Public Safety & Vigilance, Author at Public Safety & Vigilance

Stimulant Laxatives-New Safety Measures by MHRA-UK

Aug 20, 2020Public Safety & VigilanceDrug Safety Updates, Global Safety Alerts, Medicinal Product Updates, MHRA-United Kingdom, Pharmacovigilance, Voluntary ADR reportingDrug Abuse, Drug Misuse, MHRA Drug Safety Updates, Stimulant laxatives

New Measures for the Safety Use of Stimulant laxatives Stimulant laxatives are medicines used in the treatment of constipation (infrequent bowel moments). These class of medicines stimulates intestinal motility by promoting secretion of water into the bowel which in turn facilitates bowel movements. The OTC medicines available in the UK market are bisacodyl (such as…

Moxifloxacin-Drug Safety Alert from US-FDA

Aug 14, 2020Public Safety & VigilanceGlobal Safety Alerts, USFDA-United States of AmericaDrug safety alert, Moxifloxacin, TASS (Toxic Anterior Segment Syndrome)

Food & Drug Administration of United States has released a drug safety alert for Moxifloxacin to bring awareness to health care professionals with this safety information. Moxifloxacin is quinoline antibiotic which inhibits the growth of bacteria. It is used in the treatment of various bacterial infections. Moxifloxacin is available in two brand names in USA-Moxeza…

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:…

Class I Medical Device Recall: BodyGuard Infusion Pump System

Aug 8, 2020Public Safety & VigilanceGlobal Safety Alerts, Medical Device, Medical Device Recall, Medical Device Updates, US-FDA, USFDA-United States of AmericaBodyGuard Infusion Pump System, Class I medical device recall, Most serious type of medical device recall, USFDA Medical Device Recall

On 05-Aug-2020, US-FDA has released a recall alert for class I medical Device- BodyGuard Infusion Pump System due to the risk of over-fusion and under-infusion. Class I Medical Device Recall: As per the classification system by US-FDA, this device falls under the category of Class I medical device. This is the most serious type of…

Drug Safety Updates from Health Canada-July 2020

Aug 4, 2020Public Safety & VigilanceDrug Safety Updates, Global Safety Alerts, Health Canada, Medicinal Product Updates, Pharmacovigilance, Voluntary ADR reportingAzathioprine, Drug Safety Updates, Health Canada Safety Updates, Ibrutinib, Propafenone hydrochloride

Health Canada has published new drug safety information to raise awareness to health care professionals and public about the below safety concern which recently made safety labelling changes for the product monograph. –Health Product Info Watch –July 2020. The safety topics discussed below in brief. Risk of cerebrovascular accidents with ibrutinib Severe 6-mercaptopurine toxicity associated…

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…

USFDA Drug Safety Communication: Naloxone use for opioid use disorder

Jul 28, 2020Public Safety & VigilanceDrug Safety Updates, Global Safety Alerts, Medicinal Product Updates, Pharmacovigilance, Safety Communications, US-FDA, USFDA-United States of America, Voluntary ADR reportingNaloxone, Opioid overdose, Opioid use disorder, USFDA Drug Safety Communication

On 23-Jul-2020, United States Food and Drug Administration (USFDA) has released a recommendation for the use of Naloxone in the treatment of opioid use disorder and for patients who are at increased risk of opioid overdose. Opioids are a class of drugs which are used to reduce moderate to severe pain in patients who are…

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 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…

Recall of Class I Medical Device- GlideScope Core One TouchSmart Cable (“OneTouch cable”)

Jul 18, 2020Public Safety & VigilanceGlobal Safety Alerts, Medical Device, Medical Device Recall, US-FDA, USFDA-United States of AmericaClass I medical device recall, GlideScope Core One TouchSmart Cable, USFDA Medical Device Recall

On 17-Jul-2020, US-FDA released a recall alert for class I medical Device- GlideScope Core One TouchSmart Cable (“OneTouch cable”) due to partial or complete loss of image during use. Device Use: The GlideScope Core Video Laryngoscopy System is intended to provide a clear view of the airway and vocal cords for medical procedures. The Core…

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.