Search results for "FDA update"
FDA approves first treatment for eosinophilic esophagitis
The monoclonal antibody is indicated to treat the chronic immune disorder in adults and pediatric patients ages 12 years and older who weigh at least 40 kg.
https://gastroenterology.acponline.org/archives/2022/05/27/9.htm
27 May 2022
Histamine-2 receptor antagonists recalled due to detection of probable carcinogen
Batches of ranitidine and nizatidine have been recalled in the past month due to the potential presence of N-nitrosodimethylamine.
https://gastroenterology.acponline.org/archives/2020/01/24/7.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
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
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
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 approves new drug for travelers' diarrhea
Compared to placebo, the drug significantly reduced symptoms in a randomized controlled trial of 264 adults with travelers' diarrhea in Guatemala and Mexico.
https://gastroenterology.acponline.org/archives/2018/11/27/6.htm
27 Nov 2018
Data show higher-than-expected rates of duodenoscope contamination
While the number of medical device reports associated with patient infections has declined by 62% since peaking in 2015, the FDA and duodenoscope manufacturers continue to address issues around device reprocessing.
https://gastroenterology.acponline.org/archives/2018/12/28/7.htm
28 Dec 2018
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
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