Safety Communications Archives - Public Safety & Vigilance

Terlipressin safe and effective use recommendations to reduce risks of respiratory failure and septic shock in patients with type 1 hepatorenal syndrome

Apr 8, 2023Public Safety & VigilanceDrug Safety Updates, Global Safety Alerts, MHRA-United Kingdom, Pharmacovigilance, Safety CommunicationsDrug safety communication, MHRA Drug Safety Updates, Terlipressin

MHRA released a drug safety update to disseminate recommendations for safe and effective use of terlipressin. Terlipressin is a synthetic pituitary hormone, an analog of the vasoconstrictor vasopressin which acts by reducing portal venous pressure in the liver, in patients with portal hypertension, and also contributes to improved blood circulation in the kidney helping to…

Risk of severe hypocalcaemia with denosumab (Prolia): USFDA Drug safety communication

Dec 28, 2022Public Safety & VigilanceDrug Safety Alert, Drug Safety Updates, Global Safety Alerts, Safety Communications, US-FDA, USFDA-United States of America, Voluntary ADR reportingDenosumab, Hypocalcaemia, USFDA Drug Safety Communication

USFDA released a recent safety update for the denosumab Denosumab is a human monoclonal antibody which helps in preventing breaking down of bone cells (osteoclasts) from bone by inhibiting the receptors named – RANK (receptor activator of nuclear factor kappa beta) in the body. This medicine is intended for the treatment of following medical conditions: Osteoporosis…

Potential increased risk of death and serious adverse effects with cancer medicine Copiktra (duvelisib): USFDA Drug safety communication

Jul 20, 2022Public Safety & VigilanceDrug Safety Updates, Global Safety Alerts, Safety Communications, US-FDACopiktra, Duvelisib, Individual benefit-risk assessment, USFDA Drug Safety Communication

USFDA released a recent safety update for the duvelisib, which is used in the treatment of blood cancer – chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). It is a PI3 kinase inhibitor, which controls the multiplication and growth of cancer cells by blocking the signaling action of abnormal protein. After the product approval…

Withdrawal of FDA approval for cancer medicine-Umbralisib due to unfavorable benefit-risk profile: USFDA Drug safety communication

Jun 6, 2022Public Safety & VigilanceDrug Withdrawal, Global Safety Alerts, Safety Communications, USFDA-United States of AmericaDrug withdrawal, Umbralisib, USFDA Drug Safety Communication

In continuation to the recent drug safety communication for umbralisib in Feb-2022, USFDA further released a drug safety communication pertaining to the withdrawal of approval for umbralisib. Ukoniq (umbralisib) is a cancer medicine used in the treatment of below two specific types of lymphomas. It is a PI3 kinase inhibitor, which controls the multiplication and…

Umbralisib and potential increased risk of death [under USFDA investigation]: Need for consistent evaluation of benefits & risks

Feb 20, 2022Public Safety & VigilanceDrug Safety Alert, Global Safety Alerts, Medicinal Product Updates, Safety Communications, US-FDA, USFDA-United States of AmericaUmbralisib, USFDA Drug Safety Communication

USFDA released a drug safety communication for the updated significant safety information of the cancer medicine – umbralisib to disseminate awareness for optimal, safe & effective usage of this product in patients suffering from cancer of the lymph nodes and respective healthcare professionals involved in treating this patients. Ukoniq (umbralisib) is a cancer medicine used…

Additional Risk Minimization measures [updated recommendations] for Safe & Effective usage of Venetoclax (Venclyxto▼)

Jan 2, 2022Public Safety & VigilanceDrug Safety Updates, Global Safety Alerts, MHRA-United Kingdom, Risk Minimization Measures, Safety Communications, Voluntary ADR reportingAdditional Risk Minimization measures, Drug Safety Updates, Patient card, TLS, Venetoclax

Venetoclax is anti-cancer medication used in the treatment of chronic lymphocytic leukemia. This medicine is under additional monitoring with special focus on its safety profile consistency from post-marketing exposure. Tumor lysis syndrome (TLS) is phenomena of release of cellular contents from tumor cells into the blood stream such as uric acid, potassium leading to the…

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…

Risk of Leaking heart valves with Fluoroquinolone class of antibiotics: Drug Safety Alert Health Canada

Sep 3, 2021Public Safety & VigilanceDrug Safety Alert, Global Safety Alerts, Health Canada, Medicinal Product Updates, Safety CommunicationsFluoroquinolone antibiotics, Health Canada Safety Alerts, Heart valve regurgitation

Safety update: Potential Risk of leaking heart valves (heart valve regurgitation) associated with the use of antibiotics belonging to the Fluoroquinolone class which included ciprofloxacin-, levofloxacin-, moxifloxacin- and norfloxacin-containing medicinal products which are administered by injection or by mouth (systemic) and by breathing in (inhaled). Fluoroquinolones broader spectrum antibiotics which are used in the treatment…

Risk of microscopic colitis with sertraline: TGA Drug Safety Alert

Jul 3, 2021Public Safety & VigilanceDrug Safety Updates, Global Safety Alerts, Medicinal Product Updates, Safety Communications, TGA-Australia, Voluntary ADR reportingMedicine Safety Update - TGA, Microscopic colitis, Sertraline

Safety update: Potential risk of microscopic colitis associated with the use of sertraline. Sertraline is antidepressant medication marketed under the brand name Zoloft and multiple generic brands. It acts as a selective serotonin re-uptake inhibitor (SSRI) with the below therapeutic indications: Treatment of obsessive compulsive disorder (OCD) in children and adolescents (aged 6 years and…

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.