoing discussions on the use of chloroquine and hydroxychloroquine in the treatment of COVID-19.
Please refer to the following website in EMA for details:
http://www.ema.europa.eu/en/news/covid-19-reminder-risk-serious-side-effects-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 hypoglycaemia associated with the use of chloroquine and hydroxychloroquine was previously issued by Singapore Health Sciences Authority, and was posted on the Drug Office website on 27 Dec 2014. Letters to inform local healthcare professionals 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.
Adverse effects and precautions about heart rhythm problems, seizures, hypoglycaemia, 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/Friday, Apr 24, 2020
Issued at HKT 15:00
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