USFDA-United States of America Archives - Page 3 of 3

Medical Device Class I Recall-“HeartWare HVAD Pump Outflow Graft and Outflow Graft Strain Relief”

May 30, 2020Public Safety & VigilanceGlobal Safety Alerts, Medical Device, Medical Device Recall, Medical Device Updates, US-FDA, USFDA-United States of AmericaClass I medical device recall, HeartWare HVAD Pump Outflow Graft and Outflow Graft Strain Relief, Most serious type of medical device recall, USFDA Medical Device Recall

On 28-May-2020, US-FDA has released a recall alert for class I medical Device–HeartWare HVAD Pump Outflow Graft and Outflow Graft Strain Relief Device Use: “HeartWare HVAD Pump Outflow Graft and Outflow Graft Strain Relief” are the parts of HeartWare Ventricular Assist Device (HVAD) System which help the heart in delivering blood to the rest of…

Withdrawal Story of Weight Loss Medicine (A scenario to understand the benefit risk balance of a medicine)

Apr 15, 2020Public Safety & VigilanceDrug Safety Updates, Drug Withdrawal, Global Safety Alerts, Safety Communications, USFDA-United States of AmericaBelviq, Cancer Risk, Diet pILL, Drug withdrawal, lorcaserin, Obesity Drug, Weight loss medication

A medicine with negative benefit to risk ratio has withdrawn from the US market. (Belviq) lorcaserin is a weight loss medication developed by Arena Pharmaceuticals approved for treating obesity together with diet and exercise in adults with a body mass index (BMI) of 30 or greater (obese), or adults with a BMI of 27 or…

Hydroxychloroquine: A potential therapy for COVID-19?

Apr 12, 2020Public Safety & VigilanceClinical trial study, Drug Safety Updates, Global Safety Alerts, Safety Communications, USFDA-United States of AmericaClinical trial studies, COVID-19 Potential therapy, Hydroxychloroquine

Coronavirus disease 2019 (COVID-19), a global pandemic which is affecting human beings with an acute respiratory infectious illness by damaging multiple organ systems, including heart, lung, and blood. Most adults with COVID-19 experience fever, cough, and fatigue and then recover within one to three weeks. However, it becomes fatal for some patients who develop severe…

Recall of a Class I Medical Device: IMAGER II 5F Angiographic Catheters

Apr 9, 2020Public Safety & VigilanceGlobal Safety Alerts, Medical Device, Medical Device Recall, Medical Device Updates, USFDA-United States of AmericaBoston Scientific Corporation, Class I medical Device, IMAGER II 5F Angiographic Catheters, Most serious type of medical device recall, Recall of Class I medical Device, USFDA alerts, USFDA Medical Device Recall

A serious type of recall for medical device class I has announced by FDA for the Boston Scientific Corporation IMAGER II 5F Angiographic Catheters. This class I device is used to provide a pathway to deliver contrast agents to blood vessels including carotid arteries during angiography. During the patient procedure preparation, potential for the catheter…

Drug Recall story of Ranitidine (An established drug since 3 decades)

Apr 3, 2020Public Safety & VigilanceDrug Recall, Drug Safety Updates, Global Safety Alerts, Pharmacovigilance, Safety Communications, USFDA-United States of AmericaDrug Recall, Drug safety alert, patientsafety, Ranitidine, USFDA alerts, Zantac

A medicine having been considered as “Safe” since 1981 is recalled from the drug market. It’s not a surprise on recall of a drug from market which has an “assumed established safety profile”. Ranitidine, popularly known to public as Zantac, is a very common OTC (over the counter) drug and prescription stomach acid blocker widely…

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.