Search results for "FDA Update"
Generic form of mesalamine approved
The drug is indicated to induce remission in adults with active, mild to moderate ulcerative colitis and to maintain remission of ulcerative colitis.
https://gastroenterology.acponline.org/archives/2017/06/23/6.htm
23 Jun 2017
Warning issued on dosing of drug for primary biliary cholangitis
Clinicians should determine baseline liver function before starting patients on obeticholic acid, the FDA said.
https://gastroenterology.acponline.org/archives/2017/10/27/6.htm
27 Oct 2017
Urgent medical device correction for incontinence management system
There is a potential for radio frequency interference between the WatchCare Incontinence Management System and other medical devices in the vicinity, such as insulin pumps, telemetry devices, and infusion injection pumps.
https://gastroenterology.acponline.org/archives/2022/11/18/10.htm
18 Nov 2022
Monkeypox may be transmitted through fecal microbiota transplantation
Because of this risk, the FDA determined that additional protections are required for any investigational use of fecal microbiota transplantation if it involves stool donated on or after March 15, 2022.
https://gastroenterology.acponline.org/archives/2022/09/23/10.htm
23 Sep 2022
Batch of senna laxatives recalled
The recall follows a customer report that a bottle labeled as senna laxative actually contained naproxen sodium.
https://gastroenterology.acponline.org/archives/2018/02/23/11.htm
23 Feb 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.
https://gastroenterology.acponline.org/archives/2017/03/24/8.htm
24 Mar 2017
Potency concerns lead to recall of anti-diarrhea drug
Recalled batches of diphenoxylate hydrochloride and atropine sulfate, an adjunctive therapy for the management of diarrhea, were distributed nationwide between November 2016 and June 2017.
https://gastroenterology.acponline.org/archives/2017/11/28/8.htm
28 Nov 2017
Hepatic artery infusion pumps recalled
The recall was initiated after reports from clinicians that the pumps were delivering medications faster than expected.
https://gastroenterology.acponline.org/archives/2022/09/23/12.htm
23 Sep 2022
More laxatives recalled due to microbial contamination
Recalled products were distributed nationwide at CVS drugstore locations.
https://gastroenterology.acponline.org/archives/2022/07/22/10.htm
22 Jul 2022
Probiotics recalled due to bacterial contamination
A company recently recalled two lots of liquid probiotics due to the possibility of contamination with Pseudomonas aeruginosa.
https://gastroenterology.acponline.org/archives/2021/12/17/9.htm
17 Dec 2021