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Drug Safety Alert: Risk of Neurodevelopmental Disorders in Children during Pregnancy with Topirmate

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Drug Safety Alert

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

Date:22nd April 2024
Target Audience:·         Manufacturers and importers of Topiramate;
·         Healthcare professionals; and
·         Patients, consumers or caregivers.
Background:The Medsafe of Newzealand in April, 2023 has announced that the product information for topiramate (Topamax®) is updated to include the risk of neurodevelopmental disorders and birth defects in children whose mothers were taking topiramate during pregnancy. The risk of neurodevelopmental disorders was noted in an observational study based on data from five Nordic (Denmark, Finland, Iceland, Norway, and Sweden) pregnancy registries. The registries captured information from over 24,000 children exposed to at least one antiepileptic medicine before birth. Of these children, 471 were exposed to topiramate alone. The authors reported a 2.77-fold increase in the risk of autism spectrum disorder and a 3.47-fold increase in the risk of intellectual disability in children with an epileptic mother taking topiramate during pregnancy compared to those who are not taking any antiepileptic treatment during pregnancy.
The TGA, Australia in its product information safety update of June, 2023 has also announced that the product information for topiramate (Topamax®) is updated to include the risk of foetal neurodevelopment disorder, updated warning about women of childbearing potential, and contraindications in pregnancy and women of childbearing potential for migraine prophylaxis.
The European Medicine Agency (EMA) in July, 2023 started a review to assess new data on a potential risk of neurodevelopmental disorders in children who have been exposed to topiramate during pregnancy. At that time, a study based on data from a Nordic registry that investigated the risk of neurodevelopmental disorders associated with several anti-epileptic drugs, including topiramate was published. The study conclusions suggested a possible increase in the risk of autism spectrum disorders, intellectual disability and child neurodevelopmental disorders with the exposure to topiramate during pregnancy. The PRAC decided at that time that further
 
assessment was warranted to determine the scope and the best regulatory procedure to assess these potential risks.
Accordingly, the Pharmacovigilance Risk Assessment Committee (PRAC) (EMA’s safety committee) in September, 2023 introduced further restrictions i.e. pregnancy prevention programme on the use of topiramate to be put in place. At present, topiramate must not be used to prevent migraine or manage body weight during pregnancy and patients who can become pregnant must use effective birth control when using topiramate. For patients using topiramate for the treatment of epilepsy, the PRAC is now recommending that the medicine should not be used during pregnancy unless there is no other suitable treatment available. The PRAC also recommends additional measures, in the form of a pregnancy prevention programme, to avoid exposure of children to topiramate in the womb. These measures will inform any woman or girl who is able to have children about the risks of taking topiramate during pregnancy and the need to avoid becoming pregnant while taking topiramate. The product information for topiramate-containing medicines will be updated to further highlight the risks and the measures to be taken. A visible warning will also be added to the outer packaging of the medicine. Patients and healthcare professionals will be provided with educational materials regarding the risks of using topiramate during pregnancy, and a patient card will be provided to the patient with each medicine package. The PRAC recommendations were sent to the Co-ordination Group for Mutual Recognition and Decentralized Procedures for Human (CMDH), which on 11 October 2023 endorsed new measures recommended by EMA’s safety committee (PRAC). The CMDh has also agreed to additional measures, in the form of a pregnancy prevention programme, to avoid exposure of children to topiramate in the womb.
Therapeutic Good(s) Affected:Topiramate is a medicine used to treat epilepsy in adults and children aged two years and older. It is also indicated in adults for the prevention of migraines. At present, topiramate must not be used to prevent migraine or manage body weight during pregnancy and patients who can become pregnant must use effective birth control when using topiramate.
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 should update the prescribing information of Topiramate to include the risk of foetal neurodevelopment disorder and warning about women of childbearing potential, and also include information about not using the Topiramate in pregnancy for the treatment of epilepsy unless there is no other suitable treatment available. Furthermore, registration holders were also directed as per Rule 10 (1) (h) (ii) of Pharmacovigilance Rules, 2022 to update contraindications in pregnancy and women of childbearing potential for migraine prophylaxis.
Advice for healthcare professionals:Healthcare professionals are advised that topiramate should only be used to treat epilepsy in pregnancy if the potential benefit justifies/outweighs the potential risk to the mother and fetus. Pregnancy testing should be performed before starting treatment, and women of childbearing potential should use a highly effective contraceptive method during treatment. The use of topiramate for migraine prophylaxis is contraindicated in pregnancy. Inform women of childbearing potential about the risks of fetal harm if they become pregnant and refer epileptic women taking topiramate who become or plan to become pregnant for specialist advice.
Advice for patients:Patients are advised not to stop taking topiramate without first talking to their doctor. Topiramate can harm the way an unborn baby grows and develops during pregnancy. Anyone who is able to get pregnant should use effective contraception while taking topiramate. Therefore, those patients are advised to speak with their doctor if they are pregnant or planning to become pregnant whilst taking taking topiramate.
Guidelines for reporting Adverse Drug Reactions (ADRs):Both healthcare professionals and patients are requested to report any suspected Adverse Drug Reaction (ADR) to the 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 4th meeting of Pharmacovigilance Risk Assessment Expert Committee, DRAP.
·         Therapeutic Goods Administration of Australia Safety Updates June 2023.
·         PRAC-EMA recommendation regarding new measures to avoid topiramate exposure in pregnancy.
·  MedSafe Newzealand-Topiramate use in pregnancy: further restrictions for safety.
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Drug Safety Alert: Risk of Rare and Serious Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) with Levetiracetam and Clobazam

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Drug Safety Alert

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

Date:22nd April 2024
Target Audience:·         Manufacturers and importers of drug combinations containing Levetiracetam and Clobazam
·         Healthcare professionals; and
·         Patients, consumers or caregivers.
Background:The United States Food and Drug Administration (US-FDA) in November 2023 through a drug safety communication warned that the antiseizure medicines levetiracetam and clobazam can cause a rare but serious reaction that can be life-threatening if not diagnosed and treated quickly. This reaction is called Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) which may start as a rash but can quickly progress, resulting in injury to internal organs, the need for hospitalization, and even death. This hypersensitivity reaction to these medicines is serious but rare. DRESS can include fever, rash, swollen lymph nodes, or injury to organs including the liver, kidneys, lungs, heart, or pancreas. The US FDA accordingly decided to add new warnings about DRESS to the prescribing information and the medication guide of levetiracetam and clobazam for patients and caregivers. It was informed that the warnings for both levetiracetam and clobazam medicines would include information that “early symptoms of DRESS such as fever or swollen lymph nodes can be present even when a rash cannot be seen. This is different from other serious skin-related reactions that can happen with these medicines and where a rash is present early on, including Stevens-Johnson Syndrome (SJS) and toxic epidermal necrolysis (TEN).”
Therapeutic Good(s) Affected:Levetiracetam is an antiseizure medicine indicated for use alone or together with other medicines to control certain types of seizures in adults and children such as partial seizures, myoclonic seizures, or tonic-clonic seizures. 

Clobazam is a benzodiazepine indicated for use in combination with other medicines to control seizures in adults and children 2 years and older who have a specific severe form of epilepsy called Lennox-Gastaut syndrome).
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 as per Rule 10 (1) (h) (iv) of Pharmacovigilance Rules, 2022 that registration holders should include information about rare and serious DRESS reactions in warning and precaution sections of the prescribing information/label of medicines containing levetiracetam and clobazam.
Advice for healthcare professionals:Healthcare professionals are informed that levetiracetam and clobazam have been linked to a rare, potentially life-threatening reaction called Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), occurring 2-8 weeks post-treatment. This may lead to severe inflammation and organ damage, requiring prompt medical attention. Prescribers should inform patients, explain DRESS signs, and advise seeking immediate care. DRESS involves cutaneous reactions, eosinophilia, fever, and systemic complications. Early recognition, discontinuation, and supportive care are crucial.
Advice for patients:Patents are informed that levetiracetam and clobazam, prescribed for seizures, can trigger a rare but severe reaction called Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS). This immune system response may cause widespread inflammation and organ damage, leading to hospitalisation or death if untreated. Patients are advised not to stop the medication abruptly and; to consult their healthcare professionals if necessary. DRESS symptoms, such as fever, rash, and organ-related issues, may occur 2 to 8 weeks after starting treatment. Seek immediate medical attention for concerning symptoms.
Guidelines for reporting Adverse Drug Reactions (ADRs):Both healthcare professionals and patients are requested to report any suspected Adverse Drug Reaction (ADR) to the 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 4th meeting of Pharmacovigilance Risk Assessment Expert Committee, DRAP.
· US-FDA Drug Safety Communication regarding Levetiracetam and Clobazam.
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Drug Safety Alert: Risk of Ocular Adverse Events with Miltefosine

Asad Ullah Safety Alerts

Drug Safety Alert

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

Date:22nd April 2024
Target Audience:·         Manufacturers and importers of Miltefosine;
·         Healthcare professionals; and
·         Patients, consumers or caregivers.
Background:The World Health Organization (WHO) through its medical product alert dated 12th April 2023 informed healthcare professionals and regulatory authorities about the risk of ocular adverse events in people who have taken miltefosine and provided advice on measures to minimize this risk in patients exposed to miltefosine. Following reports of ocular disorders following miltefosine use originating mostly from South Asia, the WHO Advisory Committee on Safety of Medicinal Products (ACSoMP) recommended the WHO to investigate this issue further. The proposed method was discussed in June 2022 and WHO established an ad-hoc Multidisciplinary Technical Group (MTG) to advise on the causality, the risk characteristics and frequency, risk minimisation measures, risk communication, remaining uncertainties and the need for further studies. The MTG was also supported by the WHO, the German National Regulatory Authority (BfArM) and the Uppsala Monitoring Centre (UMC).

Based on the available data, the MTG considered that a causal relationship between ocular adverse events and exposure to miltefosine is at least a reasonable possibility. The risk of ocular adverse events, such as redness of the eye, inflammation of different eye structures (keratitis, scleritis, uveitis) and visual impairment up to blindness has been observed mostly during the treatment of patients with Post-Kala-Azar Dermal Leishmaniasis (PKDL) in South Asia in both men and women, including in children under 18 years old, and mostly beyond 28 days of treatment. No further risk factors could be identified. When the information was available, most of the cases were resolved after miltefosine was withdrawn, sometimes after a symptomatic treatment was started. However, in some cases, the adverse ocular event led to permanent loss of sight. The frequency of adverse ocular events during treatment with miltefosine could not be estimated based on the available data, and the mechanism of action remains unclear.
 
Previously, the ACSoMP discussed during its meeting on 14th of December 2022 the issue of ocular adverse events with miltefosine and inter-alia advised the inclusion of the proposed warning and list of ocular adverse events in the summary of product characteristics and the patient information leaflet for miltefosine along with the issuance of Direct Healthcare Professional Communication by National regulatory authorities.

Post-Kala-Azar Dermal Leishmaniasis (PKDL) is a sequela which can generally occur 6 months to several years after the apparent cure of VL. Although uncommon, leishmanial ocular manifestations have been reported, and keratitis and uveitis can also occur with the disease. A 12-week treatment course of Miltefosine is used to treat PKDL specific to VL endemic countries in Southeast Asia.
Therapeutic Good(s) Affected:Miltefosine is an oral anti-infective and one of the medicines with established efficacy in the treatment of some forms of leishmaniasis, a parasitic infection spread by the bite of infected female phlebotomine sandflies. Leishmaniasis can take different clinical forms, including cutaneous leishmaniasis, mucocutaneous leishmaniasis, and visceral leishmaniasis (VL).
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 should update the prescribing information/ label of Miltefosine-containing medicines by including information in the warning and precaution section about the risk of ocular adverse events and also list these in adverse drug reaction section. As per Rule 10 (1) (b) of Pharmacovigilance Rules, 2022 recommended the National Pharmacovigilance Centre to issue a safety alert/advisory related to the risk of ocular adverse events with Miltefosine-containing medicines.
Advice for healthcare professionals:The following is advised to healthcare professionals:
•    Before starting the miltefosine treatment the history of eye disorders should be collected and an eye examination should be done as appropriate.
•    In case of current or past history of ocular disorder, the benefits and the risks of treating a patient with miltefosine should be carefully considered, and advice from an ophthalmologist should be sought where feasible.
 •    All patients should be informed before starting the treatment that in case of eye problems during the treatment (e.g. red eyes, increased watering, eye pain, blurred vision) they should discontinue miltefosine and contact their healthcare professional immediately.
•    If ocular complications occur and a connection with miltefosine cannot be excluded, miltefosine should be discontinued immediately and an alternative treatment for leishmaniasis should be initiated if necessary. Since miltefosine has a very long half-life (>6 days), it is possible that ocular changes will not be reversible without treatment even after discontinuation of miltefosine. Therefore, an eye specialist should be consulted in such cases to avoid the possibility of permanent damage.
Advice for patients:Patients are advised to consult their doctors if they experience any sort of reaction/problem in their eyes after the start of the miltefosine and also inform healthcare professionals about any pre-existing eye disease.
Guidelines for reporting Adverse Drug Reactions (ADRs):Both healthcare professionals and patients are requested to report any suspected Adverse Drug Reaction (ADR) to the 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 4th meeting of Pharmacovigilance Risk Assessment Expert Committee, DRAP.
·  WHO Advisory Committee on Safety of Medicinal Products (ACSoMP): Measures to minimize the risk of ocular adverse events with miltefosine.
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Rapid Alert: Drug Product; Falsified Risek 40mg Injection identified in the Market

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Rapid Alert

DRAP Alert NoNo I/S/03-24-15
Action Date26th March 2024
Target Audience·         Regulatory Field Force.
·         Healthcare Professionals – Physicians, Pharmacists, and Nurses.
·         Procurement Managers at Hospitals, Clinics, Pharmacies and other Healthcare Institutions
·         General Public.
Problem StatementThe Federal Inspector of Drugs Karachi identified suspected samples of Risek 40mg Injection co-packed with Sterile Water for Injection from the market and sent them to the Central Drug Laboratory (CDL), Karachi for testing/analysis. The Federal Government Analyst, CDL has declared the sample as falsified/spurious under section 3(z-b) (ii) of the Drugs Act 1976.  The samples were also declared as substandard for not complying with the assay test.

The product identification details are as under: –

Therapeutic Good Affected:-

ProductCompositionBatch DetailsPurported to be Manufactured by
(as per label)
Risek 40mg injection
 
Reg No. 024170
OmeprazoleBatch No.059PA5

Mfg. Date: 11-22
Exp. Date:  05-25		Getz Pharma Pvt Limited Karachi.
(as per label)

During the investigation when the suspected samples were compared with the original product of Getz Pharma, Karachi, significant variations were revealed in various segments of the samples. Please click for details.

Threat to Public HealthSpurious or falsified pharmaceuticals may contain harmful levels of toxic substances, posing a significant risk of widespread poisoning. These substandard medications have the potential to undermine the efficacy of disease treatment and exacerbate preexisting medical conditions.
Action InitiatedThe Regulatory Field Force has been instructed to increase surveillance activities at health facilities (hospitals), as well as markets, and confiscate any falsified products. All pharmacists and chemists working at distributions and pharmacies should immediately check their stock and stop supplying any suspected products that differ from the original. Such stock should be quarantined immediately, and supplier information should be provided to the Regulatory Field Force (DRAP, provincial and state drug control administrations) to ensure the removal of these products.
Advice for Healthcare Professionals-DRAP requests increased vigilance at hospitals and within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by this product.

-Adverse Drug Reactions (ADR) 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 ConsumersConsumers should stop using this product and shall contact 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 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; Barpon 100mg/5mL Suspension (Batch # 202) by M/s. JASM Pharmaceutical, KPK

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DRAP Alert NoNo II/S/03-24-13
Action Date13th March 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 etc.
Problem / Issue Federal Government Analyst, CDL Karachi vide test report No. KQ-11-23-000155 dated 12-12-2023 has declared the subject mentioned product namely Barpon 100mg/5mL (Batch No. 202) as of substandard quality.

Therapeutic Good(s) Affected: –

Product NamesCompositionBatch No Manufacturer
Barpon 100mg/5mL Suspension
 
Reg No.114785		IbuprofenBatch No.  202
 
Mfg Dt: 07-2023
Exp.Dt: 06-2025		M/s. JASM Pharmaceutical
(Pvt.) Ltd., Risalpur.
Risk Statement:Barpon Infusion contains Ibuprofen, a medicine used to treat mild to moderate pain and fever (high temperature). Administration of substandard products may lead to complications, as well as an increased risk of failure of therapy. The age-profile of patients is important and young patients especially are at risk.
Action Initiated-The manufacturer has been directed to immediately recall the defective batch of above mentioned product from the market. All pharmacists and chemists working at distributions and pharmacies are hereby advised to 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 DRAP and Provincial Health Departments are also informed regarding the matter and are directed to 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.

    Rapid Alert: Contaminated Propylene Glycol Identified and Confiscated

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    Rapid Alert

    DRAP Alert NoNo  II/S/03-24-14
    Action Date8th March 2024
    Target Audience1.Therapeutic Goods industry
    2. Manufactures of Oral liquid preparations
    Problem StatementFederal Government Analyst, Central Drugs Laboratory Karachi vide test/analysis vide No. RM-2-24-000179 and No. RM-2-24-000180 dated 01-03-2024 declared the sample of Propylene Glycol (Raw material) sent to CDL Karachi by Federal Inspector of Drugs Islamabad-I as of substandard quality due to contamination of DEG and EG. ( Click for details)

    Two samples were collected from separate containers which were labelled as Propylene Glycol, Batch# C815L44R41 and Batch# C815L44R52, purportedly manufactured by Dow Chemical Pacific (Singapore) Private Limited. However, upon further investigation, it seems that none of the samples were actually manufactured by Dow Chemicals and the labels were false.

    It is important to note that on January 11, 2024, a rapid alert was also issued for contaminated Propylene Glycol with batch number C815N3OR41, which was labelled as being manufactured by Dow Chemicals, Thailand. However, Dow Chemicals, Thailand has clarified to DRAP that it was not their original product and was falsified by some miscreants. The company also analyzed the retained samples of the original product and shared an analysis report, which showed that it was in compliance with the required specifications.
    Risk Statement:Diethylene glycol (DEG) and Ethylene Glycol (EG) contamination in Propylene Glycol (PG) can lead to serious health risks when used in oral liquid preparations. Upon ingestion, these chemicals (EG and DEG) are converted into toxic metabolites which can affect the central nervous system and heart. Moreover, it can also cause kidney damage which may lead to fatal consequences.
    Action Initiated: –The Regulatory Field Force has taken possession of contaminated raw materials and commenced an investigation to trace the supply chain of these containers. Manufacturers of therapeutic goods have been prohibited from using propylene glycol without testing for the presence of EG/DEG levels. These materials should only be obtained from authorized suppliers of original manufacturers with thorough verification of the integrity of the supply chain and originality of the product. The Regulatory Field Force has also been directed to ensure compliance and seize any such raw materials or products found to be contaminated in the market.
    Advice for Therapeutic Goods ManufacturersManufacturers of therapeutic goods are required to follow these instructions:
     
    1.      Recall Products: If any batch of finished product has been manufactured using the same batch of the propylene glycol that has been identified as contaminated, the retained sample should be immediately analysed and these finished products should be recalled from local and export markets if found contaminated.


    2       Screen Raw Materials: Before using them in the manufacturing of oral liquid preparations, all raw materials should be screened for contamination with EG and DEG.

    3.     Analyze Finished Products: Before their release into the market, all finished products should be analyzed for EG/DEG contamination.

    4.    Compliance: Ensure compliance with all directives issued by DRAP to safeguard public health from contaminated products.

    5.     Follow Guidelines: Adhere to the pharmacopeial monograph and WHO guidelines for testing EG/DEG in oral liquid preparations during the analysis of both raw materials and finished products.

    Our utmost priority is public safety. DRAP is committed to supporting the industry in maintaining rigorous quality control and testing procedures to prevent any potential harm caused by contaminated products.
    Advice for Healthcare ProfessionalsDRAP requests healthcare professionals to stay updated with advisories and recalls. Patients should be educated about the risks and symptoms of EG toxicity. Close monitoring of patients using the affected products is crucial, and any adverse events should be reported to National or Provincial pharmacovigilance centres.

    -Adverse Drug Reactions (ADR) 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 ConsumersConsumers should stay informed about the latest advisories and recalls from DRAP. If they have experienced any problem or unusual symptoms after using oral liquid preparations, seek medical attention immediately and 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: Substandard Propylene Glycol (Batch # G01821UG) claimed to be manufactured by SK Picoglobal Korea.

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    Rapid Alert

    DRAP Alert NoNo  I/S/03-24-12
    Action Date8th March 2024
    Target Audience1. Regulatory Field Force.
    2. Therapeutic Goods industry
    3. Manufactures of Oral liquid preparations
    4. Healthcare professionals
    Problem StatementMs. MKB Pharmaceuticals (Pvt) Ltd., Peshawar sent the sample of Propylene Glycol (PG) to Central Drugs Laboratory Karachi for test/analysis that was used as a solvent in the manufacturing of oral liquid preparations. The batch was claimed to be manufactured by SK picoglobal Co. Ltd. Korea. Analysis of the sample by the Central Drug Laboratory, Karachi detected unacceptable level of Ethylene Glycol.

    The product identification details are as under: –

    Therapeutic Good Affected:-

    ProductBatch NoMfg DateExp. DatePurported to be Manufactured by
    (as per label)    		Remarks
    Propylene Glycol
    (Raw Material)    		G01821UG12-08-202311-08-2025SK Picoglobal Co. Ltd. Korea.The sample is declared substandard
    for unacceptable levels of Ethylene Glycol (0.4671%).
    Risk StatementPropylene Glycol (PG) contaminated with Ethylene Glycol (EG) when used in oral liquid preparations, can lead to serious health risks due to EG’s toxicity. When ingested, EG is metabolized into toxic metabolites that can affect the central nervous system, and heart, and can cause kidney damage, which can be fatal.
    Action InitiatedThe manufacturer has been instructed to recall finished products that were manufactured using the contaminated lot of propylene glycol. The Regulatory Field Force has also been instructed to seize all oral preparations that were made using the same batch of propylene glycol if found in the market. DRAP has directed the therapeutic goods industry to hold finished products manufactured from any other lot of propylene glycol of Ms. SK picoglobal Co. Ltd. Korea and ensure testing of finished products for EG/DEG contamination before releasing them into the supply chain.
    Advice for Therapeutic Goods ManufacturersManufacturers of therapeutic goods are required to follow these instructions:
     
    1.      Recall Products: If any batch was manufactured using the same lot (YF01200730) of propylene glycol that has been identified as contaminated, all finished products from local and export markets should be recalled.

    2.      Hold Other Batches: All finished products manufactured from any other lot of propylene glycol of SK picoglobal Co. Ltd. Korea should be held. These products should be tested for EG/DEG contamination before releasing them into the supply chain.

    3.      Screen Raw Materials: Before using them in the manufacturing of oral liquid preparations, all raw materials should be screened for contamination with EG and DEG.

    4.      Analyze Finished Products: Before their release into the market, all finished products should be analyzed for EG/DEG contamination.

    5.      Compliance: Ensure compliance with all directives issued by DRAP to safeguard public health from contaminated products.

    6.      Follow Guidelines: Adhere to the pharmacopeial monograph and WHO guidelines for testing EG/DEG in oral liquid preparations during the analysis of both raw materials and finished products.

    Our utmost priority is public safety. DRAP is committed to supporting the industry in maintaining rigorous quality control and testing procedures to prevent any potential harm caused by contaminated products.
    Advice for Healthcare ProfessionalsDRAP requests healthcare professionals to stay updated with advisories and recalls. Patients should be educated about the risks and symptoms of EG toxicity. Close monitoring of patients using the affected products is crucial, and any adverse events should be reported to National or Provincial pharmacovigilance centres.

    -Adverse Drug Reactions (ADR) 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 ConsumersConsumers should stay informed about the latest advisories and recalls from DRAP. If they have experienced any problem or unusual symptoms after using oral liquid preparations, seek medical attention immediately and 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: Contaminated Propylene Glycol Identified and Confiscated

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    Rapid Alert

    DRAP Alert NoNo I/S/02-24-11
    Action Date07th March 2024
    Target Audience1. Therapeutic Goods industry
    2. Manufactures of Oral liquid preparations
    Problem StatementFederal Government Analyst, Central Drugs Laboratory Karachi has identified contaminated Propylene Glycol (Raw material) by detecting highly unacceptable levels of Ethylene Glycol in the seven different samples of Propylene Glycol which were sent to the laboratory by the Federal Inspector of Drugs Lahore. 

    Out of the seven samples collected from different containers, six of them had labels indicating that they were from Batch#C856H85R55 and were labelled as manufactured by Dow Chemicals, Thailand. However, one of them (sample 7) had a label indicating that it was from batch F8900L8PPD6 and was labelled as manufactured by Dow Chemicals, Germany. Upon further investigation, it seems that none of the samples were actually manufactured by Dow Chemicals and the labels were false. The analysis reveals that these samples were highly contaminated.

    It is important to note that on January 11, 2024, a rapid alert was also issued for contaminated Propylene Glycol with batch number C815N3OR41, which was labelled as being manufactured by Dow Chemicals, Thailand. However, Dow Chemicals, Thailand has clarified to DRAP that it was not their original product and was falsified by some miscreants. The company also analyzed the retained samples of the original product and shared an analysis report, which showed that it was in compliance with the required specifications.
    Risk StatementDiethylene glycol (DEG) and Ethylene Glycol (EG) contamination in Propylene Glycol (PG) can lead to serious health risks when used in oral liquid preparations. Upon ingestion, these chemicals (EG and DEG) are converted into toxic metabolites which can affect the central nervous system and heart. Moreover, it can also cause kidney damage which may lead to fatal consequences.
    Action TakenThe Regulatory Field Force has taken possession of contaminated raw materials and commenced an investigation to trace the supply chain of these containers. Manufacturers of therapeutic goods have been prohibited from using propylene glycol without testing for the presence of EG/DEG levels. These materials should only be obtained from authorized suppliers of original manufacturers with thorough verification of the integrity of the supply chain and originality of the product. The Regulatory Field Force has also been directed to ensure compliance and seize any such raw materials or products found to be contaminated in the market.
    Advice for Therapeutic Goods Manufacturers: – Manufacturers of therapeutic goods are required to follow these instructions:
     
    1.      Recall Products: If any batches were produced using the same lots of Propylene Glycol that have been identified as contaminated, it is crucial to test both the raw materials and finished products for contamination immediately. If any contamination is found, the affected products should be recalled promptly from the local and export markets.

    2.      Hold Other Batches: All finished products manufactured from propylene glycol should be tested for EG/DEG contamination before releasing them into the supply chain.

    3.      Screen Raw Materials: Before using them in the manufacturing of oral liquid preparations, all raw materials should be screened for contamination of EG and DEG.

    4.      Compliance: Ensure compliance with all directives issued by DRAP to safeguard public health from contaminated products.

    5.      Follow Guidelines: Adhere to the pharmacopoeia monograph and WHO guidelines for testing EG/DEG in oral liquid preparations during the analysis of both raw materials and finished products.

    DRAP’s utmost priority is public safety. DRAP is committed to supporting the industry in maintaining rigorous quality control and testing procedures to prevent any potential harm caused by contaminated products.

    Recall Alert: Drug Product; DXL 60mg Capsule (Batch # 23136) by M/s. Titlis Pharma Lahore

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    DRAP Alert NoNo II/S/02-24-09
    Action Date27th February, 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 etc.
    Problem / Issue The Secretary, PQCB Baluchistan has reported that samples of “DXL 60mg Capsule” bearing Batch No. 23136 manufactured by M/s. M/s. Titlis Pharma, 528-A Sundar Industrial Estate, Raiwind Road, Lahore. has been declared as “Substandard” by Government Analyst, Drug Testing Laboratory, Baluchistan.

    Therapeutic Good(s) Affected: –

    Product NamesCompositionBatch No Manufacturer
    DXL 60mg Capsule
     
    Reg.No 097679    		DexlansoprazoleBatch No.  2336
     
    Mfg. Date: 03-23
    Exp. date: 03-25    		M/s. Titlis Pharma,
    528-A Sundar Industrial Estate,
    Raiwind Road, Lahore.
    Risk Statement:The use of substandard dexlansoprazole capsules may lead to untoward adverse drug reactions and may generate an unpredictable response based on individual variability.
    Action Initiated-The manufacturer has been directed by the Secretary PQCB Baluchistan 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) has 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.

      Recall Alert: Drug Product; Mencobal 500mcg Injection (Batch # 082) by M/s. Treat Pharmaceutical Industry (Pvt.) Ltd.,Bannu.

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      DRAP Alert NoNo I/S/02-24-08
      Action Date27th February, 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 etc.
      Problem / Issue The Secretary, PQCB Baluchistan has reported that samples of Mencobal Injection bearing Batch No. 082 manufactured by M/s. Treat Pharmaceutical Industry (Pvt.) Ltd., Bannu, has been declared as “Substandard” by Government Analyst, Drug Testing Laboratory, Baluchistan.

      Therapeutic Good(s) Affected: –

      Product NamesCompositionBatch No Manufacturer
      Mencobal 500mcg Injection
       
      Reg.No 075537      		MecobalaminBatch No. 082
       
      Mfg. Date: 06-23
      Exp. date: 06-25      		M/s. Treat Pharmaceutical Industry
      (Pvt.) Ltd., A-37 Small Industrial Estate,
      Township, Kohat Road, Bannu.
      Risk Statement:The impact of the use of substandard injectable preparations can be serious as it may lead to infection and others adverse reactions or even sepsis.
      Action Initiated-The manufacturer has been directed by the Secretary PQCB Baluchistan 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) has 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.