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FDA warns against use of ivermectin versus coronavirus

THE LOCAL Food and Drug Administration (FDA) reiterated its earlier warning against the experimental use of Ivermectin as a treatment for the coronavirus, after lawmakers called for an inquiry that seeks to include the anti-parasitic drug as part of the country’s medical response to the pandemic.

During a House of Representatives hearing on Tuesday, FDA Director General  Rolando Enrique D. Domingo said the only ivermectin products available locally are topical creams for humans and anti-parasitic drugs for animals.

Pills and injections that are available locally are strictly for veterinary use, he added.

While other countries sell oral Ivermectin tablets for humans, no such product is registered locally. The consumption of the veterinary Ivermectin “can be highly toxic for humans.”

“Ivermectin is not approved by the FDA for treatment of any viral infection,” Mr. Domingo told the House health committee hearing.

Some lawmakers have asked the government to look into Ivermectin’s use as a coronavirus disease 2019 (COVID-19) drug since other countries have started using it for that purpose.

Mr. Domingo said the FDA had not received any applications on Ivermectin trials for COVID-19 treatment but added if there was, the agency would evaluate it with “diligence and priority.”

Meanwhile, Anti-Red Tape Authority Director-General Jeremiah G. Belgica said the agency met with the FDA on Tuesday to discuss the use of Ivermectin as a treatment for the coronavirus.

“The application for drug emergency use is the most convenient option,” he told an online news briefing, citing Mr. Domingo. “However, these only apply for drugs that are included in the COVID-19 treatment protocol which is being given by the Department of Health.”

The FDA this month issued an advisory  saying it had not approved the use of Ivermectin for the treatment of any viral infections.

It said Ivermectin products in the country for human use are used to treat external parasites and skin conditions. Ivermectin products approved for animals seek to prevent heartworm disease and other parasites.

The regulator also said the use of the Ivermectin veterinary product for prevention or treatment of COVID-19 should be avoided because its safety and benefits had not been established.

Mr. Domingo told an online briefing on Monday those who wish to use Ivermectin as a treatment for the coronavirus may apply for a compassionate special permit with the FDA. —  Gillian M. Cortez and Vann Marlo M. Villegas

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