The Food and Drug Administration (FDA) has granted a “compassionate use” permit to a hospital for the use of anti-parasitic drug Ivermectin to treat Covid-19 patients amid a fierce debate on the medicine’s safety and efficacy.
FDA director general Undersecretary Eric Domingo made the announcement in a televised briefing, but he did not name the hospital that applied for the permit.
The compassionate use authorization allows the legal use of Ivermectin in the said hospital, but it is not an FDA’s endorsement on the drug’s safety and efficacy since a clinical trial is needed to prove such.
“From what I know, a hospital applied for a compassionate special permit for the use of Ivermectin, and it was granted today,” Domingo said.
“We know it is an investigational product and there is an ongoing clinical trial to prove its efficacy against Covid-19,” he added.
The FDA, Domingo said, also received two manufacturers applied for Ivermectin’s certificate of product registration, which will allow them to sell the drug commercially. The certificate is a guarantee that the drug is safe and effective in treating Covid-19 patients.
He said the manufacturers were given a list of requirements.
“Just like what we said earlier, the FDA is not against Ivermectin, but it needs to be registered and undergo the process to ensure its quality and safety for the public,” Domingo said.
Proponents of Ivermectin have fiercely insisted that the drug is effective in preventing or treating Covid-19, citing anecdotal evidence, even if the World Health Organization has recommended against using it except for clinical trials.
Ivermectin manufacturer Merck, as well as medical experts here and abroad, have also warned against the use of Ivermectin, noting the lack of reliable data demonstrating its benefits.
They have also expressed concern over the drug’s risks and potential side effects such as hypotension or low blood pressure, allergic reactions, seizures, coma, and even death.
Ivermectin products commercially available in the country are limited to treating parasitic ailment of animals and are in the form of a topical cream for skin application.