Category: Drugs Advisories

FDA Advisory No. 2019-190-A || Babala sa Publiko Tungkol sa Pagbili at Paggamit ng Lima Pang Peken Bersyon ng VERORAB RABIES VACCINE FOR HUMAN USE, PREPARED ON CELL CULTURES (INACTIVATED)

Binabalaan ng Food and Drug Administration (FDA) ang publiko laban sa pagbili at paggamit ng lima pang pekeng bersyon ng VERORAB RABIES VACCINE FOR HUMAN USE, PREPARED ON CELL CULTURES (INACTIVATED).

Ayon sa pagsusuri ng FDA kasama ang Marketing Authorization Holder, Sanofi Pausteur Inc., ang nasabing mga produkto sa Larawan 1, 2, 3, 4,5 & 8 ay napatunayang peke.

Ang mga lot number na nakumpirma ng Marketing Authorization Holder (MAH), Sanofi Pausteur Inc. na mga pekeng bersyon ay ang mga sumusunod. Bukod dito, ang FDA ay hindi naglabas ng mga Lot Release Certificate ukol sa mga Lot number na ito:

1. Lot no. H1742 (Counterfeit version 1)
2. Lot no. H1833 (Counterfeit version 2 & 3)
3. Lot no. N1E353M (Counterfeit version 4)
4. Lot no. N1J75V (Counterfeit version 5)

to continue reading, click the attachment below…

Attachment-> : FDA Advisory No. 2019-190-A

/ In Drugs Advisories / By Administrator / Comments Off on FDA Advisory No. 2019-190-A || Babala sa Publiko Tungkol sa Pagbili at Paggamit ng Lima Pang Peken Bersyon ng VERORAB RABIES VACCINE FOR HUMAN USE, PREPARED ON CELL CULTURES (INACTIVATED)

FDA Advisory No. 2019-190 || Public Health Warning Against the Purchase and Use of Five Other Versions of Counterfeit VERORAB RABIES VACCINE FOR HUMAN USE, PREPARED ON CELL CULTURES (INACTIVATED)

The Food and Drug Administration (FDA) warns the public against the purchase and use of five other versions of counterfeit VERORAB RABIES VACCINE FOR HUMAN USE, PREPARED ON CELL CULTURES (INACTIVATED).

The FDA, together with the Marketing Authorization Holder (MAH), Sanofi Pausteur Inc., have verified that the aforementioned products in Figures 1, 2, 3, 4, 5 & 8 are counterfeit.

The Lot numbers that were confirmed by the Marketing Authorization Holder (MAH), Sanofi Pasteur Inc. as counterfeit versions are the following. Moreover, no Lot Release Certificates were issued by FDA on these product lots:

  • Lot no. H1742 (Counterfeit version 1)
  • Lot no. H1833 (Counterfeit version 2 & 3)
  • Lot no. N1E353M (Counterfeit version 4)
  • Lot no. N1J75V (Counterfeit version 5)

to continue reading, click the attachment below…

Attachment-> : FDA Advisory No.2019-190

/ In Drugs Advisories / By Administrator / Comments Off on FDA Advisory No. 2019-190 || Public Health Warning Against the Purchase and Use of Five Other Versions of Counterfeit VERORAB RABIES VACCINE FOR HUMAN USE, PREPARED ON CELL CULTURES (INACTIVATED)

FDA Advisory No. 2019-189-A || Babala sa Publiko Tungkol sa Pagbili at Paggamit ng Hindi Rehistradong Gamot na HYSSOP Mineral Drops 15 mL

Binabalaan ng Food and Drug Administration (FDA) ang publiko laban sa pagbili at paggamit ng hindi rehistradong gamot na:

  1. HYSSOP Mineral Drops 15 mL

Napatunayan sa pamamagitan ng isinagawang Post-Marketing Surveillance (PMS) ng FDA na ang nasabing gamot ay hindi dumaan sa proseso ng rehistrasyon ng ahensya at hindi nabigyan ng kaukulang awtorisasyon tulad ng Certificate of Product Registration (CPR).

Alinsunod sa Republic Act No. 9711, o ang Food and Drug Administration Act of 2009, ang paggawa, pag-angkat, pagbenta, pamamahagi, paglipat, promosyon, pagpapatalastas o sponsorship ng produktong pangkalusugan nang walang kaukulang awtorisasyon mula sa FDA ay ipinagbabawal.

Gayundin, dahil ang hindi rehistradong produktong ito ay hindi dumaan sa proseso ng pagsusuri at pag-eeksamin ng FDA, hindi masisiguro ng ahensya ang epekto at kalidad nito. Ang nasabing iligal na produkto ay maaring magdulot ng panganib sa kalusugan ng gagamit nito

Ang publiko ay pinapaalalahanang huwag bumili ng nasabing iligal na produkto at maging maingat laban sa gamot na maaring hindi rehistrado sa FDA. Ugaliing tingnan kung ang gamot ay rehistrado sa FDA bago bilhin, sa pamamagitan ng paggamit ng Search feature ng FDA website sa www.fda.gov.ph. Maaari ring tingnan ang FDA Registration number sa label ng produkto.

Ang lahat ng establisyamento at/o entidad ay binabalaang huwag mamahagi ng nasabing iligal na produkto hanggang sa ito ay mabigyan ng kaukulang awtorisasyon, sapagkat kaukulang parusa ay mahigpit na ipatutupad.

Hinihiling sa lahat ng Local Government Units (LGUs) at Law Enforcement Agencies (LEAs) na tiyaking ang produktong ito ay hindi maibebenta o magagamit sa kanilang mga nasasakupan.

Pinapakiusap sa Bureau of Customs na harangin ang napatunayang hindi rehistradong gamot sa lahat ng port of entry ng bansa.

Para sa karagdagang impormasyon at katanungan, maaaring mag-email sa [email protected]. Upang mag-report ng patuloy na pagtitinda o pangangalakal ng mga hindi rehistradong gamot, mag-email sa [email protected], o mag-report gamit ang aming online reporting facility, eReport, sa www.fda.gov.ph/ereport. Maaari ring tumawag sa Center for Drug Regulation and Research (CDRR) sa numerong (02) 809-5596.  Para sa mga hinihinalang hindi kanais-nais na reaksyon sa gamot, i-report agad sa FDA gamit ang link na ito: www.fda.gov.ph/adr-report-new at kumpletuhin ang mga kinakailangang impormasyon.

Ang lahat ay hinihikayat na palaganapin ang mga nakasaad na impormasyon.

Attachment-> : FDA Advisory No. 2019-189-A

/ In Drugs Advisories / By Administrator / Comments Off on FDA Advisory No. 2019-189-A || Babala sa Publiko Tungkol sa Pagbili at Paggamit ng Hindi Rehistradong Gamot na HYSSOP Mineral Drops 15 mL

FDA Advisory No. 2019-189 || Public Health Warning Against the Purchase and Use of the Unregistered Drug Product: HYSSOP Mineral Drops 15 mL

The Food and Drug Administration (FDA) warns the public from purchasing and using the following unregistered drug product:

  1. HYSSOP Mineral Drops 15 mL

The FDA has verified through post-marketing surveillance that the abovementioned drug product is not registered and the Certificate of Product Registration (CPR) has not been issued. Pursuant to the Republic Act No. 9711, otherwise known as “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising or sponsorship of health product without the proper authorization is prohibited.

Since this unregistered drug product has not gone through evaluation process of the FDA, the agency cannot assure its efficacy, quality and safety. The use of this violative product may pose health risk to consumers.

In light of the foregoing, the public is advised not to purchase this violative product. Moreover, the public is advised to always check if a dug product is registered with the FDA. The FDA website (www.fda.gov.ph) has a Search feature which may be used by typing in the name of the product before purchasing.

All concerned establishments are warned not to distribute the violative drug product until it has been issued the appropriate authorization, a License to Operate (LTO) for the establishment, and a CPR for the drug product.

All FDA Field Officers and Regulatory Enforcement Unit (REU) in coordination with the law enforcement agencies and Local Government Units (LGUs) are requested to ensure that violative products are not sold or made available in the market or areas of jurisdiction.

The Bureau of Customs is urged to restrict entry of this unregistered product.

For more information and inquiries, please e-mail us at [email protected]. To report continuous sale or distribution of unregistered health products, kindly e-mail us via [email protected]da.gov.ph, or through the online reporting facility, eReport, at www.fda.gov.ph/ereport. You may also call the Center for Drug Regulation and Research at telephone number (02)809-5596. For any suspected adverse drug reaction (ADR), report immediately to FDA through this link: www.fda.gov.ph/adr-report-new and fill out all the required fields.

Dissemination of this advisory to all concerned is hereby requested.

Attachment-> : FDA Advisory No. 2019-189

/ In Drugs Advisories / By Administrator / Comments Off on FDA Advisory No. 2019-189 || Public Health Warning Against the Purchase and Use of the Unregistered Drug Product: HYSSOP Mineral Drops 15 mL

FDA Advisory No. 2019-151-B || Pagwawasto ng FDA Advisory No. 2019-151-A: Babala sa Publiko Tungkol sa Pagbili at Paggamit ng Napatunayang Pekeng Bersyon ng Gamot na Co-Amoxiclav (Augmentin) Powder for Oral Suspension.

Pinapayuhan ng Food and Drug Administration (FDA) ang publiko laban sa pagbili at paggamit ng napatunayang pekeng bersyon ng gamot na Co-Amoxiclav (Augmentin) Powder for Oral Suspension.

Ayon sa pagsusuri ng FDA kasama ang Marketing Authorization Holder (MAH), GlaxoSmithKline (GSK) Philippines, Inc., ang nasabing produkto ay napatunayang peke.(please see attached photo for further details).

Ang Batch No. 217883A na may expiry date na Dec. 2020 ay hindi inangkat ng GSK sa ating bansa.

Awtentikong gamot  Pekeng gamot
 

Brand name:

 

AUGMENTIN

 

AUGMENTIN 457

 

Container:

 

Colorless Glass bottle

 

Plastic bottle

 

Dosage strength & dosage form na nakasaad sa label:

 

457mg/5mL Powder for Suspension

 

400mg/5mL for Oral Suspension

 

Pack sizes:

 

35mL and 70mL

 

100mL

 

Logo:

 

Bagong GSK Logo

 

Lumang GSK logo

Ang lahat ng healthcare professionals, local health centers, health institutions at publiko ay binabalaan tungkol sa nasabing pekeng gamot sa merkado na maaaring magdulot ng panganib sa kalusugan ng mga gagamit nito. Ang publiko, distributor at retailer ay pinapaalalahanan ring bumili lamang sa mga establisyamentong lisensyado ng FDA.

Gayundin, ang lahat ng establisyamento ay binabalaang huwag magbenta nitong napatunayang pekeng gamot na may nasabing mga katangian. Ang pag-aangkat, pagbebenta, brokering, pamamahagi at pagtataglay ng walang patunay ng lehitimong transaksyon nito ay tahasang paglabag sa Republic Act No. 9711 o ang Food and Drug Administration Act of 2009 at Republic Act No. 8203 o ang Special Law on Counterfeit Drugs, samakatuwid ay may kaukulang parusang ipapataw.

Pinapakiusap sa Bureau of Customs na harangin ang napatunayang pekeng produkto sa lahat ng port of entry ng bansa.

Hinihiling sa lahat ng Local Government Units (LGUs) at Law Enforcement Agencies (LEAs) na tiyaking ang pekeng produktong ito ay hindi maibebenta o magagamit sa kanilang mga nasasakupan.

Para sa karagdagang impormasyon at katanungan, maaaring mag-email sa [email protected] Upang mag-report ng patuloy na pagtitinda o pangangalakal ng mga peke o hindi rehistradong gamot, mag-email sa [email protected], o mag-report gamit ang aming online reporting facility, eReport, sa www.fda.gov.ph/ereport. Maaari ring tumawag sa Center for Drug Regulation and Research (CDRR) sa numerong (02) 809-5596.  Para sa mga hinihinalang hindi kanais-nais na reaksyon sa gamot, i-report agad sa FDA gamit ang link na ito: www.fda.gov.ph/adr-report-new at kumpletuhin ang mga kinakailangang impormasyon.

Ang lahat ay hinihikayat na palaganapin ang mga nakasaad na impormasyon.

FDA Advisory No.2019-151-B

Please see FDA Advisory No. 2019-151-A (Tagalog Version) for your reference:>http://bit.ly/2wM8npH

/ In Drugs Advisories / By Administrator / Comments Off on FDA Advisory No. 2019-151-B || Pagwawasto ng FDA Advisory No. 2019-151-A: Babala sa Publiko Tungkol sa Pagbili at Paggamit ng Napatunayang Pekeng Bersyon ng Gamot na Co-Amoxiclav (Augmentin) Powder for Oral Suspension.

FDA Advisory No. 2019-151-A || Amending FDA Advisory No. 2019-151: Public Health Warning Against the Purchase and Use of the Verified Counterfeit Version of Drug Product Co-Amoxiclav (Augmentin) Powder for Oral Suspension

The Food and Drug Administration (FDA) advises the public against the purchase and use of the verified counterfeit version of drug product Co-Amoxiclav (Augmentin) Powder for Oral Suspension.

The FDA, together with the Marketing Authorization Holder (MAH), GlaxoSmithKline (GSK) Philippines, Inc., have verified that the above mentioned product  is counterfeit.(please see attached photo for further details).

The Batch No. 217883A having the expiry date Dec. 2020 was not imported by GSK.

 

 Authentic

 

 Counterfeit

 

Brand name:

 

AUGMENTIN

 

AUGMENTIN 457

 

Container:

 

Colorless Glass bottle

 

Plastic bottle

 

Dosage strength & dosage form reflected on label:

 

457mg/5mL Powder for Suspension

 

400mg/5mL for Oral Suspension

 

Pack sizes:

 

35mL and 70mL

 

100mL

 

Logo:

 

New GSK Logo

 

Old GSK logo

All healthcare professionals, local health centers, health institutions and the general public are hereby warned of this counterfeit drug product in the market which pose potential danger or injury to consumers. Consumers, distributors and retailers are also reminded to purchase drug products only from FDA-licensed establishments.

Likewise, all establishments and outlets are hereby warned against selling and/or dispensing this verified counterfeit drug product with the foregoing features. The importation, selling or offering for sale, brokering, donating or possession without proof of legitimate purchase of such is in direct violation of Republic Act No. 9711, or the Food and Drug Administration Act of 2009, and Republic Act No. 8203, or the Special Law on Counterfeit Drugs, therefore a penalty shall be imposed.

The Bureau of Customs is urged to restrain the importation or entry of this counterfeit product.

All Local Government Units (LGUs) and Law Enforcement Agencies (LEAs) are requested to ensure that this counterfeit product is not sold, made available or used in their localities or areas of jurisdiction.

For more information and inquiries, please e-mail us at [email protected]. To report continuous sale or distribution of unregistered or counterfeit health products, kindly e-mail us via [email protected], or through the online reporting facility, eReport, at www.fda.gov.ph/ereport. You may also call the Center for Drug Regulation and Research at telephone number (02)809-5596. For any suspected adverse drug reaction (ADR), report immediately to FDA through this link: www.fda.gov.ph/adr-report-new and fill out all the required fields.

Dissemination of the information to all concerned is requested

Attachment:> FDA Advisory No.2019-051-A

Please see FDA Advisory No. 2019-151 for your reference:> http://bit.ly/2F4lVRU

/ In Drugs Advisories / By Administrator / Comments Off on FDA Advisory No. 2019-151-A || Amending FDA Advisory No. 2019-151: Public Health Warning Against the Purchase and Use of the Verified Counterfeit Version of Drug Product Co-Amoxiclav (Augmentin) Powder for Oral Suspension

FDA Advisory No. 2019-170-A || Babala sa Publiko Tungkol sa Pagbili at Paggamit ng mga Pekeng Bersyon ng Gamot na Rabipur PCEC rabies vaccine for human use

Binabalaan ng Food and Drug Administration (FDA) ang publiko laban sa pagbili at paggamit ng mga pekeng bersyon ng Rabipur PCEC rabies vaccine for human use.

Larawan 1. Pekeng bersyon 1 ng Rabipur® PCEC rabies vaccine for human use (Batch 3503)

Larawan 2. Pekeng bersyon 2 ng Rabipur® PCEC rabies vaccine for human use (Batch 3479)

Ayon sa pagsusuri ng FDA kasama ang Marketing Authorization Holder, GlaxoSmithKline (GSK) Philippines, Inc., ang nasabing mga produkto sa larawan 1 & 2 ay napatunayang peke.

Pekeng bersyon 1 Pekeng bersyon 2 Awtentikong produkto
Shade of gray in box label Mapusyaw Mapusyaw Mas matingkad
Font format Hindi nakalimbag sa Bold format Hindi nakalimbag sa Bold format Nakalimbag ng Bold format
QR Code Nakalimbag sa matingkad na ink Nakalimbag sa matingkad na ink Nakalimbag sa mapusyaw na ink
Label of sterile syringe and needle May nakalimbag na

“E-Mail:[email protected]

May nakalimbag na

“E-Mail:[email protected]

Walang nakalimbag na   “E-Mail:[email protected]

Larawan 3. Awtentikong produkto na Rabipur® PCEC rabies vaccine for human use

Ang mga Batch number na nakumpirma ng Marketing Authorization Holder (MAH), GlaxoSmithKline (GSK) Philippines, Inc. na pekeng bersyon ay ang mga sumusunod:

  • Batch no. 3503 (Larawan 1)
  • Batch no. 3479 (Larawan 2)

Ang lahat ng mga healthcare professional, local health center, health institution at publiko ay binabalaan tungkol sa mga nasabing mga pekeng bersyon na maaring magdulot ng panganib sa kalusugan ng mga gagamit ng mga nito. Ang publiko, mga distributor at retailer ng mga gamot ay pinapaalalahanang bumili lamang sa mga establisyamentong lisensyado ng FDA.

Gayundin, ang lahat ng establisyamento ay binabalaang huwag magbenta nitong mga napatunayang pekeng gamot na nagtataglay ng mga nasabing katangian. Ang pag-aangkat, pagbebenta, brokering, pamamahagi at pagtataglay ng walang patunay na lehitimong transaksyon ng mga ito ay tahasang paglabag sa Republic Act No. 9711 o ang Food and Drug Administration Act of 2009 at Republic Act No. 8203 o ang Special Law on Counterfeit Drugs, samakatuwid ay may kaukulang parusang ipapataw.

Pinapakiusap sa Bureau of Customs na harangin ang mga nasabing pekeng bersyon ng Rabipur PCEC rabies vaccine for human use sa lahat ng port of entry ng bansa.

Hinihiling sa lahat ng Local Government Units (LGUs) at Law Enforcement Agencies (LEAs) na tiyaking ang mga pekeng produktong ito ay hindi maibebenta o magagamit sa kanilang mga nasasakupan.

Para sa karagdagang impormasyon at katanungan, maaaring mag-email sa [email protected]Upang mag-report ng patuloy na pagtitinda o pangangalakal ng mga hindi rehistradong gamot, mag-email sa [email protected], o mag-report gamit ang aming online reporting facility, eReport, sa www.fda.gov.ph/ereport. Maaari ring tumawag sa Center for Drug Regulation and Research (CDRR) sa numerong (02) 809-5596 o mag e-mail sa [email protected].  Para sa mga hinihinalang hindi kanais-nais na reaksyon sa gamot, i-report agad sa FDA gamit ang link na ito: www.fda.gov.ph/adr-report-new at kumpletuhin ang mga kinakailangang impormasyon.

Ang lahat ay hinihikayat na palaganapin ang mga nakasaad na impormasyon.

FDA Advisory No. 2019-170-A

/ In Drugs Advisories / By Administrator / Comments Off on FDA Advisory No. 2019-170-A || Babala sa Publiko Tungkol sa Pagbili at Paggamit ng mga Pekeng Bersyon ng Gamot na Rabipur PCEC rabies vaccine for human use

FDA Advisory No. 2019-170 || Public Health Warning Against the Purchase and Use of the Counterfeit Versions of Rabipur PCEC rabies vaccine for human use

The Food and Drug Administration (FDA) warns the public against the purchase and use of the verified counterfeit versions of Rabipur PCEC rabies vaccine for human use.

Figure 1. Counterfeit version 1 of Rabipur® PCEC rabies vaccine for human use (Batch no. 3503)

Figure 2. Counterfeit version 2 of Rabipur® PCEC rabies vaccine for human use (Batch no. 3479)

The FDA, together with the Marketing Authorization Holder (MAH), GlaxoSmithKline (GSK) Philippines, Inc., have verified that the above mentioned products in Figures 1 & 2 are counterfeit.

Counterfeit version 1 Counterfeit version 2 Authentic product
Shade of gray in box label Lighter shade Lighter shade Darker shade
Font format Not printed in Bold format Not printed in Bold format Printed in Bold format
QR Code Printed with darker ink Printed with darker ink Printed with lighter ink
Label of sterile syringe and needle Bears printed text

“E-Mail:[email protected]

Bears printed text

“E-Mail:[email protected]

“E-Mail:[email protected]” is not printed on label

 

Figure 3. Authentic product Rabipur® PCEC rabies vaccine for human use

The Batch numbers that were counterfeited as confirmed by the Marketing Authorization Holder (MAH), GlaxoSmithKline Philippines, Inc. are the following:

  • Batch no. 3503 (Figure 1)
  • Batch no. 3479 (Figure 2)

All healthcare professionals, local health centers, health institutions and the general public are hereby warned of these counterfeit versions which pose potential danger or injury to consumers. Consumers, distributors and retailers are also reminded to purchase drug products only from FDA-licensed establishments.

Likewise, all establishments and outlets are hereby warned against selling and/or dispensing these verified counterfeit drug products with the foregoing features. The importation, selling or offering for sale, brokering, donating or possession without proof of legitimate purchase of such is in direct violation of Republic Act No. 9711, or the Food and Drug Administration Act of 2009, and Republic Act No. 8203, or the Special Law on Counterfeit Drugs, therefore a penalty shall be imposed.

The Bureau of Customs is urged to restrict the entry of these counterfeit versions of Rabipur PCEC rabies vaccine for human use.

All Local Government Units (LGUs) and Law Enforcement Agencies (LEAs) are requested to ensure that these counterfeit versions are not sold, made available or used in their localities or areas of jurisdiction.

For more information and inquiries, please e-mail us at [email protected]. To report continuous sale or distribution of unregistered health products, kindly e-mail us via [email protected], or through the online reporting facility, eReport, at www.fda.gov.ph/ereport. You may also call the Center for Drug Regulation and Research at telephone number (02)809-5596 or e-mail [email protected]. For any suspected adverse drug reaction (ADR), report immediately to FDA through this link: www.fda.gov.ph/adr-report-new and fill out all the required fields.

Dissemination of this advisory to all concerned is requested

FDA Advisory No. 2019-170

/ In Drugs Advisories / By Administrator / Comments Off on FDA Advisory No. 2019-170 || Public Health Warning Against the Purchase and Use of the Counterfeit Versions of Rabipur PCEC rabies vaccine for human use

FDA Advisory No. 2019-169 || Safety Information: SGLT2 inhibitors and risk of necrotizing fasciitis of the perineum (Fournier’s gangrene)

Introduction

The US FDA has released safety announcement on rare occurrences of a serious infection of the genitals with sodium-glucose cotransporter-2 (SGLT2) inhibitors. The serious rare infection, called necrotizing fasciitis of the perineum, is also referred to as Fourneir’s gangrene.

Scientific Discussion

SGLT2 inhibitors are approved for use as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes. They lower plasma glucose concentrations by increasing renal excretion of glucose.

Three SGLT2 inhibitors have been registered in the Philippines since 2014, either as single ingredient or fixed-dose combinations. These are:

SGLT2 inhibitors Brand Market Authorization Holders
Canagliflozin Invokana Johnson & Johnson (Phils.) Inc.
Dapagliflozin Forxiga AstraZeneca Pharmaceuticals (Phils.), Inc.
Dapagliflozin + Metformin Xigduo XR AstraZeneca Pharmaceuticals (Phils.), Inc.
Dapagliflozin + Saxagliptin Qtern AstraZeneca Pharmaceuticals (Phils.), Inc.
Empagliflozin Jardiance Boehringer Ingelheim (Philippines), Inc.
Empagliflozin + Metformin Jardiance Duo Boehringer Ingelheim (Philippines), Inc.
Empagliflozin + Linagliptin Glyxambi Boehringer Ingelheim (Philippines), Inc.

 

Fournier’s gangrene is an extremely rare but life-threatening bacterial infection of the tissue under the skin that surrounds muscles, nerves, fat, and blood vessels of the perineum. Men are more often affected than women. Identified predisposing factors include diabetes mellitus, obesity, and other conditions leading to immunosuppression.

To date, FDA Philippines has not received any adverse drug reactions reports of fournier’s gangrene with SGLT2 inhibitors.

Safety Advisory

Healthcare professionals are advised to assess patients for Fournier’s gangrene if they present symptoms of pain, tenderness, erythema, or swelling in the genital or perineal area, along with fever or malaise. If suspected, consider discontinuation of SGLT2 inhibitor, provide appropriate alternative therapy for glycemic control and start treatment immediately with broad-spectrum antibiotics and surgical debridement if necessary.

Advise all patients to seek medical attention immediately if they experience any symptoms above.

Healthcare professionals are also encouraged to report any serious adverse reactions, including Fournier’s gangrene, related to SGLT2 inhibitors to the FDA.

Information for Market Authorization Holders

The Market Authorization Holders of SGLT2 inhibitors as listed above shall update their respective package inserts to appear the information on risk of necrotizing fasciitis of the perineum (Fournier’s gangrene). This information shall be discussed under Warnings and Precautions. MAHs who have not yet submitted their revised package inserts in relation to the above safety concern shall submit variation application within 3 months after this issuance.

FDA Advisory No. 2019-169

/ In Drugs Advisories / By Administrator / Comments Off on FDA Advisory No. 2019-169 || Safety Information: SGLT2 inhibitors and risk of necrotizing fasciitis of the perineum (Fournier’s gangrene)

FDA Advisory No. 2019-167-A || Babala sa Publiko Tungkol sa Pagbili at Paggamit ng Hindi Rehistradong Gamot na Juicy Pop! Skin Injection Serum

Binabalaan ng Food and Drug Administration (FDA) ang publiko laban sa pagbili at paggamit ng hindi rehistradong gamot na:

  1. Juicy Pop! Skin Injection Serum

Napatunayan sa pamamagitan ng isinagawang Post-Marketing Surveillance (PMS) ng FDA na ang nasabing gamot ay hindi dumaan sa proseso ng rehistrasyon ng ahensya at hindi nabigyan ng kaukulang awtorisasyon tulad ng Certificate of Product Registration (CPR).

Alinsunod sa Republic Act No. 9711, o ang Food and Drug Administration Act of 2009, ang paggawa, pag-angkat, pagbenta, pamamahagi, paglipat, promosyon, pagpapatalastas o sponsorship ng produktong pangkalusugan nang walang kaukulang awtorisasyon mula sa FDA ay ipinagbabawal.

Gayundin, dahil ang hindi rehistradong produktong ito ay hindi dumaan sa proseso ng pagsusuri at pag-eeksamin ng FDA, hindi masisiguro ng ahensya ang epekto at kalidad nito. Ang nasabing iligal na produkto ay maaring magdulot ng panganib sa kalusugan ng gagamit nito

Ang publiko ay pinapaalalahanang huwag bumili ng nasabing iligal na produkto at maging maingat laban sa gamot na maaring hindi rehistrado sa FDA. Ugaliing tingnan kung ang gamot ay rehistrado sa FDA bago bilhin, sa pamamagitan ng paggamit ng Search feature ng FDA website sa www.fda.gov.ph. Maaari ring tingnan ang FDA Registration number sa label ng produkto.

Ang lahat ng establisyamento at/o entidad ay binabalaang huwag mamahagi ng nasabing iligal na produkto hanggang sa ito ay mabigyan ng kaukulang awtorisasyon, sapagkat kaukulang parusa ay mahigpit na ipatutupad.

Hinihiling sa lahat ng Local Government Units (LGUs) at Law Enforcement Agencies (LEAs) na tiyaking ang produktong ito ay hindi maibebenta o magagamit sa kanilang mga nasasakupan.

Pinapakiusap sa Bureau of Customs na harangin ang napatunayang hindi rehistradong gamot sa lahat ng port of entry ng bansa.

Para sa karagdagang impormasyon at katanungan, maaaring mag-email sa [email protected] o tumawag sa (02) 809-5596

Upang mag-report ng patuloy na pagtitinda o pangangalakal ng mga hindi rehistradong gamot mag-report gamit ang aming online reporting facilityeReport, sa www.fda.gov.ph/ereport. Para sa mga hinihinalang hindi kanais-nais na reaksyon sa gamot, i-report agad sa FDA gamit ang link na ito: www.fda.gov.ph/adr-report-new at kumpletuhin ang mga kinakailangang impormasyon.

Ang lahat ay hinihikayat na palaganapin ang mga nakasaad na impormasyon.

FDA Advisory No. 2019-167-A

/ In Drugs Advisories / By Administrator / Comments Off on FDA Advisory No. 2019-167-A || Babala sa Publiko Tungkol sa Pagbili at Paggamit ng Hindi Rehistradong Gamot na Juicy Pop! Skin Injection Serum

FDA Advisory No. 2019-167 || Public Health Warning Against the Purchase and Use of the Unregistered Drug Product: Juicy Pop! Skin Injection Serum

The Food and Drug Administration (FDA) warns the public from purchasing and using the following unregistered drug product:

  1. Juicy Pop! Skin Injection Serum

The FDA has verified through post-marketing surveillance that the abovementioned drug product is not registered and no Certificate of Product Registration (CPR) has been issued. Pursuant to the Republic Act No. 9711, otherwise known as “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising or sponsorship of health product without the proper authorization is prohibited.

Since this unregistered drug product has not gone through evaluation process of the FDA, the agency cannot assure its efficacy, quality and safety. The use of this violative product may pose health risks to consumers.

In light of the foregoing, the public is advised not to purchase this violative product. Moreover, the public is advised to always check if a dug product is registered with the FDA. The FDA website (www.fda.gov.ph) has a Search feature which may be used by typing in the name of the product before purchasing.

All concerned establishments are warned not to distribute the violative drug product until it has been issued the appropriate authorization, a License to Operate (LTO) for the establishment and a CPR for the drug product.

All FDA Field Officers and Regulatory Enforcement Unit (REU) in coordination with the law enforcement agencies and Local Government Units (LGUs) are requested to ensure that violative products are not sold or made available in the market or areas of jurisdiction.

The Bureau of Customs is urged to restrict the entry of this unregistered product.

For more information kindly contact the FDA Center for Drug Regulation and Research through e-mail at [email protected], or call (02) 809-5596.

To report any sale or distribution of unregistered drug product, the online reporting facility, eReport can be accessed at www.fda.gov.ph/ereport For any suspected adverse drug reaction (ADR), report immediately to FDA through this link: www.fda.gov.ph/adr-report-new and fill out all the required fields.

Dissemination of this advisory to all concerned is hereby requested.

FDA Advisory No. 2019-167

/ In Drugs Advisories / By Administrator / Comments Off on FDA Advisory No. 2019-167 || Public Health Warning Against the Purchase and Use of the Unregistered Drug Product: Juicy Pop! Skin Injection Serum

FDA Advisory No. 2019-166-A || Babala sa Publiko Tungkol sa Pagbili at Paggamit ng mga Hindi Rehistradong Gamot na:

Binabalaan ng Food and Drug Administration (FDA) ang publiko laban sa pagbili at paggamit ng mga hindi rehistradong gamot na:

  1. Lady Guada SALICYLIC ACID 25 mL
  2. Lady Guada TINCTURE OF BENZAL 15 mL
  3. Lady Guada OIL OF WINTER GREEN 25 mL
  4. Lady Guada Aceite De Manzanilla 30 mL
  5. Lady Guada EUCALYPTUS OIL 10 mL
  6. Lady Guada HYDROGEN PEROXIDE AGUA OXIGENADA SOLUTION USP XIV

Napatunayan sa pamamagitan ng isinagawang Post-Marketing Surveillance (PMS) ng FDA na ang nasabing mga gamot ay hindi dumaan sa proseso ng rehistrasyon ng ahensya at hindi nabigyan ng kaukulang awtorisasyon tulad ng Certificate of Product Registration (CPR).

Alinsunod sa Republic Act No. 9711, o ang Food and Drug Administration Act of 2009, ang paggawa, pag-angkat, pagbenta, pamamahagi, paglipat, promosyon, pagpapatalastas o sponsorship ng produktong pangkalusugan nang walang kaukulang awtorisasyon mula sa FDA ay ipinagbabawal.

Gayundin, dahil ang mga hindi rehistradong produktong ito ay hindi dumaan sa proseso ng pagsusuri at pag-eeksamin ng FDA, hindi masisiguro ng ahensya ang epekto at kalidad ng mga ito. Ang nasabing mga iligal na produkto ay maaring magdulot ng panganib sa kalusugan ng mga gagamit ng mga ito.

Ang publiko ay pinapaalalahanang huwag bumili ng nasabing mga iligal na produkto at maging maingat laban sa mga gamot na maaring hindi rehistrado sa FDA. Ugaliing tingnan kung ang gamot ay rehistrado sa FDA bago bilhin, sa pamamagitan ng paggamit ng Search feature ng FDA website sa www.fda.gov.ph. Maaari ring tingnan ang FDA Registration number sa label ng produkto.

Ang lahat ng establisyamento at/o entidad ay binabalaang huwag mamahagi ng nasabing mga iligal na produkto hanggang sa ang mga ito ay mabigyan ng kaukulang awtorisasyon, sapagkat kaukulang parusa ay mahigpit na ipatutupad.

Hinihiling sa lahat ng Local Government Units (LGUs) at Law Enforcement Agencies (LEAs) na tiyaking ang mga produktong ito ay hindi maibebenta o magagamit sa kanilang mga nasasakupan.

Para sa karagdagang impormasyon at katanungan, maaaring mag-email sa [email protected] o tumawag sa (02) 809-5596

Upang mag-report ng patuloy na pagtitinda o pangangalakal ng mga hindi rehistradong gamot mag-report gamit ang aming online reporting facilityeReport, sa www.fda.gov.ph/ereport. Para sa mga hinihinalang hindi kanais-nais na reaksyon sa gamot, i-report agad sa FDA gamit ang link na ito: www.fda.gov.ph/adr-report-new at kumpletuhin ang mga kinakailangang impormasyon.

Ang lahat ay hinihikayat na palaganapin ang mga nakasaad na impormasyon.

FDA Advisory No. 2019-166-A

FDA Advisory No. 2019-166 || Public Health Warning Against the Purchase and Use of the Following Unregistered Drug Products:

The Food and Drug Administration (FDA) warns the public from purchasing and using the following unregistered drug products:

  1. Lady Guada SALICYLIC ACID 25 mL
  2. Lady Guada TINCTURE OF BENZAL 15 mL
  3. Lady Guada OIL OF WINTER GREEN 25 mL
  4. Lady Guada Aceite De Manzanilla 30 mL
  5. Lady Guada EUCALYPTUS OIL 10 mL
  6. Lady Guada HYDROGEN PEROXIDE AGUA OXIGENADA SOLUTION USP XIV

The FDA has verified through Post-Marketing Surveillance that the abovementioned drug products are not registered and no Certificates of Product Registration (CPR) have been issued. Pursuant to the Republic Act No. 9711, otherwise known as “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising or sponsorship of health products without the proper authorization is prohibited.

Since these unregistered drug products have not gone through evaluation process of the FDA, the agency cannot assure their efficacy, quality and safety. The use of such violative products may pose health risks to consumers.

In light of the foregoing, the public is advised not to purchase these violative products. Moreover, the public is advised to always check if a drug product is registered with the FDA. The FDA website (www.fda.gov.ph) has a Search feature which may be used by typing in the name of the product before purchasing.

All concerned establishments are warned not to distribute the violative drug products until they have been issued the appropriate authorization, a License to Operate (LTO) for the establishment and a CPR for the drug product.

All FDA Field Officers and Regulatory Enforcement Unit (REU) in coordination with the law enforcement agencies and Local Government Units (LGUs) are requested to ensure that violative products are not sold or made available in the market or areas of jurisdiction.

For more information kindly contact the FDA Center for Drug Regulation and Research through e-mail at [email protected], or call (02) 809-5596.

To report any sale or distribution of unregistered drug product, the online reporting facility, eReport can be accessed at www.fda.gov.ph/ereport. For any suspected adverse drug reaction (ADR), report immediately to FDA through this link: www.fda.gov.ph/adr-report-new and fill out all the required fields.

Dissemination of this advisory to all concerned is hereby requested.

 

FDA Advisory No. 2019-165-A || Babala sa Publiko Tungkol sa Pagbili at Paggamit ng mga Hindi Rehistradong Gamot na:

Binabalaan ng Food and Drug Administration (FDA) ang publiko laban sa pagbili at paggamit ng mga hindi rehistradong gamot na:

  1. Beauty OrganicsTM HAIR VITA (Gugo+Aloe Vera+Minoxidil) HAIR GROWER SHAMPOO 150 mL
  1. METHYL SALICYLATE+CAMPHOR KUTO-ALIS Herbal Oil 50 mL

Napatunayan sa pamamagitan ng isinagawang Post-Marketing Surveillance (PMS) ng FDA na ang mga nasabing gamot ay hindi dumaan sa proseso ng rehistrasyon ng ahensya at hindi nabigyan ng kaukulang awtorisasyon tulad ng Certificate of Product Registration (CPR).

Alinsunod sa Republic Act No. 9711, o ang Food and Drug Administration Act of 2009, ang paggawa, pag-angkat, pagbenta, pamamahagi, paglipat, promosyon, pagpapatalastas o sponsorship ng produktong pangkalusugan nang walang kaukulang awtorisasyon mula sa FDA ay ipinagbabawal.

Gayundin, dahil ang mga hindi rehistradong produkto ay hindi dumaan sa proseso ng pagsusuri at pageeksamin ng FDA, hindi masisiguro ng ahensya ang epekto at kalidad ng mga nito. Ang mga nasabing iligal na produkto ay maaring magdulot ng panganib sa kalusugan ng mga gagamit nito.

Ang publiko ay pinapaalalahanang huwag bumili ng mga nasabing iligal na produkto at maging maingat laban sa mga gamot na maaring hindi rehistrado sa FDA. Maaaring malaman kung ang gamot ay rehistrado sa FDA sa pamamagitan ng paggamit ng Search feature ng FDA website sa www.fda.gov.ph. Maaari ring tingnan ang FDA Registration number sa label ng produkto.

Ang lahat ng establisyamento at/o entidad ay binabalaang huwag mamahagi ng mga nasabing iligal na produkto hanggang sa ang mga ito ay mabigyan ng awtorisasyon, sapagkat kaukulang parusa ay mahigpit na ipatutupad.

Hinihiling sa lahat ng Local Government Units (LGUs) at Law Enforcement Agencies (LEAs) na tiyaking ang mga produktong ito ay hindi maibebenta o magagamit sa kanilang mga nasasakupan.

Para sa karagdagang impormasyon at katanungan, maaaring mag-email sa [email protected] o tumawag sa (02) 809-5596

Upang mag-report ng patuloy na pagtitinda o pangangalakal ng mga hindi rehistradong gamot mag-report gamit ang aming online reporting facilityeReport, sa www.fda.gov.ph/ereport. Para sa mga hinihinalang hindi kanais-nais na reaksyon sa gamot, i-report agad sa FDA gamit ang link na ito: www.fda.gov.ph/adr-report-new at kumpletuhin ang mga kinakailangang impormasyon.

Ang lahat ay hinihikayat na palaganapin ang mga nakasaad na impormasyon.

FDA Advisory No. 2019-165-A

FDA Advisory No. 2019-165 || Public Health Warning Against the Purchase and Use of the Following Unregistered Drug Products:

The Food and Drug Administration (FDA) warns the public against the purchase and use of the following unregistered drug products:

  1. Beauty OrganicsTM HAIR VITA (Gugo+Aloe Vera+Minoxidil) HAIR GROWER SHAMPOO 150 mL
  1. METHYL SALICYLATE+CAMPHOR KUTO-ALIS Herbal Oil 50 mL

The FDA has verified through post-marketing surveillance that the abovementioned drug products are not registered and no Certificates of Product Registration (CPR) have been issued. Pursuant to the Republic Act No. 9711, otherwise known as “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising or sponsorship of these health products without the proper authorization is prohibited.

Since these unregistered drug products have not gone through evaluation process of the FDA, the agency cannot assure their efficacy, quality and safety. The use of such violative products may pose health risks to consumers.

In light of the foregoing, the public is advised not to purchase these violative products. Moreover, the public is advised to always check if a dug product is registered with the FDA. The FDA website (www.fda.gov.ph) has a Search feature which may be used by typing in the name of the product before purchasing.

All concerned establishments are warned not to distribute the violative drug products until they have been issued the appropriate authorization, a License to Operate (LTO) for the establishment and a CPR for the drug product.

All FDA Field Officers and Regulatory Enforcement Unit (REU) in coordination with the law enforcement agencies and Local Government Units (LGUs) are requested to ensure that violative products are not sold or made available in the market or areas of jurisdiction.

For more information kindly contact the FDA Center for Drug Regulation and Research through e-mail at [email protected], or call (02) 809-5596.

To report any sale or distribution of unregistered drug product, the online reporting facility, eReport can be accessed at www.fda.gov.ph/ereport For any suspected adverse drug reaction (ADR), report immediately to FDA through this link: www.fda.gov.ph/adr-report-new and fill out all the required fields.

Dissemination of this advisory to all concerned is hereby requested.

FDA Advisory No. 2019-165

“Saving lives through vigilant reporting.” #BePHARMAcoVIGILANT #CDRR #PhFDA

“Siguraduhing tama ang ibinibigay na gamot sa inyong pasyente. Ipaliwanag ang mga side effects na maaaring maranasan at ang kahalagahan sa pagsunod sa dosage at instruction sa paginom nito.”

I-report ang side effects upang makatulong sa ligtas na paggamit ng mga gamot:

https://primaryreporting.who-umc.org/Reporting/Reporter?OrganizationID=PH

“Saving lives through vigilant reporting.” #BePHARMAcoVIGILANT #CDRR #PhFDA

“Make sure the medicine is right for the parent, baby or child. Discuss the potential of side effects and the importance of following recommended dosages and instruction.”

Reporting side effects helps the safe use of medicines:

https://primaryreporting.who-umc.org/Reporting/Reporter?OrganizationID=PH

“Saving lives through vigilant reporting.” #BePHARMAcoVIGILANT #CDRR #PhFDA

“Ang mga gamot na iniinom ng buntis o nagpapasuso ay maaring may epekto rin sa kanilang mga anak. Ugaliin ang pagkonsulta sa doktor bago uminom ng gamot.”

I-report ang side effects upang makatulong sa ligtas na paggamit ng mga gamot:

https://primaryreporting.who-umc.org/Reporting/Reporter?OrganizationID=PH

“Saving lives through vigilant reporting.” #BePHARMAcoVIGILANT #CDRR #PhFDA

“Medicines taken when pregnant or breastfeeding means they may reach your baby. Always speak to a doctor. Reporting side effects helps the safe use of medicines for babies and children”

Reporting side effects helps the safe use of medicines:

https://primaryreporting.who-umc.org/Reporting/Reporter?OrganizationID=PH

“Saving lives through vigilant reporting.” #BePHARMAcoVIGILANT #CDRR #PhFDA

“Alam mo ba na maaring iba ang epekto ng gamot sa mga bata? Laging siguraduhin na ang inyong mga anak ay nabibigyan ng tamang gamot na may tamang sukat at paraan ng paginom.”

I-report ang side effects upang makatulong sa ligtas na paggamit ng mga gamot:

https://primaryreporting.who-umc.org/Reporting/Reporter?OrganizationID=PH