Risk of serious upper gastrointestinal toxicity with over-the-counter nonaspirin nonsteroidal anti-inflammatory drugs.
OBJECTIVE
Use of prescription nonaspirin nonsteroidal anti-inflammatory drugs (NANSAIDs) increases the risk of serious upper gastrointestinal toxicity. Less is known about over-the-counter (OTC) NANSAIDs, which are typically used at lower doses and for shorter durations. This study assessed the risk of toxicity with OTC NANSAIDs.


METHODS
A total of 359 case subjects hospitalized for upper gastrointestinal bleeding, perforation, or benign gastric outlet obstruction were recruited from 28 hospitals. A total of 1889 control subjects were recruited by random digit dialing from the same region. Data on medication use were collected via structured telephone interview.


RESULTS
Use of OTC NANSAIDs on > or = 4 days during the most recent week had an adjusted odds ratio (OR) of 1.83 (95% confidence interval [CI], 1.14-2.95). Use of high-dose OTC NANSAIDs during the index week had an adjusted OR of 5.21 (95% CI, 2.32-11.69). In contrast, use of OTC NANSAIDs <4 times during the index week (adjusted OR, 0.67; 95% CI, 0.43-1.06) and use of very low doses of prescription or OTC NANSAIDs during the index week (adjusted OR, 0.74; 95% CI, 0.49-1.12) were not significantly associated with an increased risk of serious gastrointestinal toxicity. We did not observe a significant difference between the risk of toxicity with OTC naproxen versus OTC ibuprofen (adjusted OR, 0.84; 95% CI, 0.26-2.70).


CONCLUSIONS
Use of OTC NANSAIDs at recommended doses has a relatively good safety profile compared with prescription NANSAIDs. However, use of high-dose OTC NANSAIDs (comparable to a prescription dose) is associated with serious gastrointestinal toxicity.
Lewis
James D
JD
Center for Clinical Epidemiology and Biostatistics, University of Pennsylvania, Philadelphia, Pennsylvania, USA. jlewis@cceb.med.upenn.edu
Kimmel
Stephen E
SE
Localio
A Russell
AR
Metz
David C
DC
Farrar
John T
JT
Nessel
Lisa
L
Brensinger
Colleen
C
McGibney
Karen
K
Strom
Brian L
BL
D000328:Adult; D000368:Aged; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000009:adverse effects*; D005767:Gastrointestinal Diseases / Q000139:chemically induced* / Q000473:pathology; D006471:Gastrointestinal Hemorrhage / Q000139:chemically induced / Q000473:pathology; D006801:Humans; D007052:Ibuprofen / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D009288:Naproxen / Q000009:adverse effects; D004366:Nonprescription Drugs / Q000009:adverse effects*; D011897:Random Allocation; D012307:Risk Factors; D041742:Upper Gastrointestinal Tract / Q000473:pathology*
D000894:Anti-Inflammatory Agents, Non-Steroidal; D004366:Nonprescription Drugs; D009288:Naproxen; D007052:Ibuprofen