FDA recalls locally-made COVID-19 test kits for ‘minor defects’

Marje Pelayo   •   May 21, 2020   •   818

MANILA, Philippines — Some ‘minor defects’ have been seen in the test kits made by the University of the Philippines – National Institute of Health (UP-NIH), according to the Food and Drug Administration (FDA). 

This prompted the agency to order the recall of all locally-made coronavirus disease (COVID-19) test kits and stop its use in medical facilities until the problem is resolved.

Specifically, FDA Director Eric Domingo said evidence of contamination had been traced in the reagents that were used in the test kits of UP-NIH; hence, they should not be sold or used for now. 

The said locally-made test kits were approved for use by the FDA in April.

Nonetheless, Health Spokesperson Undersecretary Maria Rosario Vergeire ascertained that the UP-NIH is soon to complete correcting the deficiencies in their test kits. 

“They are in the final stages of correcting the identified deficiencies of the kits by RITM and hopefully by next week they can be re-validated by RITM and we can already use the UP testing kits,” Vergeire said. 

As regards the rapid antibody test kits, Malacañang maintained that local government units (LGU) may still use the said kits despite claims by medical societies that the use of such would be a waste of resources when they only give false results. 

According to Presidential Spokesperson Secretary Harry to  Roque, the LGUs just need to confirm the results of the rapid antibody test kits through real-time reverse transcription polymerase chain reaction (rRT-PCR) test within the succeeding 14 days. 

Sa ngayon po, dahil po wala pa tayong sapat na kakayahan at dahil tayo po ay nagbi-build up pa lang ng capacity ng PCR testing, siguro naman walang mawawala kung ira-rapid testing natin ang gusting magpa-rapid testing at yung mga positive, ipa-verify natin sa PCR [For now, since we do not have enough capacity yet and we are still building up our PCR testing capacity, there’s no harm if we still proceed with rapid testing to those who request it, and if it yields a positive result, then have it confirmed through PCR],” Roque explained.

 FDA-approved rapid test kits costs around P3,500 and up depending on the source company and the country of origin. MNP (with reports Aiko Miguel)

Philippines approves emergency use of J&J, Bharat Biotech COVID-19 vaccines

Marje Pelayo   •   April 20, 2021

MANILA, Philippines – The Food and Drug Administration (FDA) granted emergency use authorization (EUA) to the COVID-19 vaccines of Bharat Biotech International and Janssen Pharmaceuticals, FDA Director General Eric Domingo confirmed Monday (April 19).

The agency, however, has not released details on the indication and contraindication of the vaccines as well as the procedure of administration and to whom it should be prescribed.

India’s Bharat Biotech is known for its Indirab rabies vaccine while Janssen Pharmaceuticals is the medical research and pharmaceutical product development arm of the New Jersey-based American corporation Johnson & Johnson.

To date, six pharmaceutical companies have applied and have been granted EUA for their vaccines in the Philippines.

These are Pfizer Biontech, Gamaleya, Astrazeneca ,Sinovac , Bharat Biotech and Janssen.

PH Defense receives 50K COVID-19 swab test kits from Singapore

Robie de Guzman   •   April 16, 2021

MANILA, Philippines – The Department of National Defense (DND) and the Armed Forces of the Philippines (AFP) have received 50,000 units of COVID-19 swab test kits from the Singapore Ministry of Defense.

The donated test kits were turned over to the DND and the AFP on Thursday, April 15.

The DND said the test kits will be issued to the Veterans Memorial Medical Center (VMMC) and the AFP Medical Center (AFPMC).

The VMMC, which is mandated to provide quality medical care and treatment to veterans and their dependents, is under the purview of the Philippine Veterans Affairs Office (PVAO).

The AFPMC, meanwhile, provides medical care to the military and civilian personnel of the AFP.

“Both PVAO and AFP are government bureaus under the DND,” the department said.

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

Marje Pelayo   •   March 18, 2021

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.

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