FDA warns against consumption of unregistered Kirkland Signature Vitamin C 1000mg tablet

Marje Pelayo   •   July 15, 2021   •   1133

MANILA, Philippines — The Food and Drug Administration (FDA) released a warning regarding the consumption of unregistered Kirkland Signature Vitamin C 1000mg tablet.

In an advisory on Facebook, the FDA cited a result of its Post-Marketing Surveillance (PMS) which revealed that the product did not go through the agency’s registration process.

The FDA Philippines said it cannot assure the product’s quality and safety.

The agency also asked for assistance from local government units and law enforcement agencies in ensuring that the product is not being used or sold in the market.

The advisory is addressed to all healthcare professionals and the general public.

FDA, may babala vs mga ospital na maniningil ng higit kaysa COVID-19 drug price cap

Robie de Guzman   •   September 17, 2021

MANILA, Philippines – Binalaan ng Philippine Food and Drug Administration (FDA) ang mga ospital na maniningil ng higit kaysa itinakdang price cap para sa mga gamot na ginagamit para sa mga pasyenteng may COVID-19.

Sa panayam sa programang Get it straight with Daniel Razon, sinabi ni FDA director general Eric Domingo na maaaring patawan ng parusang pagkakakulong at suspension ng lisensiya ang mga ospital gayundin ang mga botika na nagbebenta ng COVID-19 drugs na mas mahal kumpara sa price ceiling.

Ginawa ng FDA ang babala kasunod ng mga ulat ng overpricing sa mga gamot na ginagamit sa treatment ng COVID-19 patients tulad ng Remdesivir at Tocilizumab .

“Pag ospital po, kwestyonable ang presyo, at least yung quality sigurado tayo dahil yung ospital hindi naman yan bibili, bawal po silang bumili sa unlicensed distributor. Pero mayroon silang pananagutan dahil lumalagpas po sila sa retail price na pinapayagan po ng DOH,” ang paliwanag ni Domingo.

Alinsunod sa kautusan ng DOH, nasa P8,000 hanggang P28,000 ang suggested retail price ng Tocilizumab na ginagamit sa treatment ng critical hanggang severe COVID cases.

Nasa P1,500 hanggang P8,200 ang retail price ng bawat 100 milligram vial ng Remdesivir.

Samantala, kaugnay naman ng pagkakaloob ng compassionate special permit o CSP sa COVID-19 drugs, inihayag ni Domingo na halos lahat ng ospital sa bansa ay may special permit na para sa isa o dalawang gamot kontra COVID-19.

Dagdag pa nito, hindi masyadong istrikto ang FDA sa pagbibigay ng CSP basta lisensyado ang ospital at mga doktor na gagamit ng gamot para sa COVID-19 patients.

“Actually lahat ng ospital ngayon sa Pilipinas, may special permit na sila for one drug or another, para sa ating COVID dahil talagang puno ng COVID-19 cases. At tayo naman po, hindi tayo very strict,” ani Domingo.

Ayon sa FDA, nade-desisyunan naman agad sa loob ng 24 hanggang 48 oras ang aplikasyon para sa CSP ng isang ospital. Maaari ding mag-apply in advance ng CSP ang mga ospital para sa COVID-19 patients nito sa pamamagitan ng email address na odg@fda.gov.ph.

Kaugnay naman ng investigational drug na Leronlimab, sinabi ni Domingo na wala pang price ceiling na itinakda ang pamahalaan dito dahil kakaunti lamang ang nanghihingi ng special permit para sa suplay ng gamot na ito. – RRD (mula sa ulat ni Correspondent Rosalie Coz)

FDA warns: Nasal spray products are not substitutes for medicines, vaccines

Marje Pelayo   •   September 13, 2021

MANILA, Philippines — The Food and Drug Administration (FDA) has cautioned the public on the claims of nasal spray products authorized in the Philippines.

In an advisory dated September 10, the agency noted that “these nasal spray products have been authorized as medical devices which are intended for short-term use in the nasal cavity and serves as mechanical barrier from particulates. These are sprays that coat the nasal mucosa with substances that have a non-specific effect against pathogens.”

The FDA explained that these nasal spray products “do not have active pharmaceutical ingredients that directly treat, eliminate or prevent diseases.”

Therefore, the agency reminded consumers that these products “should not be used as substitutes to medicines and vaccines to prevent or treat SARS-CoV-2 Infection or COVID-19.”

The FDA encourages the public to be vigilant in using these products claiming prevention or treatment of COVID-19.

 

FDA warns against purchase of verified fake drugs

Marje Pelayo   •   September 10, 2021

MANILA, Philippines — The Food and Drug Administration (FDA) has warned the public against purchasing and using verified fake drugs.

In its advisory shared on its Facebook account, the FDA posted images of authentic packaging of popular drugs, some used as home remedy drugs, in comparison to the fake ones.

“Ang lahat ng healthcare professionals at publiko ay binabalaan tungkol sa paglipana ng mga nasabing pekeng gamot sa merkado na maaring magdulot ng panganib sa kalusugan ng mga gagamit nito,” the advisory reads.

“Ang publiko ay pinaaalalahanan ding bumili lamang sa mga establisyementong lisensyado ng FDA,” it added.

Medicines that are warned of having counterfeits include:
1. Carbocisteine (Solmux®) 500 mg Capsule
2. Phenylephrine HCl / Chlorphenamine Maleate / Paracetamol (Bioflu®) 10 mg/2 mg/500 mg Film-Coated Tablet
3. Phenylephrine HCl / Chlorphenamine Maleate / Paracetamol (Neozep® Forte) 10 mg/2 mg/500 mg Tablet
4. Loperamide (Diatabs®) 2 mg Capsule
5. Mefenamic Acid (Dolfenal®) 500 mg Film-Coated Tablet
6. Paracetamol (Biogesic®) 500 mg Tablet
7. Aluminum Hydroxide / Magnesium Hydroxide / Simeticone (Kremil-S®) 178 mg / 233 mg / 30 mg Chewable Tablet
8. Ibuprofen (Medicol® Advance) 200 mg Softgel Capsule
9. Hyoscine N-butylbromide (Buscopan®) 10 mg Tablet
10. Ibuprofen / Paracetamol (Alaxan® FR) 200 mg / 325 mg Capsule
11. Meclizine HCl (Bonamine*) 25 mg Chewable Tablet
12. Loperamide HCl (Lomotil®) 2 mg Tablet
13. Dexamethasone (Decilone® Forte) 4 mg Tablet
14. Loperamide (Imodium) 2 mg Capsule

The FDA warns establishments that importation, sale, and distribution of fake drugs is against R.A. 9711 or the Food and Drug Administration Act of 2009 and R.A. 8203 or Special law on Counterfeit Drugs.

Violators shall face appropriate penalties under the law.

REACH US

The Philippine Broadcast Hub

UNTV, 915 Barangay Philam,

EDSA, Quezon City M.M. 1104

(+632) 8396-8688 (Tel)

info@untv-newsandrescue.com (General inquiries)

ABOUT UNTV

UNTV is a major TV broadcast network with 24-hour programming. An Ultra High Frequency station with strong brand content that appeal to everyone, UNTV is one of the most trusted and successful Philippine networks that guarantees wholesome and quality viewing experience.