Product Label Updates 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…

Pigmentary maculopathy associated with long term use of Pentosan polysulfate sodium

Oct 15, 2021Public Safety & VigilanceDrug Safety Updates, Global Safety Alerts, Medicinal Product Updates, Product Label Updates, TGA-AustraliaMedicine Safety Update - TGA, Pentosan polysulfate sodium, Pigmentary maculopathy

Pentosan polysulfate sodium is a semi-synthetically produced heparin which has anticoagulant and fibrinolytic effect. It is used in the treatment of bladder pain and discomfort caused by cystitis (bladder inflammation or irritation). Product information (PI) of Pentosan polysulfate sodium (‘Section 4.4 Special Warnings and Precautions for Use’ and ‘Section 4.8 Adverse Effects’) are updated with…

Propylthiouracil and Carbimazole: Product label update of Pregnancy category from “C” to “D”

Sep 28, 2021Public Safety & VigilanceDrug Safety Updates, Global Safety Alerts, Medicinal Product Updates, Product Label Updates, TGA-AustraliaCarbimazole, Congenital malformations, Medicine Safety Update - TGA, Propylthiouracil

Propylthiouracil and Carbimazole are the medications used in the treatment of hyperthyroidism. The product information (PI) documents which were previously having status of category “C” for use in pregnant women is being updated to category “D” Category C status: Based on the mechanism of action & pharmacological activity, suspicion of causing harmful effects to the…

Hypertension risk associated with Erenumab use: TGA safety alert

Sep 16, 2021Public Safety & VigilanceDrug Safety Updates, Global Safety Alerts, Medicinal Product Updates, Product Label UpdatesErenumab, Hypertension, Medicine Safety Update - TGA

Product Information (PI) for Erenumab has been updated with the below statements- A warning about a potential causal relationship between the drug and hypertension under the ‘Special Warnings and Precautions’ section (Section 4.4) of the PI. Addition of hypertension under ‘Vascular disorders’ in the ‘Adverse Effects’ section (Section 4.8). Erenumab is a fully human monoclonal…

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.