Search results for "FDA update"
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
First targeted therapy approved to treat patients with GI stromal tumors, rare mutation
A kinase inhibitor was approved to treat adults with an unresectable or metastatic gastrointestinal (GI) stromal tumor who harbor a platelet-derived growth factor receptor alpha exon 18 mutation.
https://gastroenterology.acponline.org/archives/2020/01/24/8.htm
24 Jan 2020
FDA requests withdrawal of weight-loss drug from U.S. market
The manufacturer of lorcaserin will voluntarily withdraw the drug because a safety clinical trial showed that the drug was associated with an increased occurrence of cancer compared to placebo.
https://gastroenterology.acponline.org/archives/2020/02/28/6.htm
28 Feb 2020
FDA strengthens warning that schizophrenia drug can lead to life-threatening constipation
The agency is strengthening an existing warning that constipation caused by clozapine can uncommonly progress to serious bowel complications that can lead to hospitalization or death if not diagnosed and treated quickly.
https://gastroenterology.acponline.org/archives/2020/02/28/7.htm
28 Feb 2020
Ranitidine recalled due to nitrosamine impurity
American Health Packaging recalled 11 lots of the histamine-2 receptor antagonist due to the potential presence of excess amounts of N-nitrosodimethylamine, a probable carcinogen.
https://gastroenterology.acponline.org/archives/2020/03/27/10.htm
27 Mar 2020
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
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
First drug approved for fourth-line treatment of advanced GI stromal tumors
A new kinase inhibitor, ripretinib, is now indicated to treat adults with advanced GI stromal tumors who have previously received three or more kinase inhibitor therapies, including imatinib.
https://gastroenterology.acponline.org/archives/2020/05/22/9.htm
22 May 2020
Postapproval studies find risks of gastric balloon devices used for weight loss
A small number of patients experienced balloon hyperinflation and acute pancreatitis with the Orbera and ReShape liquid-filled intragastric balloons.
https://gastroenterology.acponline.org/archives/2020/05/22/8.htm
22 May 2020
First-line immunotherapy approved for certain patients with colorectal cancer
Pembrolizumab (Keytruda) for IV injection is now indicated to treat patients with unresectable or metastatic microsatellite instability-high or mismatch repair deficient colorectal cancer.
https://gastroenterology.acponline.org/archives/2020/07/24/8.htm
24 Jul 2020