FDA warns against use of veterinary drug Ivermectin to treat COVID-19

Marje Pelayo   •   March 18, 2021   •   593

MANILA, Philippines – The Food and Drug Administration (FDA) has issued a warning against the use of veterinary medicine  Ivermectin as treatment for COVID-19.

In an advisory, the FDA said that Ivermectin is approved only for use in animals through “oral and intravenous preparations.”

The agency explained that the drug is being used for the prevention of heartworm disease and treatment of internal and external parasites “such as head lice and skin conditions such as rosacea” in certain animal species.

“The drug is an important part of a parasite control program for some animal species and should only be administered according to its approved indication, or as prescribed by a duly licensed veterinarian,” the agency noted.

“The public is warned against taking animal drugs, as the FDA has only evaluated their safety and efficacy in the particular species for which they are labeled. Using these products in humans can cause serious harm. Animal drugs are often highly concentrated and can be highly toxic to humans,” the agency added.

The FDA said that “registered Ivermectin products in the country for human use are in topical formulations under prescription use only” which means it cannot be taken orally but can only be applied on the human skin.

The agency stressed that Ivermectin has not been approved by the FDA “for treatment of any viral infection.”

“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 agency said.

Gordon open to idea of conducting ivermectin clinical trials in PRC facilities

Marje Pelayo   •   May 7, 2021

MANILA, Philippines – Philippine Red Cross (PRC) chairman Senator Richard Gordon said the organization welcomes the conduct of clinical trials in its isolation facilities.

“Basta papayag ang mga pasyente. Wala pa naman akong nalalaman na namatay sa ivermectin. Basta papayag sila at ang gobyerno natin ang mangangasiwa,” Gordon said during the Laging Handa briefing on Friday (May 7).

During President Rodrigo Duterte’s public briefing on Thursday (May 6), Department of Science and Technology (DOST) Secretary Fortunato dela Pena reported to the President that the government is eyeing the use of PRC facilities as venues for clinical trials particularly on the use of ivermectin.

Reacting to issues concerning the popular drug, the senator said he is not against the trial of ivermectin as it will help settle the controversies.

“Pagbigyan para matapos, para malaman natin once and for all,” he said. “I will say ‘no’ kung walang proper supervision, walang approval ng gobyerno.”

The DOST said the clinical trials on ivermectin will start in June.

Clinical trials on ivermectin to start in June – DOST

Marje Pelayo   •   May 6, 2021

MANILA, Philippines – Department of Science and Technology (DOST) Secretary Fortunato dela Peña said that preparations are underway for the anticipated clinical trials on the use of ivermectin as a treatment for COVID-19.

In his report to President Rodrigo Duterte on Wednesday (May 5), the official said the trials will be spearheaded by pulmonary doctor Dr. Aileen Wang of the University of the Philippines – Philippine General Hospital (UP-PGH) and will be implemented for eight months from June 2021 to January 2022.

He said the Department of Health (DOH) has allotted a total of P22 million for the trial of ivermectin.

It will be conducted on 1,200 volunteer adults, 18 years old and above, who are asymptomatic or non-severe COVID patients.

The team is awaiting ethics approval this month before proceeding with the trial.

“Ang ginagawa ay ethics approval para sa kanilang gagawin at recruitment ng staff na mag-a-administer ng clinical trials,” Dela Peña said.

They are currently coordinating with the Philippine Red Cross for the utilization of its facilities.

Other agents also under clinical trial are as follows:

* Randomized control clinical trial on the efficacy and safety of Tawa Tawa for adjunctive treatment of mild to moderate COVID-19 patients (11 months);

* Randomized, placebo-controlled trial on the safety and efficacy of Lagundi in patients with mild COVID and without comorbidities (10 months);

* Clinical trial on the safety and efficacy of virgin coconut oil (VCO) as adjunctive therapy for hospitalized COVID patients (12 months);

* Beneficial effects of VCO among suspect and probable cases of COVID-19 (14 months, extension included);

* Melatonin as adjuvant treatment for COVID-19 in patients requiring hospitalization (9 months) ;

* Convalescent Plasma as adjunctive therapy for hospitalized COVID-19 patients. (12 months).

Dela Peña noted that the duration of clinical trials for ivermectin is almost similar in period as other agents. The progress of each study still depends on the number of patients who want to volunteer for the trial.

“Kapag dumadami ang pasyenteng magbo-volunteer, mas mapapabilis ang pagtatapos ng mga trials,” the official assured.

BOC-NAIA intercepts 20,000 tablets of ivermectin, other regulated drugs

Maris Federez   •   May 6, 2021

MANILA, Philippines — The Bureau of Customs Port of NAIA (BOC-NAIA) has intercepted undeclared ivermectin and other regulated drugs declared as food supplements and multi-vitamins and multi-mineral capsules.

In a press release dated May 6, the BOC said the shipment was imported by Finstad Inc. from New Delhi, India.

The said drugs including the undeclared 20,000 capsules of ivermectin were reportedly concealed in the inner portion of the subject shipment along with other declared regulated items, it added.

The BOC said that it coordinated with the Food and Drug Administration (FDA) regarding the shipment.

In her reply to a BOC query, FDA Director Jesusa Joyce N. Cirunay of the Center for Drug Regulation and Research said, “At present, the drug is under compassionate use in Specialized Institutions authorized by FDA through the issuance of Compassionate Special permit (CSP).”

Furthermore, Director Cirunay added, “In case ivermectin has been granted authorization, a valid License to Operate (LTO) as Drug Importer and Emergency Use Authorization (EUA) or Certificate of Product Registration (CPR) shall be presented.”

The BOC-NAIA team said that in conformance with the directive of Customs Commissioner Rey Leonardo B. Guerrero, it remains committed to expediting the processing and release of Covid-19 vaccines, drugs, and other medical supplies.

Moreover, it assured that it will also be vigilant and will further strengthen border security and protection efforts to curb all smuggling attempts to import unregistered, undeclared goods and/or misdeclared goods without the necessary clearance and permits from FDA.

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