Search results for "FDA Update"
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
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
Drug cleared to treat moderately to severely active ulcerative colitis
It is the first oral medication to be approved for chronic use in this population.
https://gastroenterology.acponline.org/archives/2018/06/22/6.htm
22 Jun 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
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
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
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
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
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