Health Canada announces that chloroquine and hydroxychloroquine may cause serious side effects, including serious heart rhythm problems. The risk of these side effects may increase at higher doses, or if the drugs are used in combination with other drugs, such as the antibiotic azithromycin. Patients should use these drugs only under the supervision of a physician. Health Canada is concerned that some people may be directly buying and using chloroquine and hydroxychloroquine to prevent or treat COVID-19 without a prescription.
Chloroquine and hydroxychloroquine are approved prescription medications to treat malaria and certain autoimmune diseases, including lupus and rheumatoid arthritis. They are known to potentially cause liver or kidney problems, low blood sugar (hypoglycemia) and nervous system problems such as dizziness, fainting, or seizures. The effects on heart rhythm, which in the most serious cases, may be fatal. Children are especially sensitive to these drugs, and even small doses taken by children can be dangerous.
Health Canada has not authorized any drugs to prevent, treat or cure COVID-19 and has warned Canadians about products making false and misleading claims. Health Canada has authorized clinical trials with chloroquine or hydroxychloroquine for COVID-19. Results from large, well-designed studies are essential to determine if the benefits of chloroquine and hydroxychloroquine outweigh their risks in the treatment of COVID-19. To date, data from clinical trials are limited, and the results have not conclusively shown that any specific medications are effective against COVID-19. Health Canada will continue to closely monitor the safety and effectiveness of chloroquine, hydroxychloroquine, and other drugs used in the treatment of COVID-19. It will take appropriate and timely action if new health risks are identified, and inform Canadians as necessary.
Patients are advised:
- Use chloroquine or hydroxychloroquine only if it has been prescribed for them by a physician who is supervising their treatment.
- Contact their physician if they experience an irregular heart rate, dizziness, fainting, seizures, or other side effects while taking these drugs.
- Be cautious when buying drugs over the internet. If they have questions about whether an internet pharmacy is legitimate, contact the pharmacy regulatory authority in their province or territory.
- Report any health product adverse events to Health Canada.
- Report any complaints regarding unauthorized products to Health Canada.
Healthcare professionals are advised:
- Investigational use of approved therapies like hydroxychloroquine and chloroquine should be done in the context of a well-designed clinical trial.
- Consult the Canadian product monographs for a full list of contraindications, warnings and precautions, adverse reactions and drug interactions.
- Monitor patients closely if treated with chloroquine or hydroxychloroquine, especially if there are pre-existing heart conditions, when using higher doses, and if prescribing in combination with other medications such as azithromycin that may prolong the QT interval.
Please refer to the following website in Health Canada for details:
http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/../72885a-eng.php
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 25 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, 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/Monday, Apr 27, 2020
Issued at HKT 15:00
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