e-3588 (Health)

Health Canada is closely tracking all potential therapeutic treatments, vaccines, diagnostic tests, medical devices, and disinfectants currently available and in development in Canada and abroad. Every day, we are adding to our knowledge of COVID-19, keeping pace with the rapid growth of new scientific evidence as it emerges.

Health Canada authorizes drugs based on the safety, efficacy and quality information that is submitted by pharmaceutical companies looking to market their products in Canada. Ivermectin (brand name STROMECTOL) is a prescription antiparasitic drug authorized by Health Canada in 2018 for the treatment of parasitic worm infections, specifically intestinal strongyloidiasis and onchocerciasis. To date, Health Canada has not received any applications from a pharmaceutical company seeking market authorization for ivermectin in the prevention or treatment of COVID-19. As such, the effectiveness of ivermectin as a therapeutic option for a COVID-19 indication has not been established by Health Canada.

At this time, Health Canada does not intend to change the status of ivermectin from a prescription to non-prescription drug. These types of changes are generally initiated by a manufacturer filing an application to Health Canada to seek a switch from prescription to over-the-counter status.  Applications must be supported by evidence to demonstrate that the drug and its conditions of use remain safe and effective in a self-care environment. As ivermectin has not been authorized as a prescription drug for use in COVID-19, its suitability for use as a self-care product has not been established. No manufacturers of ivermectin have made an application for this drug to be changed to non-prescription status.

There are serious risks associated with ivermectin interacting with other commonly used medications, such as blood-thinners, which raises concerns about whether it would be safe in a non-prescription setting without physician oversight of potential risks and complications. At this time, it would be inappropriate to remove this product from the Prescription Drug List.

For drugs that have potential to be helpful in treating COVID-19, Health Canada encourages drug manufacturers to conduct clinical trials. Evidence from well-designed studies is needed to determine whether a drug might be helpful in preventing or treating COVID-19 and provide an opportunity for the healthcare community to collect information on the effectiveness of the treatment and its associated risks. To date, Health Canada has not received any clinical trial applications for ivermectin in COVID-19 patients.

Health Canada is aware of publicly available information promoting the use of ivermectin in COVID-19 patients. The Department cannot conclude, however, that ivermectin provides any clinical benefit for the treatment or prevention of COVID-19 without conducting a comprehensive review of the safety, efficacy and quality of the data that would be provided as part of a drug submission. Evidence-based recommendations published by McMaster University also conclude that a positive effect cannot be established for ivermectin in COVID-19.

Healthcare practitioners may prescribe drugs, including ivermectin, outside of their authorized indications (also known as “off-label use”), based on other sources of information, such as medical literature. Off-label use falls under the practice of medicine and is regulated at the provincial and territorial level. Heath Canada has no jurisdiction over how health care professionals prescribe drugs once authorized. Given the potential risks outlined above, it would be more appropriate for off-label use of ivermectin to be done under the care and supervision of a physician. Maintaining ivermectin’s prescription status helps to ensure professional oversight.