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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Dimethyl fumarate induced Alopecia areata: Drug Safety Alert from Netherlands Pharmacovigilance Center (LAREB)

Drug Safety Alert, Global Safety Alerts, Medicinal Product Updates, Netherlands-LAREB, Pharmacovigilance, Signal Detection, , ,

A new drug safety signal “Dimethyl fumarate included Alopecia areata” identified by Netherlands Pharmacovigilance center, Lareb Dimethyl fumarate is an anti-inflammatory and immunomodulatory agent which is used in the treatment of relapsing multiple sclerosis and plaque psoriasis. Alopecia areata is an autoimmune disorder which involves loss of hair follicle with one or more circular bald…

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