Gov’t cautions public on ivermectin

Malacanang urged the public Tuesday to wait for regulator approval for Ivermectin, said to be useful for COVID-19 treatment and prevention, after a lawmaker said he planned to distribute the anti-parasitic drug.

Anakalusugan Party-list Rep. Mike Defensor said Monday he would distribute Ivermectin to the sick and elderly in Quezon City, despite Food and Drug Administration warnings on the unauthorized use of the drug used to treat worms in animals.

In an interview on Dobol B TV on Tuesday, Defensor said he is not doing anything illegal with pushing the use of ivermectin.

He said he has been obtaining ivermectin from legal compounding laboratories, and emphasized that a doctor's prescription is still needed to use this drug.

Justice Secretary Menardo Guevarra did not directly answer a question whether Defensor was violating the law, saying it is not a specific case before his office.

“Generally speaking, it is prohibited, under the FDA law, to manufacture, import, export, sell, offer to sell, distribute, transfer, promote, advertise, etc… health products that are unregistered with the FDA,” he said in a text message to reporters.

“I am sure that as a lawmaker, Rep. Mike Defensor knows the FDA law very well and that he is very much aware of what acts are allowed and what acts are prohibited under the said law,” Guevarra said in another message.

Also interviewed on Dobol B TV, Department of Health Undersecretary Maria Rosario Vergeire pointed out the anti-parasitic drug ivermectin is not yet registered and was still subject to the evaluation of the Food and Drug Administration.

“We want to caution the public that the government cannot assure that unregistered drugs are safe and can give protection from the disease,” she said.

The drug is currently registered for use against worm infestations and parasites in animals.

Meanwhile, World Health Organization country representative Rabindra Abeyasinghe said clinical trials should be conducted before making a conclusion whether or not the anti-parasitic drug ivermectin could treat COVID-19 patients.

“The WHO came out with a very clear position that the potential use of ivermectin as a prophylactic or as a therapeutic agent needs to be evaluated through equally strong clinical trials, not just the solidarity trials,” Abeyasinghe said.

“Let’s do a clinical trial that has the power to differentiate whether what we have seen is because of chance, or there is the actual efficacy of the drug. When we have that evidence, we will be ready to share,” he said at a Palace press briefing.

At the same time, the DOH and Food and Drug Administration were discouraging the use of Ivermectin on COVID-19 patients amid calls for them to authorize the antiparasitic drug.

The DOH and FDA said a study of six trials by reviewers from the Philippine COVID-19 Living Clinical Practice Guidelines found:

·      Ivermectin did not significantly reduce the risk of mortality among patients with mild to severe COVID-19;

·      Ivermectin was not associated with a definite benefit of other clinically important outcomes such as clinical improvement at Day 6-10, clinical deterioration, and need for mechanical ventilation;

·      Ivermectin did not significantly reduce the duration of hospitalization and the time to resolution of symptoms;

·      The rate of hospitalization discharge did not differ significantly between the Ivermectin group and the placebo group.

“Based on the current evidence from randomized controlled trials, the DOH agrees with the COVID-19 Living CPG Reviewers and does not recommend the use of Ivermectin for the treatment of COVID-19,” it said.

Several lawmakers have been hounding the agencies to authorize the use of Ivermectin on COVID-19 cases, prompting a House health panel inquiry last week.

During the hearing, FDA Director Domingo said they would study how to fast track the registration of Ivermectin.

The DOH said it wanted to see more studies proving the positive effects of Ivermectin before it backed the use of the drug on COVID-19 patients.

Topics: Ivermectin , COVID-19 , Eric Domingo , Food and Drug Administration
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