FDA warns public against purchase, use of Ever Bilena’s lip & cheek stain night berry

Robie de Guzman   •   March 17, 2021   •   1240

MANILA, Philippines – The Food and Drug Administration (FDA) has warned the public not to purchase and use cosmetic product, Ever Bilena Lip and Cheek Stain Night Berry, which it said contains microbial contaminants.

In an advisory, the FDA said the product, based on its test, was found to contain microbial contaminants beyond the 1000 cfu/g set by the agency, and as published in the ASEAN Cosmetic Directive (ACD).

***FDA Advisory No.2021-***

The Food and Drug Administration (FDA) warns the public from purchasing and using the…

Posted by Food and Drug Administration Philippines on Monday, March 15, 2021

“The aforementioned adulterated product is found to be non-compliant with the existing standards, and, thus, pose potential hazards to the consuming public,” the FDA said.

The use of adulterated cosmetic products may result in adverse reactions, including but not limited to, skin irritation, itchiness, anaphylactic shock, and organ failure, it added.

In a statement posted on social media, Ever Bilena said its currently conducting testing of the said product to validate the FDA’s findings.

“We are doing our own internal testing, results should be out in 7 days. Simultaneously, we are also engaging with a 3rd party lab for their findings,” it added.

It also clarified that the FDA advisory only pertains to batch #19A03QW of lip & cheek stain night berry variant.

“We would like to inform everyone that all of our products go through quality control before they are go signaled for distribution to the market. Each Ever Bilena product is subjected to microbial testing prior to release to trade. Everything released from the warehouse is FDA compliant,” the company said.

Mga doktor, importer at distributor ng ‘di rehistradong bakuna o gamot maaaring maharap sa parusa — FDA

Robie de Guzman   •   July 14, 2021

MANILA, Philippines — Walang anumang pananagutan sa batas ang isang indibidwal na naka-inom o nabigyan ng hindi rehistradong gamot at bakuna, ayon sa Food and Drug Administration (FDA).

Sinabi ni FDA director-general Eric Domingo na tanging ang mga doktor na nagbakuna o nagreseta ng gamot ang maaaring maharap sa reklamo alinsunod sa batas.

“Sa atin po kasing batas, wala pong pananagutan ang mga nakabili ng mga counterfeit na gamot, mga substandard na gamit or nakainom nito, nainiksyunan nito. Sa FDA po, ang meron pong kinakasuhan natin iyong nagbebenta ng unregistered, illegal, falsified, or mga poor quality drugs,” ani Domingo.

Ginawa ng FDA ang pahayag kasunod ng umano’y pagpapaturok ng tig-dalawang dose ng magkaibang brand ng bakuna si San Juan City Representative Ronaldo Zamora.

Una nang sinabi ni Zamora na nagpabakuna ito ng dalawang dose ng Sinopharm at dalawang dose ng Pfizer noong Disyembre.

Bagamat maituturing itong iligal dahil wala pang emergency use authorization mula sa FDA noon ang Sinopharm, ang medical professional na nagbigay o nagturok ng bakuna ang may malaking responsibilidad dito batay sa isinasaad ng batas.

“Ang doctor ay bawal magreseta, mag-ineksyon o magbigay ng gamot na hindi po rehistrado sa FDA. Pagkatapos iyong importer at distributor ay mayroon din pong kaso iyon dahil bawal din po magpasok at magbenta ng gamot na hindi rehistrado,” ani Domingo.

Ayon naman kay San Juan City Mayor Francis Zamora, handa si Cong Zamora na makipagtulungan sa imbestigasyon.

“I’m sure my father will be more than willing to cooperate,” ani Zamora.

“Ako po sa totoo lang nagulat din sa ikinwento niya because as far as I know ang bakunang nakuha niya lamang ay yung dalawang dose ng Pfizer mula sa San Juan. Kaya noong sinabi niya na nakapag-Sinopharm na siya previously, sa totoo lang, nag-aalala ako because as a son, I don’t know if that will affect my father’s health,” dagdag pa niya.

Samantala, muli namang nagpaalala ang Department of Health sa publiko na dalawang dose ng mga aprubadong bakuna at single-dose ng Johnson & Johnson vaccine lamang ang ginagamit sa Pilipinas.

Dapat ring sumunod ang publiko sa vaccination protocol na ipinatutupad ng pamahalaan upang masegurong magiging patas ito at ligtas para sa lahat. – RRD (mula sa ulat ni Correspondent Aiko Miguel)

FDA: Vaccines ‘still very useful’ despite drop in efficacy rate vs COVID-19 variants

Robie de Guzman   •   July 13, 2021

MANILA, Philippines ­– Available vaccines against novel coronavirus disease (COVID-19) are “still very useful’ in helping stem the spread of severe respiratory illness despite a decrease in their efficacy against coronavirus variants, the Food and Drug Administration (FDA) said.

In his report to President Rodrigo Duterte during the taped weekly briefing on Monday night, FDA director general Eric Domingo reiterated that COVID-19 vaccines remain effective despite a slight decrease in their efficacy, particularly against the Alpha and Delta variants.

Citing studies on the efficacy of the vaccines, the FDA chief said the data indicate that the US-made Pfizer vaccine has a high efficacy rate of about 95 percent against the original COVID-causing virus.

Against the Alpha variant, which was first detected in the United Kingdom, Pfizer’s vaccine efficacy rate decreased to somewhere less than 10 to 20 percent, Domingo said.

For the Beta variant, which was first reported in South Africa, Pfizer’s vaccine efficacy rate dropped by 20 to 30 percent.

Against the Delta variant, which first emerged in India, Pfizer’s vaccine efficacy rate declined to about 10 to 20 percent.

“Ibig sabihin po maganda pa rin naman po ang kanyang coverage,” Domingo said.

US-made Moderna vaccine has an efficacy rate of 94.1 percent against the original virus but is 10 to 20 percent less effective against Alpha and Delta variants, and 20 to 30 percent against Beta.

British-Swede-made AstraZeneca vaccine has an efficacy rate of 74 percent is less than 10 to 20 percent effective against Alpha and Delta variants, and 20 to 30 percent against Beta.

Russia-made Sputnik V has an efficacy rate of about 91 percent but is less than 10 percent effective against Alpha variant, and 20-30 percent against Beta variant. Its efficacy rate against Delta variant is still being studied.

Single dose US-made Janssen vaccine has an efficacy rate of 70.3 percent against the original virus but is less than 10-20 percent effective against Alpha, up to 30% less effective against Beta, and less than 10 percent against Delta variant.

China-made Sinovac has an efficacy rate of 83.5 percent against the original strain, based on recently concluded trial in Turkey. Against Alpha variant, it was found to be less than 10 percent effective, and 10-30 percent against Beta. No available data yet on its efficacy rate against the Delta variant.

Another China-made vaccine, Sinopharm has a 76.29 percent efficacy rate against the original coronavirus strain, but less than 10 percent effective against the Alpha variant and up to 20 percent less effective against Beta. Its efficacy against the Delta variant is still being studied.

“Ang mga variant po, nababawasan nang kaunti ‘yung efficacy ng vaccine pero hindi naman po siya nawawala ‘no, nagiging very useful pa rin naman po,” Domingo said.

The FDA chief then urged the public to get vaccinated as available jabs offer a certain degree of protection against COVID-19.

Vaccine expert says booster shots need study, recommendation by FDA

Aileen Cerrudo   •   July 12, 2021

MANILA, Philippines — Booster shots still need further studies and recommendations from the country’s Food and Drug Administration, according to the Philippine Foundation for Vaccination (PFV).

During a virtual public briefing, PFV Executive Director Dr. Lulu Bravo said there are many factors that must be considered before recommending a booster shot.

“It is the responsibility of the FDA. Kasi kailangang pagaralan iyan ng ating mga vaccine experts. Hindi dapat ang kumpanya or mga business firms ang magsasabi niyan. Huwag nating pangunahan. Kailangan tiyakin muna ito ng ating mga vaccine experts,” she said.

(It has to be studied by the vaccine experts. It is not for the company nor business firms to recommend it. Let us not get ahead with the vaccine experts in studying it first.)

Bravo said that booster shots would possibly have different components compared to the first dose of vaccine. She said that components of booster shots can be modified in order to become more effective against coronavirus disease (COVID-19) variants. AAC

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