Search results for "FDA update"
New data show even higher rates of duodenoscope contamination
The FDA is exploring additional steps to reduce contamination rates, which were higher in postmarket surveillance studies than the agency initially anticipated.
https://gastroenterology.acponline.org/archives/2019/04/26/9.htm
26 Apr 2019
New drug approved to treat digestive tract cancers
The orphan drug is indicated to treat adults with somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors.
https://gastroenterology.acponline.org/archives/2018/02/23/10.htm
23 Feb 2018
First oral treatment approved for moderate to severe Crohn's disease
Upadacitinib (Rinvoq) is now approved to treat adult patients with moderately to severely active Crohn's disease who have had an inadequate response or intolerance to one or more tumor necrosis factor blockers.
https://gastroenterology.acponline.org/archives/2023/05/26/9.htm
26 May 2023
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
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
More patient deaths associated with intragastric balloon weight-loss systems
Clinicians should closely monitor patients with intragastric balloons for complications and explain symptoms that could be signs of serious or life-threatening problems, the FDA advised.
https://gastroenterology.acponline.org/archives/2018/06/22/7.htm
22 Jun 2018
Ranitidine recalled due to nitrosamine impurity
American Health Packaging recalled 11 lots of the histamine-2 receptor antagonist due to the potential presence of excess amounts of N-nitrosodimethylamine, a probable carcinogen.
https://gastroenterology.acponline.org/archives/2020/03/27/10.htm
27 Mar 2020
FDA places limits on OTC loperamide
The agency is working with manufacturers to use blister packs or other single-dose packaging and curb the number of doses contained in each package.
https://gastroenterology.acponline.org/archives/2018/02/23/9.htm
23 Feb 2018
Another warning for endoscope manufacturer after facility inspection in Japan
The warning letter to Olympus Medical Systems Corporation followed previous warning letters issued to the firm and one of its subsidiaries and described numerous violations, including failure to evaluate and report user reports of adverse events.
https://gastroenterology.acponline.org/archives/2023/04/21/7.htm
21 Apr 2023