Search results for "FDA update"
Updated design, labeling cleared for duodenoscope
The changes aim to reduce the potential for patient fluids to leak into the closed elevator channel and underneath the distal cap.
https://gastroenterology.acponline.org/archives/2018/02/23/8.htm
23 Feb 2018
FDA approves first medication for adults with hepatorenal syndrome
The treatment is indicated to improve kidney function in adults with hepatorenal syndrome with rapid reduction in kidney function.
https://gastroenterology.acponline.org/archives/2022/09/23/11.htm
23 Sep 2022
Boxed warning added to liver disease drug
The drug has been incorrectly dosed daily instead of weekly in patients with moderate to severe primary biliary cholangitis, which increases the risk of serious liver injury, the FDA said.
https://gastroenterology.acponline.org/archives/2018/02/23/7.htm
23 Feb 2018
Proton-pump inhibitor recalled
One lot of pantoprazole sodium for injection (40 mg per vial) was recalled in December.
https://gastroenterology.acponline.org/archives/2018/01/26/6.htm
26 Jan 2018
FDA restricts use of liver disease drug in certain patients
The agency added new warnings to the prescribing information for obeticholic acid, including a contraindication in patients with primary biliary cholangitis and advanced cirrhosis.
https://gastroenterology.acponline.org/archives/2021/06/25/7.htm
25 Jun 2021
FDA approves new drug for travelers' diarrhea
Compared to placebo, the drug significantly reduced symptoms in a randomized controlled trial of 264 adults with travelers' diarrhea in Guatemala and Mexico.
https://gastroenterology.acponline.org/archives/2018/11/27/6.htm
27 Nov 2018
Automated reprocessors validated for use in specific duodenoscopes
The FDA had requested validation testing data from all companies that have automated endoscope reprocessors labeled to reprocess endoscopes because of the potential association with patient infection.
https://gastroenterology.acponline.org/archives/2018/04/27/8.htm
27 Apr 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.
https://gastroenterology.acponline.org/archives/2018/12/28/7.htm
28 Dec 2018
First drug approved to treat thrombocytopenia in adults with chronic liver disease who are having a medical procedure
Patients who received the drug for five days had increased platelet counts compared to those taking placebo.
https://gastroenterology.acponline.org/archives/2018/05/25/6.htm
25 May 2018
FDA approves first fecal microbiota product
The product, which is prepared from donated, tested stool and administered rectally as a single dose, is indicated for the prevention of recurrent Clostridioides difficile infection in adults who have already completed antibiotic treatment for a recurrence.
https://gastroenterology.acponline.org/archives/2022/12/23/7.htm
23 Dec 2022