Search results for "FDA update"
HCV drug approved as 8-week regimen
The combination drug is indicated to treat all treatment-naive adults and some children who have chronic hepatitis C virus (HCV) genotypes 1 through 6 infection, either without cirrhosis or with compensated cirrhosis.
https://gastroenterology.acponline.org/archives/2019/10/25/7.htm
25 Oct 2019
Probable carcinogen found in some ranitidine medicines
While the FDA is not calling for individuals to stop taking ranitidine at this time, it said that patients who wish to discontinue prescription use should talk to their clinician about other treatment options.
https://gastroenterology.acponline.org/archives/2019/09/27/9.htm
27 Sep 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
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
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
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
New drug approved for carcinoid syndrome diarrhea
The drug reduces the frequency of diarrhea by inhibiting the production of serotonin by carcinoid tumors.
https://gastroenterology.acponline.org/archives/2017/03/24/9.htm
24 Mar 2017
Ranitidine recalled due to detection of impurity
In response to the detection of N-nitrosodimethylamine, a probable carcinogen, several companies have recalled the histamine H2 receptor antagonist, although FDA testing has found that levels detected are low.
https://gastroenterology.acponline.org/archives/2019/11/22/6.htm
22 Nov 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