Here are five points:
1. The FDA is planning an advisory committee to provide input on whether additional FDA actions are needed.
2. In 2009, the agency added warnings about the risk of serious bleeding to the labels of nonprescription products that contain nonsteroidal anti-inflammatory drugs, including aspirin-containing antacids,.
3. The FDA Adverse Event Reporting System database identified eight cases of serious bleeding associated with NSAIDS and aspirin-containing antacids after the warning was added.
4. All the patients in those eight cases were hospitalized.
5. The FAERS database only includes FDA-submitted reports, so there are likely additional cases not included.
More articles on GI & endoscopy:
Olympus introduces new single use aspiration needle: 4 notes
Unsafe injection practices lead to HCV outbreak, clinic closure: 4 insights
4 key points on Mercy Health-Fairfield Hospital’s $14M plan to improve inpatient & outpatient endoscopy services
At the Becker’s 32nd Annual Meeting: The Business and Operations of ASCs, taking place October 29-31 in Chicago, ASC leaders, surgeons and healthcare executives will explore strategies to drive growth, enhance operational performance, navigate reimbursement challenges and prepare for the future of ambulatory surgery. Apply for complimentary registration now.
