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FDA gives hospital compassionate special permit to use Ivermectin
Packaging of Merck's Ivermectin.
https://dailymed.nlm.nih.gov/dailymed/

FDA gives hospital compassionate special permit to use Ivermectin

Gaea Katreena Cabico (Philstar.com) - April 8, 2021 - 1:30pm

MANILA, Philippines — The country’s Food and Drug Administration has approved a hospital’s application for “compassionate use” of anti-parasitic drug Ivermectin to treat COVID-19, the drug regulator’s chief said Thursday.

“Ang pagkakaalam ko may isang hospital sa amin na nag-apply ng compassionate special permit for the use of Ivermectin at ito ay na-grant ngayong araw na ito,” FDA Director General Eric Domingo said in a briefing.

(From what I know, a hospital applied for compassionate special permit for the use of Ivermectin and it was granted today.)

The move comes amid growing discussions over the use of Ivermectin as a potential treatment for or prophylactic against COVID-19. Scientific evidence for its efficacy remains thin, with medical authorities across the globe advising against the use of drug to treat COVID-19, a respiratory disease.

The FDA earlier said the only registered oral and intravenous preparations for Ivermectin are veterinary products, and are only approved for use to prevent heartworm disease and treat internal and external parasites.

What is currently available in the Philippines for human use is in topical formulation, which is used to treat head lice and skin conditions such as rosacea.

A compassionate special permit (CSP) allows doctors or hospitals to use unregistered medical products for limited off-label use. A specialized institution or speciality society will be the only ones to file a request for CSPs.

In a text message to Philstar.com, Domingo said he cannot disclose the name of the hospital that was given CSP “due to patient privacy.”

“Ivermectin is an investigational product and we know that there are ongoing clinical trials,” Domingo said.

The WHO, in its guidance, said it does not recommend Ivermectin “in patients with COVID-19 except in the context of a clinical trial.”

The United Nations health agency also said the effects of Ivermectin on mortality, mechanical ventilation, hospital admission, duration of hospitalization and viral clearance “remain uncertain because of very low certainty of evidence addressing each of these outcomes.”

Product registration

Domingo said the FDA has also received two applications for certificate of product registration (CPR) for the drug. He said CPR applications are for human use as anti-parasitic. 

CPR allows manufacturers to sell a product commercially and guarantees it is safe and effective.

“We are not against Ivermectin but the product needs to be registered and go through the right process to ensure the safety of the drug that will reach the people,” he said.

Rep. Mike Defensor (Anakalusugan party-list) earlier said his office will distribute “human-grade” Ivermectin to residents of Quezon City. The Department of Health said Wednesday those who are distributing the anti-parasitic drug are violating the law which prohibits the distribution and promotion of unregistered medical products in the country.

Merck, the company behind Ivermectin, said there is no scientific basis in using the drug as a treatment for COVID-19.

IVERMECTIN NOVEL CORONAVIRUS
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