THE United States Food and Drug Administration (FDA) yesterday advised that the antiparasitic drug Ivermectin should not used to treat or prevent COVID-19.

The caution comes a week after the Medical Association of Jamaica (MAJ) had urged the Jamaican Government to authorise the use of the drug in an effort to reduce hospitalisations caused by respiratory illness.

“There seems to be a growing interest in a drug called Ivermectin to treat humans with COVID-19. Ivermectin is often used in the US to treat or prevent parasites in animals. The FDA has received multiple reports of patients who have required medical support and been hospitalised after self-medicating with Ivermectin intended for horses,” the FDA said in an announcement.

The agency added that it has not approved Ivermectin to treat or prevent COVID-19 in humans and the drug is not an antiviral medication.

“Taking large doses of this drug is dangerous and can cause serious harm,” the FDA said, noting that even levels of Ivermectin approved for other uses can interact with other medications, such as blood thinners.

The FDA also cautioned about the possibility of people overdosing on Ivermectin, which can cause nausea, vomiting, diarrhoea, hypotension (low blood pressure), allergic reactions (itching and hives), dizziness, ataxia (problems with balance), seizures, coma and even death.

In a question and answer section on its website, the FDA also said, “A recently released research article described the effect of Ivermectin on SARS-CoV-2 in a laboratory setting. These types of laboratory studies are commonly used at an early stage of drug development. Additional testing is needed to determine whether Ivermectin might be appropriate to prevent or treat coronavirus or COVID-19.”

A few days ago, new research published in the medical journal JAMA said Ivermectin did not appear to “significantly improve” the time needed for symptoms to get better among patients with COVID-19.

Last week Thursday, MAJ President Dr Andrew Manning had said the recommendation to allow the use of Ivermectin was made because Jamaica was at a crisis point in the novel coronavirus pandemic.

“The numbers of hospital admissions and deaths are increasing. We are currently awaiting the arrival and deployment of a COVID-19 vaccine. Our hospitals are close to full capacity,” Dr Manning said in a news release.

He said with the current situation the MAJ was recommending that “any and all scientifically sound and safe measures be employed to reduce the spread of, as well as to treat COVID-19”.

“The MAJ therefore believes the Government should authorise the use of Ivermectin, at the discretion of qualified physicians, or prophylaxis and early therapy, to reduce hospitalisation, severe disease and death. An urgent move must be made to import supplies into the country,” Dr Manning said.

He said Ivermectin has been safely used for decades in the effective treatment of certain parasites in humans. “Potent anti-inflammatory and antiviral properties have now been demonstrated against SARS CoV-2. A significant body of peer-reviewed evidence has now emerged pointing to the fact that Ivermectin may decrease the case count and mortality rates when used as a prophylactic agent, and when used in the treatment of all stages of COVID-19. The safety profile of this drug is well demonstrated after 40 years of clinical use,” the MAJ president said.

However, the US National Institutes of Health (NIH), in a post on its website, notes that while some studies of Ivermectin have reported potential anti-inflammatory properties, which have been postulated to be beneficial in people with COVID-19, “There are insufficient data for the COVID-19 Treatment Guidelines Panel to recommend either for or against the use of Ivermectin for the treatment of COVID-19.”

Last weekend, in response to the MAJ's call, Jamaica's Health and Wellness Minister Dr Christopher Tufton said the Government would not approve Ivermectin for the treatment of COVID-19 at this time because more study was needed.

“The Ministry of Health and Wellness has a responsibility to ensure that recommendations given from a policy level regarding medicines and therapeutics...[are only for those] medicines with proven safety, effectiveness and efficacy are available to the population,” Tufton said.

“The use of unproven drugs can lead to a waste of resources, harmful effects and can also reduce the availability of the drug for its recommended use.”