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FDA update

The FDA is strengthening its existing warning that constipation caused by the schizophrenia medicine clozapine (Clozaril, Fazaclo ODT, Versacloz, generics) can uncommonly progress to serious bowel complications. ... Clozapine affects bowel function in a
February 2020

FDA update

reported. Serious infections have occurred in adults who received investigational fecal microbiota transplantation (FMT) containing multidrug-resistant organisms, the FDA recently warned. ... It's also necessary to test donor stool for
June 2019

FDA update

https://gastroenterology.acponline.org/archives/2019/08/23/6.htm. Based on data from an ongoing safety trial, the FDA has approved a new warning about an increased risk of blood ... The FDA has approved new warnings for the 10-mg twice-daily dose of
August 2019

FDA update

Eleven lots of ranitidine tablets, USP (150 mg) were recalled by American Health Packaging due to the potential to contain excess amounts of N-nitrosodimethylamine (NDMA), a probable carcinogen, the FDA
March 2020

FDA update

Five additional deaths have occurred in patients with two liquid-filled intragastric balloon systems used to treat obesity, the FDA announced on June 4. ... hyperinflation. The FDA continues to work with device manufacturers Apollo Endosurgery and
June 2018

FDA update

The FDA on July 21 cleared the updated design and labeling for ED-530XT duodenoscopes by Fujifilm, but the manufacturer on the same day informed customers that it was recalling all ... After receiving the new operation manuals, customers who received the
July 2017

FDA update

reprocessing failure, the FDA said in its update. ... The results show that improvements are necessary, and the FDA is exploring additional steps to reduce contamination rates.
April 2019

FDA update

The FDA announced on May 26 that it is restricting the use of obeticholic acid (Ocaliva) in patients with primary biliary cholangitis (PBC) and advanced cirrhosis. ... Based on the original clinical trials, the FDA believes the benefits of the drug
June 2021

FDA update

The FDA has approved nivolumab (Opdivo) in combination with certain types of chemotherapy for the initial treatment of patients with advanced or metastatic gastric cancer, gastroesophageal junction cancer, or esophageal adenocarcinoma, ... The drug is
April 2021

FDA update

The FDA authorized marketing of the first fully disposable duodenoscope on Dec. ... each year, and the FDA has encouraged innovative ways to improve their safety and effectiveness, particularly with regard to cleaning and disinfecting, the agency said in
December 2019

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