Irresponsible’ to distribute Ivermectin pending data vs. COVID-19; testimonials on use insufficient evidence — FDA

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(FILE PHOTO)

Metro Manila (CNN Philippines, April 7)— The Food and Drug Administration on Wednesday said it would be “irresponsible” to allow the distribution of Ivermectin to the public, reiterating there is insufficient scientific evidence for the anti-parasitic drug’s use as a possible COVID-19 treatment.

Speaking to CNN Philippines, FDA Director General Eric Domingo said that testimonials and anecdotes from those who have taken the drug are not counted as strong basis for the recommendation of its use.

“Testimonials or anecdotal findings are not considered very strong scientific evidence,” Domingo said in an interview with The Source. “You only prove the use of a drug when you have a well-designed clinical trial.”

“It would be irresponsible to give it to people right now without knowing exactly how to use it and what the effect will be,” added Domingo, who also appealed to concerned parties to wait for the results of clinical trials in other countries.

Anakalusugan party-list Rep. Mike Defensor earlier said he would distribute Ivermectin for free to some sick and elderly residents in Quezon City— despite the drug not being registered for human use in the Philippines.

Only veterinary products of Ivermectin have been approved by the FDA to date.

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

Domingo stressed that like other medicines, using Ivermectin may result in possible side effects including neurological or gastrointestinal problems.

He reiterated that marketing the product for commercial use is illegal.

Baka ‘yan ay veterinary product na pinalitan ‘yung packaging, or smuggled," Domingo warned. "Kasi wala naman sa ating commercially available. 'Yung distribution, halimbawa gagawa ka ng marami, bawal ‘yun kasi unregistered drug ‘yun.”

[Translation: They could be veterinary product whose packaging was changed, or smuggled. Because we don’t have commercially available products. The distribution, for example, if you will produce in large quantity, that’s illegal because it is an unregistered drug.]

Ivermectin use should be limited to clinical trials

Aside from the FDA, the World Health Organization has also advised against the use of Ivermectin for COVID-19 prevention and treatment due to insufficient studies.

In an online briefing, Dr. Socorro Escalante said the use of the drug should be limited to clinical trial settings.

“The effects of Ivermectin on end points such as mortality, prevention of mechanical ventilation, hospital admission, duration of hospital admission, and viral clearance are all uncertain,” Escalante said.

The Department of Health, meanwhile, warned that the “dispensing” of Ivermectin will violate the Republic Act No. 9711 or the FDA Act of 2009.

“Specific to that law, sinabi mismo na ‘yung mga hindi rehistradong gamot hindi natin pwedeng ipagamit sa ating kababayan,” DOH Undersecretary Maria Rosario Vergeire said in a separate forum.

[Translation: Specific to that law, it says that unregistered medicine cannot be used by our countrymen.]

Merck, the company behind the drug, said over the weekend that pre-clinical trials indicate "no scientific basis” for its potential therapeutic effect against COVID-19, adding there is a “concerning lack of safety data in the majority of studies.”