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Drug Safety Alert: Risk of Myasthenia Gravis and Ocular Myasthenia with Statins.

Asad Ullah Safety Alerts

Drug Safety Alert

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

Date:27th  of April, 2024
Target Audience:·         Manufacturers and Importers of statins;
·         Healthcare Professionals; and
·         Patients, Consumers or Caregivers.
Background:The Pharmacovigilance Risk Assessment Committee (PRAC) of EMA in February, 2023 has recommended a change to the product information for statins to include potential risks of myasthenia gravis and ocular myasthenia.  In a few cases, statins have been reported to induce de novo or aggravate pre-existing myasthenia gravis or ocular myasthenia. Treatment with statins should be discontinued in case of aggravation of symptoms. Recurrences when the same or a different statin was (re-) administered have been reported.
 
The MHRA-UK in September 2023 informed the healthcare professional and patient about the European’s review recommendation related to new warnings on the risk of new-onset or aggravation of pre-existing myasthenia gravis with multiple statins. The findings of the European review were considered by the Pharmacovigilance Expert Advisory Committee (PEAG) of the Commission on Human Medicines (CHM), which agreed with the recommendations. It was informed that the product information of all statins is being updated to list myasthenia gravis and ocular myasthenia gravis as adverse drug reactions with a frequency ‘not known’. New warnings will also be added to the Summaries of Product Characteristics and Patient Information Leaflets.
Therapeutic Good(s) Affected:Statins are HMG-CoA reductase inhibitors and include atorvastatin, fluvastatin, lovastatin, pitavastatin, pravastatin, rosuvastatin and simvastatin. Statins are an acceptably safe and effective group of medicines that help lower the level of low-density lipoprotein (LDL) cholesterol in the blood. Statins play an important role in the treatment of atherosclerotic cardiovascular disease.
Action in PakistanThe case was discussed in the 4th meeting of the Pharmacovigilance Risk Assessment Expert Committee (PRAEC) of the DRAP held on 26th of February, 2024 which decided the case as per Rule 10 (1) (h) (iv) of Pharmacovigilance Rules, 2022, that registration holders of statins (HMG-CoA reductase inhibitors) should update the warning and precaution section about the risk of myasthenia gravis and ocular myasthenia gravis and list as adverse drug reactions with a frequency ‘not known’ in the adverse drug reaction section.
 
Advice for healthcare professionals:Healthcare professionals are advised to refer patients presenting with suspected new-onset myasthenia gravis after starting statin therapy to a neurology specialist – it could be necessary to discontinue statin treatment depending on the assessment of the individual benefits and risks. Likewise, healthcare professionals should advise patients with pre-existing myasthenia gravis to be alert to the aggravation of symptoms while taking a statin.
Advice for patients:Patients are informed that many people who take statins do not experience side effects and, where this does happen, these are typically mild – but it is important to read the Patient Information Leaflet that comes with their medicine and talk to a healthcare professional if they are experiencing problems. Patients are also advised not to stop their statin treatment without first discussing this with their doctor. Before taking a statin, inform your doctor if you have a history of myasthenia gravis or ocular myasthenia. Talk to your doctor if you experience weakness in your arms or legs that worsens after periods of activity, double vision or drooping of your eyelids, difficulty swallowing, or shortness of breath. Seek medical help immediately if you develop severe breathing or swallowing problems.
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 the 4th meeting of the Pharmacovigilance Risk Assessment Expert Committee.
·         Statins: very infrequent reports of myasthenia gravis report of MHRA-UK.
· Product Information safety updates – October 2023 of TGA- Australia.
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Schedule of Meetings of Clinical Studies Committee (CSC) for the Year 2024

Asad Ullah Clinical Trials

The Clinical Studies Committee (CSC) of Drug Regulatory Authority of Pakistan (DRAP) is mandated under Bio Study Rules 2017 for the regulatory oversight of clinical trials and clinical studies related to therapeutic goods in the country. The CSC reviews and approves clinical study protocols, ensuring they adhere to ethical and scientific standards. It also monitors ongoing clinical trials to assess participant safety and efficacy, makes informed decisions regarding study design, and collaborates with researchers, sponsors, and other stakeholders to ensure quality clinical research and safety of the participants.

The Committee has decided that the CSC meetings will be convened after every 45 days and an annual CSC meeting schedule for 2024 (tentative) has been issued with the aims to enhance transparency, efficiency, and collaboration.

S. No.CSC MeetingProposed Dates
0149th CSC Meeting2nd week of May, 2024
0250th CSC Meeting4th week of June, 2024
0351st CSC Meeting2nd week of August, 2024
0452nd CSC Meeting4th week of September, 2024
0553rd CSC Meeting2nd week of November 2024
0654th CSC Meeting4th week of December, 2024
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Change in Manufacturing Unit of M/s Sois Life Sciences to Site at G-77. S.I.T.E. Super Highway, Phase-II, Karachi.

Ijaz Mustafa Alternative Medicines, General

The Enlistment Evaluation Committee (EEC) in 120th meeting has considered the request of M/s Sois Life Sciences for change in manufacturing facility for their products from A-84, SITE, Super Highway, Phase-I, Karachi to their manufacturing site situated at G-77, S.I.T.E, Super Highway, Phase-II, Karachi. The EEC acceded the request of the firm and revoked the Enlistment Certificate No 01304.

Henceforth, all the product of M/s Sios Sois Life Sciences will be manufactured G-77, S.I.T.E, Super Highway, Phase-II, Karachi viz-a-viz Enlistment No. 0090. Therefore, manufacturing of Alternative medicines and health products by M/s Sois Life Sciences at A-84, S.I.T.E, Super Highway, Phase-I is prohibited and punishable offence under Rule 11 of the SRO 412 (I) /2014 read with Schedule II and III of the DRAP Act, 2012. Accordingly Notifications have been issued for strict compliance.

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Revocation-of-Form-6-01304-of-Ms-Sois-KarachiDownload

Recall Alert; Drug Products: Mebzole 100mg/5mL Suspension and Bioris 1mg/ml Oral Solution by M/s Biolabs Pvt., Ltd., Islamabad

Asad Ullah Recall Alerts

Recall Alert

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DRAP Alert NoNo I/S/04-24-18
Action Date29th April 2024
Target Audience– National Regulatory Field Force.
– Pharmacists and Chemists at Distribution, Pharmacies and Medical Stores
– Healthcare Professionals- Physicians, Pharmacists, and Nurses at hospital and clinics
– General Public
Problem / Issue The Federal Government Analyst, CDL Karachi has declared the following batches of oral liquid preparations manufactured by M/s Biolab Pvt Ltd, Islamabad as of “Sub-standard” quality based on the presence of Ethylene Glycol impurity at an unacceptable level.

Therapeutic Good(s) Affected: –

Product NamesCompositionBatch No Manufactured by
Mebzole 100mg/5mL Suspension
 
Reg No. 046308		MebendazoleBatch No. 22J022(F), 22J022(B)

Mfg. Date: 09-22
Exp. date: 08-24		M/s. Biolabs
(Private.) Limited.,
Islamabad.
Bioris 1mg/ml Oral Solution
 
Reg No. 069917		RisperidoneBatch No. 23B061


Mfg. Date: 02-23
Exp. date: 01-25		M/s. Biolabs
(Private.) Limited.,
Islamabad.
Risk Statement:The presence of Ethylene Glycol (EG) in oral liquid preparations poses serious health risks due to its toxicity as small amounts of EG can be fatal, especially for children. When ingested, both diethylene glycol (DEG) and EG are metabolized into toxic compounds that can adversely affect the central nervous system, heart, and kidneys.
Action Initiated–The manufacturer has been directed to immediately recall the defective batches of affected products from the market. All pharmacists and chemists working at distributions and pharmacies should immediately check their stocks and stop supplying these batches of products.

–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 ProfessionalsDRAP requests to enhance vigilance within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by this defective batch of the product.  

-Adverse reactions or quality problems experienced with this product may be reported to the National Pharmacovigilance Centre(NPC), DRAP using the 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 these 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 product.

-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.

    Recall Alert; 03 Batches of Veterinary Drug Products by M/s Biolabs Pvt., Ltd., Islamabad

    Asad Ullah Recall Alerts

    Recall Alert

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    DRAP Alert NoNo I/S/04-24-16
    Action Date28th April 2024
    Target Audience– National Regulatory Field Force. 
    – Points of sale and distributors of veterinary medicine. 
    – Veterinary Doctors and professionals. 
    – General Public 
    Problem / Issue The Federal Government Analyst, CDL Karachi has declared has declared the following 03 batches of veterinary drug products, manufactured by M/s. Biolabs (Private) Limited, Islamabad as “Adulterated” based on the presence of unaccepted level of Ethylene Glycol and Diethylene Glycol impurities.

    Therapeutic Good(s) Affected: –

    Product NamesCompositionBatch No Remarks 
    Clo-Animectin Injection 
     
    Reg No.095618    		Clorsulon 100mg/ml 
    Ivermectin 10mg/ml     		Batch No. 009A24 
     
    Mfg. Date: 01-24 
    Exp. date: 12-25     		Sample is “Adulterated” due to presence of: 
    Ethylene Glycol: 14.36% 
    Diethylene Glycol: 2.92% 
    Bio-Oxicam 0.75% Injection 

    Reg No.088836    		Meloxicam 7.5mg/ml Batch No. 083C23 
     
    Mfg. Date: 03-23 
    Exp. date: 02-25     		Sample is “Adulterated” due to presence of
    Ethylene Glycol: 24.19% 
    Bio-E-Floxacin 10% Injection 

    Reg No.088834    		Enrofloxacin 100mg/ml Batch No. 047K22 
     
    Mfg. Date: 10-22 
    Exp. date: 09-24     		Sample is “Adulterated” due to presence of 
    Ethylene Glycol: 12.08% 
    Risk Statement:EG (Ethylene Glycol) is a toxic substance that can have serious adverse effects. EG is metabolized into toxic metabolites that can affect the central nervous system, and heart, and can cause kidney damage, which can be fatal. Although, there is no available data on the systemic absorption of injected EG, and no instances of human or animal toxicity from injection of EG have been reported in the literature.
    Action Initiated–The manufacturer has been directed to immediately recall the defected batch of product from the market. All personnel working at distributions and point of sales of veterinary medicine should immediately check their stocks and stop supplying this batch of product. The remaining stock should be quarantined and returned to the supplier/ company. Regulatory field force of all federating units (DRAP and Provincial Health Departments) should also increase surveillance in the market to ensure the effective recall of defective products(s). 

    –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 Veterinary ProfessionalsDRAP requests to enhance vigilance within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by this defective batch of the product.  

      Recall Alert; Drug Products: Artecid 75mg/3mL Injections by M/s Biolabs Pvt., Ltd., Islamabad

      Asad Ullah Recall Alerts

      Recall Alert

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      DRAP Alert NoNo I/S/04-24-17
      Action Date28th April 2024
      Target Audience– National Regulatory Field Force.
      – Pharmacists and Chemists at Distribution, Pharmacies and Medical Stores
      – Healthcare Professionals- Physicians, Pharmacists, and Nurses at hospital and clinics
      – General Public
      Problem / Issue The Federal Government Analyst, CDL Karachi has declared the batch number “23E018” of Artecid 75mg/3mL Injection, manufactured by M/s. Biolabs (Private) Limited, Islamabad as “Adulterated” based on the presence of unaccepted level of Ethylene Glycol impurity.

      Therapeutic Good(s) Affected: –

      Product NamesCompositionBatch No Manufactured by
      Artecid 75mg/3mL Injections
       
      Reg No.075186      		Diclofenac SodiumBatch No.  23E018
       
      Mfg Dt: 05-2023
      Exp.Dt: 04-2025      		M/s. Biolabs
      (Private.) Limited.,
      Islamabad.
      Risk Statement:EG (Ethylene Glycol) is a toxic substance that can have serious adverse effects. EG is metabolized into toxic metabolites that can affect the central nervous system, and heart, and can cause kidney damage, which can be fatal. Although, there is no available data on the systemic absorption of injected EG, and no instances of human or animal toxicity from injection of EG have been reported in the literature.
      Action Initiated–The manufacturer has been directed to immediately recall the defective 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 quarantined and returned to the supplier/ company. The regulatory field force of all federating units (DRAP and Provincial Health Departments) should also increase surveillance in the market to ensure the effective recall of defective products(s). 

      –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 ProfessionalsDRAP requests to enhance vigilance within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by this defective batch of the product.  

      -Adverse reactions or quality problems experienced with this product may be reported to the National Pharmacovigilance Centre(NPC), DRAP using the       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 product.

      -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.

        Decisions of 67th Meeting of Medical Device Board (Deficiency letter for Medical Devices Applications)

        Mughees Mudassir Medical Devices Board

        The Medical Device Board (MDB) of the Drug Regulatory Authority of Pakistan in 67th meeting has deferred the following applications of registration/enlistment of medical devices due to various deficiencies/shortcomings in the applications dossiers. These applicants are requested to furnish the requisite information/documentation as directed by the Medical Device Board. The detail is provided in the below attachment

        Deferred-letters-of-M-67Download

        Decisions of 66th Meeting of Medical Device Board (Deficiency letter for Medical Devices Applications)

        Mughees Mudassir Medical Devices Board

        The Medical Device Board (MDB) of the Drug Regulatory Authority of Pakistan in 66th meeting has deferred the following applications of registration/enlistment of medical devices due to various deficiencies/shortcomings in the applications dossiers. These applicants are requested to furnish the requisite information/documentation as directed by the Medical Device Board. The detail is provided in the below attachment

        Deferred-letters-of-M-66Download