نشرات الرعاية الصيدلية

نشرات اليقظة الدوائية

أولاً: التوعية الدوائية: 

Content Issue date Issue

 

Safety Notification Drug-inducedIN THIS ISSUE

Safety Reminder " Iohexol: Non-

ionic monomeric contrast media

adverse events and preventive

measurements”

EPVC News

EPVC Tips

11/2024

(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

10/2024

(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

09/2024

(176 ) Newsletter-Hundred Seventy Six

Sep2024

 

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

08/2024

(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 

07/2024

(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

06/2024

(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 

05/2024

(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 

04/2024

(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

03/2024

 

(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

02/2024

(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

01/2024

(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

12/2023

(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

11/2023

(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

10/2023

(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

09/2023

(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

08/2023

(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

07/2023

(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

06/2023

(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 

05/2023

(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 

04/2023

(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 

03/2023

(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 

02/2023

(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 

01/2023

(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 

12/2022

(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 

11/2022

(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                   

10/2022

(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 

09/2022

(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

08/2022

(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

07/2022

(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

06/2022

(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

05/2022

(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
4/2022

(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
3/2022

(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
2/2022

(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
1/2022

(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
12/2021

(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
11/2021

(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
10/2021 (141) Newsletter-Hundred Forty One October 2021
  • Colchicine: High risk of fatality with Colchicine over-dose
  • Fingolimod: Updated advice about the risks of serious liver injury and herpes meningoencephalitis
  • EPVC News
09/2021 (140) Newsletter-Hundred Forty
September 2021
  • Bendamustine: Risk of nonmelanoma skin cancer
  • Levodopa DHPC 2
  • Local Case Report: Lamivudine and Sulipride
08/2021 (139) Newsletter-Hundred Thirty-nine
August 2021
  • Obeticholic acid: Restriction of use
  • Local Case Report: Fluorouracil
  • EPVC News
07/2021

(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
06/2021

(137) Newsletter-Hundred Thirty-seven
June 2021

  • Bupropion: risk of serotonin syndrome
  • Local Case Report: Warfarin
05/2021

(136) Newsletter-Hundred Thirty-six
May 2021

  • Erythromycin: Update on Risk of Infantile Hypertrophic Pyloric Stenosis
  • Local Case Report: Ceftriaxone
  • EPVC News
04/2021

(135) Newsletter-Hundred Thirty-five
April 2021

  • Erythromycin Cardiac Risk and Interaction with Rivaroxaban
  • Local Case Report: Furosemide
  • EPVC News
03/2021

(134) Newsletter-Hundred Thirty-four
March 2021

  • SSRI/SNRI risk of post-partum hemorrhage
  • Local Case Report: Sildenafil
  • EPVC News
02/2021

(133) Newsletter-Hundred Thirty-three
February 2021

  • DHPC for Dimethyl Fumarate
  • Safety Communication for Emicizumab
  • Local Case Report: Cyclizine
  • EPVC News
01/2021

(132) Newsletter-Hundred Thirty-two
January 2021

 

ثانياً: خطابات موجهة لمقدمى الخدمات الصحية:

Content Issue date Issue

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

Dec 2024 DHPC-Hydroxyurea

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

Dec 2024 DHPC-5-fluorouracil

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

Nov-2024 DHPC- Zithromax

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

Oct-2024 DHPC OF Isotretinoin

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.

Aug-2024 DHPC- Quetiapine

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

Aug-2024 DHPC - Hydroxychloroquine sulfate

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

Jun-2024 DHPC- Hydroxyethyl Starch Solution for Infusion

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

May-2024 DHPC- Risperidone

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

May-2024 DHPC- omega-3 fatty acids

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

May-2024 DHPC- Pseudoephedrine

Fluconazole - warnings regarding use during pregnancy

Apr-2024 DHPC- Fluconazole

Cefuroxime - Clarification related to instructions for use

Mar-2024 DHPC -Cefuroxime

Topiramate :New restrictions to prevent exposure during pregnancy

Jan-2024 DHPC - Topiramate

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

Jan-2024 DHPC - Valproate

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

Dec-2023 DHPC - Simulect

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

Dec-2023 DHPC- Linezolid

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

Dec-2023 DHPC -Azithromycin

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

Dec-2023 DHPC - Cyramza

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.

Oct-2023 DHPC -Simulect

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

Oct-2023 DHPC- Hemlibra

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

Oct-2023 DHPC -perjeta

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

Oct-2023 DHPC- Mabthera

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

Oct-2023 DHPC- Ketamine

Clomiphene: risk of serious visual disturbances (blindness)

Oct-2023

DHPC-Clomiphene

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

Oct-2023

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

Sep-2023

DHPC- Pholcodine

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

Sep-2023

DHPC- Acefyllin

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

Sep-2023

DHPC- Terbutaline

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

Sep-2023

DHPC- lung surfactants

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

Aug-2023

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

july-2023

DHPC Novalgin

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

july-2023

DHPC -Ca-Gluconate

Systemic and inhaled fluoroquinolone antibiotics – reminder on restrictions of use

july-2023

DHPC- fluoroquinolone antibiotics

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

Jun-2023

DHPC -Daratumumab

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

MAY/2023

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

MAY/2023

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

MAY/2023

DHPC- Ranibizumab

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

Apr-2023

DHPC  YERVOY

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

Feb-2023

DHPC desflurane

Levothyroxine containing products: Biotin interference with laboratory tests

Feb-2023

DHPC levothyroxine

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

Jan/2023

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

Jan/2023

DHPC olaparib dhpc-removal of indication

Risk of exaggerated hypotension with rapid bolus administration of Vancomycin

Dec/2022

DHPC vancomycin

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

Dec/2022

DHPC Insulin label Update

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

Dec/2022

DHPC HES (NEW)

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

Dec/2022

DHPC Ceftriaxone 

Onasemnogene Abeparvovec - Risk for Thrombotic Microangiopathy

Dec/2022

DHPC Onasemnogene abeparvovec thrombotic microangiopathy

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

Dec/2022

 

DHPC Cefotaxime

 

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

Nov/2022

DHPC- acetyl salysilic acid+metamizole

Risk of Hypertrophic cardiomyopathy after Systemic administration of Hydrocortisone

Nov/2022

DHPC Hydrocortison risk of hypertrophic cardiomyopathy

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

Nov/2022

DHPC Evusheld change in the dosage regimen

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

Nov/2022

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

Propofol – Reminder of Instructions for Safe Use

Nov/2022

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

Oct/2022

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

Onasemnogene abeparvovec - Fatal Cases of Acute Liver Failure Reported

Oct/2022

DHPC Onasemnogene abeparvovec risk of liver failure

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

Oct/2022

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

COVID-19 Vaccination Errors in Children

Sep-2022

DPHC-COVID-19

Ketamine- Risk of Biliary Duct Dilatation

Sep-2022

DPHC-Ketamine

Colchicine Serious Poisoning– Reminder of the Rules of Proper Use

Jul-2022

DPHC Colchicine 

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

Jul-2022

Citalopram and Escitalopram

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

Jun/2022

DHPC- Halothane

Methotrexate - Risk of Progressive Multifocal Leukoencephalopathy (PML)

Jun/2022

DHPC Methotrexate risk

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

Jun/2022

DHPC Hydroxychloroquin risk

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

May-2022

Injectable Trimebutine- Risk of Cardiac Toxicity

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

Apr/2022

DHPC Azithromycin interaction with hydroxychloroquine

Gabapentin (Neurontin) and precautions regarding concomitant opioid use

Mar/2022

DHPC_Gabapentin

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

Mar/2022

DHPC- Ivermectin

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

Mar/2022

DHPC Paxlovid used in Covid

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

Mar/2022

DHPC Anagrelide

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

Mar/2022

DHPC Cladribine

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

Mar/2022

DHPC Infliximab

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

Feb/2022

DHPC Dolutegravir

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

Feb/2022

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)

Feb/2022

DHPC Olsalazine

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

Jan/2022

DHPC of tenofovir

Donepezil-QTc interval extension and Torsade de Pointes

Jan/2022

DHPC Donepezil

Glatiramer Acetate: Rare cases of severe liver damage

Jan/2022

DHPC Glatiramer

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

Jan/2022 DHPC Amiodarone

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

Jan/2022 DHPC Dapagliflozin

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

Jan/2022

DHPC Dinoprostone

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

Dec-2021

DHPC Voriconazole

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

Dec-2021

DHPC octreotide 

Important communication regarding Obeticholic acid

Dec-2021

DHPC Obeticholic

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

Dec-2021

DHPC Molnupiravir 

Levocetirizine shouldn’t be used in children less than 2

Dec-2021

DHPC Levocetirizine

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

Nov/2021

DHPC for Moderna concerning pericarditis

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

Nov/2021

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

Oct/2021

COVID-19 Vaccine AstraZeneca Risk of thrombocytopenia

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

Oct/2021

COVID-19 Vaccine Janssen Risk for immune thrombocytopenia

Baricitinib - This medicinal product is subject to additional monitoring

Aug/2021 DHPC Baricitinib

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

Jun/2021 COVID-19 Vaccine AstraZeneca contraindication

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. 

Jun/2021 Updating Dosing Information Levodopa

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)

Jun/2021

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 .

Jun/2021

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.

Apr/2021

Tofacitinib Updated safety information

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

Apr/2021

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.

Mar/2021

Leflunomide Safety Updates

 

ثالثا: تنبيهات السلامة

Content Issue date Issue

Thiocolchicoside and restrictions associated with the risk of genotoxicity

Dec-2024 Safety Alerts - thiocolchicoside

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

Dec-2024 Safety Alerts -Avanafil

Medroxyprogesterone – Risk of meningioma

Nov-2024 Safety Alerts -medroxyprogesteron

Leflunomide – warning about impaired wound healing after surgery

Sep-2024 Safety Alerts -leflunomide

Garcinia – Risk of liver injury

Aug-2024 Safety Alerts - Garcinia

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

Aug-2024 Safety Alerts -Pseudoephedrine

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

Aug-2024 Safety Alerts -Quetiapine

Upadacitinib – Risk of vertigo and dizziness

Aug-2024 Safety Alerts -Upadacitinib

Ibuprofen – Risk of Kounis Syndrome

July-2024 Safety Alerts - Ibuprofen

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

July-2024 Safety Alerts -Promethazine

Pseudoephedrine – new contraindications and risk of PRES and RCVS

July-2024 Safety Alerts -Pseudoephedrine

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:

Jun-2024 Safety Alerts -Mabthera

Osimertinib – Risk of Hyperpigmentation

Jun-2024 Safety Alerts -osimertinib

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

Jun-2024 Safety Alerts -Dacarbazine

Sunitinib – Risk of Hyperammonaemic encephalopathy

Jun-2024 Safety Alerts -sunitinib

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

May- 2024 Safety Alerts-Nirmatrelvir & Ritonavir

Azacitidine– Risk of Cutaneous vasculitis

May- 2024 Safety Alerts-Azacitidine

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

May- 2024 Safety Alerts-Hydroxychloroquine Sulfate

Citalopram/Escitalopram– Risk of QT prolongation

Apr-2024 Safety Alerts - Citalopram/Escitalopram

Ashwagandha – Risk of liver injury and GIT irritation

Apr-2024 Safety Alerts - ashwagandha

Gabapentin– Risk of SCARs and toxic epidermal necrolysis

Mar-2024 Safety Alerts - Gabapentin

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

Mar-2024 Safety Alerts - Terlipressin

Voriconazole– Interaction of Voriconazole with Flucloxacillin

Mar-2024 Safety Alerts-Voriconazole with Flucloxacillin

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

Mar-2024 Safety Alerts-Benzyl alcohol

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).

Jan-2024 Safety Alerts -Remicade

Rosuvastatin—Drug-Drug interaction of Rosuvastatin with Ticagrelor

Jan-2024 Safety Alerts -Rosuvastatin

IDACIO

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

Jan-2024 Safety Alerts - Idacio_

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

Jan-2024 Safety Alerts -Fluconazole

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

Dec-2023 Safety Alerts -alendronate

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

Nov-2023 Safety Alerts -Darzalex

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:

Nov-2023 Safety Alerts -Rybelsus

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

Oct-2023 Safety Alerts -Mesalazine

Statins - risk of Myasthenia Gravis

Oct-2023 Safety Alerts -Statins

Fentanyl transdermal Patches - risks of Accidental use and Ingestion

Oct-2023

Safety Alerts -Fentanyl

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

Oct-2023

Ibuprofen-paracetamol - Safety Alerts 

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:

Sep-2023

Safety Alerts -Glucagen

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

Aug-2023

Methyl Prednisolone- Safety Alerts

Tofacitinib sodium succinate –Risk of Hypoglycemia & Retinal venous thrombosis

Jul-2023

Tofacitinib  -Safety Alerts

Hydrocortisone sodium succinate –Risk of Tumor Lysis Syndrome

Jul-2023

hydrocortisone -Safety Alerts 

Rivastigmine and risk of QT prolongation and torsade de pointes

Jul-2023

Rivastigmine-Safety Alert

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

April 2023

Gabapentin-Safety Alert

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

Mar 2023

Vancomycin-Safety Alert

Clopidogrel—risk of hemorrhage with aspirin

Feb 2023

Clopidogrel Safety Alerts 

Bupropion and the risk of unmasking of Brugada Syndrome

Feb 2023

Bupropion-Safety alert

Betamethasone-Dexamethasone –risk of Pheochromocytoma

Jan 2023

betametnasone Safety Alerts 

Clopidogrel has been shown to increase rosuvastatin exposure in patients

Jan 2023

clopidogrel -safety alert

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

Dec 2022

dolutegravir safety alert

A new warning about Suicidal risk of Metronidazole

Dec 2022

METONIDAZOLE -Safety Alerts

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

Oct 2022

Hydroxycobalamin Safety Alert

Leflunomide relationship between leflunomide and skin ulcer

Sep 2022

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

Sep 2022

carbamazepine safety alert

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

Aug 2022

Brinzolamide -Safety Alerts

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

Aug 2022

clindamycin-Safety Alerts 

Association of Oxcarbazepine with neurodevelopmental disorders, congenital

July 2022

 OXCARBAZEPINE-Safety Alerts 

Ketamine risk of Biliary duct dilatation

July 2022

Ketamine safety alert

Linagliptin acid-risk of Hypoglycemia

Jun-2022

linagliptin Safety Alerts 

Isavuconazole and risk of Anaphylactic reaction

Jun-2022

Isavuconazole- Safety Alerts

PPIs risks of hypomagnesemia and severe cutaneous adverse drug reactions

 April 2022

PPIs- safety alert

Ribavirin risk of Embryo-Fetal Toxicity

April 2022

Ribavirin-safety alert

Donepezil-QTc interval extension and Torsade de Pointes

March 2022

Donepezil Safety Alerts 

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

March 2022

 Iopromide -Safety Alerts 

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

March 2022

 temozolomide-Safety Alerts 

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

Feb 2022

Hydrocortisone-Safety Alert

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

Feb 2022

AZ Safety Alerts 

Omeprazole Risk of risk of nephrotoxicity

Feb 2022

Omeprazole Safety Alerts

Upadacitinib and risk of diverticulitis

Feb 2022

Upadacitinib-Safety Alert

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

Feb 2022

Sacubitril/ Valsartan-Safety alert

Pregabalin and risks of Steven Johnson Syndrome and Toxic Epidermal Necrolysis

Feb 2022

Pregabalin-Safety Alerts

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

Feb 2022

Pirfenidone-safety Alerts

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

Feb 2022

Dexamethasone-Safety Alerts

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

Jan-2022

Ivermectin Safety Alert

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

Jan-2022

tenofovir Safety Alerts

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

Jan-2022

Voriconazole Safety Alerts -

Obeticholic acid-risks of hepatic decompensation and liver failure

Dec-2021

obeticholic acid Safety Alerts 

Methotrexate - Risk of Progressive Multifocal Leukoencephalopathy (PML)

Dec-2021

Methotrexate Safety Alerts

Ondansetron and risk of myocardial ischemia

Dec-2021

Ondansetron- Safety Alerts

Sulfamethoxazole-Trimethoprim-Hypersensitivity and Other Serious or Fatal Reactions

Nov-2021

Trimethoprim Safety Alerts _

Venlafaxine and risk of serious discontinuation symptoms

Nov-2021

Venlafaxine- Safety Alerts

Ethosuximide and risk of immune thrombocytopenia

Nov-2021

Ethosuximide- Safety Alerts

NSAID and the risk of oligohydramnios in the second trimester

Nov-2021

NSAID-Safety Alerts

Duloxetine may cause symptoms of sexual dysfunction

Nov-2021

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

Oct-2021

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

July 2021

 chloramphenicol-Safety Alerts

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

Apr-2021

Hydroxychloroquine Safety Alert

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