Advocates asked to wait for FDA nod before promoting Ivermectin vs COVID-19

CNN – Published and Updated Apr 6, 2021 3:13:00 PM

Metro Manila — Government officials advised advocates of antiparasitic drug Ivermectin to wait for the Food and Drug Administration’s approval for its compassionate use before urging the public to use it as an alternative treatment to COVID-19.

In his briefing on Tuesday, Presidential Spokesperson Harry Roque said the initiative of Anakalusugan Party-list Rep. Mike Defensor to distribute Ivermectin supply to the sick and elderly residents of Quezon City might raise concerns from regulatory bodies.

“Ang aking pakiusap, hintayin na lang natin dahil mabilisan naman ang desisyon ng FDA diyan. Hindi naman magtatagal iyan, at para rin po ito sa ating kapakanan at interes din dahil kailangang mapatunayang mabisa, epektibo at ligtas ang gamot na ito para sa COVID-19,” Roque said.

[Translation: My plea is to wait for the FDA’s decision because it will be out soon. It will not likely be delayed and this would serve the interest of the public by ensuring that the drug is effective and safe to use against COVID-19.]

When asked whether Defensor and other lawmakers promoting Ivermectin will be held liable, Roque noted that he cannot offer any legal advice on the issue since it is not part of his expertise.

However, Department of Health-Technical Advisory Group member Edsel Salvaña stressed that Ivermectin, when taken in high doses could even lead to brain damage.

“Pwedeng magkaroon ng brain damage ang isang tao at pwedeng mamatay kung ma-overdose nang todo-todo (A person may have brain damage and die when they get overdosed),” he said in the same briefing.

Defensor earlier said he got Ivermectin treatment while recovering from COVID-19. He urged authorities to instead consider monitoring Ivermectin’s local manufacturers and regulating the product instead of “killing” an initiative that could help people.

“Ivermectin is safe. It has been there for so many years. Wala po itong recorded na adverse effects sa mga pasyente maging sa ginagawang clinical trials sa ngayon,” Defensor said in an interview with CNN Philippines.

[Translation: Ivermectin has not recorded any adverse affectes on patients, as shown by clinical trials today.]

So far, the Food and Drug Administration has only approved Ivermectin for animal use, to prevent heartworm disease and treat parasite infestation such as head lice and scabies. No feedback has been given on its compassionate use for humans.

Defensor announced on Facebook on Monday that he will distribute the drug for free, but a prescription for it is required before receiving a supply.

Other congressmen have also been openly promoting the use of Ivermectin. Among them were Bagong Henerasyon Party-list Rep. Bernadette Herrera and COVID-19 survivor 1-PACMAN Partylist Rep. Eric Pineda.

No proof of efficacy vs COVID-19

Citing a study of six trials conducted by the Philippine COVID-19 Clinical Practice Guidelines, the FDA and the Health Department reiterated that Ivermectin did not significantly reduce the risk of death among patients with mild to severe cases. It also did not substantially reduce the hospitalization period or time resolution of symptoms.

The FDA and Health Department noted that pharmacies are allowed to compound Ivermectin, but they intend to “put the safety of Filipinos first before allowing unproven and uncertified medicines in the country.”

FDA Director General Eric Domingo stressed that the level of evidence from testimonials or anecdotal report are not sufficient basis for Ivermectin approval.

World Health Organization Country Representative Rabindra Abeyasinghe has earlier warned against the use of Ivermectin for COVID-19 prevention or treatment. He pointed out during Monday’s Palace briefing that 95% of COVID-19 patients recover without specific treatments, so it is not science or evidence if a coronavirus patient recovers after being given the antiparasitic drug.

Even Merk, the pharmaceutical company behind Ivermectin, said there is no scientific basis in using it as treatment for COVID-19.

SOURCE: https://cnnphilippines.com/news/2021/4/6/Mike-Defensor-Ivermecting-COVID-19-warning-DOH-FDA.html???????