DOH cautions doctors on ‘off label’ ivermectin prescription
MANILA, Philippines — The Department of Health (DOH) on Saturday warned doctors that prescribing ivermectin to combat COVID-19 would be an “off label” prescription and that they will be held accountable since its current certificate of product registration (CPR) with the Food and Drug Administration (FDA) is still for its use as an anti-parasitic drug.
Health Undersecretary Maria Rosario Vergeire noted that the CPR, which Lloyd Laboratories applied for, was for the use of locally-manufactured ivermectin as an “anti-nematode drug.” Nematode is a type of parasitic worm.
“Kung sakaling gagamitin ‘yang ivermectin ng ibang mga doktor [for other purposes], it’s going to be an off-label use and ang accountability and liability will be resting upon the physician who has prescribed this,” she said.
(If ivermectin will be prescribed by doctors for other purposes, it’s going to be an off-label use and the accountability will rest on the physician who has prescribed this.)
The FDA granted on Friday the CPR for Lloyd Laboratories for the manufacture and sale of human-grade ivermectin.
Previously, the drug was only approved in the country for use on animals.
FDA Director General Eric Domingo, however, clarified that the CPR was not for the use of the drug in treating and preventing COVID-19.
The country is set to conduct clinical trials to determine whether or not ivermectin can be used to treat COVID-19 patients.
The clinical trials may begin by end of May or early June, with results expected to be known by early 2022.
At least six hospitals in the country have been granted compassionate special permits to use ivermectin to treat COVID-19 patients.
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