Search results for "FDA update"
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 limits packaging for loperamide to encourage safe use
To help address abuse and misuse, the FDA approved changes to the packaging for tablet and capsule forms of the over-the-counter antidiarrheal drug.
https://gastroenterology.acponline.org/archives/2019/09/27/8.htm
27 Sep 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
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
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
FDA clears first duodenoscope with disposable elevator piece
While the FDA has previously cleared duodenoscopes with removable endcap components, the device is the first to have a disposable elevator component, a part that has been traditionally difficult to clean and reprocess.
https://gastroenterology.acponline.org/archives/2019/11/22/7.htm
22 Nov 2019
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
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
FDA recommends transition to duodenoscopes with innovative designs
To date, the FDA has cleared three duodenoscopes with newer design features that can facilitate cleaning, reduce contamination, and reduce disease transmission following reprocessing.
https://gastroenterology.acponline.org/archives/2020/01/24/6.htm
24 Jan 2020