Severe cutaneous adverse reactions (SCARs) associated with atezolizumab use: DHPC for an identified risk

Drug Safety Updates, Global Safety Alerts, Medicinal Product Updates, Pharmacovigilance, Safety Communications, Swissmedic - Switzerland, Voluntary ADR reporting, , , ,

A direct healthcare professional communication (DHPC) released by Swissmedic, Switzerland health authority pertaining to a safety concern – severe cutaneous adverse reaction (SCAR) associated with Tecentriq® (atezolizumab) use. Atezolizumab is an anticancer medicine available with the brand name – Tecentriq®. It is a monoclonal antibody used in the treatment of urothelial carcinoma, non-small cell lung…

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Metamizole induced liver injury: Direct health care professional communication (DHPC)

Drug Safety Alert, EMA-European Medicines Agency, Global Safety Alerts, Medicinal Product Updates, PRAC, Safety Communications, , ,

European Medicines Agency (EMA) released a direct health care professional letter (DHPC) pertaining to the risk of drug-induced liver injury (DILI) by metamizole. We encourage all health care professionals to be aware of this new safety alert and to disseminate this significant information to the relevant stakeholders for a better patient safety. Metamizole (also known…

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Ototoxicity associated with aminoglycoside class of medicines – MHRA drug safety update

Drug Safety Updates, Global Safety Alerts, Medicinal Product Updates, MHRA-United Kingdom, Voluntary ADR reporting, ,

Aminoglycosides are potent, broad-spectrum class antibiotics which act by inhibition of bacterial protein synthesis. These are traditional antibacterial medications for gram-negative bacterial infections. Antibacterial medicines coming under this class of ‘aminoglycosides’ are gentamicin, amikacin, tobramycin, and neomycin. Medicines and Healthcare products Regulatory Agency (MHRA) – United Kingdom regulatory health authority released a drug safety update…

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An increased risk of postpartum haemorrhage associated with SSRI/SNRI antidepressant medicines

Drug Safety Alert, Drug Safety Updates, Global Safety Alerts, Medicinal Product Updates, MHRA-United Kingdom, Pharmacovigilance, Voluntary ADR reporting, , ,

Selective serotonin reuptake inhibitors (SSRI) and serotonin and norepinephrine reuptake inhibitors (SNRI) are antidepressant class of medications used in the treatment of depression. They act by increasing the levels of serotonin and norepinephrine in the brain for therapeutic effect. United Kingdom health authority – Medicines and Healthcare products Regulatory Agency (MHRA) released a drug safety…

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An unfavourable benefit-risk profile for Ulipristal acetate 5 mg: A drug withdrawal story

Drug Safety Updates, Drug Withdrawal, EMA-European Medicines Agency, Global Safety Alerts, Health Canada, HSA-Singapore, Medicinal Product Updates, NPRA-Malaysia, Pharmacovigilance, PRAC, Risk Minimization Measures, Safety Communications, Voluntary ADR reporting, ,

Ulipristal acetate is a selective progesterone receptor modulator which acts by preventing the effects of the female progesterone hormone. This medicine is available in two brand names in market for the below two different therapeutic uses. Esmya® tablets comprising 5 mg ulipristal acetate and therapeutically indicated for Uterine fibroids. It is used for the treatment…

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Restricted use of oral antihistamines for sedation in children: MedSafe Update

Drug Safety Updates, Global Safety Alerts, Medicinal Product Updates, Medsafe- New Zealand,

Antihistamines are class of medications which are commonly used in getting relief from allergic symptoms. The most common therapeutic/adverse effect produced by antihistaminergic drugs is drowsiness (sleepiness). These sedating antihistaminic drugs are available as over the counter (OTC) medicine category and can be used for a range of conditions in both adults and children. MedSafe,…

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TRISENOX (arsenic trioxide) and potential medication errors: DHPC from Teva Pharmaceuticals

Drug Safety Alert, Drug Safety Updates, EMA-European Medicines Agency, Global Safety Alerts, HPRA-Ireland, Medication Errors, Medicinal Product Updates, Pharmacovigilance, Safety Communications, , ,

Arsenic trioxide is a chemotherapeutic medication used in the treatment of newly diagnosed low-to-intermediate risk acute promyelocytic leukaemia (APL) and relapsed/refractory APL characterized by the presence of leukaemia/retinoic-acid-receptor-alpha (PML/RAR-alpha) gene. The initial approved formulation available in market for arsenic trioxide is 1 mg/ml single-use 10 ml of glass ampoule (This formulation comprises 10 mg of…

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Risk of progressive multifocal leukoencephalopathy with Tecfidera (dimethyl fumarate): DHPC from Biogen

Drug Safety Alert, Drug Safety Updates, EMA-European Medicines Agency, Global Safety Alerts, HPRA-Ireland, Medicinal Product Updates, Risk Minimization Measures, Safety Communications, Voluntary ADR reporting, , , ,

Biogen released a direct healthcare professional communication (DHPC) pertaining to the risk of progressive multifocal leukoencephalopathy (PML) associated with Tecfidera (dimethyl fumarate) to alert healthcare professionals for safe usage of this medicine and implementing the recommended risk minimizing measures. This DHPC released in agreement with European Medicines Agency (EMA) and national health authority of Ireland…

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Fingolimod induced liver injury : DHPC from Novartis

Drug Safety Alert, EMA-European Medicines Agency, Global Safety Alerts, HPRA-Ireland, Medicinal Product Updates, Safety Communications, Voluntary ADR reporting, , ,

A direct health care professional communication (DHPC) released by Novartis in liaison with European medicines agency (EMA) and some of national competent authorities in Europe to disseminate important safety information pertaining to drug (fingolimod) induced liver injury to alert healthcare professionals for a careful benefit -risk analysis and early implementation of risk minimization measures for…

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Risk of heart valve regurgitation/incompetence with systemic and inhaled fluoroquinolones: Direct Healthcare Professional Communication

BfArM-Germany, Drug Safety Alert, EMA-European Medicines Agency, Global Safety Alerts, Medicinal Product Updates, Pharmacovigilance, Safety Communications, Voluntary ADR reporting, ,

German Health Authority – Federal Institute for Drugs and Medical Devices, released a safety alert for fluoroquinolone antibiotics for the potential risk of heart valve regurgitation. This is a direct healthcare professional communication released by marketing authorisation holder of respective medicinal products in liaison with European Medicines Agency (EMA) to inform health care professionals on…

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