Patient safety, news and press releases from EMA
- Thu, 25 Aug 2016 12:45:00 +0000: News and press releases: European Medicines Agency closed 29 August 2016 - News and press releases
EMA closed from 18:30 on Friday 26 August until 7:30 on Tuesday 30 August 2016
- Tue, 16 Aug 2016 16:00:00 +0000: News and press releases: Addressing challenges of innovative cancer immunotherapy medicines - News and press releases
EMA workshop to discuss treatments based on genetically modified T-cells
- Mon, 15 Aug 2016 09:00:00 +0000: News and press releases: Better monitoring of biological medicines - News and press releases
New chapter in guidelines on good pharmacovigilance practices
- Thu, 11 Aug 2016 09:00:00 +0000: News and press releases: Data integrity: key to public health protection - News and press releases
New guidance now available on EMA’s website
- Mon, 08 Aug 2016 15:00:00 +0000: News and press releases: EU collaboration strengthens safety monitoring of medicines - News and press releases
European Commission publishes three-year report on implementation of pharmacovigilance legislation
MedWatch Safety Alert RSS Feed
- Thu, 25 Aug 2016 16:00:00 +0000: Programmable Syringe Pumps: FDA Safety Communication - Problems With Fluid Flow Continuity at Low Infusion Rates - MedWatch Safety Alert RSS Feed
Reports of serious clinical consequences, such as over- and under- infusion of high risk or life-sustaining medications, occlusion detection failures, inadvertent boluses caused by inconsistent fluid delivery, and other malfunctions.
- Mon, 22 Aug 2016 15:45:00 +0000: Eyesaline Eyewash by Honeywell: Recall - Microbial Contamination - MedWatch Safety Alert RSS Feed
Klebsiella pneumoniae contamination, if present in the product, may result in infections that may be sight-threatening.
- Fri, 19 Aug 2016 17:00:00 +0000: Oxacillin for Injection, USP, 10g by Sagent: Recall - Iron Oxide Particulate Matter - MedWatch Safety Alert RSS Feed
Administered of metal particulate may result in serious adverse events such as stroke, heart attack, respiratory failure, kidney failure, or liver failure.
- Thu, 18 Aug 2016 18:20:00 +0000: Cetylev (acetylcysteine) Effervescent Tablets for Oral Solution by Arbor Pharmaceuticals: Recall - Inadequate Seal of Blister Pack - MedWatch Safety Alert RSS Feed
Risk of sub-therapeutic dose as well as potential microbial contamination.
- Wed, 17 Aug 2016 18:15:00 +0000: Comfort Shield Barrier Cream Cloths by Sage Products: Recall - Product Contamination - MedWatch Safety Alert RSS Feed
UPDATED 8/16/2016. Recall expanded to include an additional lot. Product with B. cepacia may cause serious, life-threatening infections in patients whose bodies cannot fight disease or in hospitalized patients, as well as certain other patient groups.