FDA: 2nd hospital given compassionate special permit to use ivermectin


Posted at Apr 16 2021 11:16 AM | Updated as of Apr 16 2021 12:24 PM

FDA: 2nd hospital given compassionate special permit to use ivermectin 1
The anti-parasitic drug ivermectin is widely circulating on the internet as an alternative drug against COVID-19. ABS-CBN News/File

MANILA (UPDATE) - A second hospital has been granted compassionate special permit to use the anti-parasitic drug ivermectin as potential treatment for COVID-19, the Food and Drug Administration said Friday.

Dr. Eric Domingo, head of the country's drug regulatory body, said his office has now allowed 2 hospitals access to ivermectin as investigational drug to counter the respiratory disease.

"Two hospitals actually applied to us and have been given CSP," Domingo told "Headstart," without mentioning names.

Earlier this month, the FDA said it gave a similar permit to a hospital as part of COVID-19 treatment.

"If a hospital requests for compassionate special permit for patients, they can do that as long as the hospital takes responsibility, and of course, the patients should be fully informed," Domingo said.

The protocol hospitals are abiding by is based on the United States, where ivermectin is given to patients with mild to moderate COVID-19 infections, he added. Hospitals are required to report to the FDA monthly.

In an advisory it issued last month, the agency said the registered ivermectin products in the country for human use were in topical formulations under prescription use only. This is used for the treatment of external parasites, such as head lice, and skin conditions, such as rosacea.

The registered oral and intravenous preparations of ivermectin are veterinary products, which are approved for use in animals for the prevention of heartworm disease and treatment of internal and external parasites in certain animal species, the FDA had said.

In the interview, Domingo clarified they were either for or against ivermectin.

"That's a common misunderstanding. They're thinking that the FDA is anti-ivermectin. We are not. We recognize that it is a drug under investigation, that there might be a possibility it will be proven to be good. There's [also] a possibility it will be proven to be useless against COVID-19 . . . What the FDA is against is unregulated drugs," he said.

The debate on ivermectin has heightened, as government has been criticized for the slow rollout of vaccines and COVID cases and deaths have reached record-high numbers in the past weeks.

The World Health Organization has warned against the use of ivermectin in patients with COVID-19, except for clinical trials because of a lack of data demonstrating its benefits.

The UN health agency's recommendation followed the European Medicines Agency's warning against the drug. The US Food and Drug Administration has also recommended it not be used for COVID-19.

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Two House leaders have filed a resolution calling for an investigation into the policies set by the FDA in approving COVID-19 products for emergency use, which they said "appear to be detrimental to public interest."

House Speaker Lord Allan Velasco and Deputy Speaker Bernadette Herrera-Dy have questioned FDA Circular No. 2020-12 and other related guidelines for "being arbitrary, bureaucratic and inhumane for causing unnecessary delays."

"While there is no actual cure for COVID-19, health, drug, and medical experts have come up with a treatment protocol including the administration of certain drugs and therapeutics currently allowed for use and treatment of COVID-19," the resolution read.

Dy, in an interview on "Matters of Fact", said the inquiry was scheduled next week and not meant to pressure the FDA.

"There are a lot of drugs that has to come in to the country so the doctors have better choices as to what COVID-19 treatment will they apply to the patients. What's important is its available to the market," she said.

Dy, who is not a medical doctor, said she was calling for the use of ivermectin after conducting her own research of the drug. She also denied there was a major lobby from lawmakers on the use of ivermectin in the country.

"On the contrary, that's why I'm supporting this because there's no big pharma behind it. If you take a look at it, the one's espousing this are compounding laboratories and actually can’t compete with big laboratories," she said.

"On the contrary, mas nararamdaman ko 'yong (I can feel the) pressure that there's lobby for those trying this cheap drug from coming in the Philippines. That's an honest assessment from my part."

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Despite caution from health experts, this didn't deter some US-based Filipinos from using ivermectin as a COVID-19 drug -- in a practice called off-labeling.

Ivermectin, which is approved in the US FDA to treat parasitic infections such as worms and head lice, is a prescription only drug.

"I take ivermectin because I do not like vaccines... and I feel I’m already protected," Dulce Cepeda said at a forum.

For Dr. Marivic Villa, "There is really a need to push for this. You have to push for the ivermectin as if your life depends on it and it does."

In an email to ABS-CBN News, R.J. Mills of the American Medical Association pointed out that the COVID-19 treatment guidelines from the National Institute of Health recommended neither for nor against the use of ivermectin for COVID-19 treatment.

Dr. Joseph Varon, popularly known as a COVID hunter, who has been using and prescribing ivermectin as prevention for COVID-19 believed that it was not a silver bullet to stop the deadly disease. 

"Ivermectin is not the answer but it buys us time. It buys us time to get all these people vaccinated and to have less casualties," he said.

Merck, the biopharmaceutical company that makes ivermectin for humans under the brand name Stromectol, said in a statement that there was no scientific basis and no meaningful evidence of the efficacy of ivermectin for the treatment of COVID-19.

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-- With a report from Don Tagala, ABS-CBN News