Drug Safety Alert Archives - Page 3 of 5 - Public Safety & Vigilance

“Benadryl Challenge” in Social media: USFDA warns about serious safety concerns associated with diphenhydramine overdose

Oct 3, 2020Public Safety & VigilanceDrug Safety Alert, Global Safety Alerts, Medicinal Product Updates, US-FDA, USFDA-United States of America, Voluntary ADR reportingBenadryl challenge, Diphenhydramine acute toxicity, Diphenhydramine overdose, USFDA Drug Safety Communication

U.S. Food and Drug Administration (FDA) alerted health care professionals and general public through recent drug safety communication which concerns about serious risks (heart problems, seizures, coma, and sometimes fatal outcomes) due to allergy medicine-diphenhydramine administration higher than the recommended dosage and overdose occurrences due to ‘Benadryl Challenge’ circulating in Social media- TikTok. Diphenhydramine is…

Drug Safety Alerts for Pramipexole & Fluvoxamine from PvPI (Pharmacovigilance Programme of India)

Sep 11, 2020Public Safety & VigilanceDrug Safety Alert, Global Safety Alerts, Medicinal Product Updates, Pharmacovigilance, PvPI-IndiaDrug Safety Alerts, Fluvoxamine, Intracranial Hypertension, Photosensitivity reaction, Pramipexole, Pulmonary Hypertension, PvPI

PvPI-Pharmacovigilance Programme for India is a national drug safety monitoring center for India maintained by Indian Pharmacopoeia Commission (IPC) located at Ghaziabad. PvPI is responsible for Public Pharmacovigilance activities which included collection of safety information, detection, assessment, understanding and prevention of safety concerns associated with medicinal products used by Indian citizens. As part of routine…

Drug Safety Alerts from NPRA-Malaysian Health Authority

Aug 29, 2020Public Safety & VigilanceDrug Safety Alert, Global Safety Alerts, Medicinal Product Updates, NPRA-Malaysia, Voluntary ADR reportingNPRA Drug Safety Alerts, Parenteral nutrition, Propofol

The Malaysian Health Authority-National Pharmaceutical Regulatory Agency (NPRA), Ministry of Health Malaysia released the following new drug safety alerts for bringing awareness to health care professionals for a better patient safety. Drug Safety Alert 1: Risk of priapism with Propofol Drug Safety Alert 2: Risk of toxic degradations of ingredients of parenteral nutrition (PN) containing…

Drug Safety Alerts from Malaysian Health Authority-August 2020

Aug 10, 2020Public Safety & VigilanceDrug Safety Alert, EMA-European Medicines Agency, Global Safety Alerts, Medicinal Product Updates, NPRA-Malaysia, Pharmacovigilance, Voluntary ADR reportingCutaneous amyloidosis, Drug Safety Alerts, Insulin, NPRA, Topiramate, Uveitis

The Malaysian Health Authority-National Pharmaceutical Regulatory Agency (NPRA), Ministry of Health Malaysia released the following new drug safety alerts for bringing awareness to health care professionals for a better patient safety. Drug Safety Alert 1: Risk of cutaneous amyloidosis with Insulin Drug Safety Alert 2: Risk of uveitis with Topiramate Drug Safety Alert 1:…

Drug Safety Updates from Japan Health Authority-PMDA

Jul 24, 2020Public Safety & VigilanceDrug Safety Alert, Drug Safety Updates, Global Safety Alerts, Medicinal Product Updates, Pharmacovigilance, PMDA-Japan, Voluntary ADR reportingCerebral angiography, Contrast-Induced encephalopathy, Iodine containing contrast agents, PMDA Drug Safety Updates

The safety profiles of the below listed Iodine containing contrast agents have updated as per the new drug safety updates published by Japan Health Authority–Pharmaceuticals and Medical Devices Agency (PMDA). Iodixanol: Iodixanol comes under the therapeutic category of x-ray contrast media which is a hydrophilic iodinated radiocontrast agent used in diagnostic imaging. This compound is…

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 Alerts from Malaysian Health Authority (NPRA)-June 2020

Jun 28, 2020Public Safety & VigilanceDrug Safety Alert, Drug Safety Updates, Global Safety Alerts, Medicinal Product Updates, NPRA-Malaysia, Pharmacovigilance, Safety Communications, Voluntary ADR reportingBenefit-Risk Profile, Domperidone, Drug Safety Alerts, Metoclopramide, NPRA, Oculogyric crisis

The Malaysian Health Authority-National Pharmaceutical Regulatory Agency (NPRA), Ministry of Health Malaysia released the following new drug safety alerts during the month of June. Restriction of domperidone use in pediatric patients less than 12 years of age Risk of oculogyric crisis associated with metoclopramide use (a reminder) Restriction of domperidone use in pediatric patients…

Drug Safety Alerts from New Zealand Health Authority-MedSafe

Jun 25, 2020Public Safety & VigilanceDrug Safety Alert, Drug Safety Updates, Global Safety Alerts, Medicinal Product Updates, Medsafe- New Zealand, Pharmacovigilance, Voluntary ADR reportingCongenital abnormalities, Individual benefit-risk assessment, Medsafe, Medsafe Drug Safety Updates, New Zealand Health Authority-Drug Safety Updates, Ondansetron, oral cleft defect, Tramadol

MedSafe- Health Authority of New Zealand government has released the below drug safety information in their latest issue-June-2020 to update public-(health care professionals & consumers) about the safe use of medicines. Tramadol use Contradicted in children & elder patients (<75 y) Oral cleft defects associated with ondansetron Tramadol use Contradicted in children &…

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…

Drug Safety Alert From IPC-PvPI

Jun 2, 2020Public Safety & VigilanceCOVID-19 Medication, Drug Safety Alert, Drug Safety Signal, Drug Safety Updates, Global Safety Alerts, Medicinal Product Updates, Pharmacovigilance, PvPI-India, Safety Communications, Voluntary ADR reportingDrug safety alert, Hydroxychloroquine, Mouth Ulceration, PvPI

A new drug safety alert (Hydroxychloroquine-Moth Ulceration) released by the Pharmacovigilance Programme of India (PvPI) from Indian Pharmacopoeia commission (IPC) Mouth Ulceration associated with Hydroxychloroquine use Hydroxychloroquine is an antimalarial class of drug which is used in the treatment and prevention of acute attacks of malaria. It also used to treat discoid or systemic lupus…

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.