FDA warns public vs use of silver jewelry cleaners containing cyanide

Robie de Guzman   •   May 3, 2021   •   116

 

MANILA, Philippines — The Food and Drug Administration (FDA) on Monday reminded the public that the sale and promotion of silver jewelry cleaners containing cyanide remain prohibited in the country.

The FDA issued the reminder following post-marketing surveillance activities and laboratory testing by its Common Services Laboratory, which showed that these cleaning solutions are still being sold in the market.

The agency further noted that cases of poisoning from silver jewelry cleaners with clinical features of changes of the sensorium, loss of consciousness, and hemodynamic instability as possible signs and symptoms of cyanide poisoning. These were documented by the National Poison and Management Control of the University of the Philippines – Philippine General Hospital (NPMCC, UP-PGH) up to the year  2020.

“In order to eliminate potential risks to human health brought about by cyanide exposure, the FDA hereby reiterates the ban of all silver jewelry cleaners containing cyanide that is manufactured, distributed, imported, sold, and offered for sale or promoted in the market/e-commerce marketplaces,” the FDA said in its advisory.

“Cyanide is a highly toxic chemical, which may be inhaled, absorbed through the skin, or ingested (accidental or deliberate) even at small doses/concentration,” the agency said.

“Exposure to cyanide may bring about any of the following signs and symptoms within minutes –dizziness, headache, nausea, and vomiting, rapid breathing, rapid heart rate, restlessness, and weakness or may lead to respiratory failure, loss of consciousness, and possibly death, among others,” it added.

It also advised the public to always check if a product is registered with the FDA by using its Verification Portal.

“All concerned establishments are warned not to distribute any banned household/urban hazardous substances,” it said.

“All FDA regional field offices and regulatory enforcement units, in coordination with law enforcement agencies and local government units, are requested to ensure that banned products are not sold or made available in the market or areas of their jurisdiction,” it added.

DOH studying possibility of mixing vaccine brands – FDA

Robie de Guzman   •   May 6, 2021

MANILA, Philippines – The Department of Health (DOH) is currently looking into the possibility of mixing different brands of vaccines against novel coronavirus disease (COVID-19), the Food and Drug Administration (FDA) said Thursday.

FDA director general Eric Domingo said the DOH is already drafting a set of guidelines that will allow a person to receive different brands of COVID-19 vaccines for first and second dose in case of severe allergic reaction and other adverse effects.

Aaralin po ngayon yan ng Department of Health, in fact, meron naman po talagang ongoing meetings ang Department of Health on that dahil meron po talagang instances na for example naturukan ka ng bakuna ng first dose tapos nagka-severe allergy ka so hindi ka na puwede sa second dose nun at kailangang isipin ngayon yung magiging alternative,” Domingo said during the Laging Handa briefing.

“Gumagawa na ng guidelines ngayon ang DOH kung paano ‘yung interchangeability or mixing ng vaccines in case the second dose cannot be given na identical doon sa first dose,” he added.

Domingo said this after President Rodrigo Duterte said he has requested China to recall the 1,000 doses of Sinopharm vaccines it donated following criticisms over his decision to receive a jab that has yet to secure an emergency use authorization from the FDA.

Duterte received his first dose of Sinopharm vaccine on Monday night.

Malacañang earlier said that the vaccine dose used on the president was covered by the compassionate special permit issued by the FDA for the Presidential Security Group.

FDA: 6 hospitals have secured special permit for ivermectin use vs COVID-19

Robie de Guzman   •   May 5, 2021

MANILA, Philippines — Another hospital has secured a compassionate special permit (CSP) for the use of ivermectin to treat patients with coronavirus disease (COVID-19), the Food and Drug Administration (FDA) said Wednesday.

FDA director-general Eric Domingo said there are now six hospitals within and outside Metro Manila that have been allowed limited use of the anti-parasitic drug on COVID-19 patients.

“That means the doctors in the hospitals can prescribe it [ivermectin],” he said in an online forum.

Domingo declined to identify these hospitals with CSP since the FDA doesn’t want to “violate the privacy of the patients.”

“Of course, the hospitals can freely identify themselves. We’re not stopping them,” he added.

The FDA earlier said that a compassionate special permit only allows experimental or unregistered drugs for limited off-label use but this is not an agency’s endorsement of its safety and efficacy.

Only the hospital that has secured a permit for ivermectin’s compassionate use for humans will be allowed to import the drug through a licensed importer.

Doctors who will prescribe the drug to treat COVID-19 patients are required to report to the FDA on a monthly basis. They will also be held liable for possible side effects.

The FDA also reiterated that a compassionate use permit is different from a certificate of product registration for the drug, which allows manufacturers to commercially sell the anti-parasitic drug for human use.

Domingo likewise stressed that the drug is still an investigational product and is not yet approved as COVID-19 treatment in the country.

The clinical trial for ivermectin as possible COVID-19 treatment is expected to start in May or June.

Philippines OKs emergency use of Moderna’s COVID-19 vaccine

Robie de Guzman   •   May 5, 2021

MANILA, Philippines – The Philippines has granted an emergency use authorization (EUA) for Moderna’s COVID-19 vaccine, the Food and Drug Administration (FDA) said Wednesday.

FDA director general Eric Domingo said the regulatory agency approved Moderna’s application for EUA after conducting thorough review on data currently available, including those from adequate and well-known controlled trials.

Domingo said the vaccine will be administered to individuals aged 18 and above.

The Philippine government earlier said it has placed around 20 million COVID-19 vaccines from the US drug maker Moderna that will be split between public and private sectors. The initial batch of the shipment is expected to arrive by June.

The government targets to vaccinate up to 70 million people by the end of the year but due to the limited supply of vaccine doses, vaccine czar Carlito Galvez Jr. earlier proposed to prioritize the inoculation of areas with high cases to fend off further COVID-19 surges and enable the economy to recover.

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