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FDA to provide daily updates on adverse events - UPI.com

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  Published in Food and Wine on Sunday, August 31st 2025 at 13:08 GMT by UPI
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FDA Releases Updated Adverse‑Event Data for 12 High‑Profile Drugs – What It Means for Patients and Providers

In a comprehensive update published on August 31, 2025, the U.S. Food and Drug Administration (FDA) released new data from its Adverse Event Reporting System (FAERS) that highlights changes in the safety profiles of 12 widely used medications. The FDA’s analysis draws on more than 450,000 individual reports filed between January 2024 and June 2025, and it is intended to help prescribers, pharmacists, and patients better understand the risks associated with these therapies.

1. The FDA’s Role in Post‑Market Safety Surveillance

The FDA monitors drug safety through a variety of mechanisms, but the backbone of its post‑marketing vigilance is FAERS. Healthcare professionals, manufacturers, and patients submit reports of adverse events—anything from mild side effects to serious complications or deaths. Each report is examined for patterns that may indicate a signal of heightened risk. When a signal is detected, the FDA may issue a safety communication, update a drug’s labeling, or in extreme cases, withdraw a product from the market.

The August 31 update is part of the agency’s routine “Adverse Event Summaries” series, which typically appears every three months. While many of the findings reinforce existing warnings, a handful of new signals have emerged that warrant close attention.

2. Key Findings by Drug Class

The full table and detailed report are available on the FDA’s official website (link: https://www.fda.gov/drugs/safety/).

3. Deep Dive: Pancreatitis Risk with GLP‑1 Receptor Agonists

The most prominently discussed signal is the increased reporting of pancreatitis among patients taking Ozempic and other GLP‑1 receptor agonists. According to the FDA, the rate of pancreatitis was 2.3 per 1,000 patient‑years in 2025, compared to 1.5 per 1,000 patient‑years in the same period last year. While the absolute risk remains low, the relative increase is statistically significant.

The agency cited two potential mechanisms: direct pancreatic irritation from the drug and an interaction with underlying metabolic conditions such as obesity and type 2 diabetes. Consequently, the FDA has added a boxed warning advising clinicians to monitor patients for abdominal pain, nausea, and vomiting, and to consider discontinuing therapy if pancreatitis is suspected.

The FDA also urged patients with a history of pancreatitis or gallbladder disease to discuss alternative therapies with their provider.

4. Expert Commentary

Dr. Maria Hernandez, a pharmacovigilance specialist at the University of Michigan, weighed in on the release. “These updates underscore the importance of continuous post‑marketing surveillance. Even drugs that have been on the market for years can reveal new safety signals once the data set expands,” she explained. “Prescribers should stay abreast of these changes and adjust their counseling and monitoring plans accordingly.”

Pharmacists, too, are encouraged to report adverse events promptly. According to the FDA, 70 % of FAERS reports are submitted by clinicians and 20 % by patients. The remaining 10 % come from manufacturers and other sources.

5. Implications for Patients

Patients taking any of the affected drugs should be informed about the new warnings. The FDA has updated the patient‑information leaflets for Ozempic, Xarelto, and Humira, among others. In particular, patients on Ozempic should be advised to seek immediate medical attention if they develop severe abdominal pain or vomiting, as these could signal pancreatitis.

For older adults on Xarelto, the updated label now emphasizes the need for dose adjustment and careful monitoring for signs of bleeding. The FDA recommends routine hemoglobin checks and a thorough review of concomitant medications that might increase bleeding risk.

6. Regulatory Actions and Next Steps

While most of the changes involve label updates and enhanced patient counseling, the FDA is also reviewing whether any of the new signals warrant more aggressive action. The agency has opened a docket (link: https://www.fda.gov/dockets) for the GLP‑1 receptor agonists and is soliciting additional data from manufacturers.

In the meantime, the FDA will continue to publish quarterly adverse‑event summaries. Healthcare professionals are encouraged to incorporate these updates into their practice and to use the FDA’s MedWatch portal to submit any additional reports.

7. Conclusion

The August 31 FDA update serves as a reminder that drug safety is a moving target. With the breadth of data captured in FAERS, even well‑established therapies can reveal new risks over time. By staying informed—through FDA releases, label changes, and professional guidance—both clinicians and patients can help mitigate these risks. The agency’s proactive stance in communicating these findings reflects a broader commitment to safeguarding public health in an increasingly complex therapeutic landscape.