Search results for "FDA update"
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
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
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
Weight-loss devices linked to patient deaths
In a letter to clinicians, the FDA noted five reports of unanticipated deaths that occurred from 2016 to the present in patients treated with liquid-filled intragastric balloon systems.
https://gastroenterology.acponline.org/archives/2017/09/22/7.htm
22 Sep 2017
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
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
Generic form of mesalamine approved
The drug is indicated to induce remission in adults with active, mild to moderate ulcerative colitis and to maintain remission of ulcerative colitis.
https://gastroenterology.acponline.org/archives/2017/06/23/6.htm
23 Jun 2017
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
IBS-D drug should not be prescribed to patients without gallbladders
The FDA suggests that clinicians should consider alternatives to eluxadoline in this population.
https://gastroenterology.acponline.org/archives/2017/03/24/8.htm
24 Mar 2017
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