Local case report Colistimethate sodium induced Bartter's syndrome 
EPVC News 
 VigiTest News 
EPVC Tips

(184 ) Newsletter-Hundred eighty four

DHPC: Risk of Medication Errors with Tranexamic Acid injection Resulting in Inadvertent Intrathecal ( spinal) Injection 
Local Case report statin-induced Muscle-Related Adverse Effects
EPVC News

EPVC Tip

(183 ) Newsletter-Hundred eighty three

DHPC : Thiocolchicoside containing
medicines for systemic use: -important
information on restrictions associated
with the risk of genotoxicity 
Local case report Terbutaline Sulfate
may exacerbate preexisting diabetes 
EPVC News 
EPVC Tips

(182 ) Newsletter-Hundred eighty Two

Mar 2025

Reminder Safety Alert : More prominent safety warnings about the neuropsychiatric effects of Montelukast
Local case report A case report of a
possible drug Interaction between
Levothyroxine and Orlistat 
EPVC News 
EPVC Tips

(181 ) Newsletter-Hundred eighty one

Feb 2025

Potential signal of impaired gastric
emptying associated with the administration of Tirzepatide 
Local case report Glyceryl Trinitrate
in hypertensive emergencies: A case of rapid decline in blood pressure after
an inappropriate initial dose 
EPVC News
EPVC Tips 

(180 ) Newsletter-Hundred eighty

Jan 2025

Safety Notification ! : Drug-induced
tendinopathy

Local case report Interferon alfa and Neuropsychiatric adverse reactions

EPVC News
EPVC Tips

(179 ) Newsletter-Hundred Seventy nine

DEC 2024

Safety Notification Drug-inducedIN THIS ISSUE

Safety Reminder " Iohexol: Non-

ionic monomeric contrast media

adverse events and preventive

measurements”

EPVC News

EPVC Tips

(178 ) Newsletter-Hundred Seventy eight

Nov 2024

Safety Notification ! New recom- tion is the way through which the promendations to minimize the risk of cesses for authorizing, regulatmeningioma with medicines con- ing, monitoring and evaluating the
taining medroxyprogesterone ace- safety of any pharmaceutical product
tate 
or medical device take place, in addi Levofloxacin Incorrect administration to disseminating any safety infortion rate medication error. mation for public health programs,

Case Report: Paclitaxel induced healthcare professionals, and the
hypersensitivity reactions 

Egyptian citizen.
EPVC News 

The Pharmaceutical vigilance ad EPVC Tips

(177 ) Newsletter-Hundred Seventy Seven

Oct 2024

Safety Notification ! Medicines
containing Garcinia gummi-gutta
(Garcinia cambogia) or hydroxycitric acid (HCA) 
Local Case Report: Cytarabine induced CNS adverse reactions 
EPVC News 

EPVC Tips 6

(176 ) Newsletter-Hundred Seventy Six

Sep2024

Safety Notification: Pseudoephedrinecontraindications 
Local case: Management of irinotecan related diarrhea 
EPVC News
EPVC Tips

(175 ) Newsletter-Hundred Seventy five

August2024

Safety Notification: Medicine-induced
hyponatremia: increased risks in older
people 
Safety Notification: Intravenous
Rituximab and Infusion-related
reactions 
EPVC News 
EPVC Tips 

(174) Newsletter-Hundred Seventy Four 

July 2024

Safety Notification: Interacting safely
with low-dose methotrexate 
Safety Notification: Promethazine
(oral): Do not use in children under
 years of age due to the risk of
psychiatric and central nervous system side effects 
EPVC News 
EPVC Tip

(173) Newsletter-Hundred Seventy three 

June 2024

Safety Notification: Unintentional
poisoning of some products 
Local Case Report: Furosemide
exposure during pregnancy 
EPVC News 
EPVC Tips 

(172) Newsletter-Hundred Seventy two 

MAY 2024

Safety Notification Drug-induced
phospholipids 
Safety Notification: Fishbane Reaction
Hypersensitivity Type to Intravenous
Iron Preparations 
Local Case Report: Potassium
    chloride Contraindications 
EPVC News 
EPVC Tips 

(171) Newsletter-Hundred Seventy one 

APR 2024

Safety Notification Uterine bleeding in people taking oral anticoagulant therapy 1
Safety Notification: Glucose meters and test strips: Safe way to use
them 2
Safety Notification ! : Radiation
Recall Phenomenon associated
with chemotherapy and certain
medications 3-4
EPVC News 5
EPVC Tips 6

(170) Newsletter-Hundred Seventy 

MAR 2024

Safety Notification ! Infusion-related
reactions – not all allergy related 1
Safety Notification !Symmetrical drug
-related intertriginous and flexural exanthema (SDRIFE) 2-3
Local case report " " Four Cases of
Keratitis and Corneal Melt Associated
with Local Anesthetic Eye Drops Use
4-5-6
EPVC News 7
EPVC Tips

(169) Newsletter-Hundred Sixty nine

Feb 2024

Safety Notification ! Infusion-related
reactions – not all allergy related 1-2
Local case report " Adverse events
following administration of Phyto
menadione (Vitamin K) intravenous
infusion.” 3-4
EPVC News 5
EPVC Tips 6

(168) Newsletter-Hundred Sixty eight

Jan 2024

Safety Notification ! : Antidepressant
withdrawal: taper antidepressants
slowly 1
Local case report Cytarabine may induce tumor lysis syndrome in acute
myeloid leukemia cases.” 2-3
Potential signal of Necrotizing soft
tissue infections with vincristine 4
Potential signal (2) Adverse outcomes
of uncompleted pregnancy following
insulin exposure 5
EPVC News 6
EPVC Tips 7

(167) Newsletter-Hundred Sixty seven

December 2023

Safety Alert ! : Vanishing bile duct
syndrome – a complication of drug
induced liver injury 1
Case report from Cairo: " Iohexol:
Non-ionic monomeric contrast media adverse events and preventive
measurements” 2-3-4-5
EPVC News 6
EPVC Tips 7

(166) Newsletter-Hundred Sixty six November 2023

Safety Alert ! : Fluoroquinolone antibiotics: suicidal thoughts and behavior 1
Case report from Cairo: Four cases
of serious extrapyramidal side effects after wrong drug dispensing
and dose administration of Cyclizine intravenous injection 2-3
EPVC News 4
EPVC Tips 5

(165) Newsletter-Hundred Sixty five October 2023

Local Alert: Sub-standardized and
Falsified (SF) Product 1
Safety Alert ! : Risk of meningioma
and progestins: General Recommendations to limit this risk 2
Two case reports from Alexandria:
Concerning Intravenous infusion
administration of Ampicillin Sodium and Sulbactam Sodium for two
Neonates resulted in Serious adverse event to Neonates . 3-4-5-6
EPVC News 7
EPVC Tips 8

(164) Newsletter-Hundred Sixty four September 2023

Local Alert: Sub-standardized and
Falsified (SF) Product
Identified Threat: Falsified Versions
Of Glucagon-Like Peptide 1 Receptor Agonist (Glp-1-Ra) Products
2-3
"Fever, Vomiting, Difficulty breathing,
Tachycardia and Cyanosis associated
with Immunoglobulin human normal.
4-5-6
EPVC News 7-8
EPVC Tips 9

(163) Newsletter-Hundred Sixty three August 2023 

Direct-acting oral anticoagulants
(DOACs): Pediatric formulations;
reminder of dose adjustments in patients with renal impairment 1

"Ca acetate caused muscle cramps to a fifth degree kidney failure patient compared to Ca carbonate being used as a phosphate binder " 2-3-4

EPVC News 5

EPVC Tips 6

(162) Newsletter-Hundred Sixty two July 2023 

Emerging Safety Issue: Statin potential risks of myasthenia gravis and ocular myasthenia
Case Study: A female got ischemic stroke while taking the combined hormonal contraceptive pill

EPVC News

EPVC Tips

(161) Newsletter-Hundred Sixty one June 2023

Safety Alert : Buproprion: unmasking of Brugada syndrome

Aflibercept induced endophthalmitis
and vitreous detachment

Two cases from Cairo : Atracurium
besilate- Isoflurane caused cardiac
arrest and bronchospasm due to inappropriate dose adjustment
(Medication error)

EPVC News

EPVC Tips 

(160) Newsletter-Hundred Sixty

May 2023

Consumer Update : Clopidogrel has
been shown to increase rosuvastatin
exposure in patients 
EPVC Investigation reports : Fingolimod induced bradycardia

EPVC Investigation reports (2): Pipazetate
hydrochloride accidental overdose

Two case reports from Alexandria: two
cases of intentional Dexamethasone misuse resulting in Type 2 diabetes mellitus/
Polycystic ovary/Moon face/ Buffalo
hump

EPVC News

EPVC Tips 

(159) Newsletter-Hundred Fifty nine April 2023

Alert: Darzalex , Napizole Counterfeit

DHPC: Levothyroxine containing
products: Biotin interference with

laboratory tests

Case report from Cairo: Isotretinoin causing depression, skin dryness

EPVC News

EPVC Tips 

(158) Newsletter-Hundred fifty eight

March 2023

Alert: Voltaren & Linezolid Counterfeit

DHPC: Hydroxyethyl Starch Solution for Infusion– Reminder of

Safety Measures to Minimize Risk
of Kidney Injury and Death

Local Case Report: Insulin - lack
of Drug Effect

EPVC News EPVC Tips 

(157) Newsletter-Hundred fifty Seven

February 2023

Alert: Averzolid, Restylane & Fortum Counterfeit 
Withdrawal & Suspension: Gemifloxacin 
DHPC: Ceftriaxone & Cefotaxime
– Reminder of Precautions to Minimize Severe Hypersensitivity Reactions and Life-threatening Adverse Events 
Local Case Report: Fexofenadine
- Ghost pill syndrome 
EPVC News 
EPVC Tips 

(156) Newsletter-Hundred fifty six

January 2023

Alert: Omnevore & Pedicort
Forte Counterfeit 
DHPC: Tixagevimab + Cilgavimab  Updated Dosage Recommendations for Pre-exposure
Prophylaxis 
Local Case Report: Gadoteric
Acid - Two Cases of Cardiac
Arrest 
EPVC News 
EPVC Tips 

(155) Newsletter-Hundred fifty five

December 2022

Alert: Nexium & Vigamox
Counterfeit 

DHPC: Propofol– Reminder of
Instructions for Safe Use 

Local Case Report: Hypersensitivity Reactions 

EPVC News 
EPVC Tips 

(154) Newsletter-Hundred fifty four

November 2022

Alert: Nevanac & Dyspot Counterfiet     

DHPC: Dexmedetomidine -Increased Risk of Mortality in Intensive Care Unit            
Local Case Report: EstradiolValerate + Prasterone Enantate Medication Error                   

(153)Newsletter-Hundred fifty three October 2022

Counterfeit and Commercial Fraud 1 (DHPC):

Colchicine Serious Poisoning – Reminder of the Rules of Proper Use 

 Local Case Report: Tigecycline - Medication Error 

Medical Device: Dermal Filler Do's and Don'ts 

(152) Newsletter-Hundred Fifty two septamber 2022

  Infliximab- Use of Live Vaccines in Infants Exposed in Utero or During Breastfeeding  

  Local Case Report: Cefotaxime - Anaphylactic shock, Hypersensitivity, Hypoxia and Rash

(151) Newsletter-Hundred Fifty One August 2022

  •Citalopram & Escitalopram - Risk of Dosedependent Qt interval prolongation 1

  •Local Case Report: Isotretinoin - Case of Skin rash, dryness and Blurred vision 2

(150) Newsletter-hundred fifty-July 2022

  • Injectable Trime-butine- Risk of Cardiac Tox-icity in the Event of Misuse

    •Local Case Report: Pheno-barbital - Case of Apnea

(149) Newsletter-Hundred Forty Nine June 2022

    • Alert: Xoraxone Vial Counterfeit 1

    • Bone marrow suppression with methotrexate and   trimethoprim or trimethoprim with   sulfamethoxazole 2

    • Local Case Report: Ceftriaxone with ketorolac -   Anaphylactic shock 3

(148) Newsletter-Hundred forty-eight May 2022

• Alert: Unictam Vial Counterfeit
• Reminder of General Measures to Prevent the Nephrotoxicity Risk with High dose Methotrexate
• Local Case Report: Paclitaxel - Convulsions and Coma
• EPVC News

(147) Newsletter-Hundred Forty Seven April 2022

• DHPC:Dapagliflozin 5mg Should No Longer be Used for the Treatment of Type 1 Diabetes Mellitus
• Local Case Report: Alendronic Acid - Case of Osteonecrosis of the Jaw
• EPVC News

(146) Newsletter-Hundred Forty Six March 2022

• DHPC: Donepezil-QTc interval extension and Torsade de Pointes
• Local Case Report: Tranexamic acid - Case of Convulsions
• EPVC News

(145) Newsletter-Hundred Forty five February 2022

• Pholcodine Containing Antitussive Drugs and Risk of Allergic Reaction to Neuromuscular Blocking Agents
• DHPC: Glatiramer acetate Rare Cases of Severe Liver Damage
• Local Case Report: A case of Guillain-Barre syndrome following Janssen COVID-19 vaccine
• EPVC News

(144) Newsletter-Hundred Forty four January 2022

• DHPC: Amiodarone Hydrochloride 50 mg/ml Concentrate for Solution for Injection/Infusion Potential for crystallization
• Local Case Report: Case of Drug Dependence and Overdose Following Xylometazoline Nasal Drops Prolonged Administration
• EPVC News

(143) Newsletter-Hundred Forty three Deecember 2021

• DHPC: COVID-19  mRNA  Vaccine Comirnaty: Risk of Myocarditis and Pericarditis.
• Local Case  Report:  A  Case  of Drug Abuse Resulted in Acute Renal  Injury,  Cardiomegaly, Muscle Weakness,  Ulcers,  Sepsis  and  Finally  Death  Following  Paraffin Oil, Anabolic Steroids and Synthol Local Administration

(142) Newsletter-Hundred Forty two November 2021

• COVID-19 Vaccine Astra-Zeneca: Warning for Guillain-Barre syndrome
• Topical corticosteroids: Information on the risk of topical steroid withdrawal reactions
• EPVC News

• Colchicine: High risk of fatality with Colchicine over-dose
• Fingolimod: Updated advice about the risks of serious liver injury and herpes meningoencephalitis
• EPVC News

• Bendamustine: Risk of nonmelanoma skin cancer
• Levodopa DHPC 2
• Local Case Report: Lamivudine and Sulipride

• Obeticholic acid: Restriction of use
• Local Case Report: Fluorouracil
• EPVC News

(138) Newsletter-Hundred Thirty-eight
July 2021

• Polyethylene glycol (PEG) laxatives and starch-based thickeners: risk of aspiration
• Local Case Report: Interaction between Warfarin and Naproxen
• EPVC News

(137) Newsletter-Hundred Thirty-seven
June 2021

• Bupropion: risk of serotonin syndrome
• Local Case Report: Warfarin

(136) Newsletter-Hundred Thirty-six
May 2021

• Erythromycin: Update on Risk of Infantile Hypertrophic Pyloric Stenosis
• Local Case Report: Ceftriaxone
• EPVC News

(135) Newsletter-Hundred Thirty-five
April 2021

• Erythromycin Cardiac Risk and Interaction with Rivaroxaban
• Local Case Report: Furosemide
• EPVC News

(134) Newsletter-Hundred Thirty-four
March 2021

• SSRI/SNRI risk of post-partum hemorrhage
• Local Case Report: Sildenafil
• EPVC News

(133) Newsletter-Hundred Thirty-three
February 2021

• DHPC for Dimethyl Fumarate
• Safety Communication for Emicizumab
• Local Case Report: Cyclizine
• EPVC News

(132) Newsletter-Hundred Thirty-two
January 2021

Paracetamol – Reminder of proper use and risks associated with
overdose

Capecitabine Caution in interpreting the results of screening for
dihydropyrimidine dehydrogenase (DPD) deficiency by measuring blood uracil
levels in patients with moderate renal impairment

Caspofungin: Recommendation not to use membrane derived from
polyacrylonitrile in patients in intensive care under hemofiltration and
receiving treatment with caspofungin

Important information on Risks associated with the simultaneous use of
Naltrexone hydrochloride / bupropion hydrochloride and opioids

Tranexamic acid containing products: Risk of Medication error leading to an
accidental exposure to tranexamic acid by intra-spinal route Causing serious
life-threatening injuries

Thiocolchicoside containing medicines for systemic use: - important
information on restrictions associated with the risk of genotoxicity

Montelukast: Reminder of serious neuropsychiatric events associated with
Montelukast

Chlorhexidine-containing products: Risks of persistent corneal injury and
significant visual impairment

N-acetyl-cysteine containing medicines: Reminder of the proper use of IV and
inhalation preparations

Obeticholic acid: Risk of Serious liver injury may be observed in patients
without cirrhosis treated with obeticholic acid

Metamizole-containing medicines: important measures to minimize the
serious outcomes of known risk of agranulocytosis

Hydroxycarbamide-containing medicinal products: Potential interference with
continuous glucose monitoring systems

Medicines containing 5-fluorouracil (i.v.): In patients with moderate or severe
renal impairment, phenotyping for dihydropyrimidine dehydrogenase (DPD)
deficiency by measuring blood uracil levels should be interpreted with caution

Azithromycin dihydrate, Zithromax 200 mg in 5 ml suspension and
replacement of the syringe inside the box to be graduated in mLs only

(isotretinoin) - Reminder of the existing restrictions on Preventing exposure during
pregnancy

Quetiapine – Risk of serotonin syndrome, a potentially fatal condition in case
of Concomitant administration with other serotonergic medications, such as
MAO inhibitors, selective serotonin reuptake inhibitors, serotonin
norepinephrine reuptake inhibitors, or tricyclic antidepressants.

Hydroxychloroquine sulfate-Potential risk of major congenital malformations
and new risks

Hydroxyethyl Starch Solution for Infusion– 2
nd Reminder of Safety Measures to
Minimize Risk of Kidney Injury and Death

Risperidone oral solution formulation-Risk of accidental overdose following
administration errors

Medicines containing omega-3 fatty acids: dose-dependent increased risk of
atrial fibrillation in patients with established cardiovascular diseases or
cardiovascular risk factors

Pseudoephedrine – Risks of posterior reversible encephalopathy syndrome
(PRES) and reversible cerebral vasoconstriction syndrome (RCVS)

Fluconazole - warnings regarding use during pregnancy

Cefuroxime - Clarification related to instructions for use

Topiramate :New restrictions to prevent exposure during pregnancy

Valproate: Potential risk to children of fathers treated with valproate - Updated
information regarding risk of neurodevelopmental disorders including autism
spectrum disorders after paternal exposure to valproate in comparison to
lamotrigine/levetiracetam

SIMULECT ® (basiliximab): Supply of Simulect 20mg packs containing only basiliximab
powder vial without the water for injection ampoule.

Linezolid, Averozolid Solution for IV infusion, clarification of yellow color appearance
and its intensifying to yellowish brown by time in the solution

Azithromycine: Reminder of risk of QT prolongation and method of IV preparation
and administration

Ramucirumab: New safety label updates in Cyramza “Ramucirumab” Patient insert
leafle

Direct Healthcare Professional Communication (DHPC) for the Water for Injection(WFI)
ampoules co-packed with Simulect (Basiliximab) 20mg vials, have been removed from batch
number SFTR2, SHEN8, SHJW3 and an alternative WFI must be used for reconstitution.

Potential Missing Package Leaflet in Folding Boxes of Hemlibra (emicizumab) 30mg/ml and
60mg/0.4ml.

Potential Missing Package Leaflet in Folding Boxes of Perjeta (pertuzumab), Kadcyla
(trastuzumab emtansine) 160mg and Phesgo (pertuzumab/trastuzumab) 600 mg.

Potential Missing Package Leaflet in Folding Boxes of Mabthera S.C. 1400 MG/11.7 ML
(rituximab)

Ketamine: prolonged use leads to serious hepatic and uro-nephrological damage

Clomiphene: risk of serious visual disturbances (blindness)

DHPC-Clomiphene

Lamotrigine: reminder of proper use in order to limit the risk of serious skin rash,
particularly at the start of treatment

DHPC- lamotrigine

Pholcodine - The use of pholcodine in the 12 months before general anesthesia with
neuromuscular blocking agents (NMBA) is a risk factor for developing an
anaphylactic reaction (a sudden, severe and life-threatening allergic reaction) to
NMBAs

DHPC- Pholcodine

Acefylline Piperazine +Phenobarbital /Acefylline Piperazine +Phenobarbitone
Risk of Drug interaction, Dependence and Many Side Effects in Long Term Use

DHPC- Acefyllin

Terbutaline Turbuhaler and Terbutaline nebulizer: important information to convey
to patients

DHPC- Terbutaline

Lung Surfactants< Product Name>, follow-up the safety and efficacy of the
product

DHPC- lung surfactants

Propofol: risk of sepsis when withdrawn multiple times from one container

DHPC- propofol

Metamizole Sodium
(“Novalgin 1 g / 2 ml Solution for Injection” and Novalgin Oblong 500 mg Film
Coated Tablet) Contraindication in pregnancy and breastfeeding women

DHPC Novalgin

Calcium Gluconate < Product Name> potential risk of underdosing with calcium
gluconate in severe hyperkalaemia

DHPC -Ca-Gluconate

Systemic and inhaled fluoroquinolone antibiotics – reminder on restrictions of use

DHPC- fluoroquinolone antibiotics

Darzalex (Daratumumab): “Interaction with Blood Compatibility Testing- Information for Blood
Transfusion Management Departments (Blood Banks)

DHPC -Daratumumab

VINORELBINE, NAVELBINE 50MG/5ML & 10MG/1ML SOLUTION FOR
INJECTION IN A VIAL, Introduction Of An Undesirable Effect: Acute Respiratory
Distress Syndrome

DHPC- vinorelbine

An Approved Safety Label Change: Risk Of Cushing’s Syndrome And Adrenal
Suppression With The Use Of Econopred Plus (Prednisolone Acetate) Eye Drops

DHPC- prednisolon

Direct Healthcare Professional Communication for Lucentis® (Ranibizumab)
10 mg/ml solution for injection regarding “label containing information
about the physical character (color of solution) that might be confusing

DHPC- Ranibizumab

Yervoy (Ipilimumab) Notification of Pack Deviation from Egypt Specific Pack to
US Pack

DHPC  YERVOY

Desflurane, SUPRANE, Introduction of 2 warnings in the updated leaflet

DHPC desflurane

Levothyroxine containing products: Biotin interference with laboratory tests

DHPC levothyroxine

Terlipressin: Serious or fatal respiratory failure and sepsis/septic shock in patients with type 1 hepatorenal syndrome (type 1 HRS)

DHPC- terlipressin

Olaparib - For Treatment of Adult Patients with Deleterious or Suspected
Deleterious Germline BRCA-mutated (gBRCAm) Advanced Ovarian Cancer who
have been Treated with Three or More Prior Lines of Chemotherapy

DHPC olaparib dhpc-removal of indication

Risk of exaggerated hypotension with rapid bolus administration of Vancomycin

DHPC vancomycin

Human Insulin – Differences between the old leaflet and the approved current
leaflet

DHPC Insulin label Update

Hydroxyethyl Starch Solution for Infusion– Reminder of Safety Measures to
Minimize Risk of Kidney Injury and Death

DHPC HES (NEW)

Ceftriaxone – Reminder of Precautions to Minimize Severe Hypersensitivity
Reactions and Life-threatening Adverse Events

DHPC Ceftriaxone 

Onasemnogene Abeparvovec - Risk for Thrombotic Microangiopathy

DHPC Onasemnogene abeparvovec thrombotic microangiopathy

Cefotaxime – Reminder of Precautions to Minimize Severe Hypersensitivity
Reactions and Life-threatening Adverse Events

DHPC Cefotaxime

Metamizole may reduce the effect of acetyl salicylic acid on platelet aggregation
when taken concomitantly

DHPC- acetyl salysilic acid+metamizole

Risk of Hypertrophic cardiomyopathy after Systemic administration of Hydrocortisone

DHPC Hydrocortison risk of hypertrophic cardiomyopathy

Tixagevimab + Cilgavimab– Updated dosage recommendations for pre-exposure
prophylaxis

DHPC Evusheld change in the dosage regimen

Estradiol Valerate + Norethisterone Enanthate - Risk of Breast Cancer Recurrence
in Patients with History of Breast Cancer

DHPC Estradiol Valerate + Norethisterone Enanthate- Risk of Breast Cancer Recurrence in Patients with History of Breast Cancer

Propofol – Reminder of Instructions for Safe Use

DHPC Propofol-Reminder of Instructions for Safe Use

Irinotecan – Recommendation for Reduction in Starting Dose to Reduce Risk of
Irinotecan-induced Neutropenia and Diarrhea in Patients with UGT1A1 *28*6
Variant

DHPC Irinotecan risk of Drug toxicity in patients with decreased UGT1A1 activity

Onasemnogene abeparvovec - Fatal Cases of Acute Liver Failure Reported

DHPC Onasemnogene abeparvovec risk of liver failure

Dexmedetomidine - Increased Risk of Mortality in Intensive Care Unit (ICU)
Patients ≤65 years

DHPC Dexmedetomidine - Increased Risk of Mortality in Intensive Care Unit (ICU) 

COVID-19 Vaccination Errors in Children

DPHC-COVID-19

Ketamine- Risk of Biliary Duct Dilatation

DPHC-Ketamine

Colchicine Serious Poisoning– Reminder of the Rules of Proper Use

DPHC Colchicine 

Citalopram and Escitalopram – Reminder of Risk of Dose Dependent QT interval Prolongation

Citalopram and Escitalopram

Cardiac events, hepatic, blood, kidney side effects and contraindication in specific
population associated with Halothane containing products

DHPC- Halothane

Methotrexate - Risk of Progressive Multifocal Leukoencephalopathy (PML)

DHPC Methotrexate risk

Hydroxychloroquine Risk of Sweet’s Syndrome and Severe Cutaneous Adverse
Reactions (SCARS)

DHPC Hydroxychloroquin risk

The off-label use of trimebutine by injection is of concern with regard to its cardiac toxicity

Injectable Trimebutine- Risk of Cardiac Toxicity

Increased risk of Cardiovascular Events & Cardiovascular Mortality when Hydroxychloroquine or Chloroquine used with Macrolide antibiotics

DHPC Azithromycin interaction with hydroxychloroquine

Gabapentin (Neurontin) and precautions regarding concomitant opioid use

DHPC_Gabapentin

Ivermectin 3 mg and 6 mg Scored tablets: Risk of Disturbance of consciousness

DHPC- Ivermectin

PAXLOVID Emergency Use Authorization (EUA) dosing and dispensing in moderate
renalimpairment, and risk of serious adverse reactions due to drug interactions

DHPC Paxlovid used in Covid

Anagrelide hydrochloride: Risk of thrombosis including cerebral infarction upon abrupt treatment discontinuation

DHPC Anagrelide

Mavenclad (Cladribine) – risk of serious liver injury and new recommendations about liver function monitoring

DHPC Cladribine

Infliximab: Use of live vaccines in infants exposed in utero or during breastfeeding

DHPC Infliximab

Neural tube defects reported in infants born to women exposed to dolutegravir at
the time of conception

DHPC Dolutegravir

Brolucizumab – Updated recommendations to minimize the known risk of
intraocular inflammation, including retinal vasculitis and/or retinal vascular
occlusion

DHPC brolucizumab

Olsalazine – Severe cutaneous adverse reactions, including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP)

DHPC Olsalazine

Tenofovir Alafenamide: Risk of Renal impairment including renal failure, proximal
Renal tubulopathy and Fanconi Syndrome

DHPC of tenofovir

Donepezil-QTc interval extension and Torsade de Pointes

DHPC Donepezil

Glatiramer Acetate: Rare cases of severe liver damage

DHPC Glatiramer

Amiodarone Hydrochloride 50 mg/ml concentrate for solution for
Injection/Infusion - Potential for crystallisation

Dapagliflozin 5mg should no longer be used for the treatment of Type 1 Diabetes Mellitus

Dinoprostone: Add A Restriction On Use And Update Of Dosage Recommendations, Warnings And Especially Adding Recommendations On The Risks Of Hyperstimulation Uterine, Uterine Rupture And Fetal / Neonatal Mortality

DHPC Dinoprostone

Voriconazole – Risk of drug-drug interaction with Lurasidone since it may result
in significant increase in Lurasidone exposure

DHPC Voriconazole

Octreotide Solution for Subcutaneous injection and intravenous infusion: Risk of
atrioventricular block

DHPC octreotide 

Important communication regarding Obeticholic acid

DHPC Obeticholic

Important Safety Information Regarding Use of Molnupiravir in Pregnancy and
Individuals of Childbearing Potential

DHPC Molnupiravir 

Levocetirizine shouldn’t be used in children less than 2

DHPC Levocetirizine

COVID-19 mRNA Vaccine Spikevax (previously Moderna): risk of myocarditis and pericarditis

DHPC for Moderna concerning pericarditis

COVID-19 mRNA Vaccine Comirnaty: risk of myocarditis and pericarditis

COVID-19 mRNA Vaccine Comirnaty: risk of myocarditis and pericarditi

COVID-19 Vaccine AstraZeneca: Risk of thrombocytopenia (including immune thrombocytopenia) with or without associated bleeding

COVID-19 Vaccine AstraZeneca Risk of thrombocytopenia

COVID-19 Vaccine Janssen: Risk for immune thrombocytopenia (ITP) and venous thromboembolism (VTE)

COVID-19 Vaccine Janssen Risk for immune thrombocytopenia

Baricitinib - This medicinal product is subject to additional monitoring

COVID-19 Vaccine AstraZeneca: contraindication in individuals with previous capillary leak syndrome

It was noted that the dosing information (specifically the timing of dosing with respect to food) in the product information for the levodopa-containing products was not optimal: it did not make clear that dosing without food is possible, and maybe preferable for some patients. 

COVID-19 Vaccine Janssen: Contraindication in individuals with previous capillary leak syndrome and update on thrombosis with thrombocytopenia syndrome

Capillary leak syndrome (CLS)

Thrombosis with thrombocytopenia syndrome(TTS)

J&J Covid 19 Vaccine
Risk Of Capillary Leak Syndrome And TTS

COVID-19 Vaccine AstraZeneca: Risk of thrombosis in combination with
thrombocytopenia — Updated information .

Astrazeneca Covid 19 Vaccine Risk Of TTS update June 2021

Tofacitinib: initial clinical trial results of increased risk of major adverse cardiovascular events and malignancies (excluding NMSC) with use of tofacitinib relative to TNF-alpha inhibitors.

Tofacitinib Updated safety information

COVID-19 Vaccine AstraZeneca: Risk of coagulation disorders with or
without thrombocytopenia

AstraZeneca Covid 19 Vaccine Risk Of TTS April 2021

As the leaflets available in the packs of Leflunomide tablets are currently undergoing important safety updates, we would like to inform you of these important safety updates till their implementation in packs.

Leflunomide Safety Updates

Carbamazepine - risks of Microcephaly, Small for gestational age (SGA), Neurodevelopmental disorders (Autism spectrum disorder, Intellectual disability,
ADHD) in Neonates

Nirmatrelvir/Ritonavir -new contraindication: co-administration with enzalutamide

Sugammadex -risk of serious Hypersensitivity Reaction

Tirzepatide-potential risk of pulmonary aspiration during general anesthesia or deep sedation 

Tacrolimus - risks of skin cancers and Kaposi's sarcoma

Oxaliplatin- risks of Splenomegaly &Microangiopathic haemolytic anaemia associated
with haemolytic uraemic syndrome

Vardenafil –Risks of Stevens-Johnson syndrome SJS ,toxic epidermal necrolysis
(TEN) and Central serous chorioretinopathy

Metformin-risks of aggravation of Mitochondrial Encephalopathy with Lactic Acidosis,
and Stroke-like episodes (MELAS) syndrome & Maternal inherited diabetes and deafness
(MIDD) in patients with mitochondrial diseases

Azathioprine –Risks of Non-cirrhotic portal hypertension, porto-sinusoidal
vascular disease and hepatic Damage

Propofol –Risks of hepatitis and acute hepatic failure

Lidocaine– New warning about risk of Kounis Syndrome

Atomoxetine-new warning about threatening behavior and thoughts of harming others

Semaglutide-Risks of Pulmonary Aspiration, intestinal obstruction & dysesthesia

Esketamine nasal spray – Risks of Bradycardia and Seizure

Teriflunomide – Risk of herpes virus infections

EDA performs label update to include the following:

Special warnings and precautions for use :Liver injury

Undesirable Effects:
Hepatobiliary Disorders
Rare: Liver injury

Valproate and increased risk of neurodevelopmental disorders (NDDs) in children
born to men treated with valproate in the 3 months prior to conception

Thiocolchicoside and restrictions associated with the risk of genotoxicity

Avanafil – Risk of Visual defects including central serous chorioretinopathy (CSCR)

Medroxyprogesterone – Risk of meningioma

Leflunomide – warning about impaired wound healing after surgery

Garcinia – Risk of liver injury

Pseudoephedrine – risk of abuse to be added as a new warning

Quetiapine – Concomitant administration of quetiapine and other serotonergic medications, such as MAO inhibitors, selective serotonin reuptake inhibitors, serotoninnorepinephrine reuptake inhibitors, or tricyclic antidepressants, may cause serotonin
syndrome, a potentially fatal condition

Upadacitinib – Risk of vertigo and dizziness

Menquadfi
EDA performs label update to include the following:

Dosage and administration

Ibuprofen – Risk of Kounis Syndrome

Promethazine—Contraindiction in children under 6 years of age due to the risk of
psychiatric and central nervous system side effects .

Pseudoephedrine – new contraindications and risk of PRES and RCVS

EDA performs label update to include the following:
Indications/Uses:
 discontinued.
Pregnancy, lactation:
Undesirable effects:
Undesirable effects from the post-marketing phase
General Administration for Pharmaceutical Vigilance
Infections and infestations
Mabthera is indicated for:
References:

Osimertinib – Risk of Hyperpigmentation

Dacarbazine – Extension of the period of contraception for women of childbearing
potential due to the genotoxic potential of dacarbazine

Sunitinib – Risk of Hyperammonaemic encephalopathy

Nirmatrelvir & Ritonavir – Contraindications with Medicinal products that are highly
dependent on CYP3A for clearance leadin to serious and/or life-threatening reactions

Azacitidine– Risk of Cutaneous vasculitis

Hydroxychloroquine Sulfate– Risk of drug-induced phospholipidosis, hepatotoxicity,
hepatitis B virus reactivation and aggravation of myasthenia gravis

Citalopram/Escitalopram– Risk of QT prolongation

Ashwagandha – Risk of liver injury and GIT irritation

Imovax Polio
EDA performs label update to include the following:

This vaccine is indicated for the prevention of poliomyelitis in infants, children
and adults, for primary vaccination (series of first vaccinations) and as a boost
er.
IMOVAX POLIO must be used according to effective official recommendations

Gabapentin– Risk of SCARs and toxic epidermal necrolysis

Terlipressin– Avoidance in patients with advanced renal dysfunction& Risk of
Respiratory failure and dyspnoea

Voriconazole– Interaction of Voriconazole with Flucloxacillin

Benzyl alcohol containing products —Risk of gasping syndrome in young children
& Allergic reaction and mild local irritation.

Remicade
Page 1
EDA performs label update to include the following:
2. What you need to know before you use Remicade
Warnings and precautions

4. Possible side effects
Uncommon: may affect up to 1 in 100 people
Weight gain (for most patients, the weight gain was small).

Rosuvastatin—Drug-Drug interaction of Rosuvastatin with Ticagrelor

IDACIO

EDA performs label update to include the following:
1. What Idacio is and what it is used for
2. How to use Idacio

Fluconazole—Risk of miscarriage and congenital malformations when using fluconazole during pregnancy also includes the use of lower doses.

Alendronate - Risk of low-energy fractures observed in bones other than the femur

Darzalex
Page 1
EDA performs label update to include the following:
4. Possible side effects
Background:

Rybelsus
Page 1
EDA performs label update to include the following:
2. What you need to know before you take Rybelsus®
4. Possible side effects
Background:

Mesalazine - risk of discolouration of urine after contact with sodium hypochlorite
(bleach) & drug reaction with eosinophilia and systemic symptoms (DRESS)

Statins - risk of Myasthenia Gravis

Fentanyl transdermal Patches - risks of Accidental use and Ingestion

Safety Alerts -Fentanyl

Ibuprofen/Paracetamol - risks of kounis syndrome &fixed drug eruption

Ibuprofen-paracetamol - Safety Alerts 

Synflorix
EDA performs label update to include the following:
Posology and method of administration

Safety Alerts -Synflorix

Glucagen
Page 1
EDA performs label update to include the following:
2. What you need to know before you use GlucaGen®.
4. Possible side effects
Background:

Safety Alerts -Glucagen

Methyl Prednisolone- risk of Tumour lysis syndrome & hypothalamic pituitary-adrenal axis suppression

Methyl Prednisolone- Safety Alerts

Tofacitinib sodium succinate –Risk of Hypoglycemia & Retinal venous thrombosis

Tofacitinib  -Safety Alerts

Hydrocortisone sodium succinate –Risk of Tumor Lysis Syndrome

hydrocortisone -Safety Alerts 

Rivastigmine and risk of QT prolongation and torsade de pointes

Rivastigmine-Safety Alert

A new warning about Risk of Toxic Epidermal Necrolysis (TEN) for
Gabapentinoids

Gabapentin-Safety Alert

A new warning about Vancomycin and Risk of risk of Kounis syndrome

Vancomycin-Safety Alert

Clopidogrel—risk of hemorrhage with aspirin

Clopidogrel Safety Alerts 

Bupropion and the risk of unmasking of Brugada Syndrome

Bupropion-Safety alert

Betamethasone-Dexamethasone –risk of Pheochromocytoma

betametnasone Safety Alerts 

Clopidogrel has been shown to increase rosuvastatin exposure in patients

clopidogrel -safety alert

Risk of neural tube defects reported in infants born to women exposed to dolutegravir at the time of conception

dolutegravir safety alert

A new warning about Suicidal risk of Metronidazole

METONIDAZOLE -Safety Alerts

Hydroxycobalamin -risk of Interference with platetelet count, aluminuim toxicity,
lab tests

Hydroxycobalamin Safety Alert

Leflunomide relationship between leflunomide and skin ulcer

Leflunomide-Safety Alerts

Carbamazepine risk of Interaction with brivaracetam, warnings and recommendations on use during pregnancy and in women of childbearing potential and addition of hyperammonemia to undesirable effects

carbamazepine safety alert

Brinzolamide risks of Stevens-Johnson syndrome (SJS) and toxic epidermal

Brinzolamide -Safety Alerts

A new warning about the nephrotoxic potential of clindamycin capsules and
injections

clindamycin-Safety Alerts 

Association of Oxcarbazepine with neurodevelopmental disorders, congenital

 OXCARBAZEPINE-Safety Alerts 

Ketamine risk of Biliary duct dilatation

Ketamine safety alert

Linagliptin acid-risk of Hypoglycemia

linagliptin Safety Alerts 

Isavuconazole and risk of Anaphylactic reaction

Isavuconazole- Safety Alerts

PPIs risks of hypomagnesemia and severe cutaneous adverse drug reactions

PPIs- safety alert

Ribavirin risk of Embryo-Fetal Toxicity

Ribavirin-safety alert

Donepezil-QTc interval extension and Torsade de Pointes

Donepezil Safety Alerts 

A new warning about Thyroid Dysfunction of Iopromide in Pediatric Patients 0
to 3 Years of Age

 Iopromide -Safety Alerts 

A new warning about temozolomide concerning duration of contraception
following the end of treatment with a genotoxic drug.

 temozolomide-Safety Alerts 

Hydrocortisone in systemic route and risk of hypertrophic cardiomyopathy and
neonatal hypoglycemia

Hydrocortisone-Safety Alert

Icreased risk of Cardiovascular Events & Cardiovascular Mortality when
Hydroxychloroquine or Chloroquine used with Macrolide antibiotic

AZ Safety Alerts 

Omeprazole Risk of risk of nephrotoxicity

Omeprazole Safety Alerts

Upadacitinib and risk of diverticulitis

Upadacitinib-Safety Alert

Sacubitril/ Valsartan risks of psychiatric disorders as hallucinations , sleep and paranoia

Sacubitril/ Valsartan-Safety alert

Pregabalin and risks of Steven Johnson Syndrome and Toxic Epidermal Necrolysis

Pregabalin-Safety Alerts

Pirfenidone Risks of Stevens-Johnson syndrome (SJS) and toxic epidermal
necrolysis (TEN)

Pirfenidone-safety Alerts

Dexamethasone in systemic route and risk of hypertrophic cardiomyopathy and neonatal hypoglycemia

Dexamethasone-Safety Alerts

Ivermectin 3 mg and 6 mg Scored tablets: Risk of Disturbance of consciousness

Ivermectin Safety Alert

Tenofovir Alafenamide: Risk of Renal impairment including renal failure, proximal

tenofovir Safety Alerts

Voriconazole – Risk of drug-drug interaction with Lurasidone since it may result
in significant increase in Lurasidone exposure

Voriconazole Safety Alerts -

Obeticholic acid-risks of hepatic decompensation and liver failure

obeticholic acid Safety Alerts 

Methotrexate - Risk of Progressive Multifocal Leukoencephalopathy (PML)

Methotrexate Safety Alerts

Ondansetron and risk of myocardial ischemia

Ondansetron- Safety Alerts

Sulfamethoxazole-Trimethoprim-Hypersensitivity and Other Serious or Fatal Reactions

Trimethoprim Safety Alerts _

Venlafaxine and risk of serious discontinuation symptoms

Venlafaxine- Safety Alerts

Ethosuximide and risk of immune thrombocytopenia

Ethosuximide- Safety Alerts

NSAID and the risk of oligohydramnios in the second trimester

NSAID-Safety Alerts

Duloxetine may cause symptoms of sexual dysfunction

Duloxetine-Safety Alerts

Pentosan – pigmentary maculopathy (changes in the retina of the eye) risk of pigmentary maculopathy (changes in the retina of the eye), especially after long-term
use

Pentosan Safety Alerts

Restriction to use Chloramphenicol in paediatric population less than 2 years since it
contains boron and may impair fertility in the future

 chloramphenicol-Safety Alerts

Hydroxychloroquine Risk of Sweet’s Syndrome and Severe Cutaneous Adverse
Reactions (SCARS)

Hydroxychloroquine Safety Alert