Drug Safety Signal Archives - Public Safety & Vigilance

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

Nov 20, 2021Public Safety & VigilanceDrug Safety Signal, EMA-European Medicines Agency, Global Safety Alerts, HPRA-Ireland, Medicinal Product Updates, Product Label Updates, Risk Minimization Measures, Safety CommunicationsBrolucizumab, Direct Health Care Professional Communication, Intraocular inflammatory reactions, Risk minimization measures

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…

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

Oct 20, 2021Public Safety & VigilanceDrug 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 reportingDrug safety alert, PRAC signal, Pregabalin, Respiratory Depression

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…

Drug Safety Signals from Pharmacovigilance Risk Assessment Committee (PRAC)-EMA

Nov 10, 2020Public Safety & VigilanceDrug Safety Signal, EMA-European Medicines Agency, Global Safety Alerts, PRAC, Signal DetectionAntidepressants, Drug safety signal, Pembrolizumab, Postpartum haemorrhage, PRAC Recommendation, Sjogren's syndrome

Pharmacovigilance Risk Assessment Committee (PRAC), which is responsible for assessing and monitoring the safety of human medicines from European medicines agency (EMA) has published new significant safety information (signals) for medicines which were identified from their monthly PRAC meeting held during the period of 28 Sep-2020 to 01 Oct 2020. PRAC Recommendations for regulatory action…

Tocilizumab and Cutaneous Vasculitis: A Drug Safety Signal from WHO-UMC

Oct 14, 2020Public Safety & VigilanceDrug Safety Signal, Global Safety Alerts, Medicinal Product Updates, Pharmacovigilance, Signal Detection, WHOCutaneous Vasculitis, Drug safety signal, Tocilizumab, WHO's VigiBase Signal

This is the third drug safety signal – “Cutaneous Vasculitis association with Tocilizumab use” detected from the VigiBase by the UMC (Uppsala Monitoring Center). UMC is a WHO Collaborating Centre present in Sweden for international service and scientific research within the field of pharmacovigilance. Tocilizumab is an immunosuppressive agent and a biologic medication (fully human…

Alectinib – Rhabdomyolysis: A Drug Safety Signal from WHO-UMC’s VigiBase Database

Oct 13, 2020Public Safety & VigilanceDrug Safety Signal, Global Safety Alerts, Medicinal Product Updates, Pharmacovigilance, Signal Detection, WHOAlectinib, Drug safety signal, Rhabdomyolysis, WHO's VigiBase Signal

A new drug safety signal- “Rhabdomyolysis association with Alectinib” identified by the UMC (Uppsala Monitoring Center), from the VigiBase, a global drug safety database maintained by UMC on behalf of WHO. UMC is a WHO Collaborating Centre present in in Sweden for international service and scientific research within the field of pharmacovigilance. Alectinib is an…

Drug Safety Signal from WHO-UMC: Acyclovir or valaciclovir – Acute generalised exanthematous pustulosis

Oct 9, 2020Public Safety & VigilanceDrug Safety Signal, Global Safety Alerts, Pharmacovigilance, Signal Detection, WHOAcute generalised exanthematous pustulosis, Acyclovir, AGEP, Drug safety signal, Valaciclovir, WHO's VigiBase Signal

A new drug safety signal “Acyclovir or valaciclovir – Acute generalised exanthematous pustulosis”, identified by the UMC (Uppsala Monitoring Center), a WHO Collaborating Centre for international service and scientific research within the field of pharmacovigilance. This drug safety signal is identified from the VigiBase, a global drug safety database maintained by UMC on behalf of…

A new drug safety signal from UMC: Cardiac arrhythmia with the use of Ginkgo biloba L.

Jul 30, 2020Public Safety & VigilanceDrug Safety Signal, Global Safety Alerts, Individual Case Safety Reports, Medicinal Product Updates, Pharmacovigilance, WHOCardiac arrhythmias, Drug safety signal, Ginkgo biloba, WHO's VigiBase Signal

WHO-Uppsala Monitoring Center (UMC) identified a new drug safety signal-“cardiac arrhythmias-Ginkgo biloba“ from the VigiBase, a global drug safety database maintained by UMC on behalf of WHO for international service and scientific research within the field of pharmacovigilance. In the month of July-2020, WHO-UMC has identified and released two new drug safety signals. Drug Safety…

A New Drug Safety Signal from Uppsala Monitoring Centre (UMC): Lack of drug dose titration (Medication error) during treatment with clozapine

Jul 26, 2020Public Safety & VigilanceDrug Safety Signal, Global Safety Alerts, Medicinal Product Updates, Pharmacovigilance, WHOClozapine, Drug safety signal, Lack of drug dose titration, Medication error, WHO's VigiBase Signal

A new drug safety signal identified by the Uppsala Monitoring Centre (UMC), Sweden a WHO Collaborating Centre for international service and scientific research within the field of pharmacovigilance. This safety signal is identified from the VigiBase, a global drug safety database maintained by UMC on behalf of WHO and published in the WHO Pharmaceuticals newsletter…

Drug Safety Alerts from PvPI-Pharmacovigilance System for India

Jul 10, 2020Public Safety & VigilanceDrug Safety Alert, Drug Safety Signal, Drug Safety Updates, Global Safety Alerts, Medicinal Product Updates, Pharmacovigilance, PvPI-India, Safety Communications, Voluntary ADR reportingDrug Safety Alerts, Fluconazole, PvPI, SGLT-2 Inhibitors

PvPI-Pharmacovigilance Programme for India is a national drug safety monitoring center for India maintained by Indian Pharmacopoeia Commission (IPC) located at Ghaziabad. As part of routine analysis of individual case safety reports (reports of adverse drug event/reactions from a patient) originated from India, PvPI has identified and released two new drug safety alerts for the…

Drug Safety Updates from European medicines agency (EMA)-June 2020

Jun 18, 2020Public Safety & VigilanceDrug Safety Alert, Drug Safety Signal, Drug Safety Updates, EMA-European Medicines Agency, Global Safety Alerts, Medicinal Product Updates, Pharmacovigilance, Safety CommunicationsDrug Safety Updates, EMA-June 2020, European Medicines Agency

European medicines agency has released a new Issue (135-June-2020) for medicine updates. The drug safety updates from this issue were discussed below in brief. Fatal Drug Interactions between fluoropyrimidines and brivudine Risk of breast cancer with hormone replacement therapy Potential medication errors with Leuprorelin depot medicines Fatal Drug Interactions between fluoropyrimidines and brivudine European…

Public Safety & Vigilance

A common platform for safety alerts, news and other important updates for Medicinal Products and Medical Devices from health regulatory authorities across the globe.