The FDA and the DOH reiterated the insufficient evidence to support the efficacy and safety of Ivermectin for COVID-19.
The Food and Drug Administration (FDA) and the Department of Health (DOH) reiterated the insufficient evidence to support the efficacy and safety of Ivermectin for COVID-19.
In a report on Manila Bulletin, the Food and Drug Administration and the Department of Health on Friday reiterated that they didn’t recommend the use of Ivermectin for the treatment of COVID-19 because of insufficient scientific evidence.
The Food and Drug Administration and the Department of Health emphasized in a joint statement that the agencies had always been consistent in their guidance to the public, and echoed that to date, the said drug was not approved for the treatment of COVID-19.
According to FDA Director-General Eric Domingo, the Food and Drug Administration and the Department of Health didn’t recommend the use Ivermectin for the prevention and treatment of COVID-19 as the benefits of the said drug for this purpose had not been established.
“President Rodrigo Duterte has also ordered the Department of Science and Technology – Philippine Council for Health Research and Development (DOST-PCHRD) to conduct a clinical trial to test the efficacy of Ivermectin against COVID-19, let’s wait for the results,” Domingo said.
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The agencies also said that investigational drugs for the treatment of COVID-19 — including Ivermectin — may be used provided that all regulatory processes in place were strictly followed.
In addition, the Food and Drug Administration and the Department of Health said that off-label use can be allowed under a “compassionate special permit (CSP)” or when it was properly dispensed by a pharmacist to a patient with a valid prescription and was compounded by a duly licensed pharmacy.
The Food and Drug Administration and the Department of Health then encouraged the public to be vigilant and sufficiently assess any prescriptions provided to them as those prescriptions will protect them and will ensure accountability from the issuing professional.
Meanwhile, the Food and Drug Administration and the Department of Health reiterated that it was not against the use of investigational drugs, but emphasized that the safety of every Filipino should take utmost precedence in using products with unproven efficacies.
“While we recognize recent calls for its use, the positive effects of Ivermectin have yet to be proven. Moreover, the danger of self-administering this drug is concerning, which is why we call on the public to refrain from self-medicating and indiscriminately using this potentially harmful product,” Health Secretary Francisco T. Duque III said.
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