Another hospital, 3rd so far, given CSP to use ivermectin, FDA says

Food and Drug Administration (FDA) director general Eric Domingo on Thursday said a compassionate special permit (CSP) was given to another hospital for the use of anti-parasitic drug ivermectin as possible treatment for COVID-19.

"Sa ngayon po mayroon pa pong na-approve na isang hospital kahapon. May pending pa po na isa daw na nag-apply din kahapon na may kulang lang na papel na isa-submit," Domingo said at a congressional hearing, noting that three hospitals now have CSPs.

(One hospital was given a compassionate special permit yesterday. There's still a pending application as the documents submitted were not yet complete.)

A compassionate use permit only allows legal administration of the drug in the country but not an endorsement of its safety and efficacy from the FDA.

Domingo also reiterated that two companies, a local manufacturer and one importer, have applied for certificate of product registration (CPR) for ivermectin from the FDA.

"Mayroon na pong nag-apply. Dalawang company, isang local manufacturer at saka isang importer, so 'yung mga regulators naman natin mabilis naman tinitingnan 'yung kanilang submissions even if they submit na piece-meal para lang po makumpleto agad," Domingo said.

(Two companies have already applied, one local manufacturer and one importer. Our regulators are fast enough in checking the applications of these companies even if they send requirements piece-meal.)

The CPR will allow manufacturers to sell the drug commercially and is an FDA guarantee that the drug is safe and effective.

There has been a debate among doctors on whether ivermectin can be used as a possible treatment for COVID-19.

Some lawmakers are also pushing for its use even though the FDA has been insisting that further study is needed to prove that it is effective as an anti-virus drug.

The FDA has since maintained that it is not against ivermectin.

Inconclusive

Earlier, the World Health Organization said ivermectin should not be used in patients with COVID-19 except in the context of a clinical trial, noting that the current evidence on the use of ivermectin to treat COVID-19 patients is inconclusive.

The US FDA, for its part, said ivermectin tablets are approved at "very specific doses for some parasitic worms" and that it is not a drug for treating viruses.

On the other hand, ivermectin manufacturer Merck said there is no scientific basis that the controversial drug has a potential therapeutic effect against COVID-19.

As early as February, Merck already advised against the use of the drug to treat COVID-19.

Dr. Tess Lawrie, director of the UK's Evidence-Based Medicine Consultancy Ltd., recommended that the Philippines must do a study on ivermectin as a prophylaxis for health workers, saying that there were few serious adverse events recorded during studies on ivermectin as a possible COVID-19 treatment.

Citing data from VigiAccess, an international database of adverse events, she said only 16 deaths have been reported involving ivermectin, compared to much higher totals for remdesivir, which is used to treat COVID-19 symptoms, as well as COVID-19 vaccines.

Department of Science and Technology Secretary Fortunato dela Peña has said the Philippines will conduct clinical trials to determine whether ivermectin could be used as possible treatment for patients diagnosed with COVID-19. -MDM, GMA News