Search results for "FDA update"
FDA alerts clinicians about cross-contamination risk with certain endoscope connectors
Endoscope connectors labeled for use in multiple patients within a 24-hour period without reprocessing are not recommended for use because the FDA has not received acceptable testing data demonstrating their safety.
https://gastroenterology.acponline.org/archives/2018/04/27/9.htm
27 Apr 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
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
More patient deaths associated with intragastric balloon weight-loss systems
Clinicians should closely monitor patients with intragastric balloons for complications and explain symptoms that could be signs of serious or life-threatening problems, the FDA advised.
https://gastroenterology.acponline.org/archives/2018/06/22/7.htm
22 Jun 2018
Drug cleared to treat moderately to severely active ulcerative colitis
It is the first oral medication to be approved for chronic use in this population.
https://gastroenterology.acponline.org/archives/2018/06/22/6.htm
22 Jun 2018
FDA approves new drug for travelers' diarrhea
Compared to placebo, the drug significantly reduced symptoms in a randomized controlled trial of 264 adults with travelers' diarrhea in Guatemala and Mexico.
https://gastroenterology.acponline.org/archives/2018/11/27/6.htm
27 Nov 2018
Data show higher-than-expected rates of duodenoscope contamination
While the number of medical device reports associated with patient infections has declined by 62% since peaking in 2015, the FDA and duodenoscope manufacturers continue to address issues around device reprocessing.
https://gastroenterology.acponline.org/archives/2018/12/28/7.htm
28 Dec 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
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
New treatment approved for complicated intra-abdominal infections
The three-drug combination injection contains imipenem-cilastatin, a previously FDA-approved antibiotic, and relebactam, a new beta-lactamase inhibitor.
https://gastroenterology.acponline.org/archives/2019/07/26/6.htm
26 Jul 2019