Chloroquine and hydroxychloroquine can have serious side effects. These drugs should be used only under the supervision of a physician.

Starting date:
April 25, 2020
Posting date:
April 25, 2020
Type of communication:
Information Update
Subcategory:
Drugs
Source of recall:
Health Canada
Issue:
Important Safety Information
Audience:
General Public, Healthcare Professionals
Identification number:
RA-72885

Last updated:

Summary

  • Product: Chloroquine and hydroxychloroquine
  • Issue: Chloroquine and hydroxychloroquine can have serious side effects. Health Canada is concerned that some people may be directly buying and using chloroquine or hydroxychloroquine to prevent or treat COVID-19.
  • What to do: Use chloroquine or hydroxychloroquine only if it has been prescribed for you by a physician who is supervising your treatment. Contact your physician if you experience an irregular heart rate, dizziness, fainting, seizures, or other side effects while taking these drugs.

Issue

Ottawa – 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-19Footnote 1 and has warned Canadians about products making false and misleading claims.

There are a number of medications being investigated to treat or prevent COVID-19, both in Canada and internationally.  The best way to access experimental therapies is through clinical trials. 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.

Patients and health care professionals are reminded to report any suspected side effects to Health Canada. 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.

If you buy drugs online, you may be putting your health at serious risk. This is especially true if you order prescription drugs without being examined in person by a health care practitioner. Some Internet pharmacies are legitimate, but many offer products and services that are dangerous.

Footnote

Footnote 1

On July 27, 2020, Health Canada granted authorization with conditions for the use of Veklury (remdesivir) to treat COVID-19 in patients with pneumonia requiring supplemental oxygen. Remdesivir is the first drug to be authorized in Canada for the treatment of COVID-19.

Return to footnote 1 referrer

What you should do

  • Use chloroquine or hydroxychloroquine only if it has been prescribed for you by a physician who is supervising your treatment.
  • Contact your physician if you 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 you have questions about whether an internet pharmacy is legitimate, contact the pharmacy regulatory authority in your province or territory.
  • Report any health product adverse events to Health Canada.
  • Report any complaints regarding unauthorized products to Health Canada.

What industry professionals should do

  • 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
    • If prescribing in combination with other medications such as azithromycin that may prolong the QT interval.

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