Drug Safety Punjab Sep23

41st
DRUG SAFETY PUNJAB Edition

NEWSLETTER | September 2023
CONTENTS The Drug Safety Punjab (DSP)

Newsletter is published with
Section A: an aim to disseminate the
Global Drug Safety latest information on the
safety of the drugs to
Section B: Healthcare Professionals.
Therapeutic Goods
Related Problem Based on information derived
(TGRP) Highlights from International Regulatory
Authorities, Therapeutic
Section C: Goods Related Problem
Quality Associated (TGRP) reports and Drug
Safety Issues Regulatory Authority of
(QASI) Pakistan (DRAP) recall alerts.
Provincial Pharmacovigilance Centre (PPC), Directorate of Drugs Control (DDC) Punjab,

Government of the Punjab, Primary & Secondary Healthcare Department Contact: 042-99206204
Email: p&pvddcp.pshealth@punjab.gov.pk
/DDC.Punjab @DDC_Punjab /DDC.Punjab Office: 48/1, Kacha Lawrence Road, Lahore
CONTENT LIST
DSA-1934: BUPROPION: POTENTIAL RISK OF CARDIAC ARREST & SUDDEN DEATH THROUGH
UNMASKING OF BRUGADA SYNDROME.
DSA-1935: CABERGOLINE: RISK OF HYPERTENSION, MYOCARDIAL INFARCTION, SEIZURES, STROKE
OR PSYCHIATRIC DISORDERS.
DSA-1936: CLOBETASOL: RISK OF SERIOUS UNDESIRABLE EFFECTS WITH PROLONGED USE
DSA-1937: GABAPENTIN ASSOCIATED RISK OF TOXIC EPIDERMAL NECROLYSIS (TEN)
DSA-1938: ITRACONAZOLE: POTENTIAL RISK OF HYPOKALEMIA
DSA-1939: LOXOPROFEN ASSOCIATED RISK OF ACUTE GENERALIZED EXANTHEMATOUS PUSTULOSIS

(AGEP)
DSA-1940: METHOTREXATE: RISK OF PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY (PML).
DSA-1941: OLANZAPINE: POTENTIAL RISK OF HYPONATREMIA
DSA-1942: MINOXIDIL ASSOCIATED RISK OF FOLLICULITIS
DSA-1943: PEGASPARGASE: RISK OF HYPERSENSITIVITY REACTIONS
DSA-1944: BUPRENORPHINE: RISK OF DENTAL PROBLEMS
DSA-1945: ZOLPIDEM ASSOCIATED RISK OF COMPLEX SLEEP BEHAVIORS
DSA-1946: FINASTERIDE: POTENTIAL RISK OF SUICIDAL IDEATION/THOUGHTS & SELF INJURY WITH
FINASTERIDE
DSA-1947: PREDNISONE ASSOCIATED RISK OF OSTEONECROSIS
DSA-1948: CYTARABINE ASSOCIATED RISK OF TUMOR LYSIS SYNDROME
DSA-1949: INJECTION RINGER LACTATE ASSOCIATED PYREXIA, CHILLS, ERYTHEMA & TACHYCARDIA
DSA-1950: INJECTION HEPARIN ASSOCIATED PYREXIA, CHILLS, RISE IN BLOOD PRESSURE & BLOOD
CLOTTING
DSA-1951: PRODUCT RECALL OF FLUORAZINE 1MG TABLET BATCH NO. T-2065 MANUFACTURED BY M/S
CKD PHARMACEUTICALS PAK (PVT) LTD, KARACHI
DSA-1952: PRODUCT RECALL OF MICOGEN-B CREAM BATCH NO. MB-012/22 MANUFACTURED BY M/S
DELUX CHEMICAL INDUSTRIES, KARACHI
Provincial Pharmacovigilance Centre (PPC), Directorate of Drugs Control (DDC) Punjab, Page 2
CONTENT LIST
DSA-1953: PRODUCT RECALL OF SURGEE DISPOSABLE INFUSION SET BATCH NO. IV0523
MANUFACTURED BY M/S REHMAN RAINBOW (PVT.), LAHORE.
DSA-1954: PRODUCT RECALL OF NEONATAL BREATHING CIRCUITS MANUFACTURED BY M/S
ARMSTRONG MEDICAL LIMITED, NORTHERN IRELAND.
DSA-1955: RAPID ALERT OF SPURIOUS PHENOBAR 30MG TABLET BATCH NO. QA019, QA025, QA016
MANUFACTURED BY STAR LABORATORIES (PVT) LTD.
DSA-1956: RAPID ALERT OF SPURIOUS & UNREGISTERED VIAGRA 100MG TABLET BATCH NO.
19990544AG MANUFACTURED BY M/S BROOKLYN NE (AS STATED ON LABEL).
DSA-1957: RAPID ALERT OF SPURIOUS SOJOURN (SEVOFLURANE) LIQUID FOR INHALATION
MANUFACTURED BY PIRAMAL CRITICAL CARE, INC. USA.
DSA-1958: RAPID ALERT OF SPURIOUS CIPROXIN TABLET 500MG BATCH NO. BAA928 PURPORTED TO
BE MANUFACTURED BY NOVARTIS PHARMA (PAKISTAN) LTD. KARACHI
DSA-1959: RAPID ALERT OF UNREGISTERED N-GAISK PLUS TABLET BATCH NO. 004 MANUFACTURED BY
M/S NAZ HOMEO PHARMACY, KARACHI
DSA-1960: RAPID ALERT OF UNREGISTERED SUGAR XL CAPSULES MANUFACTURED BY M/S NAZ
HOMEO PHARMACY, KARACHI
DSA-1961: RAPID ALERT OF UNREGISTERED HYP-RHO-D INJECTION BATCH NO. 09181943
MANUFACTURED BY M/S WOOLMAR CHEMICAL CORPORATION, USA
DSA-1962: SPURIOUS RESTANE SOLUTION FOR INHALATION BATCH NO. N0211B24 & N0211B25
MANUFACTURED BY M/S PIRAMAL CRITICAL CARE INC.
DSA-1963: SPURIOUS & SUBSTANDARD PROCAINE PENICILLIN FORTE 4,000,000 I.U. INJECTION BATCH
NO. 140350 MANUFACTURED BY M/S YANZHOU XIER KANGTAI PHARMA. CO., LTD.
DSA-1964: SPURIOUS EFASTON TABLET 10MG BATCH NO. 21101 MANUFACTURED BY M/S LAHORE
CHEMICAL & PHARMACEUTICAL WORKS (PVT.) LTD.
DSA-1965: ADULTERATED SETRIZIN SYRUP BATCH NO. 199-23 MANUFACTURED BY M/S LISKO PAKISTAN
(PVT.) LTD.
DSA-1966: SPURIOUS PHENOBAR 30 MG TABLET BATCH NO. QA 023 MANUFACTURED BY M/S STAR
LABORATORIES (PVT.) LTD.
DSA-1967: SPURIOUS PENBIOTIC 5GM POWDER FOR INJECTION BATCH NO. V141112 MANUFACTURED
BY M/S NAWAN LABORATORIES (PVT.) LTD.
DSA-1968: SPURIOUS PENIVET-5 POWDER FOR INJECTION BATCH NO. VJ-1304 MANUFACTURED BY M/S
STAR LABORATORIES (PVT.) LTD.
DSA-1969: SPURIOUS DUPHASTON 10MG TABLET BATCH NO. 214047 MANUFACTURED M/S HIGHNOON
LABORATORIES LTD. MARKETED BY M/S ABBOTT LABORATORIES PAKISTAN LTD.
DSA-1970: SUBSTANDARD & ADULTRATED LOXIBAK 50 ML INJECTION BATCH NO. I-564
MANUFACTURED BY M/S ATTABAK PHARMACEUTICAL INDUSTRIES.
DSA-1971: SPURIOUS AZOMAX 250MG CAPSULE BATCH NO. A8346 PURPORTED TO BE MANUFACTURED
BY M/S AGP LIMITED.
CONTENT LIST
DSA-1972: SPURIOUS BIOCHLOR AEROSOL SPRAY 211ML BATCH NO. BL-082, BL-083, BL-084, BL-085, BL-
088, BL-089 MANUFACTURED BY M/S SELMORE PHARMACEUTICALS (PVT.) LTD.
DSA-1973: SUBSTANDARD & ADULTERATED BALIGNO 10ML INJECTION BATCH NO. BL-1023
MANUFACTURED BY BAJWA PHARMACEUTICALS (PVT.) LTD.
DSP September 2023/41st Ed.
SECTION-A: GLOBAL DRUG SAFETY

DSA-1934: BUPROPION: POTENTIAL RISK OF CARDIAC ARREST &
SUDDEN DEATH THROUGH UNMASKING OF BRUGADA
SYNDROME.
INTRODUCTION: Authority (HPRA) has announced • WHO Pharmaceuticals
Bupropion is an anti-depressant that the use of Bupropion may Newsletter No. 01, 2023
indicated for major depressive unmask Brugada syndrome and • Drug Safety Newsletter,
disorder and smoking cessation. concluded that the Product HPRA, December 2022
Brugada Syndrome is a rare Information Leaflet for bupropion- (www.hpra.ie)
hereditary disease with characteristic containing medicines is to be
ECG changes that can lead to updated to include the risk of
cardiac arrest and sudden death. Brugada syndrome with the use
CONCLUSION: of Bupropion.
The Health Product Regulatory REFERENCE:
Advice for Healthcare Professionals:

Healthcare Professionals are advised to prescribe bupropion with caution in
patients having a family history of cardiac arrest, sudden death, and pre-existing
Brugada Syndrome. In case of any such adverse drug reaction, one must report to
the Provincial Pharmacovigilance Centre (PPC), Directorate of Drugs Control
Punjab, through http://mss.pshealthpunjab.gov.pk/
DSA-1935: CABERGOLINE: RISK OF HYPERTENSION,

MYOCARDIAL INFARCTION, SEIZURES, STROKE OR PSYCHIATRIC
DISORDERS.
INTRODUCTION: infarction, seizures, stroke, or include severe cardiac and
Cabergoline is a dopaminergic psychiatric disorders, have been psychiatric disorders.
medication that treats high reported in postpartum women REFERENCE:
prolactin levels, Prolactinoma, and treated with cabergoline to inhibit • WHO Pharmaceuticals
Parkinson’s Disease. The HPRA lactation. Newsletter No. 01, 2023
has announced that severe CONCLUSION: • Drug Safety Newsletter, HPRA,
adverse events, including The product information for December 2022 (www.hpra.ie)
hypertension, myocardial cabergoline is to be updated to
Healthcare professionals are advised to monitor the blood pressure after treatment
with Cabergoline carefully. The patient should be evaluated promptly in case of
hypertension, suggestive chest pain, severe, progressive, or unremitting headache
(with or without visual disturbances), or evidence of any central nervous system
toxicity. In case of any such adverse drug reaction, one must report to the Provincial
Pharmacovigilance Centre (PPC), Directorate of Drugs Control Punjab, through
http://mss.pshealthpunjab.gov.pk/
DSA-1936: CLOBETASOL: RISK OF SERIOUS UNDESIRABLE

EFFECTS WITH PROLONGED USE
INTRODUCTION: undesirable effects with its REFERENCE:
Clobetasol is a potent topical prolonged use, including • WHO Pharmaceuticals
corticosteroid available in various osteonecrosis, serious infections, Newsletter No. 01, 2023
formulations that are indicated for and systemic immunosuppression. • Drug Safety Newsletter, HPRA,
the relief of inflammatory and CONCLUSION: December 2022 (www.hpra.ie)
pruritic manifestations of steroid- The product information leaflet
responsive dermatoses resistant has been updated to include
to less potent corticosteroids. The undesirable severe side effects
HPRA has announced the risk of with prolonged use of Clobetasol.

Healthcare Professionals are advised to consider a less potent corticosteroid
preparation if treatment with a local corticosteroid is clinically justified beyond four
weeks. Repeated but short courses of Clobetasol may be used to control
exacerbations. In case of any such adverse drug reaction, one must report to the
Provincial Pharmacovigilance Centre (PPC), Directorate of Drugs Control Punjab,
through http://mss.pshealthpunjab.gov.pk/
DSA-1937: GABAPENTIN ASSOCIATED RISK OF TOXIC EPIDERMAL

NECROLYSIS (TEN)
INTRODUCTION: CONCLUSION: • WHO Pharmaceuticals
Gabapentin is an anticonvulsant The HPRA has announced a Toxic Newsletter No. 01, 2023
medication primarily used to treat Epidermal Necrolysis (TEN) risk • Drug Safety Newsletter, HPRA,
partial seizures and neuropathic with Gabapentin. The product December 2022 (www.hpra.ie)
pain. It is a commonly used information leaflet will be updated
medicine for managing to include this risk under the
neuropathic pain caused by Severe Cutaneous Adverse Drug
diabetic neuropathy, post-herpetic Reactions (SCARS) heading.
neuralgia, and central pain. REFERENCE:
Healthcare Professionals are advised to vigilantly monitor the patients for any signs
and symptoms of gabapentin. If signs and symptoms suggest these reactions,
gabapentin should be withdrawn immediately. In case of any such adverse drug
reaction, one must report to the Provincial Pharmacovigilance Centre (PPC),
Directorate of Drugs Control Punjab, through http://mss.pshealthpunjab.gov.pk/
DSA-1938: ITRACONAZOLE: POTENTIAL RISK OF HYPOKALEMIA

INTRODUCTION: treatment of fungal infection. potassium in blood serum.
Itraconazole is indicated for the Hypokalemia means low levels of
CASE REVIEWS: possible. reaction.

The Pharmaceutical & Medical CONCLUSION: REFERENCE:
Device Agency (PMDA), Japan, The PMDA has concluded that the • WHO Pharmaceuticals
has reviewed three cases of product information leaflet of Newsletter No. 01, 2023
hypokalemia reported domestically Itraconazole oral and intravenous • Revision of Precautions,
in which a causal relationship dosage forms should be revised to MHLW/PMDA, 12 October
between the drug and the event include the risk of hypokalemia as 2022
was found to be reasonably a clinically significant adverse drug (www.pmda.go.jp/english/)

Health-care professionals are advised to follow newly added precautions. Periodic
blood electrolyte tests should be performed in patients undergoing treatment with
Itraconazole. In case of any such adverse drug reaction, one must report to the
DSA-1939: LOXOPROFEN ASSOCIATED RISK OF ACUTE

GENERALIZED EXANTHEMATOUS PUSTULOSIS (AGEP)
INTRODUCTION: CASE REVIEWS: Adverse Drug Reaction.
Loxoprofen is a Non-Steroidal The PMDA reviewed the cases of REFERENCE:
Anti-Inflammatory Drug (NSAID) AGEP reported domestically with • WHO Pharmaceuticals
belonging to the propionic acid Loxoprofen. A total of 17 cases Newsletter No. 01, 2023
derivative group. AGEP is an have been reported, including 3 • Revision of Precautions,
acute eruption characterized by cases for which a causal MHLW/PMDA, 12 October
the development of numerous relationship between the drug and 2022
non-follicular pustules on a event was reasonably possible. (www.pmda.go.jp/english/)
background of edematous CONCLUSION:
erythema. Fever and blood The PMDA has announced that
leukocytes are its usual the patient information leaflet
manifestations. should include AGEP as an

Healthcare Professionals are advised to monitor patients for AGEP with Loxoprofen
use. In case of any such adverse drug reaction, one must report to the Provincial
Pharmacovigilance Centre (PPC), Directorate of Drugs Control Punjab, through
http://mss.pshealthpunjab.gov.pk/
DSA-1940: METHOTREXATE: RISK OF PROGRESSIVE MULTIFOCAL

LEUKOENCEPHALOPATHY (PML).
INTRODUCTION: treating inflammatory conditions damage of the brain’s white
Methotrexate is a such as Rheumatoid Arthritis. matter at multiple locations.
chemotherapeutic agent that Progressive Multifocal CASE REVIEWS:
belongs to the anti-metabolite Leukoencephalopathy is The PMDA has reviewed cases of
class. It is also indicated for characterized by progressive PML reported domestically and
They concluded that a causal established for these cases. REFERENCE:

relationship between drug and CONCLUSION: • WHO Pharmaceuticals
event was reasonably possible. A The PMDA has announced that Newsletter No. 01, 2023
total of 12 patient mortalities were the Product Information Leaflet for • Revision of Precautions,
reported internationally during the Methotrexate should be revised to MHLW/PMDA, 12 October
previous three years. However, a include the risk of Multifocal 2022
causal association between the Leukoencephalopathy with (www.pmda.go.jp/english/)
drug and death was not Methotrexate.

Healthcare Professionals are advised to follow the newly added precautions of PML
with Methotrexate. If symptoms such as disturbance of consciousness, cognitive
dysfunction, paralysis, dysarthria, and aphasia are observed, MRI imaging and
cerebrospinal fluid examination should be performed, and administration of this
drug should be discontinued. In case of any such adverse drug reaction, one must
report to the Provincial Pharmacovigilance Centre (PPC), Directorate of Drugs
Control Punjab, through http://mss.pshealthpunjab.gov.pk/
DSA-1941: OLANZAPINE: POTENTIAL RISK OF HYPONATREMIA

INTRODUCTION: India (NCC-PvPI, IPC) reviewed hyponatremia associated with
Olanzapine is an atypical 20 ICSRs of Olanzapine Olanzapine.
antipsychotic drug used to associated hyponatremia and REFERENCE:
manage schizophrenia in adult found a causal relationship • WHO Pharmaceuticals
patients, rapid control of agitation, between them. Newsletter No. 01, 2023
and disturbed behavior in CONCLUSION: • Communication from Indian
patients. Hyponatremia is a term The Central Drugs Standard Pharmacopoeia Commission
indicated for low sodium levels in Control Organization (CDSCO) (IPC), India, October 2022
blood serum. has approved the (ipc.gov.in)
CASE REVIEWS: recommendation from NCC-PvPI
The National Coordination Centre- to revise the patient information
Pharmacovigilance Programme of leaflet to include the risk of

Healthcare Professionals are advised to monitor patients for any emerging
symptoms of hyponatremia using Olanzapine. Periodic sodium blood levels should
be monitored in patients taking this drug. In case of any such adverse drug
DSA-1942: MINOXIDIL ASSOCIATED RISK OF FOLLUCILITIS

INTRODUCTION: alopecia (male pattern baldness). The NCC-PvPI reviewed 17 ICSRs
Minoxidil is an antihypertensive Folliculitis is the inflammation of of Minoxidil-associated Folliculitis
vasodilator drug that is also one or more hair follicles. having a causal association.
indicated for managing men's CASE REVIEWS:
CONCLUSION: with Minoxidil. (IPC), India, October 2022

The CDSCO has approved the REFERENCE: (ipc.gov.in)
recommendation from NCC-PvPI • WHO Pharmaceuticals
to revise the patient information Newsletter No. 01, 2023
leaflet to include folliculitis as an • Communication from Indian
adverse drug reaction associated Pharmacopoeia Commission

Healthcare Professionals are advised to monitor this potential adverse drug reaction
with Minoxidil use vigilantly. In case of any such adverse drug reaction, one must
report to the Provincial Pharmacovigilance Centre (PPC), Directorate of Drugs
Control Punjab, through http://mss.pshealthpunjab.gov.pk/
DSA-1943: PEGASPARGASE: RISK OF HYPERSENSITIVITY

REACTIONS
INTRODUCTION: tongue, itching all over the body, updated to include this potential
Pegaspargase is indicated as a shivering, red eyes, and risk. Likewise, the treatment
component of a multi-agent abdominal pain, were noted in the modification section will also be
chemotherapeutic regimen for the six cases after administration of updated. Registration holders
treatment of pediatric and adult Pegaspargase (Peg L were also directed to introduce an
patients with Acute Lymphoid Asparaginase) 3750IU. All 06 educational training program for
Leukemia (ALL). patients had a possible causal healthcare professionals on
CASE REVIEWS: association with the drug. proper preparation,
The National Pharmacovigilance CONCLUSION: administration, and monitoring of
Centre (NPC) at Drug Regulatory The 2nd Pharmaceutical Expert Pegaspargase and to ensure that
Authority of Pakistan has received Committee Meeting of NPC, resuscitation equipment is
06 case reports of hypersensitivity DRAP discussed the case. After available at the treatment sites.
reactions from Indus Hospital detailed discussion, it was REFERENCE:
Karachi, Pakistan. The events of concluded that prescribing • Drug Safety Alert No. 30, 10th
hypersensitivity reactions, information/safety April 2023 (www.drap.gov.pk)
including swelling of lips, nausea, specification/label of
rash, vomiting, swelling of the pegaspargase injection would be
Healthcare Professionals are advised to take precautionary measures such as
monitoring the patient for an hour after administering the Pegaspargase injection.
Medications for emergency conditions and necessary resuscitation equipment
should be available at the treatment sites. Healthcare Professionals are further
advised to reduce the infusion rate by 50% in case of Grade 1 hypersensitivity
reaction, interrupt the infusion, treat the symptoms when symptoms resolved,
resume the injection, and reduce the infusion rate by 50% in case of Grade 2
hypersensitivity reaction; and for Grade 3 to 4 hypersensitivity reactions
permanently discontinue the Pegaspargase. In case of any such adverse drug
DSA-1944: BUPRENORPHINE ASSOCIATED RISK OF DENTAL

PROBLEMS
INTRODUCTION: Administration (US-FDA) through The case was discussed in the
Buprenorphine is an opioid its ADR collecting database and 2nd Pharmaceutical Expert
analgesic used for the medical literature identified a total Committee Meeting of NPC,
management of analgesia and of 305 dental adverse events DRAP. After detailed discussion, it
Opioid Use Disorder (OUD). following transmucosal was concluded that prescribing
Dental problems, including tooth Buprenorphine use. In many information/safety specification of
decay, cavities, oral infections, cases, dental decay, tooth loss, orally dissolved buprenorphine
and loss of teeth have been and tooth fractures in numerous will be updated to include the risk
reported, even in patients with no teeth was reported. Of these 305 of dental problems.
prior history of dental issues. cases, 71 cases reported REFERENCE:
These problems have been treatment with tooth extraction/ • Drug Safety Alert No. 31, 10th
reported with tablets and films removal. Other treatments April, 2023 (www.drap.gov.pk)
that are dissolved under the included root canal, dental • FDA Drug Safety
tongue or placed against the surgery, and other restorative Communication, 01.12.2022
inside of the cheek. procedures such as crowns and (www.fda.gov)
CASE REVIEWS: implants.
The U.S Food and Drug CONCLUSION:
Healthcare Professionals are advised to carefully observe the patients for this
potential risk while prescribing transmucosal/oral buprenorphine. Patient’s history of
dental problems should be recorded. Patients should be guided to gently rinse their
teeth and gums with water and then swallow and to wait at least 1 hour before
brushing their teeth. In case of any such adverse drug reaction, must report to
DSA-1945: ZOLPIDEM ASSOCIATED RISK OF COMPLEX SLEEP

BEHAVIOUR
INTRODUCTION: All these behaviors may occur to serious self /other injuries or
Zolpidem belongs to the sedative- after taking the drug and without accidents. During domestic review
hypnotic class of drugs used to being fully awake with no memory of last 03 fiscal years, a total of 03
treat insomnia. Abnormal sleep of the incidence the next day. case reports have been reported
behavior also called parasomnia is CASE REVIEWS: till date (02 with zolpidem & 1 with
a condition that is characterized by Based on the published literature Triazolam).
regular occurrence of abnormal on the pharmacological CONCLUSION:
movements, vocalizations, sleep mechanisms of parasomnia and The case was discussed in the
movement or night terrors. cases reported in Japan, It was 2nd Pharmaceutical Expert
Examples of abnormal behavior as reported that non-benzodiazepine Committee Meeting of NPC,
a symptom of parasomnia include sedative hypnotics such as DRAP. After detailed discussion, it
driving a car, making or eating a zolpidem, zopiclone, eszopiclone was concluded that the prescribing
meal, making a phone call, and triazolam can increase the risk information/safety specification of
behaving violently, or calling out. of parasomnia that may also lead zolpidem containing drugs should
be updated to include risk of prescribed format. • Revision of Precautions, 20

complex sleep behaviors. It was REFERENCE: July 2022 (www.pmda.go.jp)
further decided to create a black • Drug Safety Alert No. 34, 11th
box warning as per FDA April 2023 (www.drap.gov.pk)

Healthcare professionals are advised to remain cautious while prescribing this
medicine to patients. A complete history should be taken in this regard. The drug
should not be prescribed to patients with a history of complex sleep behaviors after
taking this medicine. In case of any such adverse drug reaction, one must report to
the Provincial Pharmacovigilance Centre (PPC), Directorate of Drugs Control
DSA-1946: FINASTERIDE: POTENTIAL RISK OF SUICIDAL

IDEATION/THOUGHTS & SELF INJURY WITH FINASTERIDE
INTRODUCTION: safety review in 2022 related to Committee Meeting of NPC,
Finasteride is indicated for the same drug and event DRAP discussed the case. After
treating benign prostatic following the publishing of a detailed discussion, it was
hyperplasia and androgenic media article that discussed this concluded that the prescribing
alopecia in males. Recent drug potential risk. The study information/safety specification
safety reviews have reported the established a possible link should be updated by
potential risk of suicidal thoughts between the drug and the event. strengthening the warning
and psychological adverse events According to the DRAP, The most statements on the risks of suicidal
by Finasteride. recent Vigilyze statistics related to ideation and self-injury and
CASE REVIEWS: the finasteride and Standard including information about
The Health Sciences Authority of MedDRA Query(SMQ) selected patient screening for psychiatric
Singapore identified 356 reports Depression and suicide/self-injury risk factors before starting
of suicidality and 2926 reports of study identified 2,995 reports and treatment.
psychological adverse events 471 reports specifically with REFERENCE:
with users of Finasteride from suicidal ideation. • Drug Safety Alert No. 35, 11th
1993 to 2019. Similarly, Health CONCLUSION: April, 2023 (www.drap.gov.pk)
Canada conducted a recent The 2nd Pharmaceutical Expert

Healthcare Professionals are advised to monitor mood alterations, including
depression and, less frequently, suicidal ideation reported in patients treated with
finasteride, and guided 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 when such
thoughts are developed. In case of any such adverse drug reaction, one must report
to the Provincial Pharmacovigilance Centre (PPC), Directorate of Drugs Control
DSA-1947: PREDNISONE : RISK OF OSTEONECROSIS

INTRODUCTION: most often the hips and knees. + 2 not assessable).

Prednisone is a synthetic, anti- CASE REVIEWS: CONCLUSION:
inflammatory glucocorticoid that The Saudi Food & Drug SFDA has announced a safety
derives from cortisone. It is Administration (SFDA) has signal about the risk of
indicated as an anti-inflammatory searched their local and WHO Osteonecrosis with Prednisone.
or immunosuppressive agent. databases for prednisone- The assessed cases, literature,
Osteonecrosis, also called associated risk of osteonecrosis. and data mining suggested a
avascular necrosis (AVN) or The Saudi local database yielded causal association between the
aseptic necrosis, is the necrosis of 01 case report. In contrast, the drug and the event.
bone cells due to decreased WHO database produced 1037 REFERENCE:
blood flow. It can lead to pain and global case reports, out of which SFDA Safety Signal, 21.03.2023
collapse of areas of bone. This WHO-UMC Causality criteria were (www.sfda.gov.sa)
collapse of bone can lead to applied on 30 reports with a
degenerative arthritis (also called completeness score of 1.0 (1
osteoarthritis) of nearby joints, probable +19 possible + 8 unlikely

Healthcare Professionals are advised to consider SFDA’s recommendation for
prednisone-associated risks of Osteonecrosis. In case of any such adverse drug
DSA-1948: CYTARABINE ASSOCIATED RISK OF TUMOR LYSIS

SYNDROME
INTRODUCTION: CASE REVIEWS: assessable + 3 unlikely).
Cytarabine is an antineoplastic The Saudi Food & Drug CONCLUSION:
agent indicated for treating Administration (SFDA) has SFDA has announced a safety
various types of leukemias and searched their local and WHO signal about the risk of Tumor
lymphomas. Tumor lysis databases for Cytarabine- Lysis Syndrome using Cytarabine.
syndrome (TLS) is a constellation associated risk of Tumor Lysis The assessed cases, literature,
of metabolic abnormalities Syndrome. The Saudi local and datamining suggested a
resulting from the rapid release of database yielded 01 case report. causal association between the
intracellular metabolites when In contrast, the WHO database drug and the event.
massive lysis of tumor cells occur. produced 244 global case reports, REFERENCE:
These may include hyperkalemia, out of which WHO-UMC Causality SFDA Safety Signal, 30.04.2023
hyperphosphatemia, criteria were applied on 30 reports (www.sfda.gov.sa)
hyperuricemia from nucleic acid with a completeness score of 0.73
degradation, and hypocalcemia. (1 probable + 19 possible + 7 not

Healthcare professionals are advised to consider SFDA’s recommendation for
Cytarabine-associated Tumor Lysis Syndrome risk. In case of any such adverse
drug reaction, one must report to the Provincial Pharmacovigilance Centre (PPC),
SECTION B: TGRP HIGHLIGHTS
DSA-1949: INFUSION RINGER LACTATE ASSOCIATED PYREXIA,

CHILLS, ERYTHEMA & TACHYCARDIA
INTRODUCTION: 2304243, 2304244 & 2304245. the Chief Drug Controller, Punjab,
Each 100 mL of intravenous According to FDA-approved to direct the relevant Drugs
infusion of Ringer lactate contains literature, Hypersensitivity and Inspector to conduct re-sampling
Sodium chloride 600 mg, Sodium infusion reactions, including of the batches as mentioned
lactate 310 mg, Potassium tachycardia, pyrexia, and infusion earlier of the Inf. Ringer Lactate
chloride 30mg, Calcium chloride site skin erythema, have been and other disposables, including
dihydrate 20 mg, Water for reported with Inf. Ringer Lactate. Master-A+ Sterile Infusion Set
injection q.s, intended to restore The response is Non-serious and Batch No. 230101, Golden +
the electrolyte balance, and water declared “SIGNAL” as cluster Disposable Infusion Set Batch No.
for hydration. A combination of reports have been received. 19052022, IV Cannula W/Port
multiple electrolytes and sodium According to the VigiAccess 22G Batch No. 15850722,
lactate, an alkalinizing agent, will database, 958 case reports of Cannula B. Cat2 24G Batch No.
provide electrolyte balance and chills, 62 case reports of 15830722 and Nipro Wing Cath IV
normalize the pH of the acid-base erythema, 42 case reports of Cannula 22G Batch No.
of the physiological system. It is tachycardia, and 354 case reports 22J1106J. Furthermore, the Chief
indicated for the correction of of pyrexia upon administration of Executive Officer of the District
Electrolyte depletion, metabolic Ringer Lactate have already been Health Authority, Bahawalnagar,
acidosis, and dehydration. reported. In WHO-UMC criteria, it has been directed to stop
CASE REVIEWS: is classified as “POSSIBLE.” dispensing the above batches
Provincial Pharmacovigilance Concerning the Adverse Drug within the district immediately. The
Centre (PPC) has received 08 Reaction Scrutiny Committee case is under investigation and
TGRP reports of shivering, high- (ADRSC-005) meeting decision, it will be discussed in the upcoming
grade fever up to 103ºF, was decided that sampling of Provincial Pharmacovigilance
erythema, and tachycardia with large volume parenteral should be Committee meeting.
the Inf—Ringer Lactate done for further analysis of
manufactured by M/s Shazeb Endotoxins in case of shivering
Pharmaceuticals Industries and fever. The actions taken in
Limited Batch No. 2304241, this regard are directions issued to
All Retailers (Pharmacies, Medical Stores), Wholesalers, Distributors, and Health
Facilities are directed to stop dispensing the said batches of the product and
update the respective area drug inspector regarding their current inventory and
consumption record. In case of any adverse drug reaction, one must report to the
through https://mss.pshealthpunjab.gov.pk.
DSA-1950: INJECTION HEPARIN ASSOCIATED PYREXIA, CHILLS,
RISE IN BLOOD PRESSURE & BLOOD CLOTTING
INTRODUCTION: potentiates the action of inactivates thrombin and other
Heparin is an anticoagulant that Antithrombin III and thereby coagulation factors.
It prevents the conversion of According to FDA-approved is classified as “POSSIBLE.”
fibrinogen to fibrin; heparin also literature, generalized Directions have been issued to
stimulates the release of hypersensitivity reactions have the Chief Drugs Controller,
lipoprotein lipase (lipoprotein been reported, with chills, fever, Punjab, to conduct detailed
lipase hydrolyzes triglycerides to and urticaria as the most usual market surveillance, including
glycerol and free fatty acids). manifestations following Inj. trail, bill warranty, source of
CASE REVIEWS: Heparin. The response is Serious purchase, and lot release of the
Provincial Pharmacovigilance and declared “SIGNAL” as cluster concerned batch of Inj. Heparin.
Centre (PPC) has received reports have been received. The case is under investigation
several TGRP reports of According to the VigiAccess and will be discussed in the
shivering, high-grade fever, and database, 432 case reports of upcoming Provincial
rise in blood pressure following chills, 862 case reports of pyrexia, Pharmacovigilance Committee
the administration of different 291 case reports of hypertension, meeting.
batches and brands of Inj. and 35 case reports of hyper-
Heparin. While Hyper-coagulation coagulation upon administration
with Inj. Heparin has also been of Heparin have already been
reported in a few cases. reported. In WHO-UMC criteria, it

Healthcare Professionals are advised to monitor the patient for Inj
vigilantly—heparin-related Adverse Drug Reactions (ADRs) . In case of any
adverse drug reaction, one must report to the Provincial Pharmacovigilance
Centre (PPC), Directorate of Drugs Control Punjab, through
https://mss.pshealthpunjab.gov.pk.
SECTION C: QUALITY ASSOCIATED SAFETY ISSUES (QASI)
DSA-1951: PRODUCT RECALL OF FLUORAZINE 1MG TABLET BATCH NO. T-

2065 MANUFACTURED BY M/S CKD PHARMACEUTICALS PAK (PVT) LTD,
KARACHI
The Drug Regulatory Authority of Tablet Batch No. T-2065 vide the mentioned product are as
Pakistan (DRAP) has initiated a DRAP Alert No. NoI/S/04-23-20 follows:
Drug Recall of Fluorazine 1 mg dated 11th April 2023. Details of
Name of Product Fluorazine Tablet 1 mg (Trifluoperazine)
Manufactured By M/S CKD Pharmaceuticals Pak (Pvt) Ltd, Karachi
Batch No. T-2065
Mfg. Date 09-2022
Exp. Date 09-2025
REFERENCE:
Product Recall Alert Vide DRAP Alert No. NoI/S/04-23-20
DSA-1952: PRODUCT RECALL OF MICOGEN-B CREAM BATCH NO. MB-

012/22 MANUFACTURED BY M/S DELUX CHEMICAL INDUSTRIES, KARACHI
The Drug Regulatory Authority of Batch No. MB-012/22 vide DRAP mentioned product are as under:
Pakistan (DRAP) has initiated a Alert No. NoII/S/03-23-17 dated
Drug Recall of Micogen-B Cream 27th March 2023. Details of the
Name of Product Micogen-B Cream (Gentamicin, Miconazole & Betamethasone)
Manufactured By M/S Delux Chemical Industries, Karachi
Batch No. MB-012/22
Mfg. Date 11-2022
Exp. Date 11-2024
REFERENCE:
Product Recall Alert Vide DRAP Alert No. NoII/S/03-23-17
DSA-1953 PRODUCT RECALL OF SURGEE DISPOSABLE INFUSION SET
BATCH NO. IV0523 MANUFACTURED BY M/S REHMAN RAINBOW (PVT.),
LAHORE.
The Drug Regulatory Authority of Infusion Set Batch No. IV0523 the mentioned product are as
Pakistan (DRAP) has initiated a vide DRAP Alert No. NoI/07-23-28 follows:
Drug Recall of Surgee Disposable dated 27th July 2023. Details of
Name of Product Surgee Disposable Infusion Set
Manufactured By M/S Rehman Rainbow (Pvt.) Ltd.
Batch No. IV0523
Mfg. Date 05.2023
Exp. Date 04.2028
REFERENCE:
Product Recall Alert Vide DRAP Alert No. NoI/07-23-28
DSA-1954: PRODUCT RECALL NEONATAL BREATHING CIRCUITS
MANUFACTURED BY M/S ARMSTRONG MEDICAL LIMITED, NORTHERN
IRELAND, DISTRIBUTED BY M/S ELATE CC (PVT.) LTD. KARACHI,
PAKISTAN.
The Drug Regulatory Authority of Circuits Batch No. 230123 vide the mentioned product are as
Pakistan (DRAP) has initiated a DRAP Alert No. NoI/V/05-23-23 under:
Drug Recall of Neonatal Breathing dated 17th May 2023. Details of
Name of Product AQUAVENT NEO Neonatal CPAP Limb, Heated
Manufactured By M/S Armstrong Medical Limited, Northern Ireland.
Batch No. 230123
REFERENCE:
Product Recall Alert Vide DRAP Alert No. NoI/05-23-23.
DSA-1955: RAPID ALERT OF SPURIOUS PHENOBAR 30MG TABLET BATCH
NO. QA019, QA025, QA016 MANUFACTURED BY STAR LABORATORIES
(PVT) LTD.
The Drug Regulatory Authority of 30mg Tablet batch no. QA019, June 2023. Details of the
Pakistan (DRAP) has initiated a QA025 & QA016 vide DRAP Alert mentioned product are as under:
Rapid Alert of Spurious Phenobar No. NoI/S/06-23-24 dated 05th
Name of Product Phenobar Tablet 30 mg (Phenobarbitone)
Manufactured By M/S Star Laboratories (Pvt.) Ltd. Lahore
Batch No. QA019, QA016, QA025
REFERENCE:
Rapid Alert Vide DRAP Alert No. NoI/S/06-23-24.
DSA-1956: RAPID ALERT OF SPURIOUS & UNREGISTERED VIAGRA 100MG
TABLET BATCH NO. 19990544AG MANUFACTURED BY M/S BROOKLYN NE
(AS STATED ON LABEL).
The Drug Regulatory Authority of Unregistered Viagra 100mg Tablet dated 03rd May, 2023. Details of
Pakistan (DRAP) has initiated a batch no. 19990544AG vide the mentioned product are as
Rapid Alert of Spurious & DRAP Alert No. NoI/S/02-23-18 under:
Name of Product Viagra Tablet 100mg (Sildenafil)
Manufactured By M/S Brooklyn Ne
Batch No. 19990544AG
Mfg. Date 03/2021
Exp. Date 03/2025
REFERENCE:
Rapid Alert Vide DRAP Alert No.NoI/S/02-23-18.
DSA-1957: RAPID ALERT OF SPURIOUS SOJOURN (SEVOFLURANE) LIQUID

FOR INHALATION MANUFACTURED BY PIRAMAL CRITICAL CARE, INC.
USA.
The Drug Regulatory Authority of (Sevofluorane) Liquid for NoI/S/07-23-27 dated 24th July
Pakistan (DRAP) has initiated a Inhalation batch no. S0502C11 & 2023. Details of the mentioned
Rapid Alert of Spurious Sojourn S0512C14 vide DRAP Alert No. product are as under:
Name of Product Sojourn Liquid for Inhalation
Manufactured By M/S Piramal Critical Care, Inc. USA.
Batch No. S0502C11 , S0512C14
Mfg. Date 03/2022
Exp. Date 03/2027
REFERENCE:
DSA-1958: RAPID ALERT OF SPURIOUS CIPROXIN TABLET 500MG BATCH
NO. BAA928 PURPORTED TO BE MANUFACTURED BY NOVARTIS PHARMA
(PAKISTAN) LTD. KARACHI FOR BAYER PAKISTAN (PVT.) LTD. LAHORE.
The Drug Regulatory Authority of Tablet 500 mg batch no. BAA928 of the mentioned product are as
Pakistan (DRAP) has initiated a vide DRAP Alert No. NoII/S/06-23- follows:
Rapid Alert of Spurious Ciproxin 28 dated 19th June 2023. Details
Name of Product Ciproxin Tablet 500mg (Ciprofloxacin)
Manufactured By Novartis Pharma (Pakistan) Ltd. Karachi
Batch No. BAA928
Mfg. Date 12/2021
Exp. Date 11/2026
REFERENCE:
Rapid Alert Vide DRAP Alert No. NoII/S/06-23-28.
DSA-1959: RAPID ALERT OF UNREGISTERED N-GAISK PLUS TABLET
BATCH NO. 004 MANUFACTURED BY M/S NAZ HOMEO PHARMACY,
KARACHI
The Drug Regulatory Authority of Gaisk Plus Tablet batch no. 004 19th June 2023. Details of the
Pakistan (DRAP) has initiated a (Diclofenac Identified) vide DRAP mentioned product are as follows:
Rapid Alert of Unregistered N- Alert No. NoI/S/06-23-27 dated
Name of Product N-Gaisk Plus Tablet
Manufactured By M/S Naz Homeo Pharmacy Karachi
Batch No. 004
Mfg. Date 08/2022
Exp. Date 08/2028
REFERENCE:
DSA-1960: RAPID ALERT OF UNREGISTERED SUGAR XL CAPSULES

MANUFACTURED BY M/S NAZ HOMEO PHARMACY, KARACHI
The Drug Regulatory Authority of XL Capsule (Glibenclamide 2023. Details of the mentioned
Pakistan (DRAP) has initiated a Identified) vide DRAP Alert No. product are as follows:
Rapid Alert of Unregistered Sugar NoI/S/06-23-26 dated 19th June
Name of Product SUGAR XL CAPSULES
Manufactured By M/S Naz Homeo Pharmacy Karachi
Exp. Date Use within 05 years
REFERENCE:
Rapid Alert Vide DRAP Alert No. NoI/S/06-23-26
DSA-1961: RAPID ALERT OF UNREGISTERED HYP-RHO-D INJECTION
BATCH NO. 09181943 MANUFACTURED BY M/S WOOLMAR CHEMICAL
CORPORATION, USA IMPORTED/DISTRIBUTED BY M/S ZARYAB TRADERS
LAHORE.
The Drug Regulatory Authority of Rho-D Injection Batch No. August 2023. Details of the
Pakistan (DRAP) has initiated a 01981943 vide DRAP Alert No. mentioned product are as follows:
Rapid Alert of Unregistered Hyp- NoI/S/08-23-30 dated 02nd
Name of Product Hyp-Rho-D Injection (Immune Globulin)
Manufactured By M/S Woolmar Chemical Corporation
Batch No. 09181943
Exp. Date 08/2024
REFERENCE:
Rapid Alert Vide DRAP Alert No. NoI/S/08-23-30
DSA-1962: SPURIOUS RESTANE SOLUTION FOR INHALATION BATCH NO.
N0211B24 & N0211B25 MANUFACTURED BY M/S PIRAMAL CRITICAL CARE
INC.
The Drugs Testing Laboratory N0211B24 and N0211B25 as mentioned below:
Punjab has declared Restane “Spurious” dated 01st April 2023.
Solution for Inhalation Batch No. The details of the product are
Name of Product Restane Solution for Inhalation (Isoflurane)
Manufactured By M/S Piramal Critical Care Inc.
Batch No. N0211B24, N0211B25
REFERENCE:
TRA No. 01-74007038 & TRA No. 01-74007039 dated 01st April, 2023.
DSA-1963: SPURIOUS & SUBSTANDARD PROCAINE PENICILLIN FORTE
4,000,000 I.U. INJECTION BATCH NO. 140350 MANUFACTURED BY M/S
YANZHOU XIER KANGTAI PHARMA. CO., LTD.
The Drugs Testing Laboratory Injection Batch No. 140350 as product are mentioned as follows:
Punjab has declared Procaine “Spurious & Substandard” dated
Penicillin Forte 4,000,000 I.U. 04th April 2023. The details of the
Name of Product Procaine Penicillin Forte 4,000,000 I.U.
Manufactured By M/S Yanzhou Xier Kangtai Pharma. Co., Ltd.
Batch No. 140350
REFERENCE:
TRA No. 01-68021825 dated 04th April 2023.
DSA-1964: SPURIOUS EFASTON TABLET 10MG BATCH NO. 21101

MANUFACTURED BY M/S LAHORE CHEMICAL & PHARMACEUTICAL
WORKS (PVT.) LTD.
The Drugs Testing Laboratory Tablet 10mg Batch No. 21101 as The details of the product are
Punjab has declared Efaston “Spurious,” dated 08th April 2023. mentioned below:
Name of Product Efaston Tablet 10 mg (Duphaston)
Manufactured By M/S Lahore Chemical & Pharmaceutical Works (Pvt.) Ltd.
Batch No. 21101
REFERENCE:
TRA No. 01-68022362 dated 08th April 2023.
DSA-1965: ADULTERATED SETRIZIN SYRUP BATCH NO. 199-23
MANUFACTURED BY M/S LISKO PAKISTAN (PVT.) LTD.
The Drugs Testing Laboratory Syrup 1mg/ml Batch No. 199-23 2023.The details of the product
Punjab has declared Setrizin as “Adulterated” dated 02nd May are mentioned as under:
Name of Product Setrizin Syrup 1mg/ml (Cetirizine)
Manufactured By M/S Lisko Pakistan (Pvt.) Ltd.
Batch No. 199-23
REFERENCE:
TRA No. 01-68022824 dated 02nd May, 2023.
DSA-1966: SPURIOUS PHENOBAR 30 MG TABLET BATCH NO. QA 023
MANUFACTURED BY M/S STAR LABORATORIES (PVT.) LTD.
The Drugs Testing Laboratory 30mg Tablet Batch No. QA 023 as The details of the product are
Punjab has declared Phenobar “Spurious” dated 24th May 2023. mentioned below:
Name of Product Phenobar 30mg Tablet (Phenobarbitone)

Manufactured By M/S Star Laboratories (Pvt.) Ltd.
Batch No. QA 023
REFERENCE:
TRA No. 01-10097002815 dated 24th May 2023.
DSA-1967: SPURIOUS PENBIOTIC 5GM POWDER FOR INJECTION BATCH

NO. V141112 MANUFACTURED BY M/S NAWAN LABORATORIES (PVT.) LTD.
The Drugs Testing Laboratory 5gm powder for injection Batch 16th May 2023. The details of the
Punjab has declared Penbiotic No. V141112 as “Spurious” dated product are mentioned below:
Name of Product Penbiotic 5gm Powder for Injection (Streptopenicillin)

Manufactured By M/S Nawan Laboratories (Pvt.) Ltd.
Batch No. V141112
REFERENCE:
TRA No. 177005344 dated 16th May 2023.
DSA-1968: SPURIOUS PENIVET-5 POWDER FOR INJECTION BATCH NO. VJ-

1304 MANUFACTURED BY M/S STAR LABORATORIES (PVT.) LTD.
The Drugs Testing Laboratory Powder for Injection Batch No. VJ- May,2023. The details of the
Punjab has declared Penivet-5 1304 as “Spurious” dated 15th product are mentioned as under:
Name of Product Penivet-5 Powder for Injection

Manufactured By M/S Star Laboratories (Pvt.) Ltd.
Batch No. VJ-1304
REFERENCE:
TRA No. 177005342 dated 15th May 2023.
DSA-1969: SPURIOUS DUPHASTON 10MG TABLET BATCH NO. 214047
MANUFACTURED BY M/S HIGHNOON LABORATORIES LTD. MARKETED BY
M/S ABBOTT LABORATORIES PAKISTAN LTD.
The Drugs Testing Laboratory 10mg Tablet Batch No. 214047 as The details of the product are
Punjab has declared Duphaston “Spurious” dated 20th May 2023. mentioned as under:
Name of Product Duphaston 10mg Tablet (Dydrogesterone)
Manufactured By M/S Highnoon Laboratories Ltd.
Batch No. 214047
REFERENCE:
TRA No. 01-68023290 dated 20th May 2023.
DSA-1970: SUBSTANDARD & ADULTERATED LOXIBAK 50 ML INJECTION

BATCH NO. I-564 MANUFACTURED BY M/S ATTABAK PHARMACEUTICAL
INDUSTRIES.
The Drugs Testing Laboratory “Substandard & Adulterated” mentioned below:
Punjab has declared Loxibak dated 07th June 2023. The
50ml Injection Batch No. I-564 as details of the product are
Name of Product Loxibak 50ml Injection (Meloxicam)
Manufactured By M/S Attabak Pharmaceutical Industries
Batch No. V141112

REFERENCE:
TRA No. 01-6802374 dated 07th June 2023.
DSA-1971:SPURIOUS AZOMAX 250MG CAPSULE BATCH NO. A8346

PURPORTED TO BE MANUFACTURED BY M/S AGP LIMITED.
The Drugs Testing Laboratory mg Capsule Batch No. A8346 as The details of the product are
Punjab has declared Azomax 250 “Spurious” dated 17th July 2023. mentioned as under:
Name of Product Azomax 250mg Capsule (Azithromycin)

Manufactured By M/S AGP Limited
Exp. Date A8346
REFERENCE:
TRA No. 01-10194002112 dated 17th July 2023.
DSA-1972:SPURIOUS BIOCHLOR AEROSOL SPRAY 211ML BATCH NO. BL-
082, BL-083, BL-084, BL-085, BL-088, BL-089 MANUFACTURED BY M/S
SELMORE PHARMACEUTICALS (PVT.) LTD.
The Drugs Testing Laboratory BL-083, BL-084, BL-085 as dated 27th July 2023. The details
Punjab has declared Biochlor “Spurious” dated 10th July 2023 of the product are mentioned
Aerosol Spray Batch No. BL-082, and Batch No. BL-088, BL-089 below:
Name of Product Biochlor Spray 211ml (Chlortetracycline HCL 1.52%)
Manufactured By M/S Selmore Pharmaceuticals (Pvt.) Ltd
Exp. Date BL-082, BL-083, BL-084, BL-085, BL-088, BL-089
REFERENCE:
TRA No. 01-68023066-69 dated 10th July 2023, TRA No. 01-105002820 & TRA No. 01-105002831 dated 27th
July 2023.
DSA-1973: SUBSTANDARD & ADULTERATED BALIGNO 10ML INJECTION
BATCH NO. BL-1023 MANUFACTURED BY BAJWA PHARMACEUTICALS
(PVT.) LTD.
The Drugs Testing Laboratory Injection Batch No. BL-1023 as 04th July 2023. The details of
Punjab has declared Baligno 10ml “Substandard & Adulterated” dated product are mentioned as under:
Name of Product Baligno 10ml Injection (Lignocaine HCL 2%)
Manufactured By Bajwa Pharmaceuticals (Pvt.) Ltd.
Exp. Date BL-1023
REFERENCE:
TRA No. 01-68024282 dated 04th July 2023.

Drug Safety Punjab Sep23

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41st

DRUG SAFETY PUNJAB Edition

CONTENTS The Drug Safety Punjab (DSP)

Provincial Pharmacovigilance Centre (PPC), Directorate of Drugs Control (DDC) Punjab,

DSA-1936: CLOBETASOL: RISK OF SERIOUS UNDESIRABLE EFFECTS WITH PROLONGED USE

DSA-1937: GABAPENTIN ASSOCIATED RISK OF TOXIC EPIDERMAL NECROLYSIS (TEN)

DSA-1938: ITRACONAZOLE: POTENTIAL RISK OF HYPOKALEMIA

DSA-1939: LOXOPROFEN ASSOCIATED RISK OF ACUTE GENERALIZED EXANTHEMATOUS PUSTULOSIS

DSA-1940: METHOTREXATE: RISK OF PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY (PML).

DSA-1941: OLANZAPINE: POTENTIAL RISK OF HYPONATREMIA

DSA-1942: MINOXIDIL ASSOCIATED RISK OF FOLLICULITIS

DSA-1943: PEGASPARGASE: RISK OF HYPERSENSITIVITY REACTIONS

DSA-1944: BUPRENORPHINE: RISK OF DENTAL PROBLEMS

DSA-1945: ZOLPIDEM ASSOCIATED RISK OF COMPLEX SLEEP BEHAVIORS

DSA-1947: PREDNISONE ASSOCIATED RISK OF OSTEONECROSIS

DSA-1948: CYTARABINE ASSOCIATED RISK OF TUMOR LYSIS SYNDROME

SECTION-A: GLOBAL DRUG SAFETY

Advice for Healthcare Professionals:

DSA-1935: CABERGOLINE: RISK OF HYPERTENSION,

DSA-1936: CLOBETASOL: RISK OF SERIOUS UNDESIRABLE

Advice for Healthcare Professionals:

DSA-1937: GABAPENTIN ASSOCIATED RISK OF TOXIC EPIDERMAL

DSA-1938: ITRACONAZOLE: POTENTIAL RISK OF HYPOKALEMIA

CASE REVIEWS: possible. reaction.

Advice for Healthcare Professionals:

DSA-1939: LOXOPROFEN ASSOCIATED RISK OF ACUTE

Advice for Healthcare Professionals:

DSA-1940: METHOTREXATE: RISK OF PROGRESSIVE MULTIFOCAL

They concluded that a causal established for these cases. REFERENCE:

Advice for Healthcare Professionals:

DSA-1941: OLANZAPINE: POTENTIAL RISK OF HYPONATREMIA

Advice for Healthcare Professionals:

DSA-1942: MINOXIDIL ASSOCIATED RISK OF FOLLUCILITIS

CONCLUSION: with Minoxidil. (IPC), India, October 2022

Advice for Healthcare Professionals:

DSA-1943: PEGASPARGASE: RISK OF HYPERSENSITIVITY

DSA-1944: BUPRENORPHINE ASSOCIATED RISK OF DENTAL

DSA-1945: ZOLPIDEM ASSOCIATED RISK OF COMPLEX SLEEP

be updated to include risk of prescribed format. • Revision of Precautions, 20

Advice for Healthcare Professionals:

DSA-1946: FINASTERIDE: POTENTIAL RISK OF SUICIDAL

Advice for Healthcare Professionals:

DSA-1947: PREDNISONE : RISK OF OSTEONECROSIS

INTRODUCTION: most often the hips and knees. + 2 not assessable).

Advice for Healthcare Professionals:

DSA-1948: CYTARABINE ASSOCIATED RISK OF TUMOR LYSIS

Advice for Healthcare Professionals:

SECTION B: TGRP HIGHLIGHTS

DSA-1949: INFUSION RINGER LACTATE ASSOCIATED PYREXIA,

Advice for Healthcare Professionals:

SECTION C: QUALITY ASSOCIATED SAFETY ISSUES (QASI)

DSA-1951: PRODUCT RECALL OF FLUORAZINE 1MG TABLET BATCH NO. T-

DSA-1952: PRODUCT RECALL OF MICOGEN-B CREAM BATCH NO. MB-

DSA-1957: RAPID ALERT OF SPURIOUS SOJOURN (SEVOFLURANE) LIQUID

DSA-1960: RAPID ALERT OF UNREGISTERED SUGAR XL CAPSULES

DSA-1964: SPURIOUS EFASTON TABLET 10MG BATCH NO. 21101

Name of Product Phenobar 30mg Tablet (Phenobarbitone)

DSA-1967: SPURIOUS PENBIOTIC 5GM POWDER FOR INJECTION BATCH

Name of Product Penbiotic 5gm Powder for Injection (Streptopenicillin)

DSA-1968: SPURIOUS PENIVET-5 POWDER FOR INJECTION BATCH NO. VJ-

Name of Product Penivet-5 Powder for Injection

DSA-1970: SUBSTANDARD & ADULTERATED LOXIBAK 50 ML INJECTION

Batch No. V141112

DSA-1971:SPURIOUS AZOMAX 250MG CAPSULE BATCH NO. A8346