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.
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