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DOH, FDA reiterate insufficient evidence to support safety, efficacy of Ivermectin for COVID-19
DOH, FDA reiterate insufficient evidence to support safety, efficacy of Ivermectin for COVID-19
Due to insufficient scientific evidence, the Department of Health (DOH) and the Food and Drug Administration (FDA) on Friday, April 30, reiterated that they do not recommend the use of antiparasitic drug Ivermectin for the treatment of the coronavirus disease (COVID-19).
In a joint statement, the DOH and FDA emphasized that the agencies have always been consistent in their guidance to the public, and echoed that to date, Ivermectin is not approved for the treatment of COVID-19.
“We have said this many times before and we will say it again. We do not recommend the use of Ivermectin for the prevention and treatment of COVID-19 as the benefits of this antiparasitic drug for this purpose has 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,” FDA Director General Rolando Enrique Domingo said.
It said investigational drugs for the treatment of COVID-19 may be used provided that all regulatory processes in place are strictly followed.
The DOH and FDA said off-label use can be allowed under a compassionate special permit (CSP) or when it is compounded by a duly licensed pharmacy and properly dispensed by a pharmacist to a patient with a valid prescription.
With regard to the distribution of Ivermectin capsules to different communities in Quezon City, the DOH said it has received reports of alleged invalid prescriptions being given to individuals.
The DOH said it will officially endorse the reports to the Professional Regulation Commission (PRC) to investigate the veracity of the reports and impose sanctions as deemed necessary, based on existing laws.
The DOH and FDA echoed the statements of various medical and pharmacist associations on the distributed prescriptions and strongly advised the public on what constitutes a valid prescription.
The DOH said a valid prescription should contain the date of prescription, the patient’s name, age, and sex.
It added that pertinent details about the prescribing physician should also be included such as name, office address, professional regulation number, and professional tax receipt number (if applicable).
The DOH and FDA then urged the public to be vigilant and sufficiently assess any prescriptions provided to them, as these prescriptions will protect them and ensure accountability from the issuing professional.
The agencies also called on those who received the prescriptions and the drugs to report any invalid prescriptions to the PRC, and any adverse reactions to the FDA at (02) 8809-5596 or [email protected].
Meanwhile, the DOH and FDA reiterated that it is not against the use of investigational drugs, but emphasized that in using products with unproven efficacies, the safety of every Filipino should take utmost precedence.
“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.