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…
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:…
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…
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…
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…
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 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…
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…
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…
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…