In the FDA’s June 2018 procedural document, Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities—Questions and Answers, the FDA notes that the term, “should,” which is utilized in the droperidol boxed warning for ECG monitoring before and after dose administration, is a suggestion or recommendation, “but not required.” ¹⁴ In a bulletin published by the FDA in 1982, they state that, “With respect to its role in medical practice, the package insert is informational only.”¹⁵ In fact, the Food, Drug, and Cosmetic Act does not limit the manner in which a physician may use an approved drug.¹⁵

21 years after droperidol’s boxed warning, CDPH continues to practice medicine, forcing providers to magically meet the FDA’s stringent requirements while simultaneously placing 12-lead ECGs on every hostile patient throwing bedpans. The realistic (or preferred?) outcome of this is the removal of droperidol from the hospital formulary which unfortunately happened at our institution.

Why does the boxed warning for droperidol still exist? Good question—we have not found an answer. Clearly, the FDA can (with enough motivation, we suppose) reverse course. It did so with varenicline on December 16, 2016 and canagliflozin on August 26, 2020.^16,17 Perhaps the FDA requires large clinical trial findings (as was cited by them as the reason for reversing their position on these two agents). Good luck with that; we doubt anyone is spending money on an ancient drug to perform a large clinical trial.

When will CDPH reign in its surveyors? When will the FDA unequivocally state that a package insert cannot be used by regulatory agencies to practice medicine? That to us has a higher chance of causing harm than droperidol induced TdP.

Mr. Joson is a clinical pharmacy and residency program director. 

Dr. Pho is a practicing emergency medicine physician and the medical director of a busy community emergency department in California’s Central Valley, which functions as a tertiary referral center within its network.

Mr. Al-Saiegh, a board-certified emergency medicine pharmacist specialist with over seven years practice experience with special interests in cardiac arrest resuscitation and high-performance resuscitation teams, first brought droperidol to his emergency department in 2020, pivotally advocating for its use as the “Swiss army knife” of the ED.

Dr. Seng has been a practicing Emergency Medicine physician for 12 years and works at several community and academic departments across Central California.

References

1. S. Food and Drug Administration. Droperidol prescribing information. Available at: [https://www.americanregent.com/media/1574/droperidol_prescribing-information.pdf](https://www.americanregent.com/media/1574/droperidol_prescribing-information.pdf). Accessed April 8, 20251.
2. van Zwieten K, Mullins ME, Jang T. Droperidol and the black box warning. Ann Emerg Med. 2004;43(1):139-40.
3. Singh K, Jain A, Panchal I, et al. Ondansetron-induced QT prolongation among various age groups: a systematic review and meta-analysis. Egypt Heart J. 2023;75(1):56.
4. Cole JB, Lee SC, Martel ML, et al. The incidence of QT prolongation and torsades des pointes in patients receiving droperidol in an urban emergency department. West J Emerg Med. 2020;21(4):728-736.
5. Nuttall GA, Malone AM, Michels CA, et al. Does low-dose droperidol increase the risk of polymorphic ventricular tachycardia or death in the surgical patient? Anesthesiology. 2013;118(2):382-6.
6. Martel ML, Driver BE, Miner JR, et al. Randomized double-blind trial of intramuscular droperidol, ziprasidone, and lorazepam for acute undifferentiated agitation in the emergency department. Acad Emerg Med. 2021;28(4):421-434.
7. American College of Emergency Physicians. Emergency department violence poll results. Available at: [https://www.emergencyphysicians.org/siteassets/files/pdfs/2018acep-emergency-department-violence-pollresults-2.pdf](https://www.emergencyphysicians.org/siteassets/files/pdfs/2018acep-emergency-department-violence-pollresults-2.pdf). Accessed April 8, 20257.
8. American College of Emergency Physicians. ACEP member poll: ED violence. Available at: [https://www.acep.org/siteassets/new-pdfs/advocacy/acepmemberpoll-edviolencejan2024.pdf](https://www.acep.org/siteassets/new-pdfs/advocacy/acepmemberpoll-edviolencejan2024.pdf). Accessed April 8, 20258.
9. S. Congress. H.R. 2663. Available at: [https://www.congress.gov/bill/118th-congress/house-bill/2663](https://www.congress.gov/bill/118th-congress/house-bill/2663). Accessed April 8, 20259.
10. S. Congress. H.R. 2584. Available at: [https://www.congress.gov/bill/118th-congress/house-bill/2584/text](https://www.congress.gov/bill/118th-congress/house-bill/2584/text). Accessed April 8, 202510.
11. American College of Emergency Physicians. Clinical policies: severe agitation. Available at: [https://www.acep.org/siteassets/new-pdfs/clinical-policies/severe-agitation-cp.pdf](https://www.acep.org/siteassets/new-pdfs/clinical-policies/severe-agitation-cp.pdf). Accessed April 8, 202511.
12. Roppolo LP, Morris DW, Khan F, et al. Improving the management of acutely agitated patients in the emergency department through implementation of Project BETA (Best Practices in the Evaluation and Treatment of Agitation). J Am Coll Emerg Physicians Open. 2020;1(5):898-907.
13. American College of Emergency Physicians. Use of droperidol in the emergency department. Available at: [https://www.acep.org/siteassets/new-pdfs/policy-statements/use-of-droperidol-in-the-emergency-department.pdf](https://www.acep.org/siteassets/new-pdfs/policy-statements/use-of-droperidol-in-the-emergency-department.pdf). Accessed April 8, 202513.
14. S. Food and Drug Administration. Drug and device manufacturer communications with payors, formulary committees, and similar entities. Available at: [https://www.fda.gov/regulatory-information/search-fda-guidance-documents/drug-and-device-manufacturer-communications-payors-formulary-committees-and-similar-entities](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/drug-and-device-manufacturer-communications-payors-formulary-committees-and-similar-entities). Accessed April 8, 202514.
15. S. Food and Drug Administration. FDA revises description of mental health side effects of varenicline. Available at: [https://www.fda.gov/drugs/drug-safety-and-availability/fda-drug-safety-communication-fda-revises-description-mental-health-side-effects-stop-smoking](https://www.fda.gov/drugs/drug-safety-and-availability/fda-drug-safety-communication-fda-revises-description-mental-health-side-effects-stop-smoking). Accessed April 8, 202515.
16. S. Food and Drug Administration. FDA removes boxed warning about risk of leg and foot amputations with diabetes medicine canagliflozin. Available at: [https://www.fda.gov/drugs/drug-safety-and-availability/fda-removes-boxed-warning-about-risk-leg-and-foot-amputations-diabetes-medicine-canagliflozin](https://www.fda.gov/drugs/drug-safety-and-availability/fda-removes-boxed-warning-about-risk-leg-and-foot-amputations-diabetes-medicine-canagliflozin). Accessed April 8, 202516.