Quick questions—and answers—on anti-parasitic drug Ivermectin
MANILA, Philippines — As the Philippines grapples with a surge in COVID-19 cases, posts endorsing veterinary anti-parasitic drug Ivermectin and touting it as a potential treatment for or as a prophylactic against COVID-19 have proliferated on social media.
The House of Representatives even included the use of Ivermectin in the agenda of a committee hearing on the government’s COVID-19 response. A week later, a party-list congressman, who claimed he got better after taking Ivermectin, announced he will give Quezon City residents access to the drug.
But scientific evidence for its efficacy remains thin. Local and global medical authorities such as the World Health Organization also advised against the use of the cheap anti-parasitic drug to treat COVID-19, a severe respiratory illness.
Still curious about Ivermectin? Here are the answers to some of your questions:
What are the registered Ivermectin products in the Philippines?
What is available in the country for human use is in topical formulation that must be prescribed by doctors. Topical treatments, usually in the form of creams and ointments, are applied to specific parts of the body.
In Ivermectin's case, it is used to treat head lice and skin conditions such as rosacea.
The only registered oral and intravenous preparations of Ivermectin are veterinary products, and are only approved for use to prevent heartworm disease and treat internal and external parasites.
Are animal drugs such as Ivermectin safe for human consumption?
FDA said using animal products can cause serious harm as they are “often highly concentrated and can be highly toxic to humans.”
Can Ivermectin be used for the prevention or treatment of COVID-19?
In an advisory, the FDA said the use of Ivermectin veterinary products to prevent or treat COVID-19 “should be avoided as the benefits and safety for this purpose has not been established.” The agency added it has not approved Ivermectin for treatment of any viral infection.
The World Health Organization said it does not recommend Ivermectin “in patients with COVID-19 except in the context of a clinical trial.”
Stringent drug regulators such as the European Medicines Agency and US FDA likewise advised against using it. Even Merck, the company behind Ivermectin, said there is no scientific basis in using the drug as a treatment for COVID-19.
Can Ivermectin reduce the risk of mortality among COVID-19 patients?
Medical organizations in the Philippines have stressed that Ivermectin does not significantly reduce the mortality risk of patients with mild to severe COVID-19 cases. Neither does it shorten the duration of hospitalization and the time to resolution of symptoms.
WHO, in its guidance, 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.”
Are pharmacies allowed to compound Ivermectin?
FDA Director General Eric Domingo said licensed pharmacies can compound — make according to prescribed specifications — Ivermectin as long as a doctor prescribes it.
“Compounded Ivermectin is indicated as an anti-parasitic. If the doctor prescribes it for off-label use, based on his clinical evaluation and experience, then they have to explain this to the patient,” Domingo told Philstar.com.
He also said there is no sufficient data showing that Ivermectin, even if compounded, is effective in treating COVD-19.
Can compounded Ivermectin be mass produced?
“They (pharmacies) can compound per prescription. And they are responsible for the quality of the raw materials and end product,” Domingo told Philstar.com.
Is it legal to distribute Ivermectin even if it is not registered for human use in the country?
Rep. Mike Defensor (Anakalusugan party-list) said his office will give out human-grade Ivermectin to residents of Quezon City for free, especially to senior citizens and those with comorbidities.
“I suppose they would, being a congressman, do it through a legal way,” Domingo said in an interview with ABS-CBN Channel Tuesday.
He said the use of human-grade Ivermectin is legal if prescribed by a doctor and compounded by a licensed pharmacy.
But the FDA chief pointed out that unregistered drugs cannot be distributed.
“Those that are now allowed are unauthorized or unregistered drugs and, of course, these should not be distributed without prescription,” he said.
Defensor, in an interview with ABS-CBN Channel, said he is getting stocks of Ivermectin from a “compounding laboratory.”
Is there an application to register Ivermectin?
The FDA is processing an application for product registration.
Malacañang said Monday the proponents of Ivermectin for COVID-19 patients applied for a compassionate use permit with the FDA. Compassionate use permits cover only the specific application, as in the one issued to the Presidential Security Group to take Sinopharm vaccines.
So, what’s the bottomline?
Filipinos should wait for the results of major clinical trials before using Ivermectin on a massive scale, Domingo said.
“We keep reminding people: we all want to find a cure for COVID-19. But so far, the scientific evidence for the use of Ivermectin against COVID-19 is not enough,” he said.
“There are many ongoing [clinical trials]. Let’s wait before we use it on a large scale.”
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