Search results for "FDA update"
Updated design, labeling cleared for duodenoscope
On Feb. 7, the FDA cleared the updated design and labeling for the Pentax Medical Duodenoscope Model ED-3490TK. ... The FDA continues to monitor the association between reprocessed endoscopes and transmission of infectious agents.
February 2018
FDA approves new drug for travelers' diarrhea
The FDA has approved the oral antibacterial rifamycin (Aemcolo) to treat adults with travelers' diarrhea, the agency announced on Nov. ... 16. Compared to placebo, the drug significantly reduced symptoms in a randomized controlled trial of 264 adults
November 2018
Data show higher-than-expected rates of duodenoscope contamination
While the number of medical device reports associated with patient infections has declined by 62% since peaking in 2015, the FDA and duodenoscope manufacturers continue to address issues around device reprocessing. ... duodenoscope manufacturers
December 2018
Proton-pump inhibitor recalled
One lot of pantoprazole sodium for injection (40 mg per vial) was recalled from hospitals nationwide, the FDA announced on Dec.
January 2018
Generic form of mesalamine approved
On June 5, the FDA approved the first generic form of mesalamine delayed-release oral tablets USP (1.2 g).
June 2017
More patient deaths associated with intragastric balloon weight-loss systems
Five additional deaths have occurred in patients with two liquid-filled intragastric balloon systems used to treat obesity, the FDA announced on June 4. ... hyperinflation. The FDA continues to work with device manufacturers Apollo Endosurgery and
June 2018
Boxed warning added to liver disease drug
The FDA announced on Feb. 1 that it will add a new boxed warning to highlight the correct dosing for obeticholic acid (Ocaliva). ... In addition, a new medication guide required by the FDA will inform patients about the issue.
February 2018
Automated reprocessors validated for use in specific duodenoscopes
System 83 Plus automated endoscope reprocessors (AERs) by Custom Ultrasonics may now be used to process certain duodenoscopes, the FDA announced on April 10. ... The FDA determined that the data show that the AERs can achieve high-level disinfection of
April 2018
IBS-D drug should not be prescribed to patients without gallbladders
The FDA suggests that clinicians should consider alternatives to eluxadoline in this population. ... Eluxadoline (Viberzi), a drug used to treat irritable bowel syndrome with diarrhea, should not be used in patients without gallbladders, the FDA warned
March 2017
New data show even higher rates of duodenoscope contamination
reprocessing failure, the FDA said in its update. ... The results show that improvements are necessary, and the FDA is exploring additional steps to reduce contamination rates.
April 2019