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. Author manuscript; available in PMC: 2024 Mar 6.
Published in final edited form as: Pharmacoepidemiol Drug Saf. 2021 Nov 24;31(2):225–234. doi: 10.1002/pds.5384

Table 2.

National Estimates of Emergency Department (ED) Visits for Over-the-Counter (OTC) Cough and Cold Medication (CCM)-related Harms, by Clinical Manifestations, 2017-2019a

Manifestationsb Therapeutic Use Nonmedical Usec Self-harm
Cases Annual Estimate Cases Annual Estimate Cases Annual Estimate
No. No. % 95% CI No. No. % 95% CI No. No. % 95% CI
Severe allergic reaction 56 1,271 12.3 (8.7 - 15.9) 1 -- -- -- 0 -- -- --
Altered mental status/unresponsiveness 54 1,227 11.9 (8.2 - 15.6) 199 3,533 44.9 (37.3 - 52.5) 75 1,583 21.4 (13.5 - 29.4)
Presyncope/syncope/fall/injury 61 1,367 13.2 (9.1 - 17.4) 20 -- -- -- 11 -- -- --
Psychiatric or other central nervous system effect 50 1,275 12.4 (8.9 - 15.9) 34 591 7.5 (4.6 - 10.4) 9 -- -- --
Cardiovascular effect 44 1,229 11.9 (8.2 - 15.6) 15 -- -- -- 11 -- -- --
Mild-to-moderate allergic reaction 132 2,872 27.8 (23 - 32.6) 1 -- -- -- 0 -- -- --
Other effect 33 694 6.7 (3.3 - 10.1) 20 470d 6.0 (2.4 - 9.5) 32 -- -- --
Increased drug level only 1 -- -- -- 4 -- -- -- 43 717 9.7 (6.7 - 12.7)
No documented clinical manifestations 23 -- -- -- 138 2,349 29.9 (22 - 37.7) 236 4,278 58.0 (49.1 - 66.8)
Total 454 10,319 100.0 432 7,870 100.0 417 7,382 100.0

CI = confidence interval.

a

Estimates are from the National Electronic Injury Surveillance System–Cooperative Adverse Drug Event Surveillance project, Centers for Disease Control and Prevention. Estimates based on <20 cases or total estimates <1200 for the study period are considered statistically unstable and are not shown (--). ED visits for unsupervised pediatric CCM exposures are not shown (1,164 estimated visits annually). There we no documented clinical manifestations for 74.1% of ED visits for unsupervised CCM exposures among children aged ≤10 years.

b

Clinical manifestations were categorized in a mutually exclusive and hierarchical manner (e.g., a case involving depressed consciousness and nausea would be classified as altered mental status/unresponsiveness based on the depressed consciousness). An estimated 61.3% of ED visits for nonmedical CCM use and 75.9% of visits for CCM-related self-harm had documentation of concurrent use of other medications, alcohol, or illicit drugs, and therefore it may be difficult to assess the role that the CCM played in the clinical manifestations, particularly for ED visits for harms involving non-therapeutic CCM use.

c

Nonmedical use includes abuse (clinician diagnosis of abuse or documentation of recreational use), misuse (using medication for symptom relief, but not using medication as directed), and overdoses without documentation of therapeutic intent, misuse, abuse, or self-harm.

d

Coefficient of variation >30%.