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Drug Safety Alert: Risk of Major Congenital Malformations with Pregabalin

Asad Ullah 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 Pregabalin;
• Healthcare Professionals; and
• Patients, consumers or caregivers.
Background:The Medicine and Healthcare Products Regulatory Agency (MHRA) of the United Kingdom on 19th April, 2022 announced that the product information for pregabalin will be updated to include information from a new study which has suggested pregabalin may slightly increase the risk of major congenital malformations if used in pregnancy. The MHRA reviewed the results of a Nordic observational study that consisted of 2,700 pregnancies exposed to pregabalin in the first trimester, alongside a recent European review which had the same conclusions. The study showed a higher prevalence of major congenital malformations in the babies (live or stillborn) exposed to pregabalin in the first trimester of pregnancy compared with those not exposed to pregabalin or any other antiepileptic drug.
The review concluded that pregabalin’s use during the first trimester of pregnancy may cause a slight increase in the risk of major congenital malformations in the unborn child. Furthermore, the Health Products Regulatory Authority (HPRA) of Ireland back in February 2022 also recommended that product information of Pregabalin along with other anti-epileptic drugs be updated based on the evidence of risks associated with in-utero exposure to these drugs. The product information of pregabalin continues to advise that effective contraception should be used during treatment and that use in pregnancy should be avoided unless it is necessary.
Therapeutic Good(s) Affected:Name of Drug: Pregabalin

Pregabalin is indicated for the treatment of peripheral and central neuropathic pain in adults, as adjunctive therapy in adults with partial seizures with or without secondary generalization, and for generalized anxiety disorder in adults.
Action in PakistanAccordingly, the case of the risk of major congenital malformations with Pregabalin 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 after detailed deliberation and discussion decided as per Rule 10 (1) (h) (iv) and (vi) of Pharmacovigilance Rules, 2022 (reliance mechanism) to update prescribing information of Pregabalin to include information from a new study that pregabalin may slightly increase the risk of major congenital malformations if used in pregnancy and include advise on effective contraception during treatment in pregnancy.
Advice for healthcare professionals:A new study has demonstrated that pregabalin may slightly increase the risk of major congenital malformations if used in first trimester of pregnancy. Therefore, healthcare professionals should provide counselling to the patients on potential risks to an unborn baby with pregabalin and also on the need to use effective contraception during the treatment. Healthcare professionals are also advised to continue to avoid the use of pregabalin during pregnancy unless clearly necessary and only if the benefit to the patient clearly outweigh the potential risk to the fetus. In case where the benefit outweighs the risk, and it is clearly necessary that pregabalin has to used during the pregnancy, then the lowest effective dose should be used.
Advice for patients:Patients are advised to talk to their doctors before initiation of treatment with Pregabalin and discuss the benefit-risk of the medicine, particularly related to their case. Patients are also advised to talk with their healthcare professionals and use an appropriate contraception method during the treatment with Pregabalin to avoid pregnancy.
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.
Pregabalin (Lyrica): findings of safety study on risks during pregnancy of MHRA.
    27_Safety_Alert_of_Risk_of_Major_Congenital_Malformations_with_Pregabalin.Download

    Rapid Alert: Drug Product; Falsified Xanax 0.5mg Tablets identified in the market

    Asad Ullah News & Updates, Recall Alerts, Regulatory Updates

    Rapid Alert

    Suspected Falsified Product

    DRAP Alert NoNoI/S/11-22-37
    Action Date28th 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 Ferozewala District Sheikhupura Punjab, Regulatory Field Force has identified the suspected sample of Xanax 0.5mg Tablets and sent for analysis. The Provincial Drugs Testing Laboratory, has declared the samples as “spurious” based on the analysis report. Details of the falsified product is as under: –

    Therapeutic Good(s) Affected:-

    SrProduct NameCompositionBatch #Manufactured by (as stated on label)
    1Xanax 0.5mg TabletAlprazolam 0.5mgFM7597M/s Pfizer Pakistan Ltd,
    B-2, S.I.T.E, Karachi.
    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 this falsified product.
    Advice for Healthcare Professionals-DRAP requests increased vigilance within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by this defective batch of above-mentioned product(s).

    -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 reporting problems 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 only 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-xanax-0.5mg-TabDownload

    DRAP finalized guidelines on Post Registration Variations of Pharmaceutical and Biological Drug Products

    Asad Ullah Drugs, General, Regulatory Updates

    DRAP has finalized its guidelines on procedure and data requirement for post registration variation of pharmaceutical and biological drug products. This document will assist manufacturers and importers to incorporate variations in their product to account administrative changes, technical and scientific progress, or to improve or introduce additional safeguards.

    These Guidelines will assist both Regulators and Industry on the regulation of variation / changes to the original registrations / Market Authorization of products in terms of procedures and criteria for the appropriate categorization, reporting of changes and subsequent approval as required. Data requirements are listed out to evaluate the impact of the proposed / intended change on the quality, safety and efficacy of the locally manufactured / imported finished pharmaceutical and biological drug products intended for human and veterinary use.

    Registration holders of Pharmaceutical / Biological drug products for human and veterinary use are responsible for the safety, efficacy and quality of a finished pharmaceutical / biological drug product that is placed on the market throughout its approved life cycle. These guidelines are intended to provide supportive information for submission of post registration variation application by the registrations / marketing authorization holders of the finished drug products to implement a change. These guidelines will:-

    1. Facilitate the interpretation of the relevant regulations and decisions of Registration Board regarding post registration variations of registered drug products.
    2. Assist applicants to determine type of variation applies in each case with the classification entailing prior approval or intimation to DRAP.
    3. Provide guidance as per applicable SOPs on the conditions and other data requirements to support variance application.

    The draft guidelines on data requirements for post registration variation were prepared three years ago and was available on the DRAP’ s website. Stakeholders have submitted their comments on the draft document and accordingly guidelines have been finalized after careful consideration of stakeholder’s comments.

    Post Registration Variation GuidelinesDownload

    For more information on Regulatory Guidelines published by DRAP, please navigate to Publications tabs on our website.

    Stakeholder Comments are invited on the Draft Therapeutic Goods (Federal Inspectors, Laboratories and Federal Government Analysts) Rules, 2022

    Asad Ullah Licensing and Inspections, News & Updates, Notifications, Regulatory Updates

    Drug Regulatory Authority of Pakistan Act, 2012 provides the legal mandate to inspect and enforce GXPs through out the supply chain of therapeutic Goods. Inspection of establishments is an essential regulatory function, to monitor the regulatory compliance to ensure that operations at these establishments are carried out in accordance with approved standards, conditions, guidelines and legislations. The scope of the Inspections applies to different Good Practices (GXPs) including Good Manufacturing Practices (GMPs), Good Distribution Practices(GDPs) and Good Clinical Practices (GCPs), etc.

    DRAP Act 2012, under its Schedule-V provides the legal provisions for appointment, powers and procedures for working of Inspectors. These draft rules are intended to replace the existing Drugs (Federal Inspectors, Federal Drug Laboratory and Federal Government Analyst) Rules, 1976 and are aimed at converting Inspection activities to be based on a risk management approach, capable of revealing weaknesses and deficiencies in the production, quality control, storage or distribution of therapeutic goods, as well as to devise a uniform procedures for taking regulatory actions and handling of products with suspected quality defects or identified as substandard and falsified.

    These draft Therapeutic Goods (Federal Inspectors, Laboratories and Federal Government Analysts) Rules, 2022 were uploaded on the official website of DRAP dated 24th November, 2022, seeking comments and suggestions from stakeholders on the draft rules. Stakeholders can submit their comments and suggestions within 14 days of uploading this draft using prescribed format, (further information on comments submission is available on this link). Comments and suggestions can be forwarded via email to aamar.latif∂dra.gov.pk , copying at ajmal.shoail∂dra.gov.pk , or can be posted at mailing address, Additional Director, Division of Legal Affairs, Drug Regulatory Authority of Pakistan, 1st floor, TF Complex, 7th Mauve Area, G-9/4, Islamabad.

    Draft-Therapeutic-Goods-Federal-Inspectors-Laboratories-and-Federal-Government-Analysts-Rules-2022Download

    DRAP invited Comments from Stakeholders on the Draft Therapeutic Goods (Advertisement) Rules, 2022

    Ijaz Mustafa Advertisements, Drugs, Notifications, Publications

    Drug Regulatory Authority of Pakistan Act, 2012 under section 7 (c)(iii) and (x) mandated the DRAP for the regulation of Advertisements, enforcement and monitoring of advertisement rules and ban on false advertisement. Schedule II- B of the DRAP Act, 2012 prohibits the advertisements of any therapeutic goods except in accordance with the prescribed conditions.

    The current changing trend of advertisement and promotional activities by pharmaceutical companies and the requirement of extension of scope from drugs to therapeutic goods has led to the development of these draft rules. These draft rules contain provisions almost similar to the ones given in Rule 31 of the Drugs (Licensing, Registering & Advertising) Rules 1976, included but not limited to; amended Schedule with the list of drugs permissible for advertisement as earlier consulted with stakeholders, Schedule with diseases for which advertisement is prohibited, schedule with the details on advertisement or promotional material keeping in consideration the ethical criteria; Forms for submitting applications of advertisement approval, Formats for granting approval for advertisement and schedule with details on advertisement or promotional material keeping in consideration the ethical criteria.
    These draft Therapeutic Goods (Advertisement) Rules, 2022 were uploaded on the official website of DRAP dated 21st November, 2022, seeking comments and suggestions from stakeholders on the draft rules. Stakeholders can submit their comments and suggestions within 14 days of uploading this draft using prescribed format, (further information on comments submission can be accessed on this link). Comments and suggestions can be forwarded via email to aamar.latif∂dra.gov.pk , copying at aqsa.hashmi∂dra.gov.pk , or can be posted at mailing address, Additional Director, Division of Legal Affairs, Drug Regulatory Authority of Pakistan, 1st floor, TF Complex, 7th Mauve Area, G-9/4, Islamabad.

    Click here to View/Download the draft Therapeutic Goods (Advertisement) Rules, 2022

    Draft-Therapeutic-Goods-Advertisement-Rules-2022Download

    Medicine Safety Week 2022; DRAP’s Call to Healthcare Professionals and Patients to Report Suspected Adverse Reactions of drugs and vaccines.

    Asad Ullah News & Updates, Pharmacovigilance, Press Releases

    The seventh annual Social Media Campaign #MedSafetyWeek was launched on the 7th of November, 2022 by the National Pharmacovigilance Centre, DRAP, which was observed until 13th November 2022, to encourage everyone to report suspected side effects of medicines. The International campaign was led by the Uppsala Monitoring Centre (UMC), the World Health Organisation (WHO) Collaborating Centre for International Drug Monitoring.

    This year’s global campaign involved medicines regulators from 81 countries and focused on the key role of every healthcare professional, patient, and caregivers who reports a suspected side effect and contributes to using medicines safely. This campaign was supported by the members of the International Coalition of Medicines Regulatory Authorities (ICMRA)

    #MedSafetyWeek 2022

    Every report to the National Pharmacovigilance Centre, DRAP helps to improve the safety of medicines for all patients.

    People are encouraged to report suspected side effects of medicines as part of the global #MedSafetyWeek social media campaign

    Why Reporting is required?

    All medicines may cause side effects in some patients, so there are steps in place to continuously monitor their safety after they are placed on the market. The purpose of safety monitoring is to gain more information about known side effects and find out about new ones. Regulatory bodies operate systems to detect and analyse those side effects and prevent harm to future patients.

    The National Pharmacovigilance Centre, DRAP, collects, organises, and investigates reports of suspected side effects / Adverse effects.

    By reporting suspected side effects, you are actively participating in identifying emerging safety issues, so that DRAP can take action when necessary and protect you and others from harm.

    Every Report is important for us

    Every report made by a patient, a healthcare professional, or a caregiver plays a key role in gaining more knowledge about the benefits and risks of medicines in clinical use and allows action to be taken to minimize risks and can result in better tailored prescribing advice, which can improve patient outcomes.

    Patients / care givers and all healthcare professionals can report suspected side effects to the National Pharmacovigilance Centre, DRAP. You can submit a report in many ways:

    Are you a Pharmacist?

    You are the first person patients go to when they have questions about their medicines.  Please report any new side effects of a medicine via the [Med Safety App & E reporting https://primaryreporting.who-umc.org/PK 

    DRAP Signed MoU with Pakistan Single Window to Foster Cooperation

    Asad Ullah News & Updates, Press Releases
    DRAP Signed MoU with Pakistan Single Window to Foster Cooperation

    The Islamabad 11th Nov, 2022; Drug Regulatory Authority of Pakistan signed a memorandum of understanding with the Pakistan Single Window (PSW) in a ceremony held on 11th Nov 2022 at Islamabad. This MoU is aimed at enhancing cooperation among two departments through digital integration of IT System of PSW with the regulatory processed of DRAP. This will enable therapeutic goods industry to utilize an integrated electronic platform for import and export of raw materials and finished products using single entry point.  PSW will support international trade of therapeutic goods by recognizing standardized information and documents on an online platform which will fulfill all import, export, and transit regulatory requirements.

    Speaking to the participant at the ceremony, Mr. Asim Rauf, CEO DRAP lauds the efforts and contribution of PSW team and stated that DRAP is continuously transforming its regulatory operations into IT based electronic solutions and various initiatives are underway to revamp drug regulatory system in the country. DRAP is one of the largest organizations in public sector that has fully replaced the manual filling system with an electronic office module for intradepartmental communication and decision making. This MoU will mutually benefit both Regulators and Industry by enabling one window working environment in electronic format which support compliance with all regulatory requirement and processes for cross border trade of therapeutic goods. DRAP and PSW will continue to support each other for provision of more facilitating regulatory environment to industry. In future, DRAP will also integrate licensing and registration systems for therapeutic goods with PSW.         

    Suspected Falsified Alert; Drug Products; Suspected Anti-D Immunoglobulin Injection in the market

    Asad Ullah Recall Alerts, Regulatory Updates

    Rapid Alert

    DRAP Alert NoNoI/S/10-22-29
    Action Date28th October 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 StatementDRAP received a complaint regarding the presence of following suspected product in the market. This product is not imported and marketed by the authorized registration holder and neither DRAP has issued import clearance for this product. National Control Laboratory for Biological has also not issued any lot release to this product.
    SrProduct NameCompositionBatch #Manufactured by (as stated on label)
    101 IMMUNORHO 300µg (1.500iu)
    (PFS; Pre-filled syringe)     		Human anti-D immunoglobulinM05W25212M/s. KEDRION BIOPHARMA.
    Action InitiatedThe Regulatory Field Force has been directed to increase the market surveillance and confiscate this 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 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 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.
    Pictures of Suspected falsified product
    immunorho-safety-alert-revisedDownload

    Regulatory Update / Advisory; Recall of Targocid 200mg powder for solution for injection/infusion or oral solution in UK

    Asad Ullah News & Updates, Recall Alerts, Regulatory Updates

    Date:   31st October, 2022

    Target Audience: –  

    • Healthcare Professionals- Physicians, Pharmacists, and Nurses.
    • General Public

    Problem or Issue: –

    Sanofi UK has initiated an urgent recall of two batches of Targocid 200mg powder for solution for injection/infusion or oral solution (Batch Number 0J25D1 and Batch Number 0J25D2). Reason for recall is the out of specifications results obtained for bacterial endotoxins in the retained samples.

    However, both of these batches were not imported or marketed in Pakistan by the authorized registration holder company, hence, Pakistan’s market will not be affected by this recall operation.

    Nonetheless, DRAP has directed registration holder company to test the retaining samples of other batches which are supplied in Pakistan to ensure that problem is not extended beyond the identified two batches.  

    Advice for healthcare professional: –

    Healthcare professionals should be aware of the clinical symptoms related to the potential risk to patient health; a high temperature (fever) or low body temperature, chills and shivering, cold, clammy and pale or mottled skin, a fast heartbeat, fast breathing, severe breathlessness, severe muscle pain, feeling dizzy or faint, a change in mental state – such as confusion or disorientation, loss of consciousness, slurred speech, nausea and vomiting and/or diarrhea.

    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.  Further information on how to report a problem to DRAP is available on this link.

    Advice for general public: –

    Since, these affected batches have not been imported or supplied in Pakistan by the marketing authorization holder, no recall is initiated for this product in Pakistan. These these batches were supplied and being recalled in the UK market only. However, if any person has carried these affected batches for their personal use they are advised not to consume it, and consult their healthcare provider immediately.

    ADVISORY-TARGOCID-final-revisedDownload