[Posted: January 28, 2020] AUDIENCE: Patient, Health Professional ISSUE: FDA is strengthening an existing warning that constipation caused by the schizophrenia medicine clozapine (Clozaril, Fazaclo ODT, Versacloz, generics) can, uncommonly, progress to serious bowel complications. This can lead to hospitalization or even death if constipation is not diagnosed and treated quickly. BACKGROUND: Clozapine affects how…

Summary Company Announcement Date: January 24, 2020 FDA Publish Date: January 24, 2020 Product Type: Medical Devices Reason for Announcement: Recall Reason Description Device exhibits a reversed image Company Name: King Systems Brand Name: Brand Name(s) King Vision Product Description: Product Description Laryngoscope Adapter Company Announcement On November 5, 2019, King Systems initiated a voluntary…

The FDA posts Medical Device Safety Communications to describe the FDA’s current analysis of an issue and contain specific regulatory approaches and clinical recommendations for patient management. 2020 Safety Communications Content current as of: 01/23/2020 Regulated Product(s) Article source: http://www.fda.gov/medical-devices/safety-communications/2020-safety-communications

Date Issued: January 23, 2020 The U.S. Food and Drug Administration (FDA) is raising awareness among health care providers and facility staff that cybersecurity vulnerabilities in certain GE Healthcare Clinical Information Central Stations and Telemetry Servers may introduce risks to patients while being monitored. These devices are used mostly in health care facilities for displaying…

Summary Company Announcement Date: January 15, 2020 FDA Publish Date: January 16, 2020 Product Type: Drugs Reason for Announcement: Recall Reason Description Lack of Assurance of Sterility Company Name: FUSION IV Pharmaceuticals, Inc dba. AXIA Pharmaceutcal Brand Name: Brand Name(s) AXIA Pharmaceutical Product Description: Product Description Sterile Drug Products Company Announcement FUSION IV Pharmaceuticals, Inc…

[Posted 01/16/2020] AUDIENCE: Patient, Health Professional, Risk Manager ISSUE: The medical device manufacturer Cardinal Health alerted its customers to potential quality issues affecting some of its Level 3 surgical gowns and accompanying PreSource procedural packs.  FDA also understands this issue may already be impacting patient care at health care facilities, such as the cancellation of…

Duodenoscopes play a vital role in the assessment and treatment of diseases and conditions of the pancreas and bile ducts, and are used in more than 500,000 endoscopic retrograde cholangiopancreatography (ERCP) procedures each year in the U.S. These devices have complex designs that include reusable hard-to-clean components. Failure to correctly reprocess a duodenoscope could result…

[Posted 01/14/2020] AUDIENCE: Patient, Health Professional, Pharmacy ISSUE: The FDA is alerting the public that results from a clinical trial assessing safety show a possible increased risk of cancer with the weight management medicine Belviq, Belviq XR (lorcaserin). At this time, the cause of the cancer is uncertain, and we cannot conclude that lorcaserin contributes to…