Drug safety communication 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…

Potential medication error and unintentional overdose associated with methotrexate use

Oct 15, 2020Public Safety & VigilanceEMA-European Medicines Agency, Global Safety Alerts, Medicinal Product Updates, MHRA-United Kingdom, Pharmacovigilance, Safety CommunicationsDrug safety communication, Medication error, Methotrexate overdose, Risk minimizing measures

Methotrexate is an immunosuppressant medication used in the treatment of autoimmune diseases and some type of cancers. It acts by competitively inhibiting the dihydrofolate reductase (DHFR), a key enzyme involved in the synthesis of DNA, RNA, thymidylates, and proteins. Different regulatory bodies issued alerts on the safety concerns of medication errors and fatal overdose occurrences…

Boxed Warning for Benzodiazepine class of medicines: US-FDA Drug Safety Communication

Oct 2, 2020Public Safety & VigilanceDrug Safety Updates, Global Safety Alerts, Medicinal Product Updates, Safety Communications, US-FDA, USFDA-United States of America, Voluntary ADR reportingBenzodiazepines, Boxed warning, Drug safety communication

U.S. Food and Drug Administration (FDA) released a drug safety communication to update health care professionals and consumers on the significant safety information pertaining to the benzodiazepines class of medications which included “serious risks of drug abuse, drug addiction, physical dependence, and drug withdrawal reactions” which require a boxed warning to be included in all…

USFDA’s Drug Safety Communication: Caution on COVID-19 medication

Apr 27, 2020Public Safety & VigilanceDrug Safety Updates, Pharmacovigilance, Safety Communicationschloroquine, COVID-19 Potential Treatment, Drug safety communication, Emergency Use Authorization, EUA, Hydroxychloroquine, QT Prolongation

Food and Drug Administration (FDA) in the United States announced a serious safety concern on the use of hydroxychloroquine or chloroquine for the treatment of 2019 Coronavirus Disease (COVID-19) due to abnormal heart rhythms like QT prolongation and ventricular tachycardia. Currently, there are no medicines proven effective for the treatment of COVID-19. On 28‑Mar‑2020, FDA released…

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