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FDA grants compassionate permit for Ivermectin

Republika

The Food and Drug Administration on Friday last week gave a hospital a compassionate special permit to use anti-parasitic drug Ivermectin for the treatment of Covid19 patients.

More and more physicians have been advocating for the drug’s use due to the soaring number of infections, but the Department of Health and FDA had, until recently, been steadfast in barring this option because of the lack of scientific evidence that it reduces mortality rates and other “clinically important outcomes.”


A compassionate special permit (CSP) is granted to allow use of drugs not registered or are still in the process of registration. Currently, Ivermectin is a veterinary drug.


Members of various medical groups are of the mind that Ivermectin could help fill the gap caused by slow vaccination rollout in the country, but still needs to be subjected to clinical trials to determine its efficacy and safety.


The Philippine Council for Health Research and Development, which is charged with supervising all clinical trials for vaccines and anti-Covid19 drugs alike, said that it would be best to await results of clinical studies in other countries.


FDA chief Eric Domingo also clarified that a CSP is not a permit to market the drug.


However, some are not happy with the FDA’s move. Ex-health sec Janette Garin said that the decision was “political rather than medical” and deemed it “a big joke.”


“Issuing a compassionate use permit for just one hospital but saying it cannot be distributed and used for Covid19 treatment in general seems to be more of a political accommodation than a medical decision,” she said.


According to Garin, herself a doctor, compassionate use “means access is a potential pathway for a patient with an immediate and urgent life-threatening condition or serious disease when no other option is available.”


She also called on health secretary Francisco Duque to review Domingo’s grant of the CSP and to stop its use should the situation call for it.


House health committee chair Helen Tan also voiced her concerns over her colleagues’ aggressive endorsement of Ivermectin: “I feel it’s quite dangerous for some to advocate its use even without license from FDA,” she said. “I know we’re desperate for a solution but we shouldn’t be shortsighted with what’s happening.”

Photo: Daily Tribune


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