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Rapid Alert; H&OTC Product: Falsified and Unregistered Sugar XL Capsules by M/s Naz Homoeo Pharmacy

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Rapid Alert

Falsified and Unregistered Sugar XL Capsules

DRAP Alert NoNo  II/S/06-23-26
Action Date19th June 2023
Target Audience1. Regulatory Field Force
2. Pharmacists and Chemists at Distribution, Pharmacies, and Medical Stores
3. General Public
Problem StatementFederal Inspector of Drugs Karachi took the sample of Sugar XL capsules and sent it to Central Drug Laboratory, Karachi for test/analysis. Federal Government Analyst has declared the sample as Unregistered under the Drugs Act 1976.

The product detail as under: –

Therapeutic Goods Affected:-

SrProduct NameBatch #Manufactured by Remarks
1Sugar XL Capsules
 
Registration No.: Nil

Mfg. Date: Nil
Exp. date: use within 5 years		NilM/s. Naz Homoeo Pharmacy, KarachiGlibenclamide has been identified on an assay test (3.34mg) which is an allopathic drug and the sample is not registered with DRAP. Hence the sample is declared as “Un-registered Drug Product.”
Risk Statement:The Claimed Product is Homoeopathic with some quantity of an allopathic ingredient Glibenclamide which is an oral hypoglycemic drug used to treat type 2 diabetes. As the product is unregistered this infers that the quality and safety attributes of the product are not accepted and approved by DRAP.
 
Unregistered products containing Glibenclamide may cause adverse reactions including variation in blood glucose level which may lead to hypoglycemic conditions and the patient may get faint.
Action InitiatedThe Regulatory Field Force has been directed to increase surveillance throughout the supply chain to confiscate the product. All Pharmacists, chemists, and other healthcare professionals working at distributions, pharmacies, healthcare facilities, and other aspects of the supply chain system should immediately check the stock, and information related to the supplier of such products should be provided to the Regulatory field force (DRAP, Provincial Health Departments and States) to ensure the removal of this product.
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 the above-mentioned 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 ConsumersConsumers should not use this product and shall contact their physician or healthcare provider if they have experienced any problem related to taking or using this drug product and should report the incident to the Drug Regulatory Authority of Pakistan / National Pharmacovigilance Centre.

All therapeutic goods must be obtained from 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.

Rapid Alert: Drug Product; Falsified Defitelio Infusion  identified in the WHO Regions of Europe and the Eastern Mediterranean

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Rapid Alert

WHO Medical Product Alert N°3/2023 On Falsified DEFITELIO (defibrotide sodium)

DRAP Alert NoNo  I/S/06-23-25
Action Date19th June 2023
Target Audience1. Regulatory Field Force
2. Healthcare Professionals- Physicians, Pharmacists, and Nurses at hospitals and clinics, etc.
3. Pharmacists and Chemists at Distribution, Pharmacies, and Medical Stores
4. Patients, Caregivers, and General Public.
Problem StatementWHO issued Medical Product Alert No. 3/2023 on falsified batch No. 19G19A, Expiry Date 01/2025, of DEFITELIO identified in the United Arab Emirates and publically reported by the national regulatory authority (in November 2022). The falsified batch was also identified in Kyrgyzstan (in March 2023). They have been identified in UK/Ireland packaging and US packaging. This falsified product is not registered in Pakistan.
The genuine manufacturer of DEFITELIO has confirmed that the products referenced in WHO alert are falsified. Lab analysis of a sample of falsified products found it did not contain any of the stated active ingredients. The genuine manufacturer has also advised that:
    i.  Stated batch number 19G19A is not a genuine DEFITELIO batch number
    ii.   Expiry dates are falsified
    iii.   Falsified US pack with batch 19G19A / Exp. 01/2025- the vial inside the pack has a different batch number- M06B466E which is not a genuine batch number.
Therapeutic Goods Affected:-DEFITELIO 80 mg/ml Concentrate for Infusion
Active Ingredient: (Defibrotide Sodium)
Registration No.: Nil
Batch No. Outer carton Batch: 19G19A Exp. date: 01/2025 and Inner vial Batch: M06B466E
Purported Manufacturer (as per label) M/s. Gentium SRl

For further information please click for details of the affected products.
Risk StatementDEFITELIO (Defibrotide sodium) is an antithrombotic agent used to treat severe venous-occlusive disease (VOD) in adult and pediatric patients undergoing hematopoietic (blood) stem cell transplantation.
·         Use of falsified products will compromise the treatment of disease and may intensify the existing condition.
·         It may lead to life-threatening reactions due to intravenous administration as safety, sterility and quality of product are unknown.
Action InitiatedThe Regulatory Field Force has been directed to increase the surveillance activities at Health facilities (Hospitals) in addition to markets and confiscate the batch of products if available. All Pharmacists and chemists working at distributions and Pharmacies should immediately check the stock and stop supplying this batch 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 these 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 the above-mentioned products.

-Pharmacists and procurement officers present at healthcare facilities are requested to remain vigilant and inform patients of procuring medical products only from authorized channels.

-Adverse reactions or quality problems experienced with the use of these products 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 ConsumersTo ensure authenticity, consumers should always obtain medical products from authorized licensed pharmacies /outlets. The authenticity of these products should be carefully checked and If the consumer has any doubt, advice must be sought from your pharmacist.

In case a consumer has experienced any problem related to taking or using these drug product(s), they should cease the use of the product in question immediately and contact their Physician or Pharmacist and should also report the incident to the Drug Regulatory Authority of Pakistan.

Rapid Alert; Drug Product: Falsified Ciproxin 500mg Tablets identified in the Market

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Rapid Alert

Falsified Ciproxin 500mg Tablets

DRAP Alert NoNo  II/S/06-23-28
Action Date19th June 2023
Target Audience1. Regulatory Field Force
2. Pharmacists and Chemists at Distribution, Pharmacies and, Medical Stores
3. General Public
Problem StatementProvincial Drug Control team has seized suspected falsified Ciproxin 500mg Tablets during the market surveillance activities in the District Kasur, Punjab. The Manufacturing Authorization holder company i.e. M/s Bayer Pakistan (Pvt) Ltd, Karachi has stated that based on the physical verification of security features, the products seized are not genuine, and thus it is a spurious/falsified products.

The product detail as mentioned on the label is as under: –

Therapeutic Goods Affected:-

SrProduct NameComposition as per labelBatch #Manufactured by (as stated on label)
1Ciproxin 500mg Tablets

Mfg.Date: 12-21
Exp.Date: 11-26		CiprofloxacinBAA928M/s.Novartis Pharma (Pakistan) Ltd, Karachi
For Bayer Pakistan (Pvt) Ltd, Lahore
Risk Statement:Consequences of use of Spurious/ Falsified Drugs includes but not limited to followings:
-Falsified/Spurious drugs may contain toxic and narcotic/psychotropic ingredients in unacceptable doses which may be life threating.
-These are manufactured under unhygienic condition without the proper inspection and approval, which are highly injurious to human health.
-Poor-quality medicines compromise the treatment of diseases and may intensified the existing condition.
Action InitiatedThe Regulatory Field Force has been directed to increase surveillance throughout the supply chain to confiscate the product. All Pharmacists, chemists, and other healthcare professionals working at distributions, pharmacies, healthcare facilities, and other aspects of the supply chain system should immediately check the stock, and information related to the supplier of such products should be provided to the Regulatory field force (DRAP, Provincial Health Departments and States) to ensure the removal of this product.
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 products.

-Adverse reactions or quality problems experienced with the use of these 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 ConsumersConsumers should not use this product and shall contact their physician or healthcare provider if they have experienced any problem related to taking or using this drug product and should report the incident to the Drug Regulatory Authority of Pakistan / National Pharmacovigilance Centre.

All therapeutic goods must be obtained from 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.

Rapid Alert; Drug Product: Falsified Phenobar 30mg Tablets identified in the Market

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Rapid Alert

Falsified Phenobarbitone 30mg Tablets

DRAP Alert NoNo I/S/06-23-24
Action Date5th June 2023
Target Audience1. Regulatory Field Force
2. Pharmacists and Chemists at Distribution, Pharmacies and, Medical Stores
3. General Public
Problem StatementDrug Inspectorate field force including various Provincial Inspector of Drugs took samples of Phenobar 30mg Tablets from the market and asked the manufacturer stated on the label for verification of authenticity. The purported manufacturer i.e. M/s Star Laboratories (Pvt) Ltd., Lahore, has informed that following batches were not manufactured by them.

The product detail as mentioned on the label is as under: –

Therapeutic Goods Affected:-

SrProduct NameComposition as per labelBatch #Manufactured by (as stated on label)
1Phenobar Tablets 30mgPhenobarbitoneQA019,
QA025,
QA016.		M/s Star Laboratories (Pvt) Ltd .Lahore
Risk Statement:Consequences of use of Spurious/ Falsified Drugs includes but not limited to followings:
-Falsified/Spurious drugs may contain toxic and narcotic/psychotropic ingredients in unacceptable doses which may be life threating.
-These are manufactured under unhygienic condition without the proper inspection and approval, which are highly injurious to human health.
-Poor-quality medicines compromise the treatment of diseases and may intensified the existing condition.
Action InitiatedThe Regulatory Field Force has been directed to increase surveillance throughout the supply chain to confiscate the product. All Pharmacists, chemists, and other healthcare professionals working at distributions, pharmacies, healthcare facilities, and other aspects of the supply chain system should immediately check the stock, and information related to the supplier of such products should be provided to the Regulatory field force (DRAP, Provincial Health Departments and States) to ensure the removal of this product.
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 products.

-Adverse reactions or quality problems experienced with the use of these 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 ConsumersConsumers should not use this product and shall contact their physician or healthcare provider if they have experienced any problem related to taking or using this drug product and should report the incident to the Drug Regulatory Authority of Pakistan / National Pharmacovigilance Centre.

All therapeutic goods must be obtained from 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.

Recall Alert: Medical Devices; Aquavent Neonatal Breathing Circuits by M/s. Armstrong Medical Limited, Ireland

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DRAP Alert NoNo I/V/05-23-23
Action Date17th May 2023
Target Audience-Healthcare Professionals particularly working in the critical care areas of hospitals including Physicians, Pharmacists, and Nurses.
-Procurement Officers at Hospitals and Healthcare Institutions,
-Pharmacists and Chemists at Distribution, Pharmacies and Medical Stores
Product(s) Affected AQUAVENT NEO Neonatal CPAP limb
(Ventilator breathing circuit)
Manufactured by: Armstrong Medical Limited, Northern Ireland, Distributed by M/s. Elate C.C (Pvt) Ltd. Karachi, Pakistan
Batch No. 230123 (230123 as per the list in the Field Safety Notice)
Problem / Issue Armstrong Medical Limited, Ireland received reports for their Neonatal Breathing Circuits for risk of patient harm as a result of tubing (and a connector attached to the tubing) disconnecting from the elbow within Neonatal Breathing Circuits. Accordingly, the manufacturing company has issued a field safety notice and initiated recall of the defective product from the international market including Pakistan. 
Action Initiated-The manufacturing company has initiated a recall of the affected lots of defective products from the market where it was distributed.

-All healthcare professionals working in critical care units of hospitals as well as pharmacists and chemists working at distributions and pharmacies should immediately check their stocks and stop supplying these lots of the product. The remaining stock should be quarantined and returned to the supplier/company.

-Distributors and pharmacies are advised to be vigilant and report any suspected batch of the product(s) in the supply chain to the DRAP using the online form, or through phone at +92 51 910 73 17, or by 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 this product’s defective batch(es) to the importer/company.

-Adverse reactions or quality problems experienced with 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). They shall contact their physician or healthcare provider(s) if they have experienced any problem that may be related to using this Medical Device.

-All therapeutic products must be obtained from authorized licensed pharmacies /outlets. Their authenticity and condition should be carefully checked. If you have any doubts, please seek advice from your pharmacist.

    Rapid Alert: Falsified Sildenafil Citrate 100mg Tablets identified in the market

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    Rapid Alert

    Falsified and Unregistered Sildenafil Citrate 100mg Tablets

    DRAP Alert NoNoI/S/02-23-18
    Action Date3rd May 2023
    Target Audience1. Regulatory Field Force
    2. Pharmacists and Chemists at Distribution, Pharmacies and, Medical Stores
    3. General Public
    Problem StatementFederal Inspector of Drugs Karachi seized a sample of an unregistered product “Viagra 100mg Tablet” from the market and also sent the samples to Central Drug Laboratory, Karachi for testing/analysis. Federal Government Analyst has declared the sample as Spurious under section 3(z-b) (i) of the Drugs Act 1976.

    The product detail as mentioned on the label is as under: –

    Therapeutic Goods Affected:-

    SrProduct NameComposition as per labelBatch #Manufactured by (as stated on label)
    1Viagra 100mg Tablets

    Mfg. Date: 03-2021
    Exp. date:  03-2025    		Sildenafil Citrate19990544AGMs. Brooklyn, Ne.
    * Tablet Viagra sold in the black market is not registered with DRAP, hence considered Spurious /Falsified and unregistered, and its Quality, Safety, and Efficacy are not ascertained, hence its consumption may be harmful.
    Risk Statement:Consequences of the use of unregistered, Spurious/ Falsified Drugs include but are not limited to the followings:
    ·     Falsified/Spurious drugs may contain toxic ingredients which are manufactured under unhygienic conditions without the proper inspection and approval of the product, which are highly injurious to human health.
    ·     Poor-quality medicines compromise the treatment of diseases and may intensify the existing condition.
    Action InitiatedThe Regulatory Field Force has been directed to increase surveillance throughout the supply chain to confiscate the product. All Pharmacists, chemists, and other healthcare professionals working at distributions, pharmacies, healthcare facilities, and other aspects of the supply chain system should immediately check the stock, and information related to the supplier of such products should be provided to the Regulatory field force (DRAP, Provincial Health Departments and States) to ensure the removal of this product.
    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 products.

    -Adverse reactions or quality problems experienced with the use of these 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 ConsumersConsumers should not use this product and shall contact their physician or healthcare provider if they have experienced any problem related to taking or using this drug product and should report the incident to the Drug Regulatory Authority of Pakistan / National Pharmacovigilance Centre.

    All therapeutic goods must be obtained from 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.

    Recall Alert: Drug Product; Fluorazine 1mg Tablet (Batch # T-2065) CKD Pharmaceuticals Pak (Pvt) Ltd, Karachi

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    Recall Alert

    DRAP Alert NoNoI/S/04-23-20
    Action Date11th April 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 Fluorazine 1mg Tablets
    Composition: Trifluoperazine HCl
    Manufactured by: M/s. CKD Pharmaceutical, Karachi
    Batch No. 2040006
    Problem / Issue Provincial Drug Inspector, Karachi took the sample of Fluorazine 1mg Tablet. Provincial Government Analyst/Director, Drug Testing Laboratory, Karachi has declared the Batch No. T-2065 of the product as of substandard quality.
    Action Initiated-The manufacturing company/registration holder has been directed to immediately recall the defective product batch from the market.

    -All Pharmacists and chemists working at distributions and Pharmacies should immediately check their stocks and stop supplying this product batch. The remaining stock should be quarantined and returned to the supplier/company.

    -Distributors and pharmacies are advised to be vigilant and report any suspected batch of the product(s) in the supply chain to the DRAP using the online form, or through phone at +92 51 910 73 17, or by 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 this product’s defective batch(es) to the importer/company.

    -Adverse reactions or quality problems experienced with 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). They shall contact their physician or healthcare provider(s) if they have experienced any problem that may be related to taking or using this product.

    -All drug products must be obtained from authorized licensed pharmacies /outlets. Their authenticity and condition should be carefully checked. If you have any doubts, please seek advice from your pharmacist.
      Fluorazine-1mg-Recall-alertDownload

      Recall Alert: Drug Product; Spadix Injection (Batch# 570) by M/s. Tabros Pharma Karachi

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      Recall Alert

      DRAP Alert NoNoI/S/20-23-21
      Action Date20th April 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 Spadix 4mL Injection
      Composition: Phloroglucinol and Trimethylphloroglucinol
      Manufactured by: M/s. Tabros Pharma, (Pvt) Ltd., Karachi
      Batch No. 570
      Problem / Issue A video is circulating on social media regarding presence of a fly/insect in a liquid injection ampoule visible with naked eye, apparently seems to be having adulterated quality. The matter is still under investigation, however as a precautionary measure, to prevent any public health hazard, the alleged drug is being recalled from market.
      Risk StatementDrug Product contains fly/insect is of adulterated quality which may compromise the standard quality of drugs as not being sterile. The sterility is a basic quality attribute of all Injectable drugs. In this case such adulterated drug may initiate but not limited to following reaction in patients/users
      (i) Anaphylactic shock in patients which may lead to death of patient
      (ii) Skin rashes, itching, difficulty in breathing
      (iii) Sub optimal to no therapeutic effect for indicated medical treatment.
      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.
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        Drug Safety Alert: Potential risk of suicidal ideation/thoughts & self-injury with Finasteride

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        Drug Safety Alert

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

        Date:11th of April, 2023
        Target Audience:• Manufacturers and importers of Finasteride;
        • Healthcare Professionals; and
        • Patients, consumers or caregivers.
        Background:The Health Sciences Authority (HSA) of Singapore in August 2022 reminded healthcare professionals of the potential risk of suicidal ideation with the use of finasteride following results of a recent pharmacovigilance study that suggests younger patients with alopecia may be more vulnerable to the risk of suicide ideation. In the study, disproportionality analysis was used to assess whether suicidality or psychological adverse events (AEs) were more frequently reported for finasteride than would be expected by chance alone by comparing them against similar reports for all other drugs in VigiBase (WHO global database of ICSRs). The study identified 356 reports of suicidality and 2,926 reports of psychological AEs in users of finasteride, reported from 1993 to 2019. Among the reports with data available, the majority (99%) occurred in males, and 71% occurred in individuals aged between 18 and 44 years. Significant disproportionality signals for suicidality (reporting odds ratio [ROR], 1.63; 95% CI, 1.47-1.81) and psychological AEs (ROR, 4.33; 95% CI, 4.17-4.49) were identified in finasteride users.
         
        On 19th of January, 2023, Health Canada through its summary safety review informed that it is
         
        working with the manufacturers to update the product safety information in the Canadian product monographs (CPM) for finasteride-containing products to strengthen the warning statements on the risks of suicidal ideation and self-injury, and to include information about patient screening for psychiatric risk factors prior to starting treatment, as well as continuous patient monitoring during and after stopping treatment. The safety review was triggered by the publication of a media article that discussed the potential risk of suicide in patients using Propecia (finasteride) for male pattern hair loss. Health Canada’s review of the available information found a possible link between the use of finasteride and the risks of suicidal ideation and self-injury. At this time, there is not enough information to establish a link for the risk of suicide. However, strengthening of warning statements was warranted.
        It was informed that Health Canada was monitoring the risk of suicidal ideation with the use of finasteride since 2012 and has completed 2 safety reviews in 2012 and 2015, and the information available at the time was considered too limited to determine whether there was a link between the use of finasteride and suicidal thoughts and behaviours (suicidality). In 2019, following reports of Canadian and international cases of suicide, suicidal ideation and self-injury with the use of finasteride, the agency completed a third safety review that found a possible link between finasteride and the risk of suicidal ideation. The CPMs of finasteride were accordingly updated to include the risk of suicidal ideation.
        Most recently in 2022, due publication of a media article that discussed the potential risk of suicide in patients using Propecia (finasteride) for male pattern hair loss, Health Canada completed a review of the risk of suicidal ideation and potential risks of suicide and self-injury with the use of finasteride. The purpose of the current review was to consider recent information and determine if additional measures were warranted. A review of the available information found a possible link between the use of finasteride and the risks of suicidal ideation and self-injury. At this time, there is not enough information to establish a link between the use of
         
         
        finasteride and the risk of suicide. Therefore, strengthening of warning statements on the risks of suicidal ideation and self-injury was warranted and Health Canada is working on it.
        Furthermore, the most recent Vigilyze statistics related to the finasteride and Standard MedDRA Query(SMQ) selected Depression and suicide/self-injury study identified 2,995 reports and 471 reports specifically with suicidal ideation. The larger portion of the reactions in known gender occurred in males (31.9%, and 45.6% in individuals aged between 18 and 44 years respectively, with the broader SMQ and specifically suicidal ideation. Significant disproportionality signals for suicidal ideation (reporting odds ratio [ROR], 10.6) and SMQ (ROR, 4.5) were identified.
        Therapeutic Good(s) Affected:Name:  Finasteride. 

        Finasteride is indicated for the treatment of benign prostatic hyperplasia and androgenic alopecia.
        Action in PakistanAccordingly, the case of the potential risk of suicidal ideation/thoughts & self-injury with finasteride 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 decided as per Rule 10 (1) (h) (iv) of Pharmacovigilance Rules, 2022 that registration holders should update prescribing information/safety specification of finasteride containing drugs by strengthening the warning statements on the risks of suicidal ideation and self-injury, and to include information about patient screening for psychiatric risk factors before starting treatment.
        Advice for healthcare professionals:Healthcare professionals are informed that mood alterations including depression and, less frequently, suicidal ideation have been reported in patients treated with finasteride and are hereby advised to consider the potential risk of psychological adverse events when assessing the benefit-risk of finasteride for their patients. Healthcare professionals should also advise their patients to consult their doctors at the earliest when such thoughts are developed.
        Advice for patients:Patients are advised to immediately consult their doctors if they experience mood alterations including depression and less frequently, suicidal ideation or self-injury etc.
        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.
          35-Safety-Alert-of-Potential-risk-of-suicidal-ideation-thoughts-self-injury-with-FinasterideDownload

          Drug Safety Alert: Risk of complex sleep behaviours with Zolpidem

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          Drug Safety Alert

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

          Date:11th of April, 2023
          Target Audience:• Manufacturers and importers of Zolpidem
          • Healthcare Professionals; and
          • Patients, consumers or caregivers.
          Background:The Ministry of Health Labour and Welfare (MHLW) and the Pharmaceutical and Medical Device Agency (PMDA) of Japan in July, 2022 have announced that the product information for triazolam, zolpidem, zopiclone and eszopiclone should be revised to include the risk of abnormal behaviour as parasomnia. In addition, the use of triazolam, zolpidem or zopiclone is to be contraindicated in patients who have experienced abnormal behaviour such as parasomnia. Based on the published literature on the pharmacological mechanisms of parasomnia and cases of parasomnia reported in Japan, it was concluded the four drugs can increase the risk of abnormal behaviour as parasomnia, which may lead to serious self/other injuries or accidents. Also, a contraindication is considered necessary for triazolam, zolpidem and zopiclone in patients with a history of drug-induced parasomnia due to the risk of recurrence. Regarding eszopiclone, careful administration is still required but it is not a contraindication at this time, as there have been no reports of parasomnia in Japan for this drug.
          Previously, the United States Food and Drug Administration (US-FDA) in April 2019 announced that rare but serious injuries have occurred with some medicines used to treat insomnia such as eszopiclone (Lunesta®), zaleplon (Sonata®) and zolpidem (Ambien®.). The
           
          injuries are a result of sleep behaviours which include: sleepwalking, sleep driving and engaging in other activities while not fully awake. These complex sleep behaviours have also resulted in deaths. Serious injuries and death from complex sleep behaviours have occurred in patients with and without a history of such behaviours, even at the lowest recommended doses, and the behaviours can occur after just one dose. These behaviours can occur after taking these medicines with or without alcohol or other central nervous system depressants that may be sedating such as tranquillizers, opioids, and anti-anxiety medicines. As a result, FDA required information about this risk to be added to the Boxed Warning, the FDA’s prominent warning and also to the contraindication (strongest warning) to avoid use in patients who have previously experienced an episode of complex sleep behaviour with eszopiclone, zaleplon, and zolpidem.
          Therapeutic Good(s) Affected:Name:  Zolpidem. 

          Zolpidem tartrate is indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation.
          Action in PakistanAccordingly, the case of the risk of complex sleep behaviours with Zolpidem 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 decided as per Rule 10 (1) (h) (ii), (iv) and (vi) of Pharmacovigilance Rules, 2022 that registration holders should update the prescribing information/safety specification of zolpidem-containing drugs by including information related to complex sleep behaviour in the warning and precaution sections, information related to contraindications in patients who have experienced complex sleep behaviours after taking these drugs in the past, and to create a boxed warning as per the format of Reference Regulatory Authority (RRA).
          Advice for healthcare professionals:Healthcare professionals are requested to ask patients and their families or other caregivers at the time of prescribing or dispensing of zolpidem tartrate as to whether the patients have experienced abnormal behaviour as a symptom of parasomnia after they used these drugs in the past. Examples of abnormal behaviour as a symptom of parasomnia include: walking around indoors or outdoors; driving a car; making or eating a meal; making a phone call; behaving violently or calling out, etc. Most of the abnormal behaviours occur after the use of the drug without being fully awake, and those behaviours are not remembered the next day. Healthcare professionals are also advised to not prescribe zolpidem to patients who have previously experienced complex sleep behaviours after taking this medicine. Also, healthcare professionals should advise all patients that although rare, those behaviours have led to serious injuries or death and that if patients experience an episode of complex sleep behaviour, they should discontinue taking the medicines.
          Advice for patients:Patients should stop taking Zolpidem and contact their healthcare professionals right away if they experience a complex sleep behaviour where a patient is engaged in activities while he/she is not fully awake or if the patient do not remember activities they have done while taking the medicine.
          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.
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