FDA: 2 more hospitals may use ivermectin vs COVID-19
The Food and Drug Administration (FDA) on Tuesday said two more hospitals had been granted compassionate special permits (CSPs) to use controversial drug ivermectin to treat COVID-19 patients.
This brings to five the number of hospitals granted such permits, as confirmed by FDA Director General Eric Domingo in a text message. He did not name any of these hospitals.
According to him, a CSP specifies how many doses of the medicine and for how long this can be used, and which patients may take it.
Doctors prescribing drugs which are only allowed under a CSP instead of a certificate of product registration are responsible for discussing possible side effects with their patients.
CSPs can be issued if the drug concerned is already undergoing clinical trials, or if it is not available locally but is registered overseas.
There are several ongoing clinical trials abroad to determine whether ivermectin, which is mainly a veterinary medication to treat parasite infections, is helpful to patients suffering from COVID-19.
Domingo and Science Secretary Fortunato dela Peña earlier confirmed that the country was set to conduct its own trials, as ordered by President Duterte himself.
According to Domingo, at least two companies are seeking a certificate of product registration for human-grade, or human-edible, ivermectin.
“We have one local manufacturer applying, and [an] expression of interest from an importer,” he said.
The FDA, as well as the Department of Health (DOH), had earlier warned the public against using ivermectin to treat COVID-19, prompting the displeasure of some lawmakers at the House of Representatives who affirm the efficacy of the drug.
Deputy Speaker Rodante Marcoleta and Anakalusugan Rep. Michael Defensor said they would launch the “Ivermectin Pan-three” on Thursday in Quezon City, to distribute ivermectin “to those in dire need” of it.
In a joint statement on Monday, the two lawmakers said they would donate a minimum of three tablets of ivermectin to each beneficiary seeking the drug—thus, the name of this charity effort, “Pan-three.”
“After the inquiries conducted by two committees of the House of Representatives where both foreign and local experts were engaged on the potential use of [i]vermectin, we have decisively come to a critical decision to distribute [it] to those who are in dire need of this drug,” they said.
The venue for the free distribution of ivermectin tablets is Matandang Balara Barangay Hall Park at No. 19 Doña Filomena Street, Villa Beatriz Subdivision, Quezon City. Distribution starts at 9 a.m.
In a text message to reporters, Defensor said each beneficiary would be given a doctor’s prescription from the Concerned Doctors and Citizens-PH.
He and Marcoleta also criticized anew the “complacency, if not indifference,” of the DOH and FDA on the use of ivermectin. INQ
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