Ivermectin for humans must be registered with FDA before use: official

ABS-CBN News

Posted at Mar 28 2021 10:48 AM | Updated as of Mar 28 2021 04:15 PM

Food and Drug Authority at the one-stop center in Ali Mall, Cubao. ABS-CBN News/file

MANILA (UPDATE) - Anti-parasitic drug ivermectin for humans must be registered with the Food and Drug Administration before it is used as treatment against COVID-19, its chief said Sunday.

Proponents of the drug may apply for its emergency use against COVID-19, said FDA director general Eric Domingo.

"Ang FDA po ay hindi anti-ivermectin. Pero bawal po ang unregistered drugs, bawal po yan sa Pilipinas. Since 2018, wala na pong nagrehistro ng ivermectin na human preparation, for oral intake ng humans," told ABS-CBN's TeleRadyo.

(The FDA is not anti-ivermectin. But the country prohibits unregistered drugs. Since 2018, no one has registered ivermectin for human preparation, for oral intake of humans.)

"Itong propronents natin, if they have the scientific data--wala pa pong consensus dito, talagang may nagsasabing useful, may nagsasabing hindi. Tayo, we’ll take all of these into consideration."

(If proponents have the scientific data--there's no consensus yet, some say it's useful, some say it's not--, we’ll take all of these into consideration.)

Proponents of the drug may also apply for compassionate use per patient, approval of which takes 24 to 48 hours, according to Domingo.

Doctors may also use the drug in prior approval, but must take full responsibility for its effects and must monitor the patient and the outcome, Domingo said.

Dr. Benigno Agbayani, Jr., chairman of the Manila Doctors Hospital Orthopedics Department who is an advocate for ivermectin, said other countries have already used the drug to treat COVID-19.

Ivermectin, considered a probiotic, is primarily for humans and should be under the country’s essential drug list, Agbayani said.

“Bakit nag-a-anounce sila na para sa hayop? Na hindi nililinaw na para sa tao? Meron sila half-truth, meron siguro sila gusto takutin. Eh, dapat nga available,” he said.

Agbayani, who is also President of the Concerned Doctors and Citizens of the Philippines, said that as far as he knows, Dr. Allan Landrito, his fellow advocate, has applied to be licensed as a trader but is facing some delays. 

“In application, nakita ko effective siya (I saw it's effective). May (it has) 80 percent reduction in overall mortality. It is cheap, safe and available, best for this COVID-19 pandemic,” Landrito told reporters.

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The FDA earlier advised the public against using the veterinary drug ivermectin to prevent or treat COVID-19 as clinical trials have yet to show benefits.

Animal drugs are often highly concentrated and can be toxic to humans, the FDA said in an advisory.

The Department of Health earlier said there was not enough evidence for them to recommend its use.

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