Ivermectin gets FDA nod for human consumption | Inquirer News
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Ivermectin gets FDA nod for human consumption

NOT YET FOR COVID-19 A health worker shows a bottle of Ivermectin, which some countries use to treat COVID-19. —AFP

MANILA, Philippines — Food and Drug Administration (FDA) Director-General Eric Domingo on Friday confirmed that his agency had issued a certificate of product registration (CPR) to Lloyd Laboratories for the manufacture and sale of ivermectin, thus paving the way for its legal human consumption.

In a text message, Domingo said the CPR, which Lloyd Laboratories applied for, was on the use of “locally manufactured ivermectin as an antinematode drug.” Nematode is a type of parasitic worm.

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“[This] was granted after they submitted data to support [the] quality and stability of the product,” Domingo said.

He clarified that the CPR was not for use in treating or preventing COVID-19, adding that the purpose of the drug is still antiparasitic.

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But the CPR granted to Lloyd Laboratories means anyone with a valid prescription for it can now purchase the drug.

‘Stand firm’

Sought for comment, epidemiologist Tony Dans of the Health Professionals Alliance Against COVID-19 said, “It’s up to the people who to believe. I’m hoping 41 societies will make a difference.”

Associate groups of the alliance earlier warned against the use of ivermectin.

Dr. Tony Leachon, a health reform advocate, said the CPR was proof the FDA was “at its weakest.”

In a text message, the former government adviser warned: “The believers of ivermectin will surely use this for off-label indication—for COVID. A CPR allows the manufacturer to import the materials for the country. This makes the problem worse because the off-label indication will be abused.”

“Off-label” refers to the use of an approved medicine outside of its approved indication.

According to the United States’ FDA, “off-label” can mean a drug is used for a disease or medical condition it is not approved to treat.

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“Our regulatory agencies like the FDA and even the DOH (Department of Health) should stand firm,” Leachon said. “It’s unfortunate that this would happen at a time when we should be focused on COVID pandemic response.”

Anakalusugan Rep. Michael Defensor called the FDA’s decision a “great victory for the advocates of ivermectin.”

“I congratulate the doctors who stood their ground knowing that ivermectin will save our people, especially the poorest of the poor. I hope the medical associations will retract their statements against our ivermectin doctors and we all work together in fighting COVID-19. Off-label prescription is the right of every doctor and patients fighting for their lives,” he said.

For more news about the novel coronavirus click here.
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TAGS: COVID-19, drug, FDA, Ivermectin, Lloyd Laboratories
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