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

ABS-CBN News – Posted and Updated as of Apr 16 2021 12:24 PM

MANILA – 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.

SOURCE: https://news.abs-cbn.com/news/04/16/21/fda-2nd-hospital-given-compassionate-special-permit-to-use-ivermectin