FDA chief: Caution on ivermectin based on dangerous side effects

MANILA, Philippines—Food and Drug Administration (FDA) Director General Eric Domingo admitted that the agency was exercising caution on clearing the use of ivermectin as treatment for COVID-19 because of what Domingo said were the drug’s possibly dangerous side effects on humans.

At a pre-recorded address by President Rodrigo Duterte on Thursday (April 15), Domingo explained to the President that there were documented side effects of ivermectin if used in increased doses, like pulmonary conditions which could worsen rather than help cure the disease.

COVID-19 is an infection caused by the coronavirus SARS Cov2. In severe cases, symptoms of COVID-19 could lead to pneumonia, or infection of the lungs. SARS stands for Severe Acute Respiratory Syndrome, a condition which leads to difficulty in breathing in extreme cases.

“Even if it is safe to use and even if it has been used largely for the past 40 years on animals and humans, there are side effects like in cases where you administer extremely high doses, the patient may get a fever and sustain damage to the liver,” Domingo told Duterte in Filipino.

“Some develop pulmonary problems while having neurologic and brain damage, that’s why we are exercising caution and prudence because there are side effects,” he said.

According to Domingo, the FDA was basing its cautious approach on studies done by scientists in Australia, where an extremely high dose of ivermectin was used to test its effectivity against COVID-19.

While scientists were able to kill the coronavirus in monkey cells, it required a dose higher than what is being normally administered to humans and animals and hence the need for further studies.

“Now what does it have to do with COVID-19? Where did this start?” Domingo said.

“Last April 2020, when the COVID-19 pandemic started and they were able to isolate the virus, one group of scientists in Australia used cells from a monkey and had it infected with the COVID-19 virus, and then placed an extremely high dose of ivermectin,” he said partly in Filipino.

“It’s higher than the usual dose used for deworming. Then they saw that within 24 to 48 hours, the COVID-19 virus died. Of course their conclusion back then was that we need to study use in humans and check for its possible effects,” Domingo said.

Domingo also noted that the drug has not been approved for use on COVID-19 patients in Australia, where the experiment was done.

People and groups lobbying for ivermectin use have used the Australian experiment to support their push for ivermectin, saying that the drug was able to eradicate the virus in 24 to 48 hours. They did not mention, though, that extremely high doses were used.

Among supporters of ivermectin use included several industry leaders and players and government officials who said they believed that the anti-parasitic drug can be an option for COVID-19 patients especially as existing medicines are more expensive.

They also advocated for ivermectin as the country grappled with a surge of COVID-19 cases in Metro Manila and nearby areas. As of Thursday, the country has 183,527 active COVID-19 cases, after 11,429 new infections were confirmed by the Department of Health. The death toll stood at 15,594.

READ: Businessmen ask gov’t to consider Ivermectin for COVID-19 treatment

READ: Total COVID-19 cases in PH top 900K with 11,429 new infections 

Currently, there is a growing debate within the medical community on whether COVID-19 patients would be given access to ivermectin. Those against ivermectin have stressed that the World Health Organization itself admitted that there is no strong evidence supporting claims about the drug’s efficacy against COVID-19.

READ: WHO: No ‘strong enough’ data to advocate Ivermectin use vs COVID-19 

READ: Ivermectin question sets off debate in PH medical community 

TSB