FDA gives hospital compassionate use permit for Ivermectin vs COVID-19

Jamaine Punzalan and Kristine Sabillo, ABS-CBN News

Posted at Apr 08 2021 12:12 PM | Updated as of Apr 08 2021 12:46 PM

A man holds the anti-parasite drug ivermectin after buying it with a medical prescription at a local pharmacy in Santa Cruz, Bolivia, May 19, 2020. Rodrigo Urzagasti, Reuters/File

MANILA — The Food and Drug Administration said on Thursday it granted a "compassionate use permit" to a hospital for the use of anti-parasite drug ivermectin to counter COVID-19, despite previous warning by international health organizations.

Ivermectin is usually used to treat parasites in animals, according to an earlier FDA advisory.

"Ang pagkakaalam ko may isang ospital sa amin na nag-apply ng compassionate special permit for the use of ivermectin at ito po ay na-grant ngayong araw na ito," FDA Director General Eric Domingo said in a public briefing.

(From what I know, a hospital applied for compassionate special permit for the use of ivermectin, and it was granted today.)

Domingo declined to name the hospital "out of patient privacy." 

Other hospitals that want to use ivermectin should secure separate compassionate use permit from the drug regulator, Domingo told ABS-CBN News in a text message. 

Groups that want to distribute a large number of the drug can apply under one permit, he added. 

A compassionate special permit allows experimental or unregistered drugs for limited off-label use. Acquiring such a permit does not mean, however, that the drug is proven to be effective since that requires clinical trial. 

Clinical trials for the use of ivermectin against COVID-19 are ongoing, said Domingo. 
 
The FDA has received 2 applications for certificate of product registration for the drug. The applicants were given a list of requirements, he said. 

"Ito lang naman po ang laging sinasabi ng FDA, hindi po kami kontra sa ivermectin, kailangan lang po na irehistro ang produkto at dumaan lamang po sa tamang proseso ng pagsiguro po ng quality ng gamot na makakarating sa tao," Domingo said.

(The FDA is only saying that we are not against ivermectin, but the product needs to be registered and go through the right process to ensure the safety of the drug that will reach the people.)

Ivermectin recently made headlines after Anakalusugan Party-list Rep. Mike Defensor said he would distribute Ivermectin to the sick and elderly in Quezon City, despite FDA warnings. 

Unauthorized use of veterinary drugs could lead to brain damage and death, infectious disease expert Dr. Edsel Maurice Salvana earlier said. 

The World Health Organization (WHO) last week recommended against using ivermectin in patients with COVID-19 except for clinical trials, because of a lack of data demonstrating its benefits.

The recommendation follows 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.

Merck, an ivermectin manufacturer, has also said its analysis did not support the drug's safety and efficacy for COVID-19.

— With a report from Reuters 

Video courtesy of PTV