The Food and Drug Administration (FDA) on Thursday, April 8, has approved a compassionate special permit (CSP) application of a hospital for the use of anti-parasitic drug Ivermectin despite concerns of its possible effects when used on humans.
“Ang pagkaka-alam ko po may isang ospital sa amin na nag apply ng compassionate special permit for the use of Ivermectin at ito po ay na grant na ngayong araw na ito (As far as I know, there is one hospital that has applied for a compassionate special permit for the use of Ivermectin and this was granted today),” FDA Director General Eric Domingo said during the Laging Handa press briefing.
In a text message to Manila Bulletin, Domingo refused to disclose who applied for the CSP citing “patient privacy.”
“May (There is a) patient privacy so I can’t tell you who,” Domingo said when asked who applied for the CSP. “But CSP is for the treatment of COVID-19.”
Domingo said FDA was not against Ivermectin but he noted the drug must be registered.
“Ito lang naman po palaging sinasabi ng FDA, hindi po kami kontra sa Ivermectin pero Kailangan po i-rehistro yung produkto at dumaan lamang po sa tamang proseso ng pagsiguro ng quality ng gamot na makakarating sa tao (This is what the FDA always says, we are not against Ivermectin but the product needs to be registered and go through the right process to ensure the quality of the medicine that reaches the people),” he said.
The FDA and the Department of Health (DOH) had earlier said that they do not recommend the use of Ivermectin for the treatment of COVID-19.
“Based on the current evidence from randomized controlled trials, the DOH agrees with the COVID-19 Living CPG Reviewers and does not recommend the use of Ivermectin for the treatment of COVID-19,” health authorities said Monday, April 5.
Dr. Edsel Salvana, a member of the Department of Health (DOH) Technical Advisory group, has also warned against taking Ivermectin in high doses as it could lead to people suffering from brain damage and even death.
In a previous advisory issued by the FDA, it warned the public against the purchase and use of Ivermectin veterinary products against COVID-19.
It also noted that “Ivermectin is not approved by the FDA for treatment of any viral infection.”
The FDA has also warned the public against taking animal drugs.
“Using these products in humans can cause serious harm. Animal drugs are often highly concentrated and can be highly toxic to humans,” it said.
“Any use of Ivermectin veterinary products for the prevention or treatment of COVID-19 should be avoided as the benefits and safety for this purpose has not been established,” it added.