Metro Manila (CNN Philippines, April 6) — Infectious diseases expert Dr. Rontgene Solante on Tuesday said repurposing anti-parasitic drug Ivermectin could result in “detrimental effects” in humans.
At present, Ivermectin is only approved for veterinary use to prevent heartworm disease in animals. It is also used to treat parasite infestation such as head lice and scabies.
Several lawmakers and businessmen, however, have been pushing the government to consider repurposing the drug to prevent and treat COVID-19 infections.
Solante said taking these kinds of off-label drugs could lead to headaches and abdominal pain, and could even damage vital internal organs.
“Merong detrimental effects na hindi pa natin alam that can damage liver or kidneys [There are detrimental effects that we don’t know of yet that can damage the liver or kidneys]…” he told a media briefing.
“You have to be careful in taking this drug,” he added.
Ivermectin has not been approved for compassionate use. It is also not registered for human use at the Food and Drug Administration.
Nevertheless, Anakalusugan Party-list Rep. Mike Defensor is still pushing through with his plan to distribute the unregistered drugs for free even though health experts — including the World Health Organization — warned that its safety and efficacy against the coronavirus has not been proven.
Solante said those who illegally distribute Ivermectin beyond what is allowed by the FDA could face legal sanctions.
“Kapag nagkaproblema ‘yan because of side effects, sino isu-sue? Hindi ang gobyerno [If there will be side effects, who will be sued? Not the government],” he pointed out. “There are legal implications on that aspect.”
The FDA said the drug may be prescribed for off-label use, but the doctor will be held responsible.
FDA Director General Eric Domingo remains adamant to allow its use given that there is no clinical trial yet to prove that Ivermectin is effective against COVID-19 infection.
“Hindi kasi mataas na level of evidence ang mga testimonials o anecdotal report,” he argued. “Bago ma-approve ang kahit anong gamot sa buong mundo, kailangan po talaga dumaan sa masusing pag-aaral at ma-prove na useful siya.”
[Translation: Testimonials or anecdotal reports are not considered a high level of evidence. Before a drug gets approved, it has to go through stringent evaluation and it has to be proven useful.]
The FDA said it is not closing its doors to possibility that Ivermectin could work against the coronavirus. However, it reminded the public that it is best to wait until the clinical trial is over — although no application has been lodged so far before the regulatory body.
CNN Philippines correspondent Carolyn Bonquin contributed to this report.
