Search results for "FDA update"
Warning issued on dosing of drug for primary biliary cholangitis
Clinicians should determine baseline liver function before starting patients on obeticholic acid, the FDA said.
https://gastroenterology.acponline.org/archives/2017/10/27/6.htm
27 Oct 2017
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
New HCV drug combo approved
The fixed-dose tablet combines the previously approved drugs sofosbuvir and velpatasvir with a new drug, voxilaprevir.
https://gastroenterology.acponline.org/archives/2017/07/28/10.htm
28 Jul 2017
Batch of senna laxatives recalled
The recall follows a customer report that a bottle labeled as senna laxative actually contained naproxen sodium.
https://gastroenterology.acponline.org/archives/2018/02/23/11.htm
23 Feb 2018
FDA alerts clinicians about cross-contamination risk with certain endoscope connectors
Endoscope connectors labeled for use in multiple patients within a 24-hour period without reprocessing are not recommended for use because the FDA has not received acceptable testing data demonstrating their safety.
https://gastroenterology.acponline.org/archives/2018/04/27/9.htm
27 Apr 2018
Regorafenib now FDA-approved to treat hepatocellular carcinoma
Approved use of the drug has been expanded to include treatment of patients with hepatocellular carcinoma who have been treated with sorafenib.
https://gastroenterology.acponline.org/archives/2017/05/26/7.htm
26 May 2017
Potency concerns lead to recall of anti-diarrhea drug
Recalled batches of diphenoxylate hydrochloride and atropine sulfate, an adjunctive therapy for the management of diarrhea, were distributed nationwide between November 2016 and June 2017.
https://gastroenterology.acponline.org/archives/2017/11/28/8.htm
28 Nov 2017
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
Sodium polystyrene sulfonate should be taken separately from other oral meds, FDA advises
The FDA's recommendation follows a study finding that sodium polystyrene sulfonate also binds to many common oral medications, which decreases their absorption and effectiveness.
https://gastroenterology.acponline.org/archives/2017/09/22/6.htm
22 Sep 2017
Duodenoscopes recalled
The recall of ED-530XT duodenoscopes by Fujifilm includes replacement of the ED-530XT forceps elevator mechanism (including the O-ring seal), replacement of the distal end cap, and new operation manuals.
https://gastroenterology.acponline.org/archives/2017/07/28/9.htm
28 Jul 2017