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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Boxed Warnings for Pregabalin and Gabapentin

Drug Safety Alert, Global Safety Alerts, Medicinal Product Updates, Safety Communications, TGA-Australia, USFDA-United States of America, Voluntary ADR reporting, , , , , ,

Pregabalin is an anticonvulsant and anxiolytic medication used in the treatment of epileptic seizures, neuropathic pain, restless leg syndrome, fibromyalgia, and generalized anxiety disorder. Gabapentin is an anticonvulsant medication used in the treatment of partial seizures and neuropathic pain. Both Pregabalin and gabapentin which are referred as “gabapentinoids” acts on voltage dependent calcium channels in…

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