Search results for "FDA update"
FDA requests removal of all ranitidine from market due to impurity
As a result of the immediate market withdrawal request, ranitidine medications, commonly known by the brand name Zantac, will not be available for new or existing prescription or over-the-counter use in the U.S.
https://gastroenterology.acponline.org/archives/2020/04/24/6.htm
24 Apr 2020
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
Endoscopic spray device approved to be marketed to treat GI bleeding
The device delivers a mineral blend to sites of upper or lower GI bleeding and is applied during an endoscopic procedure.
https://gastroenterology.acponline.org/archives/2018/05/25/7.htm
25 May 2018
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
New data show even higher rates of duodenoscope contamination
The FDA is exploring additional steps to reduce contamination rates, which were higher in postmarket surveillance studies than the agency initially anticipated.
https://gastroenterology.acponline.org/archives/2019/04/26/9.htm
26 Apr 2019
New drug approved to treat digestive tract cancers
The orphan drug is indicated to treat adults with somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors.
https://gastroenterology.acponline.org/archives/2018/02/23/10.htm
23 Feb 2018
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
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
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