Both local and international health bodies advised the public against the use of Ivermectin veterinary products to treat COVID-19, citing scant clinical trials on its safety and effectivity.
The Ivermectin is an anti-parasitic drug registered and approved in the Philippines and in the United States for treating parasite infestation such as scabies, lice and other tropical disease.
Since the pandemic started last year, however, there were reports of the medication being sold in some parts of the world, including in the country, as COVID-19 treatment.
In the new advisory posted on March 17, the Department of Health and the country’s Food and Drug Administration stressed that the registered Ivermectin is not approved for viral infections such as COVID-19.
“Ivermectin is NOT APPROVED by the FDA for treatment of any viral infection,” read the advisory.
Both agencies also stressed that the drug is only for certain animal species and not for humans.
“The FDA advises the public AGAINST the purchase and use of Ivermectin veterinary products against COVID-19. The registered Ivermectin veterinary products are only approved for use the prevention of heartworm disease and treatment of internal and external parasites in certain animal species,” it said.
Under the advisory, FDA had only so far evaluated the efficacy and safety of the tablet labeled for animals, thus being a veterinary product.
“The public is warned against taking animal drugs, as the FDA has only evaluated their safety and efficacy in the particular species for which they are labeled. Using these products in humans can cause serious harm. Animal drugs are often highly concentrated and can be highly toxic to humans,” it said.
What health orgs said
The DOH had been warning the public against such use of the medicine in the past months.
In December 2020, Health Undersecretary Maria Rosario Vergeire said there is not enough evidence for them to recommend the Ivermectin for the deadly pathogen.
This decision was made after the DOH looked into recent studies in Bangladesh and Dakha in India.
“Meron silang initial result ng kanilang pag-aaral ukol sa ivermectin against COVID-19. Pero ang kanilang sample size is just very small, which is not really enough to conclude and to give us appropriate conclusions na talagang magwo-work ito,” she said in a briefing that time.
This time, in the comments section of DOH’s post, there are still commenters alleging that international health groups approved Ivermectin against COVID-19.
Is it approved in the US and by the WHO?
“The National Institute of Health (NIH) in the US has taken a neutral stance on human Ivermectin…that it may or may not work. Ivermectin is a relatively safe drug so if it may work…that’s good enough for me… If I can just get my hands on some,” a user said.
Both the US FDA and the National Institutes of Health did not issue any recommendations to use Ivermectin to handle COVID-19 cases and lessen the COVID-19 risk.
US FDA pointed out that the Ivermectin for humans are only for getting rid of parasites in the body, not viruses.
“Ivermectin tablets are approved at very specific doses for some parasitic worms, and there are topical (on the skin) formulations for head lice and skin conditions like rosacea. Ivermectin is not an anti-viral (a drug for treating viruses),” the organization said.
NIH similarly highlighted that studies to recommend it are not enough.
“There are insufficient data for the COVID-19 Treatment Guidelines Panel (the Panel) to recommend either for or against the use of ivermectin for the treatment of COVID-19,” they said.
Moreover, the World Health Organization did not issue any guidelines or statement on using Ivermectin specifically for coronavirus infections.
There is a product for humans but not for COVID-19
“Why buy Ivermectin for animals when there is one for human! I am not sure if they have FDA approval for humans in the Philippines, but in other countries certainly they have,” one Facebook user claimed.
The country’s FDA confirmed the availability of Ivermectin for humans. However, these are only for prescription use and in dealing with other health conditions.
“Currently, the registered Ivermectin products in the country for human use are in topical formulations under prescription use only. This is used for the treatment of external parasites such as head lice and skin conditions such as rosacea,” the agency said.
Its counterpart in the US also warned of possible severe side-effects, such as:
- Skin rash,
- Facial or limb swelling
- Neurologic adverse events (dizziness, seizures, confusion)
- Liver injury (hepatitis)