Another private hospital gets compassionate special permit to use ivermectin
MANILA, Philippines — The Food and Drug Administration (FDA) has granted the application of another private hospital for the “compassionate use” of anti-parasitic drug ivermectin for the treatment of COVID-19.
“There are two hospitals na actually ‘yong nag-apply sa atin and have been given CSP (compassionate special permit),” FDA Director General Eric Domingo told ABS-CBN News Channel on Friday.
(There are two hospitals that actually applied and have been given CSP.)
The FDA announced last week that it approved a private hospital’s application for a CSP to use ivermectin on COVID-19 patients.
Domingo said he could not disclose what hospitals were granted the special permit supposedly to protect the privacy of patients.
A CSP allows doctors or hospitals to use unregistered medical products for limited off-label use. A specialized institution or speciality society will be the only ones to file a request for CSPs.
What’s the verdict on ivermectin?
Ivermectin is only registered for human use as a topical cream in the Philippines, but oral formulations of the drug can be obtained from hospitals with CSPs or from registered pharmacies compounding it upon the prescription of a doctor.
Any prescription of it for the prevention or treatment of COVID-19, however, is considered off-label use and is not endorsed by the Department of Health or the FDA.
The World Health Organization also does not recommend using ivermectin on COVID-19 patients except in a clinical trial.
It also 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.”
A review by several medical groups in the country of six trials of ivermectin showed that it did not significantly reduce the risk of death among patients with COVID-19 and did not significantly reduce time in the hospital.
Ivermectin is also not associated with a definite benefit in terms of other clinically important outcomes. There is also no significant difference in the rate of hospital discharge between patients who took the anti-parasitic drug and those who did not.
That said, dozens of clinical trials on the use of ivermectin for the treatment of COVID-19 are still ongoing, which means the final verdict for ivermectin has yet to be handed down.
Pressure on FDA?
Domingo admitted that there is pressure on the FDA in its regulation of ivermectin, but said that this has not affected their scrutiny of the drug commonly used in veterinary settings.
“People are attacking me from every side. I’ve been to congressional hearings. People who are in power try to give their opinion about it,” he said.
He continued, “But science kasi doesn’t work that way. It’s not something you can hurry up or that your passion can make the conclusions go either way. It has to be very objective.”
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