FDA warns online shops that put prescription drugs on sale

Maris Federez   •   December 12, 2019   •   368

MANILA, Philippines — The Food and Drugs Administration (FDA) has warned online shops that sell medicines and put prescription drugs on sale, especially this holiday season.

DOH spokesperson and FDA officer-in-charge Usec. Eric Domingo said that the agency has already penalized three online selling platforms for such infraction.

“It’s very rampant. At itong ibang na fine natin nakita na natin yan. Winarningan na natin. Tapos mawawala ng dalawa, tatlong araw iyong mga produkto tapos after a while babalik na naman. And then we have to remind them again na bawal. And we urge them na that they have to police their own ranks,” Domingo said.

The official also advised pharmacies to apply for separate license to operate and certificate of product registration from the FDA should they decide to also venture into online selling.

“Unang – una ang ating mga drug stores allowed lang kayo to sell the products within the premises of the store.  Kung gusto niyong tumanggap ng online orders you can apply for it as an extra activity with the FDA. But even then, may limitations iyon,” he added.

Domingo said the limitation is basically applicable to prescription medicines.

“Maaring mag- online, mag-order online ng isang kliyente nila pero kapag kukunin na iyong gamot kailangan pa rin niyang kunin sa pharmacy kung saan naka- store nang tama at ma- check ang reseta bago ibigay sa kaniya,” the official explained.

The FDA is still verifying several reports against online shops that openly sell medicines at a much cheaper price.

They shall be meted out with fines and corresponding charges. — (from the report of Aiko Miguel) /mbmf

FDA prepares for clinical trials on six COVID-19 vaccine candidates

Marje Pelayo   •   July 30, 2020

MANILA, Philippines – The Food and Drug Administration (FDA) is set to launch the clinical trials on six drugs that are candidates for the treatment of coronavirus disease (COVID-19).

According to FDA Director General Eric Domingo, the selected drugs are based on the updates from the Department of Science and Technology (DOST), the agency that has been helping the FDA in searching for a potential vaccine for COVID-19.

The FDA, however, has not disclosed the details on the six candidate vaccines.

In addition to these, Domingo said the Philippines is now preparing to join the Phase 3 Clinical Trials together with other participating countries.

“Posibleng mag-apply at magsasagawa ng Phase 3 Clinical Trials on candidate COVID-19 vaccines sa bansa [We may apply and conduct a Phase 3 Clinical trials on candidate COVID-19 vaccines here in the country],” Domingo said. 

“Pinag-uusapan na rin ang pakikilahok ng Pilipinas sa gagawing Solidarity Vaccine Trials ng World Health Organization [There are also discussions on the participation of the Philippines in the upcoming Solidarity Vaccine Trials by the World Health Organization],” he added. 

Five of the 166 COVID-19 candidate vaccines that are already in the Phase 3 Clinical Trials include:

  • Sinovac
  • Sinopharm- Wuhan Institute of Biological Products
  • Sinopharm- Beijing Institute of Biological Products 
  • Astrazeneca- University of Oxford 
  • Moderna/ NIAD

The FDA clarified that though the agency is not involved in the clinical trials, it is the one that regulates the clinical products such as vaccines for public use.

Kapag napatunayan na ligtas at epektibo ang mga produktong ito, puwede na silang mag-apply for registration sa FDA upang maging available ang mga ito sa merkado,” Domingo explained.

[Once a product is proven safe and effective, the owner may apply for registration to the FDA so it may be available to the market.]

In his state of the nation address, President Rodrigo Duterte mentioned that a vaccine for COVID-19 may soon be out specifically by September this year. 

The FDA clarified, however, that developing a vaccine may take months to years, not to mention the strong scientific evidence from clinical trials and the effectiveness and safety of the product for human consumption. 

Nonetheless, the FDA is prioritizing the review of a number of applicants for potential vaccine and treatment for COVID-19.

The agency stressed, however, that there is no vaccine or drugs that have been approved yet to be taken by COVID-19 patients.

All drugs that have been selected for trial are still on trial stage and undergoing experts’ evaluation.

“Wala pa pong bakuna kontra COVID-19, kahit saang bansa [There is no vaccine yet for COVID-19 anywhere in the world],” he added.

The official advised the public to report to the agency any anti-COVID product that is being sold online through its email covidresponse@fda.gov.ph or at ereport@fda.gov.ph.

“Ipakita ninyo po sa amin. Ipadala ninyo po sa amin ang mga detalye at bahala po ang mga ahente namin na manghuhuli dahil mga manloloko po iyan [Show us the product. Send the details to us and our agents will track them and process their arrest because those are fraudulent],” Domingo stressed. –MNP (with reports from Aiko Miguel)

FDA warns against use of masks with valves vs COVID-19

Maris Federez   •   July 18, 2020

MANILA, Philippines — The Food and Drug Administration (FDA) has urged the public not to use masks with valves as protection against the coronavirus disease (COVID-19).

In an interview, FDA Director-General Eric Domingo said masks with valves are not registered for medical purposes and they are manufactured only to provide protection against dust, such as those used in industrial firms.

Domingo pointed out that those who wear masks with valves are only provided one-way protection.

“Ang proteksyon niya one-way, eh ang gusto natin ang proteksyon ng mask ay two-way. Kung tayo ay walang sakit hindi tayo mahahawa, kung tayo ay may sakit hindi tayo manghahawa,” Domingo added.

Domingo advised that wearing medical and surgical masks is still best to be used in public, adding that even cloth masks will serve the purpose.

“Sa mga ospital o sa mga naga-alaga ng may sakit, gusto po talaga natin medical or surgical use na mga masks. Pero kung everyday use, kahit naman po mga cloth masks. Mas safe pa po ang mga regular masks na walang valve,” he said.

Domingo added that the FDA has also advised hospitals to prohibit the entry of persons wearing masks with valves.

On Friday (July 17), the Medical City Clinic, has released its advisory against wearing masks with valves, prohibiting those wearing such entry to its premises.

While masks with valves are designed to ease exhalation and decrease humidity for the wearer, they do not block…

Posted by The Medical City Clinic on Wednesday, 15 July 2020

Meanwhile, data from the Department of Health (DOH) shows that, as of 4PM of July 17, the total number of COVID-19 cases is now at 63,001.

The data also shows a total of 1,841 confirmed cases based on the total tests done by 76 out of 84 current operational labs.

The DOH likewise announced 311 recoveries that brings the total number of recoveries to 21,748. — /mbmf

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FDA warns vs unsupervised use of Dexamethasone drug linked to COVID-19 treatment

Robie de Guzman   •   June 19, 2020

MANILA, Philippines – The Food and Drug Administration (FDA) on Friday warned the public against the use of steroid drug Dexamethasone without a prescription, following reports on its potential to treat novel coronavirus disease (COVID-19).

In an advisory, the FDA reminded the public that misuse or unsupervised chronic use of dexamethasone may lead to serious adverse reactions such as:

  • Immunosuppression or impairment of the body’s ability to fight infection
  • Gastrointestinal bleeding and ulcers
  • Electrolyte imbalance
  • Osteoporosis
  • Muscle weakness
  • Poor wound healing
  • Prolonged use of the drug may cause suppression of growth among infants and children
  • Obesity

If stopped abruptly, it may cause withdrawal symptoms such as hypotension, shock and coma.

“Dexamethasone is a steroid drug and is prescribed by a licensed physician based on the patient’s medical condition,” the FDA said.

“All are enjoined to report the dispense and/or use of the drug without a valid prescription to FDA Center for Drug Regulation and Research e-mail at cdrr.od@fda.gov.ph,” it added.

The agency also urged those using the drug to report any adverse reactions through this link.

The FDA warned that violators will be dealt with legal actions.

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