Search results for "FDA Update"
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
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
Ulcerative colitis medicine may increase risk of serious heart-related problems, cancer
Preliminary results from a safety clinical trial indicate that tofacitinib may be associated with an increased risk of serious heart-related events and cancer compared to tumor necrosis factor inhibitors.
https://gastroenterology.acponline.org/archives/2021/02/26/8.htm
26 Feb 2021
Warning on risks of serious adverse events with use of fecal microbiota for transplantation
Several patients who have received fecal microbiota for transplantation from a U.S.-based stool bank have developed serious or life-threatening infections caused by pathogenic bacteria.
https://gastroenterology.acponline.org/archives/2020/03/27/9.htm
27 Mar 2020
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
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
Patient dies after fecal microbiota transplantation
One immunocompromised patient died and another was infected after receiving fecal microbiota for transplantation that contained multidrug-resistant bacteria, the FDA reported.
https://gastroenterology.acponline.org/archives/2019/06/28/6.htm
28 Jun 2019
First drug approved to treat thrombocytopenia in adults with chronic liver disease who are having a medical procedure
Patients who received the drug for five days had increased platelet counts compared to those taking placebo.
https://gastroenterology.acponline.org/archives/2018/05/25/6.htm
25 May 2018
Boxed warning added to liver disease drug
The drug has been incorrectly dosed daily instead of weekly in patients with moderate to severe primary biliary cholangitis, which increases the risk of serious liver injury, the FDA said.
https://gastroenterology.acponline.org/archives/2018/02/23/7.htm
23 Feb 2018
Incontinence management system recalled due to potential interference with other devices
About a month after issuing an urgent medical device correction, the manufacturer announced a class I recall of the WatchCare Incontinence Management System due to potential radio frequency interference with other medical devices.
https://gastroenterology.acponline.org/archives/2022/12/23/8.htm
23 Dec 2022