US FDA cautions against using animal anti-parasite drug Ivermectin to treat Covid-19

KUALA LUMPUR (July 28): Health Minister Datuk Seri Adham Baba yesterday said the ministry had given special approval for the anti-parasitic drug known as Ivermectin to be used off-label for a clinical study to determine the safety and efficacy of the drug to treat Covid-19 patients.

Off-label use refers to the use of a pharmaceutical drug for an unapproved indication or in an unapproved age group, dosage or route of administration.

The minister said the use of Ivermectin as part of the Covid-19 treatment regime is currently being tested in 18 general hospitals nationwide.

Ivermectin not FDA-approved for Covid-19 treatment

However, the US Food and Drug Administration (FDA) has not approved the use of the drug for the prevention or treatment of Covid-19.

Ivermectin is FDA-approved for use in animals for prevention of heartworm disease in some small animal species, and for treatment of certain internal and external parasites in various animal species.

“There are approved uses of Ivermectin in people and animals, but it is not approved for the prevention or treatment of Covid-19.

“Ivermectin tablets are approved by the FDA to treat people with intestinal strongyloidiasis and onchocerciasis, two conditions caused by parasitic worms. In addition, some topical (on the skin) forms of ivermectin are approved to treat external parasites like head lice and for skin conditions such as rosacea.

“Some forms of Ivermectin are used in animals to prevent heartworm disease and certain internal and external parasites. It’s important to note that these products are different from the ones for people, and safe when used as prescribed for animals only.

“You should not take any medicine to treat or prevent Covid-19 unless it has been prescribed to you by your healthcare provider and acquired from a legitimate source,” according to the FDA’s website. 

Ivermectin side effects

The FDA said some of the side effects that may be associated with Ivermectin include skin rash, nausea, vomiting, diarrhea, stomach pain, facial or limb swelling, neurologic adverse events such as dizziness, seizures, confusion, a sudden drop in blood pressure, severe skin rash potentially requiring hospitalisation and liver injury (hepatitis).

“Laboratory test abnormalities include a decrease in the white cell count and elevated liver tests. Any use of Ivermectin for the prevention or treatment of Covid-19 should be avoided as its benefits and safety for these purposes have not been established.

“Though this is understandable, please beware. The FDA’s job is to carefully evaluate the scientific data on a drug to be sure that it is both safe and effective for a particular use, and then to decide whether or not to approve it. Using any treatment for Covid-19 that’s not approved or authorised by the FDA, unless part of a clinical trial, can cause serious harm,” it added.

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