Search results for "FDA update"
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
New boxed warning for ulcerative colitis drug
Based on data from an ongoing safety trial, the FDA has approved a new warning about an increased risk of blood clots and of death with the 10-mg twice-daily dose of tofacitinib (Xeljanz, Xeljanz XR).
https://gastroenterology.acponline.org/archives/2019/08/23/6.htm
23 Aug 2019
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
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
FDA clears first fully disposable duodenoscope
The device is intended to be used on a single patient, removing the infection risks associated with ineffective cleaning and disinfecting between patients.
https://gastroenterology.acponline.org/archives/2019/12/27/6.htm
27 Dec 2019
Laxatives and antacids recalled due to microbial contamination
The recall includes several lots of milk of magnesia and magnesium hydroxide/aluminum hydroxide/simethicone sold to clinics and hospitals nationwide.
https://gastroenterology.acponline.org/archives/2022/06/24/9.htm
24 Jun 2022
Marketing authorized for endoscopic sleeve gastroplasty systems
The systems are the first to be authorized by the FDA for the minimally invasive weight-loss procedure, which is intended for adults with obesity who have not been able to lose weight or maintain weight loss through measures such as diet and exercise.
https://gastroenterology.acponline.org/archives/2022/08/26/12.htm
26 Aug 2022
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
First immunotherapy approved for initial treatment of gastric cancer
Nivolumab (Opdivo) is approved in combination with certain types of chemotherapy for the initial treatment of patients with advanced or metastatic gastric cancer, gastroesophageal junction cancer, or esophageal adenocarcinoma.
https://gastroenterology.acponline.org/archives/2021/04/23/9.htm
23 Apr 2021
Laxative recalled due to potential microbial contamination
A company recently recalled one lot of senna syrup, which was distributed to a wholesaler, due to potential microbial contamination.
https://gastroenterology.acponline.org/archives/2022/01/28/6.htm
28 Jan 2022