Not recommending Ivermectin but welcomes application

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DESPITE the pronouncement that anti-parasitic drug ivermectin has no scientific proof that its use would be fit and safe for humans, the Food and Drug Administration (FDA) said that they would be glad to validate an application for its registration and emergency use authorization (EUA).

Interviewed over the radio, FDA Director General Eric Domingo said that proponents of the drug may apply for its emergency use against COVID-19.

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. 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,” Domingo said.

He added that proponents of the drug may also apply for compassionate use per patient, adding that the FDA may issue approval within two days – or use the drug in prior approval but “take full responsibility for its effects and must monitor the patient and the outcome.”

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.

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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