Local Anesthetic Safety and Deaths: A Summary of an FDA Reporting Analysis
Local anesthetics such as lidocaine and bupivacaine are used every day for numbing, nerve blocks, and spinal and epidural anesthesia. They are very safe when used correctly, but at high blood levels they can affect the brain and heart, a problem called local anesthetic systemic toxicity. One hundred years after the American Medical Association reported on deaths from these drugs, how often they contribute to deaths today is not well described. A 2025 study in the British Journal of Anaesthesia looked at US safety reports to find out more.
This summary is based on the published abstract. Read the abstract on PubMed
What the authors did
The team studied reports to the US Food and Drug Administration Adverse Event Reporting System (FAERS) from 1968 to 2023.
- They compared local anesthetics with other drugs using a reporting odds ratio (ROR). A value below 1 means death made up a smaller share of that drug’s reports than it did for other drugs.
- They checked whether professional society advisories on systemic toxicity were followed by changes in death reports for long-acting local anesthetics and for lidocaine.
- They pulled individual published case citations for an exploratory look at deaths.
What they found
- Totals: 22,050 adverse events involved local anesthetics, including 1,473 reports of death.
- Compared with other drugs: death was reported less often for both amide (ROR 0.4) and ester (ROR 0.12) local anesthetics.
- Lidocaine: this was the local anesthetic most often reported in deaths.
- After the advisories: death reports for long-acting local anesthetics fell compared with the previous 10 years (ROR 0.61). Death reports for lidocaine did not change (ROR 0.95).
- Recent years: over the past 5 years, lidocaine death reports were similar to other agents (ROR 0.95).
- Main contributors: since 2010, the cited cases pointed to high-dose lidocaine, nerve catheters, and high neuraxial anesthesia (a spinal or epidural block that spreads too high).
The authors conclude that the potential lethality of lidocaine, an extremely common drug, deserves further study.
Limitations
Voluntary reporting systems have important limits. They do not show how many people received each drug, so they cannot give true rates of harm, and reports can be incomplete or inaccurate. A drop in reports after the advisories does not prove the advisories caused it. The case review was exploratory.
Safety takeaways
- Rare, but not zero. Deaths linked to local anesthetics are reported less often than for many other drugs, but they do occur.
- Guidance may help. Death reports for long-acting agents fell after toxicity advisories.
- Do not take lidocaine for granted. It is familiar and widely used, yet its death reports did not show the same decline.
- Dose and technique matter. High doses, nerve catheters, and high neuraxial blocks were the main contributors in reported deaths, which supports careful dose limits and monitoring.
- Be prepared. Facilities that use these drugs benefit from clear plans to recognize and treat toxicity quickly.
- Know the warning signs. Tell your care team right away about ringing in the ears, numbness around the mouth, a metallic taste, confusion, or a racing or slow heartbeat after a numbing injection.
Reference
- Fettiplace MR, Weinberg G, Chiang C, Nixon HC, Gitman M. Contemporary local anaesthetic-associated adverse events and mortality: a pharmacovigilance analysis of a US reporting system. Br J Anaesth. 2025 Oct;135(4):1015-1025. DOI: 10.1016/j.bja.2025.06.044. PMID: 40877109. Abstract: https://pubmed.ncbi.nlm.nih.gov/40877109/
Related: Anesthesia Medication and Medication Error Cases
This article is educational information, not legal or medical advice.
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