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Recall Alert: Drug Product; Paracet 1g/100mL Infusion by M/s Standpharm Pakistan Pvt Ltd, Lahore.

Asad Ullah Product Recalls, Recall Alerts, Safety Info

Recall Alert

DRAP Alert NoNoI/S/01-23-43
Action Date3rd January 2023
Target Audience1. Pharmacists and Chemists at Distributions, Pharmacies and Medical Stores
2. Healthcare Professionals- Physicians, Pharmacists, and Nurses at Hospitals, Clinics and Healthcare Providing Institutions
3. General Public
Product(s) Affected Paracet 1g/100mL Infusion,
Active Ingredient(s): Paracetamol
Company: M/s. Standpharm Pakistan Pvt Ltd, Lahore
Batch No. CIJI70
Manufacturing Date: 20-09-2022
Expiry Date: 20-09-2024
Problem / Issue CDL Karachi has declared the batch No. CIJI70 of Paracet 1g/100ml Infusion manufactured by M/s. Standpharm Pakistan (Pvt.) Ltd., Lahore as substandard & adulterated drug product.
Action Initiated-The manufacturing company has been directed to immediately recall the defected batch of product from the market.

-All Pharmacists and chemists working at distributions and Pharmacies are required to immediately return the stock of above-mentioned batch of product to the supplier / importer / company.

-Distributors and pharmacies are advised to be vigilant and report any suspected batch of product(s) in the supply chain to the DRAP using online form, or through phone at +92 51 910 73 17, or Email at gsms∂dra.gov.pk.

-Regulatory field force of all federating units (DRAP, Provincial Health Departments and States) has also increased the surveillance in the market to ensure the effective recall of defective product(s).
Advice for Healthcare Professionals-DRAP requests increase vigilance within the supply chains of healthcare institutions and hospital pharmacies to identify and return the defective batch(es) of this product to the importer / company.

-Adverse reactions or quality problems experienced with the use of this product may be reported to the National Pharmacovigilance Centre(NPC), DRAP using Adverse Event Reporting Form or online through this link.

-Please click here for further information on problem reporting to DRAP.
Advice for Consumers-Consumers should stop using this product bearing the affected batch number(s) and shall contact to their physician or healthcare provider(s) if they have had experienced any problem that may be related to taking or using this product.

-All drug products must be obtained from the authorized licensed pharmacies /outlets. Their authenticity and condition should be carefully checked. If you have any doubt, please seek advice from your pharmacist.
    Paracet-1g-Inj-StandpharmDownload

    Voluntary Recall Alert: Drug Product; Cytotol 200mcg Tablets (Batch # 176,177,178,179,180) by M/s Saffron Pharmaceutical, Faisalabad

    Asad Ullah Product Recalls, Recall Alerts, Safety Info

    Voluntary Recall Alert

    DRAP Alert NoNoI/S/12-22-42
    Action Date20th December 2022
    Target Audience1.Pharmacists and Chemists at Distribution, Pharmacies and Medical Stores
    2.Healthcare Professionals- Physicians, Pharmacists, and Nurses at hospitals and clinics etc.
    3. General Public
    Product(s) Affected Cytotol 200mcg Tablets,
    Active Ingredient(s): Misoprostol
    Company: M/s. Saffron Pharmaceutical Faisalabad
    Batch No. 176,177,178,179,180
    Problem / Issue Saffron Pharmaceuticals (Pvt.) Limited has initiated a voluntary recall of batch No. 176,177,178,179,180 of their product “Cytotol 200mcg Tablet”.
    Action Initiated-The manufacturing company is recalling the defected batches of product from the market.

    -All Pharmacists and chemists working at distributions and Pharmacies are required to immediately return the stock of above-mentioned batch of product to the supplier / importer / company.

    -Distributors and pharmacies are advised to be vigilant and report any suspected batch of product(s) in the supply chain to the DRAP using online form, or through phone at +92 51 910 73 17, or Email at gsms∂dra.gov.pk.

    -Regulatory field force of all federating units (DRAP, Provincial Health Departments and States) has also increased the surveillance in the market to ensure the effective recall of defective product(s).
    Advice for Healthcare Professionals-DRAP requests increase vigilance within the supply chains of healthcare institutions and hospital pharmacies to identify and return the defective batch(es) of this product to the importer / company.

    -Adverse reactions or quality problems experienced with the use of this product may be reported to the National Pharmacovigilance Centre(NPC), DRAP using Adverse Event Reporting Form or online through this link.

    -Please click here for further information on problem reporting to DRAP.
    Advice for Consumers-Consumers should stop using this product bearing the affected batch number(s) and shall contact to their physician or healthcare provider(s) if they have had experienced any problem that may be related to taking or using this product.

    -All drug products must be obtained from the authorized licensed pharmacies /outlets. Their authenticity and condition should be carefully checked. If you have any doubt, please seek advice from your pharmacist.
      Voluntary-Recall-of-Cytotol-200mcg-TabletsDownload

        Recall Alert: Drug Product; Tosson 0.4mg SR Capsule by M/s MTI Medical Pvt Ltd, Lahore.

        Asad Ullah Recall Alerts

        Recall Alert

        DRAP Alert NoNoI/S/12-22-41
        Action Date5th December 2022
        Target Audience1. Pharmacists and Chemists at Distributions, Pharmacies and Medical Stores
        2. Healthcare Professionals- Physicians, Pharmacists, and Nurses at Hospitals, Clinics and Healthcare Providing Institutions
        3. General Public
        Product(s) Affected Tosson 0.4mg SR Capsules,
        Active Ingredient(s): Tamsulosin
        Company: M/s. MTI Medical Pvt Ltd, Lahore
        Batch No. 487
        Problem / Issue DTL Lahore has declared the Batch No. 487 of Tosson SR 0.4mg Capsule manufactured by M/s. MTI medical Lahore as substandard drug product.
        Action Initiated-The manufacturing company has been directed to immediately recall the defected batch of product from the market.

        -All Pharmacists and chemists working at distributions and Pharmacies are required to immediately return the stock of above-mentioned batch of product to the supplier / importer / company.

        -Distributors and pharmacies are advised to be vigilant and report any suspected batch of product(s) in the supply chain to the DRAP using online form, or through phone at +92 51 910 73 17, or Email at gsms∂dra.gov.pk.

        -Regulatory field force of all federating units (DRAP, Provincial Health Departments and States) has also increased the surveillance in the market to ensure the effective recall of defective product(s).
        Advice for Healthcare Professionals-DRAP requests increase vigilance within the supply chains of healthcare institutions and hospital pharmacies to identify and return the defective batch(es) of this product to the importer / company.

        -Adverse reactions or quality problems experienced with the use of this product may be reported to the National Pharmacovigilance Centre(NPC), DRAP using Adverse Event Reporting Form or online through this link.

        -Please click here for further information on problem reporting to DRAP.
        Advice for Consumers-Consumers should stop using this product bearing the affected batch number(s) and shall contact to their physician or healthcare provider(s) if they have had experienced any problem that may be related to taking or using this product.

        -All drug products must be obtained from the authorized licensed pharmacies /outlets. Their authenticity and condition should be carefully checked. If you have any doubt, please seek advice from your pharmacist.
          TOSSON-SR-0.4MG-CAPSULEDownload

          Recall Alert: Drug Product; Ximex 100mg/5mL Suspension by Farmaceutics International Karachi

          Asad Ullah Product Recalls, Recall Alerts, Safety Info

          Recall Alert

          DRAP Alert NoNoI/S/11-22-39
          Action Date30th November 2022
          Target Audience1. Pharmacists and Chemists at Distributions, Pharmacies and Medical Stores
          2. Healthcare Professionals- Physicians, Pharmacists, and Nurses at Hospitals, Clinics and Healthcare Providing Institutions
          3. General Public
          Product(s) Affected Ximex 100m/5mL Suspension,
          Active Ingredient(s): Cefixime 100mg/5mL
          Company: M/s. Farmaceutics International Karachi
          Batch No. F-C-539
          Manufacturing Date: 06-2022
          Expiry Date: 06-2024
          Problem / Issue Federal Government Analyst, CDL Karachi has declared the batch No. F-C-539 of product ‘Ximex 100mg/5mL Suspension” manufactured by M/s. Farmaceutics International Karachi, as of substandard quality based on the analysis report.
          Action Initiated-The manufacturing company has been directed to immediately recall the defected batch of product from the market.

          -All Pharmacists and chemists working at distributions and Pharmacies are required to immediately return the stock of above-mentioned batch of product to the supplier / importer / company.

          -Distributors and pharmacies are advised to be vigilant and report any suspected batch of product(s) in the supply chain to the DRAP using online form, or through phone at +92 51 910 73 17, or Email at gsms∂dra.gov.pk.

          -Regulatory field force of all federating units (DRAP, Provincial Health Departments and States) has also increased the surveillance in the market to ensure the effective recall of defective product(s).
          Advice for Healthcare Professionals-DRAP requests increase vigilance within the supply chains of healthcare institutions and hospital pharmacies to identify and return the defective batch(es) of this product to the importer / company.

          -Adverse reactions or quality problems experienced with the use of this product may be reported to the National Pharmacovigilance Centre(NPC), DRAP using Adverse Event Reporting Form or online through this link.

          -Please click here for further information on problem reporting to DRAP.
          Advice for Consumers-Consumers should stop using this product bearing the affected batch number(s) and shall contact to their physician or healthcare provider(s) if they have had experienced any problem that may be related to taking or using this product.

          -All drug products must be obtained from the authorized licensed pharmacies /outlets. Their authenticity and condition should be carefully checked. If you have any doubt, please seek advice from your pharmacist.
            Ximex-100mg-Suspension-Recall-AlertDownload

            Recall Alert: Drug Product; Kempol 120ml/5mL Pediatric Syrup by M/s Alkemy Pharmaceutical Laboratories Pvt Ltd Hyderabad

            Asad Ullah Product Recalls, Recall Alerts

            Recall Alert

            DRAP Alert NoNoI/S/11-22-39
            Action Date30th November 2022
            Target Audience1. Pharmacists and Chemists at Distributions, Pharmacies and Medical Stores
            2. Healthcare Professionals- Physicians, Pharmacists, and Nurses at Hospitals, Clinics and Healthcare Providing Institutions
            3. General Public
            Product(s) Affected Kempol 120mg/5mL Syrup,
            Active Ingredient(s): Paracetamol 120mg/5mL
            Company: Ms. Alkemy Pharmaceutical Laboratories Pvt Ltd Hyderabad
            Batch No. P-707
            Manufacturing Date: 09-2022
            Expiry Date: 08-2024
            Problem / Issue Federal Government Analyst, CDL Karachi has declared the Batch No. P-707 of product ‘Kempol 120mg/5mL Syrup” manufactured by M/s. Alkemy Pharmaceutical Laboratories Pvt Ltd Hyderabad and declared it as “Substandard” based on the analysis.
            Action Initiated-The company is directed to immediately recall the defected batch of product from the market.

            -All Pharmacists and chemists working at distributions and Pharmacies are required to immediately return the stock of above-mentioned batch of product to the supplier / importer / company.

            -Distributors and pharmacies are advised to be vigilant and report any suspected batch of product(s) in the supply chain to the DRAP using online form, or through phone at +92 51 910 73 17, or Email at gsms∂dra.gov.pk.

            -Regulatory field force of all federating units (DRAP, Provincial Health Departments and States) has also increased the surveillance in the market to ensure the effective recall of defective product(s).
            Advice for Healthcare Professionals-DRAP requests increase vigilance within the supply chains of healthcare institutions and hospital pharmacies to identify and return the defective batch(es) of this product to the importer / company.

            -Adverse reactions or quality problems experienced with the use of this product may be reported to the National Pharmacovigilance Centre(NPC), DRAP using Adverse Event Reporting Form or online through this link.

            -Please click here for further information on problem reporting to DRAP.
            Advice for Consumers-Consumers should stop using this product bearing the affected batch number(s) and shall contact to their physician or healthcare provider(s) if they have had experienced any problem that may be related to taking or using this product.

            -All drug products must be obtained from the authorized licensed pharmacies /outlets. Their authenticity and condition should be carefully checked. If you have any doubt, please seek advice from your pharmacist.
              Kempol-120ml-Syrup-Recall-AlertDownload

              Rapid Alert: Drug Product; Falsified Restane Inhalational Solution Identified and Confiscated

              Asad Ullah Product Recalls, Recall Alerts

              Rapid Alert

              DRAP Alert NoNoI/S/12-22-40
              Action Date1st December 2022
              Target Audience• Regulatory Field Force
              • Healthcare Professionals- Anesthesiologist, Surgeons, Pharmacists, and Nurses
              • Pharmacists and Chemists at Distribution, Institutional suppliers
              • General Public
              Problem StatementDuring the surveillance activities in different Hospitals of Punjab, Regulatory Field Force had drawn samples of this product for test/analysis. The Provincial Drugs Testing Laboratory, Faisalabad has declared the samples as spurious and adulterated.
              The product detail is as under: –

              Therapeutic Good Affected:-

              SrProduct NameCompositionBatch #Manufactured by (as stated on label)Marketed by
              (as label)
              1
              RESTANE Inhalation Solution 100ml
              		IsofluraneN0111B24
              N0892A10
              M/s Piramal Critical Care, Inc. Schelden Circle Bethlehem PA 18017, USA
              		Allied Distributors 103-K, Block-2 P.E.C.H.S, Karachi Pakistan.
              Action InitiatedThe Regulatory Field Force has been directed to increase the surveillance activities at Health Facilities (Hospitals) in addition to markets and confiscate these batches of product. All Pharmacists and chemists working at Hospital distributions and Pharmacies should immediately check the stock and stop supplying these batches of product. The remaining stock should be quarantined immediately, and supplier’s information should be provided to the Regulatory field force (DRAP, Provincial Health Departments and States) in order to ensure the removal of this products.
              Advice for Healthcare Professionals-DRAP requests increased vigilance at hospitals and within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by this product. Anesthesiologists and the supporting staff involved in surgical procedures where anesthetics are involved should remain vigilant about the suspected batches of said products.

              -Adverse reactions or quality problems experienced with the use of this product shall be reported to the National Pharmacovigilance Centre (NPC), DRAP using Adverse Event Reporting Form or online through this link.

              -Please click here for further information on problem reporting to DRAP.
              Advice for Consumers-If you are intending to plan any surgeries where anesthetic procedures are involved, or you are an attendant to a such patient, you are requested to cross check the originality of this product with your healthcare professionals (e.g. physicians, surgeons, gynecologist, anesthesiologist, etc.) to ensure the originality of product.
              Suspected-Falsified-Product-in-market-Restane-Inhalation-SolnDownload

              Rapid Alert: Drug Product; Falsified Tablin 300mg Capsule identified in the market

              Asad Ullah News & Updates, Product Recalls, Recall Alerts, Regulatory Updates

              Rapid Alert

              Suspected Falsified Product

              DRAP Alert NoNoI/S/10-22-36
              Action Date24th November 2022
              Target Audience1. Regulatory Field Force
              2. Pharmacists and Chemists at Distribution, Pharmacies and Medical Stores
              3. Healthcare Professionals- Physicians, Pharmacists, and Nurses at hospitals, Clinics and Healthcare Institutions
              4. General Public
              Problem StatementDuring the market surveillance activities in different areas of District Sheikhupura Punjab, Regulatory Field Force has identified the suspected sample for product and sent for analysis to laboratory. The Provincial Drugs Testing Laboratory, has declared the samples as “spurious”. The stated manufacturers on the label has informed that they have not manufactured this batch number of product.
              Product detail is as under:-

              Therapeutic Good Affected:-

              SrProduct NameCompositionBatch #Manufactured by (as stated on label)
              1TABLIN 300mg Capsule
              		Pregabalin 300mgBatch No. 699M/s Theramed Pharmaceuticals (Pvt) Ltd, Lahore.
              Action InitiatedThe Regulatory Field Force has been directed to increase the market surveillance and confiscate this batch of the product. All Pharmacists and chemists working at distributions and Pharmacies should immediately check the stock and stop supplying this product. The remaining stock should be quarantine immediately, and supplier(s) information should be provided to the Regulatory field force (DRAP, Provincial Health Departments and States) in order to ensure the removal of suspected products.
              Advice for Healthcare Professionals-DRAP requests increased vigilance within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by these batches of above-mentioned product.

              -Adverse reactions or quality problems experienced with the use of this product shall be reported to the National Pharmacovigilance Centre (NPC), DRAP using Adverse Event Reporting Form or online through this link.

              -Please click here for further information on problem reporting to DRAP.
              Advice for Consumers-Consumers should stop using this product and shall contact to their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product, and report the incident to Drug Regulatory Authority of Pakistan / National Pharmacovigilance Centre.

              -All therapeutic goods must be obtained from the licensed pharmacies, and other authorized / licensed retail outlets. The authenticity and condition of products should be carefully checked. Seek advice from your pharmacists or other healthcare professionals in case of any doubt.
              Suspected-Falsified-Product-in-market-Tablin-300mg-CapsuleDownload

              Recall Alert: Drug Product; Ponstan Forte 500mg Tablets (Batch # 2050533) by M/s Pfizer Pakistan Ltd, Karachi.

              Asad Ullah Recall Alerts, Regulatory Updates

              Recall Alert

              DRAP Alert NoNoI/S/10-22-35
              Action Date30th November 2022
              Target Audience1. Pharmacists and Chemists at Distributions, Pharmacies and Medical Stores
              2. Healthcare Professionals- Physicians, Pharmacists, and Nurses at Hospitals, Clinics and Healthcare Providing Institutions
              3. General Public
              Product(s) Affected Ponstan Forte 500mg Tablets,
              Active Ingredient(s): Mefenamic Acid
              Company: M/s. Pfizer Pakistan Ltd, Karachi
              Batch No. 2050533
              Manufacturing Date: 09-2020
              Expiry Date: 08-2025
              Problem / Issue The Drug Testing Laboratory, Baluchistan has analyzed the sample of batch No. 2050533 of Ponstan Forte 500mg Tablets manufactured by M/s. Pfizer Pakistan Ltd Karachi, Pakistan and declared it as “Substandard” based on the analysis.
              Action Initiated-The company is directed to immediately recall the defected batch of product from the market.

              -All Pharmacists and chemists working at distributions and Pharmacies are required to immediately return the stock of above-mentioned batch of product to the supplier / importer / company.

              -Distributors and pharmacies are advised to be vigilant and report any suspected batch of product(s) in the supply chain to the DRAP using online form, or through phone at +92 51 910 73 17, or Email at gsms∂dra.gov.pk.

              -Regulatory field force of all federating units (DRAP, Provincial Health Departments and States) has also increased the surveillance in the market to ensure the effective recall of defective product(s).
              Advice for Healthcare Professionals-DRAP requests increase vigilance within the supply chains of healthcare institutions and hospital pharmacies to identify and return the defective batch(es) of this product to the importer / company.

              -Adverse reactions or quality problems experienced with the use of this product may be reported to the National Pharmacovigilance Centre(NPC), DRAP using Adverse Event Reporting Form or online through this link.

              -Please click here for further information on problem reporting to DRAP.
              Advice for Consumers-Consumers should stop using this product bearing the affected batch number(s) and shall contact to their physician or healthcare provider(s) if they have had experienced any problem that may be related to taking or using this product.

              -All drug products must be obtained from the authorized licensed pharmacies /outlets. Their authenticity and condition should be carefully checked. If you have any doubt, please seek advice from your pharmacist.
                Recall-of-Ponstan-Forte-TabDownload

                Recall Alert: Drug Product; Diamicron 80mg Tablets (Batch#1740) by M/s. Servier Research & Pharmaceuticals Pakistan (Pvt) Ltd Lahore.

                Asad Ullah Recall Alerts, Regulatory Updates

                Recall Alert

                DRAP Alert NoNoII/S/10-22-33
                Action Date23rd November 2022
                Target Audience1. Pharmacists and Chemists at Distributions, Pharmacies and Medical Stores
                2. Healthcare Professionals- Physicians, Pharmacists, and Nurses at Hospitals, Clinics and Healthcare Providing Institutions
                3. General Public
                Product(s) Affected Diamicron 80mg Tablets,
                Active Ingredient(s): Gliclazide
                Company: M/s. Servier Research & Pharmaceuticals Pakistan (Pvt) Ltd Lahore.
                Batch No. 1740
                Manufacturing Date: 04-2022
                Expiry Date: 04-2025
                Problem / Issue Central Drug Laboratory, Karachi has analyzed the samples of Diamicron 80mg Tablets manufactured by M/s Servier Research & Pharmaceuticals Pakistan (Pvt) Ltd Lahore and declared the batch No. 1740 as “substandard” based on the analysis report.
                Action Initiated-The company is directed to immediately recall the defected batch of product from the market.

                -All Pharmacists and chemists working at distributions and Pharmacies are required to immediately return the stock of above-mentioned batch of product to the supplier / importer / company.

                -Distributors and pharmacies are advised to be vigilant and report any suspected batch of product(s) in the supply chain to the DRAP using online form, or through phone at +92 51 910 73 17, or Email at gsms∂dra.gov.pk.

                -Regulatory field force of all federating units (DRAP, Provincial Health Departments and States) has also increased the surveillance in the market to ensure the effective recall of defective product(s).
                Advice for Healthcare Professionals-DRAP requests increase vigilance within the supply chains of healthcare institutions and hospital pharmacies to identify and return the defective batch(es) of this product to the importer / company.

                -Adverse reactions or quality problems experienced with the use of this product may be reported to the National Pharmacovigilance Centre(NPC), DRAP using Adverse Event Reporting Form or online through this link.

                -Please click here for further information on problem reporting to DRAP.
                Advice for Consumers-Consumers should stop using this product bearing the affected batch number(s) and shall contact to their physician or healthcare provider(s) if they have had experienced any problem that may be related to taking or using this product.

                -All drug products must be obtained from the authorized licensed pharmacies /outlets. Their authenticity and condition should be carefully checked. If you have any doubt, please seek advice from your pharmacist.
                  Diamicron-80mg-Recall-AlertDownload

                  Drug Safety Alert: Risk of Kidney Injury and Death due to Hydroxyethyl-Starch Solutions for Infusion.

                  Asad Ullah Pharmacovigilance, Regulatory Updates, Safety Alerts

                  Drug Safety Alert

                  Update from Pharmacovigilance Risk Assessment Expert Committee (PRAEC) of Pakistan

                  Date:29th of November, 2022
                  Target Audience:• Manufacturers and importers of hydroxyethyl-starch solutions for infusion.
                  • Healthcare Professionals; and
                  • Patients, consumers or caregivers.
                  Background:The Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicine Agency (EMA) on 11th February, 2022 recommended that the market authorization of hydroxyethyl-starch (HES) solutions for infusion should be suspended across the European Union. These solutions for infusion products are indicated as an addition to other treatments for plasma volume replacement following acute (sudden) blood loss.
                  The safety of these solutions for infusion was reviewed in 2013, and a number of restrictions and measures to minimise the risk of kidney injury and death in certain patients (those critically ill, with burn injuries or with sepsis, a bacterial infection in the blood) were put in place at that time.

                  Likewise, as a result of a third review conducted in 2018, the use of HES solutions for infusion was further restricted to only accredited hospitals, and healthcare professionals prescribing or administering the medicines had to be trained in their appropriate use. In addition, further warnings were introduced to remind healthcare professionals that these medicines must not be used in patients with sepsis or kidney impairment or in other vulnerable patients such as the critically ill in order to ensure these solutions for infusion were not used in patients who were at increased risk of harm. Market authorization holders of HES solutions for infusion were also requested to conduct a drug utilization study to check that the restrictions were adhered to in clinical practice.

                  The PRAC of the EMA accordingly reviewed the results of the study, which show that HES solutions for infusion are still being used outside the recommendations included in the product information and concluded that the further restrictions introduced in 2018 have not sufficiently ensured that the medicines are used safely and that HES solutions were continually used in certain groups of patients in whom serious harm has been demonstrated. In view of the serious risks that certain patient populations were still exposed to, the PRAC recommended the suspension of the marketing authorizations for HES solutions for infusion in the European Union. Accordingly, the European Commission on 24th May, 2022 issued a legal decision confirming the suspension of the market authorization of HES solution for infusion.
                  Therapeutic Good(s) Affected:Name: Hydroxyethyl-Starch solutions for infusion.

                  These solutions for infusion products are indicated as an addition to other treatments for plasma volume replacement following acute (sudden) blood loss.
                  Action in PakistanAccordingly, the case of the risk of kidney injury and death due to hydroxyethyl-starch solutions for infusion was discussed in the 1st meeting of the Pharmacovigilance Risk Assessment Expert Committee (PRAEC) of the National Pharmacovigilance Centre (NPC), Division of Pharmacy Services, Drug Regulatory Authority of Pakistan (DRAP). The PRAEC-DRAP after detailed deliberation and discussion and as per Rule 10 (1) (h) (v) of Pharmacovigilance Rules, 2022 (reliance mechanism) decided to recommend to the Registration Board of the DRAP to suspend the registration of Hydroxyethyl-Starch (HES) solutions in Pakistan subject to the availability of alternative treatment options.
                  Advice for healthcare professionals:Healthcare professionals are informed that the National Pharmacovigilance Centre, DRAP is working with the Registration Board and manufacturers/importers of hydroxyethyl-starch solutions for infusion to suspend the registration of these solutions in Pakistan. Therefore, healthcare professionals are reminded that there are alternative solutions for infusion available in the Pakistani market for the treatment of plasma volume replacement following acute (sudden) blood loss and the same must be considered as the treatment in these conditions.
                  Advice for patients:Patients are informed that the National Pharmacovigilance Centre, DRAP is working with the Registration Board and manufacturers/importers of hydroxyethyl-starch solutions for infusion to suspend the registration of these solutions in Pakistan. Therefore, talk with your doctor before initiation of treatment with those solutions as alternative treatment options are available in the market.
                  Guidelines for reporting Adverse Drug Reactions (ADRs):Both healthcare professionals and patients are requested to report any suspected Adverse Drug Reaction (ADR) to National Pharmacovigilance Centre, Drug Regulatory Authority of Pakistan through Med Vigilance E-Reporting system available on DRAP website.
                  Similarly, ADRs can also be reported through MedSafety App that is available for download from App store (for iOS devices) and Google Play (for Android devices).
                  References:Minutes of 1st meeting of Pharmacovigilance Risk Assessment Expert Committee.
                  European Medicine Agency update regarding hydroxyethyl-starch solutions for infusion recommended for suspension from the market.
                    29_Safety_Alert_of_Risk_of_Kidney_Injury_and_Death_due_Hydroxyethyl-Starch_Solutions_for_Infusion.Download