أولاً: التوعية الدوائية:
| Content | Issue date | Issue |
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Alert: Darzalex , Napizole Counterfeit 1 |
03/2023 |
(158) Newsletter-Hundred fifty eight
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Alert: Voltaren & Linezolid Counterfeit 1 |
02/2023 | |
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Alert: Averzolid, Restylane & Fortum Counterfeit 1 |
01/2023 | |
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Alert: Omnevore & Pedicort |
12/2022 |
(155) Newsletter-Hundred fifty five
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Alert: Nexium & Vigamox
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11/2022 | |
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Alert: Nevanac & Dyspot Counterfiet DHPC: Dexmedetomidine -Increased Risk of Mortality in Intensive Care Unit |
10/2022 | |
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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
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09/2022 | |
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• 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 | |
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•Citalopram & Escitalopram - Risk of Dosedependent Qt interval prolongation 1 •Local Case Report: Isotretinoin - Case of Skin rash, dryness and Blurred vision 2 |
07/2022 | |
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• Injectable Trime-butine- Risk of Cardiac Tox-icity in the Event of Misuse •Local Case Report: Pheno-barbital - Case of Apnea |
06/2022 | |
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• 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
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4/2022 | |
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3/2022 | |
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2/2022 | |
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1/2022 | |
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12/2021 | |
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11/2021 | |
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10/2021 | (141) Newsletter-Hundred Forty One October 2021 |
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09/2021 | (140) Newsletter-Hundred Forty September 2021 |
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08/2021 | (139) Newsletter-Hundred Thirty-nine August 2021 |
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07/2021 | |
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06/2021 | |
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05/2021 | |
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04/2021 | |
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03/2021 | |
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02/2021 | |
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01/2021 |
ثانياً: خطابات موجهة لمقدمى الخدمات الصحية:
| Content | Issue date | Issue |
|
Olaparib - For Treatment of Adult Patients with Deleterious or Suspected |
1/2023 | |
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Human Insulin – Differences between the old leaflet and the approved current |
12/2022 | |
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Hydroxyethyl Starch Solution for Infusion– Reminder of Safety Measures to |
12/2022 | |
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Ceftriaxone – Reminder of Precautions to Minimize Severe Hypersensitivity |
12/2022 | |
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Onasemnogene Abeparvovec - Risk for Thrombotic Microangiopathy |
12/2022 | |
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Cefotaxime – Reminder of Precautions to Minimize Severe Hypersensitivity |
12/2022 |
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Risk of Hypertrophic cardiomyopathy after Systemic administration of Hydrocortisone |
11/2022 | |
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Tixagevimab + Cilgavimab– Updated dosage recommendations for pre-exposure |
11/2022 | |
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Estradiol Valerate + Norethisterone Enanthate - Risk of Breast Cancer Recurrence |
11/2022 | |
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Propofol – Reminder of Instructions for Safe Use |
11/2022 | |
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Irinotecan – Recommendation for Reduction in Starting Dose to Reduce Risk of |
10/2022 |
DHPC Irinotecan risk of Drug toxicity in patients with decreased UGT1A1 activity |
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Onasemnogene abeparvovec - Fatal Cases of Acute Liver Failure Reported |
10/2022 | |
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Dexmedetomidine - Increased Risk of Mortality in Intensive Care Unit (ICU) |
10/2022 |
DHPC Dexmedetomidine - Increased Risk of Mortality in Intensive Care Unit (ICU) |
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Methotrexate - Risk of Progressive Multifocal Leukoencephalopathy (PML) |
6/2022 | |
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Hydroxychloroquine Risk of Sweet’s Syndrome and Severe Cutaneous Adverse |
6/2022 | |
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Increased risk of Cardiovascular Events & Cardiovascular Mortality when Hydroxychloroquine or Chloroquine used with Macrolide antibiotics |
4/2022 | |
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Important communication regarding Obeticholic acid |
3/2022 | |
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PAXLOVID Emergency Use Authorization (EUA) dosing and dispensing in moderate |
3/2022 | |
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Anagrelide hydrochloride: Risk of thrombosis including cerebral infarction upon abrupt treatment discontinuation |
3/2022 | |
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Mavenclad (Cladribine) – risk of serious liver injury and new recommendations about liver function monitoring |
3/2022 | |
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Infliximab: Use of live vaccines in infants exposed in utero or during breastfeeding |
3/2022 | |
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Brolucizumab – Updated recommendations to minimize the known risk of |
2/2022 | |
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Levocetirizine shouldn’t be used in children less than 2 years |
2/2022 | |
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Important Safety Information Regarding Use of Molnupiravir in Pregnancy and Individuals of Childbearing Potential |
2/2022 | |
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Octreotide Solution for Subcutaneous injection and intravenous infusion: Risk of atrioventricular block |
2/2022 | |
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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 | |
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Tenofovir Alafenamide: Risk of Renal impairment including renal failure, proximal |
1/2022 | |
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Donepezil-QTc interval extension and Torsade de Pointes |
1/2022 | |
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Glatiramer Acetate: Rare cases of severe liver damage |
1/2022 | |
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Amiodarone Hydrochloride 50 mg/ml concentrate for solution for |
1/2022 | DHPC Amiodarone |
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Dapagliflozin 5mg should no longer be used for the treatment of Type 1 Diabetes Mellitus |
1/2022 | DHPC Dapagliflozin |
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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 | |
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COVID-19 mRNA Vaccine Spikevax (previously Moderna): risk of myocarditis and pericarditis |
11/2021 | |
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COVID-19 mRNA Vaccine Comirnaty: risk of myocarditis and pericarditis |
11/2021 |
COVID-19 mRNA Vaccine Comirnaty: risk of myocarditis and pericarditi |
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COVID-19 Vaccine AstraZeneca: Risk of thrombocytopenia (including immune thrombocytopenia) with or without associated bleeding |
10/2021 | |
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COVID-19 Vaccine Janssen: Risk for immune thrombocytopenia (ITP) and venous thromboembolism (VTE) |
10/2021 | |
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Baricitinib - This medicinal product is subject to additional monitoring |
8/2021 | DHPC Baricitinib |
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COVID-19 Vaccine AstraZeneca: contraindication in individuals with previous capillary leak syndrome |
6/2021 | COVID-19 Vaccine AstraZeneca contraindication |
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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 |
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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 |
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COVID-19 Vaccine AstraZeneca: Risk of thrombosis in combination with |
6/2021 | |
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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 | |
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COVID-19 Vaccine AstraZeneca: Risk of coagulation disorders with or |
4/2021 | |
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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 | |
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The off-label use of trimebutine by injection is of concern with regard to its cardiac toxicity |
5/2022 | |
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Citalopram and Escitalopram – Reminder of Risk of Dose Dependent QT interval Prolongation |
7/2022 | |
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Colchicine Serious Poisoning– Reminder of the Rules of Proper Use |
7/2022 | |
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COVID-19 Vaccination Errors in Children |
9/2022 | |
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Ketamine- Risk of Biliary Duct Dilatation |
9/2022 | |
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Levothyroxine containing products: Biotin interference with laboratory tests |
2/2023 |
ثالثا: تنبيهات السلامة
| Content | Issue date | Issue |
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Clopidogrel has been shown to increase rosuvastatin exposure in patients |
Jan 2023 | |
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Risk of neural tube defects reported in infants born to women exposed to dolutegravir at the time of conception |
Dec 2022 | |
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A new warning about Suicidal risk of Metronidazole |
Dec 2022 | |
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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 | |
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A new warning about the nephrotoxic potential of clindamycin capsules and |
Aug 2022 | |
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Association of Oxcarbazepine with neurodevelopmental disorders, congenital |
July 2022 | |
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Ketamine risk of Biliary duct dilatation |
July 2022 | |
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PPIs risks of hypomagnesemia and severe cutaneous adverse drug reactions |
April 2022 | |
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Ribavirin risk of Embryo-Fetal Toxicity |
April 2022 | |
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A new warning about Thyroid Dysfunction of Iopromide in Pediatric Patients 0 |
March 2022 | |
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A new warning about temozolomide concerning duration of contraception |
March 2022 | |
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Restriction to use Chloramphenicol in paediatric population less than 2 years since it |
July 2021 |