إصدارات الهيئة

نشرات اليقظة الدوائية

أولاً: التوعية الدوائية: 

Content Issue date Issue

Alert: Darzalex , Napizole Counterfeit 1
DHPC: Levothyroxine containing
products: Biotin interference with
laboratory tests 2-3
Case report from Cairo: Isotretinoin causing depression, skin dryness 4- 5
EPVC News 6
EPVC Tips 7

03/2023

(158) Newsletter-Hundred fifty eight

March 2023

 

Alert: Voltaren & Linezolid Counterfeit 1
DHPC: Hydroxyethyl Starch Solution for Infusion– Reminder of
Safety Measures to Minimize Risk
of Kidney Injury and Death 2
Local Case Report: Insulin - lack
of Drug Effect 3
EPVC News 6
EPVC Tips 8

02/2023

(157) Newsletter-Hundred fifty Seven

February 2023

Alert: Averzolid, Restylane & Fortum Counterfeit 1
Withdrawal & Suspension: Gemifloxacin 2
DHPC: Ceftriaxone & Cefotaxime
– Reminder of Precautions to Minimize Severe Hypersensitivity Reactions and Life-threatening Adverse Events 3
Local Case Report: Fexofenadine
- Ghost pill syndrome 5
EPVC News 7
EPVC Tips 8

01/2023

(156) Newsletter-Hundred fifty six

January 2023

Alert: Omnevore & Pedicort
Forte Counterfeit 1
DHPC: Tixagevimab + Cilgavimab  Updated Dosage Recommendations for Pre-exposure
Prophylaxis 2
Local Case Report: Gadoteric
Acid - Two Cases of Cardiac
Arrest 4
EPVC News 7
EPVC Tips 9

12/2022

(155) Newsletter-Hundred fifty five

December 2022

 

Alert: Nexium & Vigamox
Counterfeit 1


DHPC: Propofol– Reminder of
Instructions for Safe Use 2


Local Case Report: Hypersensitivity Reactions 3


EPVC News 5
EPVC Tips 6

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 2

 Local Case Report: Tigecycline - Medication Error 3

Medical Device: Dermal Filler Do's and Don'ts 5

 

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

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

1/2023

DHPC olaparib dhpc-removal of indication

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

12/2022

DHPC Insulin label Update

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

12/2022

DHPC HES (NEW)

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

12/2022

DHPC Ceftriaxone 

Onasemnogene Abeparvovec - Risk for Thrombotic Microangiopathy

12/2022

DHPC Onasemnogene abeparvovec thrombotic microangiopathy

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

12/2022

 

DHPC Cefotaxime

 

Risk of Hypertrophic cardiomyopathy after Systemic administration of Hydrocortisone

11/2022

DHPC Hydrocortison risk of hypertrophic cardiomyopathy

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

11/2022

DHPC Evusheld change in the dosage regimen

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

11/2022

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

Propofol – Reminder of Instructions for Safe Use

11/2022

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

10/2022

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

Onasemnogene abeparvovec - Fatal Cases of Acute Liver Failure Reported

10/2022

DHPC Onasemnogene abeparvovec risk of liver failure

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

10/2022

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

Methotrexate - Risk of Progressive Multifocal Leukoencephalopathy (PML)

6/2022

DHPC Methotrexate risk

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

6/2022

DHPC Hydroxychloroquin risk

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

4/2022

DHPC Azithromycin interaction with hydroxychloroquine

Important communication regarding Obeticholic acid

3/2022

DHPC Obtecholic

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

3/2022

DHPC Paxlovid used in Covid

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

3/2022

DHPC Anagrelide

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

3/2022

DHPC Cladribine

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

3/2022

DHPC Infliximab

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

2/2022

DHPC brolucizumab

Levocetirizine shouldn’t be used in children less than 2 years

2/2022

DHPC Levocetirizine

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

2/2022

DHPC Molnupiravir

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

2/2022

DHPC Octreotide

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)

2/2022

DHPC Olsalazine

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

1/2022

DHPC of tenofovir

Donepezil-QTc interval extension and Torsade de Pointes

1/2022

DHPC Donepezil

Glatiramer Acetate: Rare cases of severe liver damage

1/2022

DHPC Glatiramer

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

1/2022 DHPC Amiodarone

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

1/2022 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

1/2022

DHPC Dinoprostone

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

11/2021

DHPC for Moderna concerning pericarditis

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

11/2021

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

10/2021

COVID-19 Vaccine AstraZeneca Risk of thrombocytopenia

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

10/2021

COVID-19 Vaccine Janssen Risk for immune thrombocytopenia

Baricitinib - This medicinal product is subject to additional monitoring

8/2021 DHPC Baricitinib

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

6/2021 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. 

6/2021 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)

6/2021

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 .

6/2021

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.

4/2021

Tofacitinib Updated safety information

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

4/2021

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.

3/2021

Leflunomide Safety Updates

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

5/2022

Injectable Trimebutine- Risk of Cardiac Toxicity

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

7/2022

Citalopram and Escitalopram

Colchicine Serious Poisoning– Reminder of the Rules of Proper Use

7/2022

DPHC Colchicine 

COVID-19 Vaccination Errors in Children

9/2022

DPHC-COVID-19

Ketamine- Risk of Biliary Duct Dilatation

9/2022

DPHC-Ketamine

Levothyroxine containing products: Biotin interference with laboratory tests

2/2023

DHPC levothyroxine

 

ثالثا: تنبيهات السلامة

Content Issue date Issue

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

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

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

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

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 

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

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