FDA: Ivermectin, not approved for prevention or treatment of COVID-19

By Ryan Lesigues

The Food and Drug Administration (FDA) warned the public today that taking Ivermectin as an antidote to COVID-19 can have adverse effects on a person’s health.

This is because the use of Ivermectin to combat COVID-19 is not registered with the FDA. The agency said there are two types of Ivermectin registered in our country: one that can be taken orally and is for animals, while the other is an ointment or lotion that can be used to kill parasites on human skin.

The FDA issued the warning following numerous reports that people are using the drug to fight the virus.

At the Laging Handa Briefing today, FDA Director-General Undersecretary Eric Domingo said a person can develop encephalopathy or other adverse effects on the brain if the drug is taken in “very high doses.”

Although Ivermectin can be used for humans, he said, no one has registered it in the Philippines for the past three years.

“Ang Ivermectin, ito’y gamot naman ng tao. Wala nga lang nagre-rehistro dito sa Pilipinas for the past three years, so [pero] medyo safe naman siya. ‘Pag mataas na dose, ‘yun lang nagkakaroon ng encephalopathy, nagkakaroon ng epekto sa utak, pero at very high doses.”

[Ivermectin is a drug for humans. No one has registered it in the Philippines for the past three years, [but] it can be considered safe. When the dose is high, encephalopathy develops, there is an effect on the brain, but at very high doses.]

Domingo also clarified that Ivermectin still has not been proven to help fight COVID-19, so he asked the public not to use the drug.

“Ang sinasabi po natin, hindi pa naman proven kung talagang ito ay nakakatulong sa COVID-19, at definitely hindi po natin alam kung ito ay nakaka-prevent sa COVID-19. Kaya huwag po sana tayong uminom nito, at tapos baka mamaya ang tapang natin, akala natin hindi na tayo magkakasakit… kailangan po mag-i-ingat po tayo.”

[What we are saying is that it has not been proven that it can help against COVID-19, and definitely we do not know if it can prevent COVID-19. So please don’t drink this, because maybe we are so brave about it, we think we won’t get sick… we need to take care.]

Meanwhile, the FDA is ready to face the House of Representatives should that chamber hold a hearing on the use of Ivermectin.

“Well, mabuti naman po, we will take the opportunity para ma-explain po natin kung ano ang regulatory process natin dito sa FDA, at kung paano maipapasok ng legal at saka safe ang gamot,” Domingo said.

[Well, that would be good, we will take the opportunity to explain about the FDA regulatory process and how this drug can be brought in legally and safely.]

He also explained that Ivermectin manufacturers can apply for a compassionate special permit, as the suppliers of the COVID-19 drug Remdesivir have done.

“Actually eligible naman po for application for compassionate special permit ang Ivermectin, kahit last week sinasabi na po natin ‘yun. Kaya lang, wala lang pong nag a-apply dito sa atin,” Domingo said.

[(They) are eligible to apply for a compassionate special permit for Ivermectin, we’ve been saying that since last week. But no one has applied yet.]

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