FDA: Use of ivermectin still not recommended, but hospitals may apply for special permit

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Metro Manila (CNN Philippines, April 14) — The Food and Drug Administration said it does not recommend the use of ivermectin for COVID-19 patients due to lack of evidence on its efficacy against the virus.

However, FDA Director General Eric Domingo said hospitals may still apply for a compassionate special permit of the anti-parasitic drug if they think it could help their patients.

Hindi pa natin ito mare-rekomenda sa ngayon pero open naman po iyong option sa mga hospitals na kung sakaling palagay nila ay wala silang ibang gamot na maibibigay na at naniniwala silang makakatulong ito sa pasyente nila, then they can get a compassionate special permit for this drug,” he explained during the Laging Handa briefing Wednesday.

[Translation: We currently do not recommend its use but the option is open for hospitals in case they cannot prescribe any other medication and they believe that this can help their patients, then they can get a compassionate special permit for this drug.]

He also reiterated that the hospital or doctor that requested for the permit may use the drug and the outcome of its use shall be reported to health authorities.

Last week, the regulator said it granted a hospital’s request for a CSP to use ivermectin against COVID-19, but it did not specify other details. It also dismissed claims that it was pressured to grant the permit, saying all rules and regulations were followed in its issuance.

RELATED: 'Pressured’ FDA can be liable for granting compassionate permit to use ivermectin vs. COVID-19 — ex-DOH chief

The FDA earlier said oral ivermectin products are only approved for use on animals to prevent heartworm disease and treat infections due to parasites. Doctors can prescribe topical ivermectin to treat parasitic infestations such as head lice and other skin conditions for humans.

Health experts already raised their concerns on the lack of evidence on the efficacy of the drug against the coronavirus. Some have pointed out that existing studies do not have solid proof due to factors like using ivermectin with other interventions, thus it is difficult to conclude that the outcome was solely due to it.

Despite this, several lawmakers are also pushing for the use of ivermectin against the coronavirus.

The government said it has no plans to conduct clinical trials for the drug to assess its efficacy since similar studies are ongoing in other countries.