MANILA, Philippines — A group of physicians called on the Department of Health and the Food and Drug Administration to act urgently on the mass distribution of ivermectin as it reiterated warnings that there is insufficient evidence on the safety and efficacy of the anti-parasitic drug.
The Philippine College of Physicians, the umbrella organization of internists in the country, issued statement Sunday opposing the dispensing of unregistered drugs such as ivermectin “for indications that have not been scientifically established.”
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This came after Rep. Mike Defensor (Anakalusugan party-list) and Rep. Rodante Marcoleta (Sagip party-list) distributed ivermectin capsules to residents of Quezon City last week.
Official Statement of the Philippine College of Physicians on the Ivermectin Use for COVID-19 pic.twitter.com/BuT6cThpSU
— Philippine College of Physicians (@pcp1953) May 2, 2021
“Amid the chaos and controversies we find ourselves in, we call on everyone, particularly the thought leaders of communities and institutions, to stay firm with our resolve to be guided by science and medical information based on robust research. We have to resist being swayed by others despite the absence of enough scientific evidence,” PCP said.
To date, the FDA has issued compassionate special permits to five hospitals, allowing them to use ivermectin to treat COVID-19 patients. It also allows a duly licensed pharmacy to compound the drug and properly dispense to a patient with a valid prescription.
Exposing people to potential harm
“Let us also refrain from thinking we are giving them medicines that are not proven remedies. We may be exposing them to unwanted and possibly harmful side effects,” it also said.
PCP said current evidence from randomized controlled trials showed that ivermectin does not significantly improve clinical outcomes or reduce deaths among adults with mild COVID-19 infection.
It added the drug is associated with side effects such as nausea, vomiting, diarrhea, stomach pain, facial or limb swelling, neurologic adverse events, sudden drop in blood pressure potentially requiring hospitalization, and liver injury.
The World Health Organization recommended that the drug only be used within clinical trials until more data become available.
“We strongly recommend that the prescription and use of the drug ivermectin for prevention or treatment of COVID-19 be put on hold until we have sufficient evidence on its safety and effectiveness,” the organization said.
During the event dubbed “Ivermectin Pan-three,” beneficiaries received prescriptions written on pieces of paper that did not include information of the doctors who prescribed them. They were also made to sign a waiver before receiving the anti-parasitic drugs.
In a statement last week, the DOH and the FDA, who both maintained that they do not recommend the use of ivermectin for the prevention and treatment of COVID, said it will officially endorse reports of invalid prescriptions to the Professional Regulation Commission.
However, it remains to be seen if efforts to distribute ivermectin would be penalized.