The Volunteers Against Crime and Corruption (VACC) has called on the Food and Drug Administration (FDA) to approve the anti-parasitic drug Ivermectin for emergency use.
The group has defined the drug as a “safe, effective and affordable medicine in the fight against” coronavirus disease (COVID-19).
But health authorities have been warning the public against the use of the drug in the COVID-19 treatment, saying that there is not enough evidence to support claims that the drug is effective against the disease.
“We are at war. And our people are at risk of infection and death. With Ivermectin, we have a good fighting chance to win it,” Cory Quirino, chairman of VACC, said in a statement sent to reporters.
“Institutions should not delay nor deny the individual his ultimate and inviolable right to life and to self-preservation,” she added.
In their statement, VACC called on the FDA to act on the following measures:
1. The approval of emergency use authorization for Ivermectin along with its recognition as an over-the-counter medication;
2. Speed up the approval for License to Operate and Certificate of Product Registration application of a certain physician, as well as the applications of other pharmacies; and
3. Review the relevance and the ethical presence of the Philippine Society of Microbiologists and Infectious Diseases which was tasked by the FDA and the Department of Health (DOH) as a certifying body.
According to VACC, Dr. Benigno Agbayani Jr., president of Concerned Doctors and Citizens of the Philippines, said that studies conducted abroad on Ivermectin “should be sufficient enough to validate the claims on the very high safety and efficacy of the drug against COVID-19 both as prophylaxis and early treatment.”
The group said Ivermectin is now being used against COVID-19 in South Africa, Slovakia, Panama, Peru, (Uttar Pradesh) India, (Chiaca) Mexico, Czech Republic and many other countries.
It added that the drug is currently prescribed by doctors in the United States, Australia, Canada as off-label use on their patients for COVID-19.
In an advisory, the FDA stressed that the only registered Ivermectin products in the country for human use are in topical formulations under prescription use only used for the treatment of external parasites.
It added that the registered oral and intravenous preparations of Ivermectin are veterinary products, which are approved for use in animals for the prevention of heartworm disease and treatment of internal and external parasites in certain animal species.
“Any use of Ivermectin veterinary products for the prevention or treatment of COVID-19 should be avoided as the benefits and safety for this purpose has not been established,” the FDA said.
“Ivermectin is not approved by the FDA for treatment of any viral infection,” the agency added.
Dr. Rabindra Abeyasinghe, country representative of the World Health Organization (WHO), had said that there is no evidence that supports the use of ivermectin to treat COVID-19, even as a preventive measure.
The DOH and the FDA said they do not recommended the use of Ivermectin for the treatment of COVID-19, as the evidence from randomized controlled trials showed that the drug “did not significantly reduce the risk of mortality among patients with mild to severe COVID-19 cases.”
Dr. Edsel Salvaña, a member of the DOH Technical Advisory group, has also warned against taking Ivermectin in high doses as it could lead to people suffering from brain damage and even death.