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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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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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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