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
Use duodenoscopes that are fully disposable or have disposable components, FDA recommends
Interim results from one duodenoscope model with a removable component showed a contamination rate of 0.5%, compared with as high as 6% among older duodenoscope models, an FDA safety communication noted.
https://gastroenterology.acponline.org/archives/2022/04/22/11.htm
22 Apr 2022
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
FDA requires updated boxed warnings on heart-related events, other risks for certain Janus kinase inhibitors
The agency is requiring revisions to the boxed warning for the arthritis and ulcerative colitis medicine tofacitinib, as well as two other Janus kinase inhibitors, to include information about the risks of serious heart-related events, cancer, blood clots, and death.
https://gastroenterology.acponline.org/archives/2021/09/24/9.htm
24 Sep 2021
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
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 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
Marketing authorized for new device that removes dead pancreatic tissue
The system is the first device indicated to treat patients with walled-off pancreatic necrosis resulting from complications of acute pancreatitis.
https://gastroenterology.acponline.org/archives/2021/01/22/7.htm
22 Jan 2021
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
Probable carcinogen found in some ranitidine medicines
While the FDA is not calling for individuals to stop taking ranitidine at this time, it said that patients who wish to discontinue prescription use should talk to their clinician about other treatment options.
https://gastroenterology.acponline.org/archives/2019/09/27/9.htm
27 Sep 2019