Home > Safety Info

Safety Info

Drug Safety Alert: Potential Risk of Abuse, Dependence and Withdrawal with Benzodiazepines

Asad Ullah Safety Alerts

Drug Safety Alert

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

Date:10th of April, 2023
Target Audience:• Manufacturers and importers of Benzodiazepines containing medicines;
• Healthcare Professionals; and
• Patients, consumers or caregivers.
Background:The Medsafe of Newzealand in June 2022 reminded prescribers about the update to the product information for benzodiazepines regarding the potential risks of abuse, dependence and withdrawal, even when taken at recommended dosages. As per information, the dispensing data of New Zealand showed that diazepam and lorazepam are the most dispensed benzodiazepines. The total amount of these medicines that were dispensed for all indications increased in the period between 2016 and 2020 which suggested frequent and/or long-term use. As per data shared, between August 1969 and March 2022, the Centre for Adverse Reactions Monitoring (CARM) received 23 case reports of withdrawal and/or dependence with the use of benzodiazepines. Clonazepam (nine cases) was the most frequently reported benzodiazepine, followed by lorazepam (five), diazepam (three) and triazolam (three). Therefore, Medsafe advised healthcare professionals to counsel patients about the risks of benzodiazepines when initiating treatment, regularly review the ongoing need for treatment, and gradually taper benzodiazepines following continuous or high-dose use to reduce the risk of withdrawal reactions.
Back in September 2020 and also through Podcast in January 2022, the United States Food and
 
Drug Administration (US-FDA) through a Drug Safety Communication informed that the agency is requiring Boxed warnings of all benzodiazepines drugs to include information about the risk of abuse, misuse, addiction, physical dependence and withdrawal reactions. Abuse and misuse can result in overdose or death, especially when benzodiazepines are combined with other medicines, such as opioid pain relievers, alcohol, or illicit drugs. Physical dependence can occur when benzodiazepines are taken steadily for several days to weeks, even as prescribed. Stopping these medicines abruptly or reducing the dosage too quickly can result in withdrawal reactions, including seizures, which can be life-threatening. The boxed warning also states that concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death. Therefore, these medicines may be reserved concomitant prescribing for use in patients for whom alternative treatment options are inadequate.
Therapeutic Good(s) Affected:Name: Benzodiazepines such as Diazepam, Alprazolam, Clonazepam, Lorazepam, Bromazepam etc.

Benzodiazepines are indicated to treat generalized anxiety disorders, insomnia, seizures, social phobia and panic disorders.
Action in PakistanAccordingly, the case of the potential risk of abuse, dependence and withdrawal with benzodiazepines was discussed in the 2nd 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) which after detailed deliberation and discussion decided as per Rule 10 (1) (h) (iv) & (vi) of Pharmacovigilance Rules, 2022 to update the prescribing information/safety specification of benzodiazepines containing medicines by including information related to abuse, misuse, addiction and withdrawal in the warning and precaution section and  to create a boxed warning as per FDA format.
Advice for healthcare professionals:Healthcare professionals are advised to assess each patient’s risk for abuse, misuse, and addiction before prescribing and throughout treatment. Likewise, caution should be taken when prescribing benzodiazepines to patients with a history of alcohol or drug abuse. When prescribing a benzodiazepine for anxiety or insomnia, it must be ensured that the patient understands that these medicines are intended for short-term use (2-4 weeks). Ongoing use of benzodiazepines may lead to dependence that increases with the dose and duration of treatment and in patients with a history of alcohol or drug abuse or a marked personality disorder. Therefore, healthcare professionals should regularly review the ongoing need for treatment, particularly if the patient is at high risk of dependence.  Abrupt discontinuation or rapid dosage reduction of benzodiazepines after continued use may lead to withdrawal reactions. The likelihood and degree of severity of withdrawal depend on the duration of treatment, dose and degree of dependency. Sudden cessation of benzodiazepines that have been used continually and/or at high doses is associated with serious withdrawal reactions, such as convulsions, delirium or psychosis.

Therefore, healthcare professionals should inform patients of these risks and advise them to consult their doctor before decreasing the dose or abruptly stopping the medicine. Patients should also be advised that stopping treatment requires an individualized tapering schedule which is supervised by their doctor.
Advice for patients:Patients are advised to inform healthcare professionals about all the prescription and over-the-counter (OTC) medicines that the patient are taking or any other substances the patient is using, including alcohol. Benzodiazepines should be taken exactly as prescribed by healthcare professionals. If there is a need to discontinue the medicines, discuss a plan for slowly decreasing the dose and frequency of benzodiazepine(s) with your healthcare professional. A healthcare professional should be immediately contacted if any withdrawal symptoms are experienced.
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 2nd meeting of Pharmacovigilance Risk Assessment Expert Committee.
    32-Safety-Alert-of-Potential-Risk-of-Abuse-Dependence-and-Withdrawal-with-BenzodiazepinesDownload

    Drug Safety Alert: Risk of dental problems with orally dissolved Buprenorphine

    Asad Ullah Safety Alerts

    Drug Safety Alert

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

    Date:10th of April, 2023
    Target Audience:• Manufacturers and importers of Buprenorphine medicines;
    • Healthcare Professionals; and
    • Patients, consumers or caregivers.
    Background:The United States Food and Drug Administration (US-FDA) on 12th of January, 2022 through a drug safety communication warned that dental problems have been reported with medicines containing buprenorphine that are dissolved in the mouth. Dental problems, including tooth decay, cavities, oral infections, and loss of teeth have been reported, even in patients with no prior history of dental issues. The buprenorphine medicines that are associated with dental problems are tablets and films that are dissolved under the tongue or placed against the inside of the cheek. There are also buprenorphine products for pain and opioid use disorder (OUD) delivered by other routes such as a skin patch and injection, but FDA has not identified a concern for dental health related to these other forms.
    Therapeutic Good(s) Affected:Name: Buprenorphine medicines that are orally dissolved.

    Buprenorphine is an opioid used to treat opioid use disorder (misuse of prescribed opioid medications) and pain. The comprehensive approach of buprenorphine combined with counselling and other behavioural therapies is often one of the most effective ways to treat OUD. At proper doses, buprenorphine also decreases the pleasurable effects of other opioids, making misuse of them less appealing.
    Action in PakistanAccordingly, the case of risk of dental problems with orally dissolved Buprenorphine was discussed in the 2nd  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) which after detailed deliberation and discussion decided
     
     
    as per Rule 10 (1) (h) (iv) of Pharmacovigilance Rules, 2022 to update the prescribing information/safety specification of buprenorphine medicines that are dissolved in the mouth by including information related to the risk of dental issues, pre-prescribing assessment of patients and guidelines of taking extra steps after use in the warning and precaution sections.
    Advice for healthcare professionals:Healthcare professionals are advised to be aware that the benefits of buprenorphine medicines still clearly outweigh the risks in treating OUD patients and should ask patients about their oral health history before prescribing treatment with the transmucosal/oral buprenorphine medicines. Healthcare professionals should also counsel patients about the potential for dental problems and the importance of taking extra steps after the medicine has completely dissolved, including to gently rinse their teeth and gums with water and then swallow and to wait at least 1 hour before brushing their teeth.
    Advice for patients:Patients are advised to continue taking buprenorphine medicine as prescribed and not to stop it suddenly as it could lead to serious consequences including withdrawal symptoms. Patients are also advised to take extra steps to reduce the risk of serious dental problems such as rinsing their mouth with water and waiting at least 1 hour before brushing their teeth after buprenorphine medicines are dissolved to avoid damage to their teeth.
    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 2nd meeting of Pharmacovigilance Risk Assessment Expert Committee.
      31-Safety-Alert-Risk-of-dental-problems-orally-dissolved-BuprenorphineDownload
      Minutes of 2nd Meeting of Pharmacovigilance Risk Assessment Expert Committee (PRAEC) held on March 07, 2023

      Drug Safety Alert: Risk of Hypersensitivity Reactions with Pegaspargase (Peg L Asparaginase)

      Asad Ullah Safety Alerts

      Drug Safety Alert

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

      Date:10th of April, 2023
      Target Audience:• Manufacturers and importers of Peg L Asparaginase;
      • Healthcare Professionals; and
      • Patients, consumers or caregivers.
      Background:The National Pharmacovigilance Centre (NPC), Division of Pharmacy Services, Drug Regulatory Authority of Pakistan (DRAP) received six cases of hypersensitivity reactions from Indus Hospital Karachi with Pegaspargase (Peg L Asparaginase) with different batches having the same importer i.e. M/S Lab Diagnostic System and same manufacture i.e. Jiangsu Hengrui Medicine Co Ltd, China. The drug was prescribed for Acute Lymphoid Leukemia/ Leukemia with a dose of 2500 IU/m2 in children. The events of hypersensitivity reactions including swelling of lips, nausea, rash, vomiting, swelling of the tongue, itching all over the body, shivering, red eyes and abdominal pain were noted in the six cases after administration of Pegaspargase (Peg L Asparaginase) 3750IU. The time to onset of reactions was one day. The Pegaspargase was withdrawn in all cases except one case where the status is unknown and the patients recovered in all those cases. The causality assessment of all six cases was performed by the Causality Assessment Group of the National Pharmacovigilance Centre (NPC) and classified all six cases to have a possible relationship with drug intake.
       
      Further assessment was carried out at the National Pharmacovigilance Centre (NPC), Drug Regulatory Authority of Pakistan (DRAP), where the signal was confirmed from the approved label of Peg L Asparaginase of United States Food and Drugs Administration (US-FDA) and Summary of Product Characteristics (SmPC) of Medicine and Health Products Agency (MHRA) and from the published research articles of hypersensitivity reactions with the drug. There was also significant disproportionality and potential association of hypersensitivity with Pegaspargase as per statistical tool available in VigiLyze of the Uppsala Monitoring Centre, Sweden.
       
       The case was therefore discussed in the 2nd meeting of the Pharmacovigilance Risk Assessment
      Expert Committee (PRAEC) of the NPC, DRAP which after detailed deliberation, decided to update the prescribing information/ safety specification/ label of Pegaspargase injection with the inclusion of information related to hypersensitivity reactions and its monitoring in the warning and precaution section and information on treatment modification as per the grade of hypersensitivity reactions in dosage and administration sections. Registration holder was also directed to introduce an educational training programme for healthcare professionals on proper preparation, administration and monitoring of Pegaspargase and to ensure that resuscitation equipment are available at the treatment sites.
      Therapeutic Good(s) Affected:Name: Pegaspargase (Peg L Asparaginase)

      Pegaspargase is indicated as a component of a multi-agent chemotherapeutic regimen for the treatment of pediatric and adult patients with Acute Lymphoid Leukaemia (ALL) and hypersensitivity to native forms of L-asparaginase.
      Advice for healthcare professionals:Healthcare professionals are informed that hypersensitivity reactions to Pegaspargase, including life-threatening anaphylaxis, can occur during therapy, including in patients with known hypersensitivity to E. coli-derived asparaginase formulations. Other hypersensitivity reactions can include angioedema, lip swelling, eye-swelling, erythema, decreased blood pressure, bronchospasm, dyspnoea, pruritus and rash. Premedicate patients 30-60 minutes before administration of pegaspargase. As a routine precautionary measure, the patient should be monitored for an hour after administration and resuscitation equipment and other appropriate means for the treatment of anaphylaxis such as epinephrine, oxygen, intravenous steroids, etc should be available at the treatment sites. Pegaspargase should be discontinued in patients with serious hypersensitivity reactions. Monitoring of patients and modification of treatment is recommended as per the following schedule: reduce the infusion rate by 50% in case of Grade 1 hypersensitivity reaction; interrupt the infusion, treat the symptoms, when symptoms resolved, resume the infusion and reduce the infusion rate by 50% in case of Grade 2 hypersensitivity reaction; and for Grade 3 to 4 hypersensitivity reactions permanently discontinue the pegaspargase.
      Advice for patients:Patients are informed that hypersensitivity reactions with Pegaspargase injection can occur during chemotherapy of Acute Lymphoid Leukaemia (ALL). Talk to your doctor if you have a history of hypersensitivity with conventional asparaginase formulations.
      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 2nd meeting of Pharmacovigilance Risk Assessment Expert Committee.
        30-Safety-Alert-of-Hypersensitivity-Reactions-with-Pegaspargase-Peg-L-Asparaginase.Download

        Recall Alert: Drug Product; Micogen-B Cream (Batch#MB-012/22) by M/s. Delux Chemical Industries, Karachi

        Asad Ullah Recall Alerts

        Recall Alert

        DRAP Alert NoNoII/S/03-23-17
        Action Date27th March 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 Micogen-B Cream
        Composition: Gentamicin, Miconazole and Betamethasone
        Manufactured by: M/s. Delux Chemical Industries, Karachi
        Batch No. MB-012/22
        Manufacturing Date: 11-2022
        Expiry Date: 11-2024
        Problem / Issue Federal Government Analyst, CDL Karachi has declared the Batch No. MB-012/22 of the product “Micogen-B Cream” as of substandard quality.
        Risk StatementDrug Product contains multiple ingredients including Betamethasone, Gentamicin & Miconazole, is indicated for treatment of fungal and bacterial infections of the skin. Impact of use of substandard product on basis of Bio Assay test may leads to sub optimal to no therapeutic effect and may intensify/ flare the existing bacterial and fungal infection.
        Action Initiated-The manufacturing company / registration holder has been directed to immediately recall the defected batch of product from the market.

        -All Pharmacists and chemists working at distributions and Pharmacies should immediately check their stocks and stop supplying this batch of product. The remaining stock should be quarantine and return to the supplier / 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.
          Micogen-B-Cream-Batch-MB-012-22Download

          Recall Alert: Drug Product; Mefco 50mg/5ml Suspension (Batch# 2J041) by M/s. Eros Pharmaceuticals (Pvt) Ltd., Karachi

          Asad Ullah Recall Alerts

          Recall Alert

          DRAP Alert NoNoII/S/03-23-19
          Action Date29th March 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 Mefco 50mg/5ml Suspension
          Composition: Mefenamic Acid
          Manufactured by: M/s. Eros Pharmaceutical (Pvt) Ltd., Karachi
          Batch No. 2J041
          Manufacturing Date: 10-2022
          Expiry Date: 10-2024
          Problem / Issue Federal Government Analyst, CDL Karachi has declared the Batch No. 2J041 of the product “Mefco 50mg/5ml Suspension” as of substandard quality.
          Risk StatementMefenamic acid is used to treat mild to moderate pain. Impact of use of substandard product on basis of pH test may significantly altered the solubility and interfere with its absorption.
          Action Initiated-The manufacturing company / registration holder has been directed to immediately recall the defected batch of product from the market.

          -All Pharmacists and chemists working at distributions and Pharmacies should immediately check their stocks and stop supplying this batch of product. The remaining stock should be quarantine and return to the supplier / 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.
            Mefco-50mg-Suspension-batch-2J041-Eros-PharmaDownload

            Recall Alert: Drug Product; Opth-Carb Sterile Intraocular Solution (Batch#OP154) by M/s Opth Pharma (Pvt) Ltd., Karachi.

            Asad Ullah Recall Alerts

            Recall Alert

            DRAP Alert NoNoI/S/03-23-16
            Action Date9th March 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 Ophth-Carb Sterile Intraocular Solution
            Manufactured by: M/s. Ophth Pharma (Pvt.) Ltd., Karachi
            Batch No. OP154
            Manufacturing Date: 12-2022
            Expiry Date: 11-2024
            Problem / Issue Federal Government Analyst, CDL Karachi has declared the Batch No. OP154 of product “Ophth-Carb Sterile Intraocular Solution” as of substandard quality.
            Risk StatementCarbachol is primarily used in the treatment of glaucoma, it is also used during ophthalmic surgery. All ophthalmic products must meet a number of requirements of safety and sterility and if the product is not sterile (free from bacteria or microorganisms), it may lead to serious infection which includes but not limited to redness of eyes, itching in eyes, watery discharge, blurred vision and loss of vision.
            Action Initiated-The sole agent / registration holder has been directed to immediately recall the defected batch of product from the market.

            -All Pharmacists and chemists working at distributions and Pharmacies should immediately check their stocks and stop supplying this batch of product. The remaining stock should be quarantine and return to the supplier / 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.
              Opth-Carb-Intraoculat-Soln-Recall-AlertDownload

              Safety Alert: WHO Global Alert on Tetracycline Hydrochloride Ophthalmic Ointment USP 1%

              Asad Ullah Recall Alerts, Regulatory Updates, Safety Alerts

              Safety Alert

              Update from WHO Global Surveillance and Monitoring System

              Date:28th February 2023
              Target Audience:· Healthcare Professionals- Physicians, Pharmacists, and Nurses at hospitals and clinics etc.
              · International travelers/General Public
              · NGO’s/Supply Donations/Humanitarian Medicines
              Problem or IssueWorld Health Organization (WHO) issued Medical Product Alert No. N°2/2023 dated 22nd February 2023 which refers to the batches of Tetracycline Hydrochloride Ophthalmic Ointment USP 1%, manufactured by Galentic Pharma (India) Pvt. Ltd, located at R-673, T.T.C. MIDC Rabale, Thane- Belapur Road, Navi Mumbai – 400701, Maharashtra, India Supplied in various countries under various labels.
              Visual examination of random samples had shown a range of quality issues with the random samples of the product batches e.g. particles ranging in color, size and shape on the nozzle, in the cap and in the ointment inside each tube, black spots and brown splotches on the inner foil layer of the tube, and phase separation.
              DRAP has never authorized sale of any products from Galentic Pharma (India) Pvt. Ltd (Thane Belapur Road, Navi Mumbai, India). These products are neither registered nor available on Pakistan market, however these may have been carried for personal use while visiting other countries.
              The manufacturer has initiated a voluntary recall for several batches. The manufacturer has indicated that other batches may be included in the voluntary recall
              Potential Hazards:There is currently no established evidence of any adverse events from the affected batches of TETRACYCLINE HYDROCHLORIDE OPHTHALMIC OINTMENT USP 1%. Redness and swollen eyes are common reactions to general use of tetracycline eye ointment. There is currently no indication that the above-mentioned quality issues may give rise to adverse events that are not listed in the product labelling. The affected TETRACYCLINE HYDROCHLORIDE OPHTHALMIC OINTMENT USP 1% is supplied in bulk and as a component of various medical kits supplied by some international organizations providing humanitarian assistance.
              Advice for healthcare professionals:DRAP requests increased vigilance within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by this affected batch of product. Adverse reactions or quality problems experienced with the use of any product shall be reported to the National Pharmacovigilance Centre(NPC), DRAP using Adverse Event Reporting Form or online through this link.  Further information of reporting problems to DRAP is available on this link.
              Advice for patients:Consumers should stop using this product bearing the affected batch number(s) 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.
                Safety-Alert-for-TetracyclineDownload

                All therapeutic goods must be obtained from the licensed pharmacies, and other authorized retail outlets. The authenticity and condition of products should be carefully checked. Seek advice from your pharmacists or other healthcare professional in case of any doubt.

                Recall Alert: Drug Product; Oscal-D Tablets (Batch # 6904) by M/s Aries Pharmaceuticals (Pvt) Ltd, Peshawar.

                Asad Ullah Recall Alerts

                Recall Alert

                DRAP Alert NoNoI/S/02-23-14
                Action Date24th February 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 Oscal-D Tablets
                Manufactured by: M/s. Aries Pharmaceuticals (Pvt) Ltd, Peshawar.
                Batch No. 6904
                Manufacturing Date: 07-2022
                Expiry Date: 07-2024
                Problem / Issue Federal Government Analyst, CDL Karachi has declared the Batch No. 6904 of product “Oscal-D Tablets” as of substandard quality.
                Risk StatementOscal-D Tablets may be used to treat conditions caused by low calcium levels such as osteoporosis, osteomalacia/rickets, hypoparathyroidism and latent tetany. Inaccurate use of the product may lead to adverse reactions including but not limited to irregular heartbeat, weakness, drowsiness, headache, dry mouth or a metallic taste in your mouth or muscle or bone pain. Impact of use of substandard product on basis of assay test may leads to low to no therapeutic effect etc.
                Action Initiated-The sole agent / registration holder has been directed to immediately recall the defected batch of product from the market.

                -All Pharmacists and chemists working at distributions and Pharmacies should immediately check their stocks and stop supplying this batch of product. The remaining stock should be quarantine and return to the supplier / 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-Alert-Oscal-D-tabletsDownload

                  Recall Alert: Drug Product; Calcium Gluconate Injection (Batch # 220325) by M/s Shaheen Agency Karachi

                  Asad Ullah Recall Alerts

                  Recall Alert

                  DRAP Alert NoNoI/S/02-23-11
                  Action Date23rd February 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 Calcium Gluconate Injection
                  Company: Importer Name; M/s. Shaheen Agency, Karachi , Manufactured by: M/s. China National M/H Shanghai China
                  Batch No. 220325
                  Manufacturing Date: 03-2022
                  Expiry Date: 03-2025
                  Problem / Issue Drug inspector Quetta took the sample of Calcium Gluconate Injection Batch no. 220325 which has declared as Misbranded by Provincial Drug Testing Laboratory, Quetta. Details of the product is given as under:
                  Risk Statementinjection Calcium gluconate is a lifesaving drug which is indicated for pediatric and adult patients for the treatment of acute symptomatic hypocalcemia. Wrongful use /misleading information due to delible printing upon label of Injection Calcium Gluconate, may disturb the patient’s body calcium balance and may lead to adverse reactions including but not limited to following:
                  (i) Arrhythmias with Concomitant Cardiac Glycoside Use.
                  (ii) End-Organ Damage due to Intravascular Ceftriaxone-Calcium Precipitates.
                  (iii) Tissue Necrosis and Calcinosis.
                  (iv)Hypotension, Bradycardia, and Cardiac Arrhythmias.
                  Action Initiated-The sole agent / registration holder has been directed to immediately recall the defected batch of product from the market.

                  -All Pharmacists and chemists working at distributions and Pharmacies should immediately check their stocks and stop supplying this batch of product. The remaining stock should be quarantine and return to the supplier / 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.
                    Calcium-Gluconate-Inj-Shaheen-Agency-Recall-AlertDownload

                    Recall Alert: Drug Product; Chloroquine Injection (Batch # 201238) by M/s Mehran International Karachi

                    Asad Ullah Recall Alerts

                    Recall Alert

                    DRAP Alert NoNoI/S/02-23-12
                    Action Date23rd February 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 Chloroquine Injection
                    Company: Importer Name; M/s. Mehran International, Karachi , Manufactured by: M/s. Shanxi Shuguana Pharma Co Ltd, China
                    Batch No. 201238
                    Manufacturing Date: 12-2020
                    Expiry Date: 12-2023
                    Problem / Issue Drug inspector Quetta took the sample of Chloroquine 5ml Injection Bach No. 201238 which has declared as Misbranded by Provincial Drug Testing Laboratory, Quetta.
                    Risk StatementChloroquine is used to prevent and treat of Malaria and Amebiasis. Improper labels due to delible printing of label may lead to misleading information, accidentally administering the wrong medication or wrong dose, may cause a patient to experience a negative health outcome. Further it may lead to adverse reactions including but not limited to Allergic reactions, Cardiac effects, Nausea, Vomiting, Abdominal cramps, Headache, and Diarrhea.
                    Action Initiated-The sole agent / registration holder has been directed to immediately recall the defected batch of product from the market.

                    -All Pharmacists and chemists working at distributions and Pharmacies should immediately check their stocks and stop supplying this batch of product. The remaining stock should be quarantine and return to the supplier / 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-Alert-Chloroquine-InjDownload