Originally published by robertslawfirm.
The U.S. Food and Drug Administration (FDA) recently issued new guidance on warning labels and recalls for opioid medicines, a vascular patch product and a faulty catheter guide as follows: Opioids and Benzodiazepines Following the release of several recent research studies on opioids, the FDA said it is requiring manufacturers to add new labels that warn consumers and healthcare providers about serious risks when opioids are taken in combination with benzodiazepines. These “black box” warnings — the FDA’s most severe — cover nearly 400 opioid painkillers, including oxycodone, hydrocodone and morphine; cough medicines that contain opioids; and benzodiazepines like Xanax, Valium, Versed, Ativan, Klonopin and more. Vascu-Guard Patch After receiving multiple reports of severe bleeding associated with the Vascu-Guard Peripheral Vascular Patch, including three deaths, the FDA issued a warning to health care professionals, stating, “The FDA is concerned that the Vascu-Guard patch may not be performing as intended and that patients who are treated with the product may be at risk for serious adverse health consequences, such as severe bleeding, hematomas, and death. After CEA surgery in particular, arterial bleeding in the neck could rapidly lead to airway obstruction, hypoxia, diminished brain perfusion, stroke and/or cardiac arrest.“ The agency recommended that health care professionals watch for post-surgery bleeding and discuss all treatment options with patients. Cook Roadrunner Catheter Guide In June 2016, Cook Medical recalled its Roadrunner UniGlide Hydrophilic Wire Guide for devices distributed between May 2, 2016 and June 17, 2016. The FDA has classified this recall as […]
The post Latest FDA Warnings on Opioids, Vascular Patch and Catheter Guides appeared first on Roberts & Roberts.
Curated by Texas Bar Today. Follow us on Twitter @texasbartoday.
from Texas Bar Today http://ift.tt/2gOjQ1F
via Abogado Aly Website
No comments:
Post a Comment