Issue date

Risk of Seizures in Breastfed Infants Due to Mothers’ Use of Dicyclomine/DicycloverineContaining Products

Ocrevus® (ocrelizumab) 300 mg/10mL concentrate for infusion
Ocrevus® (ocrelizumab) 920mg/23mL solution for injection
Liver Injury with Ocrevus

SGLT2 inhibitors: Reminder to prevent the risks of diabetic ketoacidosis and Fournier's
gangrene (perineal necrotizing fasciitis)

Hydrocortisone-Risk of Thyrotoxic Periodic Paralysis (TPP)

Carbamazepine (liquid oral formulation): Contraindicated in Neonates( below 4 weeks of age) and Preterm babies (less than 44 post-menstrual weeks of age) due to propylene glycol 

Metformin- risk of lactic acidosis exacerbation and neurologic complications in patients
with mitochondrial diseases as Mitochondrial Encephalopathy with Lactic Acidosis, and
Stroke-like episodes (MELAS) syndrome & Maternal inherited diabetes and deafness
(MIDD)

Medroxyprogesterone acetate Risk of meningioma and measures to minimize
this risk

Kisqali® (ribociclib) 200 mg film coated tablet: Observed Patient Enrolled on Kisqali
Patient Support Program with Early Breast Cancer (off-label use)

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

DHPC content

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

DHPC content

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

DHPC content

DHPC Name

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