Search results for "FDA Update"
New treatment approved for complicated intra-abdominal infections
The three-drug combination injection contains imipenem-cilastatin, a previously FDA-approved antibiotic, and relebactam, a new beta-lactamase inhibitor.
https://gastroenterology.acponline.org/archives/2019/07/26/6.htm
26 Jul 2019
Marketing authorized for first AI device to detect potential signs of colon cancer
The device uses artificial intelligence (AI) based on machine learning to assist clinicians in the real-time detection of lesions, such as polyps or suspected tumors, in the colon during a colonoscopy.
https://gastroenterology.acponline.org/archives/2021/04/23/10.htm
23 Apr 2021
Hepatitis C medicines have led to liver decompensation in some patients
The FDA has identified 63 cases of liver decompensation with medications to treat hepatitis C, most of which occurred in patients with moderate to severe liver impairment who should not have been prescribed the drugs.
https://gastroenterology.acponline.org/archives/2019/09/27/6.htm
27 Sep 2019
First targeted therapy approved to treat patients with GI stromal tumors, rare mutation
A kinase inhibitor was approved to treat adults with an unresectable or metastatic gastrointestinal (GI) stromal tumor who harbor a platelet-derived growth factor receptor alpha exon 18 mutation.
https://gastroenterology.acponline.org/archives/2020/01/24/8.htm
24 Jan 2020
FDA recommends transition to duodenoscopes with disposable endcaps
While a full transition away from conventional duodenoscopes to innovative models will take time, health care facilities should develop plans to transition away from older models that have fixed endcaps, the FDA said.
https://gastroenterology.acponline.org/archives/2019/09/27/7.htm
27 Sep 2019
First-line immunotherapy approved for certain patients with colorectal cancer
Pembrolizumab (Keytruda) for IV injection is now indicated to treat patients with unresectable or metastatic microsatellite instability-high or mismatch repair deficient colorectal cancer.
https://gastroenterology.acponline.org/archives/2020/07/24/8.htm
24 Jul 2020
FDA strengthens warning that schizophrenia drug can lead to life-threatening constipation
The agency is strengthening an existing warning that constipation caused by clozapine can uncommonly progress to serious bowel complications that can lead to hospitalization or death if not diagnosed and treated quickly.
https://gastroenterology.acponline.org/archives/2020/02/28/7.htm
28 Feb 2020
FDA requests removal of all ranitidine from market due to impurity
As a result of the immediate market withdrawal request, ranitidine medications, commonly known by the brand name Zantac, will not be available for new or existing prescription or over-the-counter use in the U.S.
https://gastroenterology.acponline.org/archives/2020/04/24/6.htm
24 Apr 2020
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
Endoscopic spray device approved to be marketed to treat GI bleeding
The device delivers a mineral blend to sites of upper or lower GI bleeding and is applied during an endoscopic procedure.
https://gastroenterology.acponline.org/archives/2018/05/25/7.htm
25 May 2018