DHPC from Novartis: Updated recommendations to minimize the known risk of intraocular inflammation, including retinal vasculitis and/or retinal vascular occlusion

Drug Safety Signal, EMA-European Medicines Agency, Global Safety Alerts, HPRA-Ireland, Medicinal Product Updates, Product Label Updates, Risk Minimization Measures, Safety Communications, , ,

Drug Safety Communication pertaining to the safe & effective use of Beovu® (brolucizumab) released from Novartis via a direct healthcare professional communication (DHPC) letter for the implementation of updated recommendations based on the recent safety evidence from MERLIN Study (Interventional clinical trial being conducted for the comparison of Safety and Efficacy of Brolucizumab to Aflibercept…

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Reminder for importance of adhering to risk minimization measures for the safe and effective usage of Direct oral anticoagulants (DOACs)

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

Direct oral anticoagulants (DOACs) are the medications used in the prevention of thrombosis in several cardiovascular contexts viz. in the treatment and prevention of blood clots in veins, and for the prevention of stroke and embolism in people with atrial fibrillation. DOACs are direct factor Xa (activated factor X) inhibitors which included apixaban (Eliquis and…

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Risk of Respiratory depression with Pregabalin: Drug Safety Alert from Europe Medicines Agency

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

Safety Alert: Serious risk of respiratory depression associated with the use of pregabalin even without concomitant use of opioid medications or other CNS depressants. Health Authority: Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) Pregabalin-containing medicinal products are marketed under various brand names for the treatment of following conditions: Generalized anxiety disorder…

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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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Potential risk of congenital malformations with the use of Modafinil during pregnancy

Drug Safety Alert, Global Safety Alerts, HPRA-Ireland, Medicinal Product Updates, Voluntary ADR reporting, , ,

Ireland Health authority, Health Products Regulatory Authority – HPRA has released a drug safety alert for modafinil association with congenital malformations (congenital heart defects, hypospadias and orofacial clefts) in foetus when exposed to a pregnant woman or to women of childbearing potential. Modafinil is a wakefulness promoting medicinal product used in the treatment of too…

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Ingenol mebutate is having negative benefit to risk ratio: PRAC concludes

Drug Safety Updates, Drug Withdrawal, EMA-European Medicines Agency, Global Safety Alerts, HPRA-Ireland, Safety Communications, , , , , ,

In a new release from European Medicines Agency (EMA), Pharmacovigilance Risk Assessment Committee (PRAC) stated that ingenol mebutate may increase the risk of skin cancer and concluded that risks for ingenol mebutate medicine are greater than its benefits. On 09-May-2019, PRAC initiated the procedure of review for assessing the benefit risk profile for ingenol mebutate…

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