Further studies needed to guide recommendation for using Ivermectin, Tufton saysSunday, February 28, 2021
KINGSTON, Jamaica -- Health Minister Dr Christopher Tufton says further studies are needed to guide the recommendation for using the drug Ivermectin at the policy level, and as it stands, there is not enough evidence to recommend for or against it in the COVID-19 response.
He said the data available for the use of Ivermectin in COVID-19 has been extensively reviewed by the National Institute of Health in the United States, and the US Food and Drug Administration, which have concluded that there is not enough evidence to recommend for or against in the COVID-19 response.
Dr Tufton, who was speaking at a COVID press briefing this evening, said the World Health Organization and PAHO also indicated that more clinical studies are needed as it relates to the use of this particular drug.
He said the drug, as labelled, is currently recommended by the manufacturer for human and animal use as an anti-parasitic medication, and not for COVID-19.
“We know that there is mounting pressure both locally and internationally from medical professionals and private organisations for the national regulatory authorities to provide approval for use for COVID-19 as a policy directive; we also note that there are some fairly large scale studies that are underway and we await those outcomes to provide further guidance on safety and efficacy,” he said.
He said the ministry has spent considerable time reviewing the information.
Dr Tufton added that in patient-doctor relationships, some doctors are using the medication for use in the treatment of COVID-19 based on the available information. He said this is ideally done in the framework of a clinical study, and in these situations, there should be discussion and agreement between patient and doctor and appropriate documentation and follow-up.
“There has previously been no demand for human use in Jamaica, and no preparation for human use is presently registered in the country,” he said.
“There has been no application for registration of the drug by any distributor, and the ministry will expedite registration of the drug for its labelled use as an anti-parasitic once we receive an application."
He added: “Where doctors choose to prescribe it for patients, we urge... that it is known that there is insufficient evidence to establish safety in pregnancy, safety in children, and effective and safe dose for COVID-19 patients through the well designed studies to date.”
Last week, the Medical Association of Jamaica (MAJ) urged the Government to authorise the use of Ivermectin, an antiparasitic drug used to treat several tropical diseases, in an effort to reduce hospitalisations caused by COVID-19.
According to MAJ President Dr Andrew Manning, the recommendation was being made because Jamaica now finds itself at a crisis point in the novel coronavirus pandemic.
He said Ivermectin has been safely used for decades in the effective treatment of certain parasites in humans.
“Potent anti-inflammatory and anti-viral 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.
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