THE Ministry of Health & Wellness says that, after spending a considerable amount of time reviewing the available data, there is not enough information to recommend for or against the anti-parasitic drug Ivermectin for use in COVID-19 treatment.

Some medical doctors have been pushing for the use of the drug to treat COVID-19 patients and have criticised the ministry for what they claim has been a near two-month delay in approving procurement of the drug.

“There has been extensive review of Ivermectin use in COVID-19 by recognised bodies such as the National Institutes of Health in the United States and the US Food and Drug Administration (FDA) and have concluded that there is not enough evidence to recommend for or against. The World Health Organization/Pan American Health Organization (WHO/ PAHO) also indicated that more clinical studies are needed,” a ministry release said yesterday.

“The Ministry of Health and Wellness has a responsibility to ensure that recommendations given from a policy level regarding medicines and therapeutics includes medicines with proven safety, effectiveness and efficacy. The use of unproven drugs can lead to a waste of resources, harmful effects, and can also reduce availability of the drug for its recommended use,” the release quoted Chief Medical Officer Dr Jacquiline Bisasor McKenzie.

The ministry added that, although there is mounting pressure both locally and internationally from medical professionals as well as other private sector organisations for national regulatory authorities to provide approval for Ivermectin to be used in COVID-19 as a policy directive, the Ministry of Health and Wellness awaits the outcome of several large scale studies that are currently ongoing to provide further guidance on safety and efficacy.

“The Ivermectin drug when used as labelled, as an anti-parasitic, has been found to be safe. We recognise, however, that in patient-doctor relationships some doctors and their patients are using the medication for treatment of COVID-19 based on the available information. This is ideally done in the framework of a clinical study. In these situations, there should be discussion and agreement between patient and doctor and appropriate documentation and follow-up,” Dr Bisasor-McKenzie said.

Said the release: “As for its availability of the drug in Jamaica, Ivermectin is currently recommended by the manufacturer for human and animal use as an anti-parasitic medication. There has been previously no demand for human use in Jamaica, and no preparation for human use is presently registered in the country. Animal preparations are not to be used in humans.

“Additionally, there has been no application for registration of the drug by any distributor and the ministry will process registration of the drug for its labelled use as an anti-parasitic once it receives an application.

“Where doctors choose to prescribe [it] for their patients, they must note that there is insufficient evidence to establish safety in pregnancy and safety in children. There is no paediatric data to support [use of] Ivermectin for COVID-19 in children; and an effective and safe dose for COVID-19 treatment has not been established through well-designed studies,” said the release.

Ivermectin is a US Food and Drug Administration-approved anti-parasitic drug that is used to treat several neglected tropical diseases, including onchocerciasis, helminthiases, and scabies.