LETTER
Over-the-Counter Naproxen Sodium and Esophageal Injury
Laura H. Kahn, MD, MPH;
Min Chen, MS, RPh; and
Robert Eaton, RPh
15 June 1997 | Volume 126 Issue 12 | Page 1006
TO THE EDITOR:
We report a case series involving predominantly young, healthy persons who developed esophageal problems after consuming over-the-counter naproxen sodium. This drug (at a dose of 220 mg) was approved for marketing in January 1994. The U.S. Food and Drug Administration's Spontaneous Reporting System received 81 reports of esophageal symptoms occurring with the drug; these cases made up approximately 1% of all reports for over-the-counter naproxen sodium received through December 1995.
The mean patient age in our series was 35.9 years, and 65 patients (80%) were women. Intake of the tablet (as opposed to the caplet) form was reported in 61 (77%) of the reports. Forty-two (52%) patients reported that the pill "stuck" in their throat. Nine patients required either barium-swallow testing or upper endoscopy for evaluation; 7 were found to have esophageal ulcerations. One patient was hospitalized.
No hemorrhage was reported, but long-term sequelae of the patients who developed ulcerations is unknown. Forty patients (49%) had symptoms after taking only one 220-mg pill. Twenty-three patients had symptoms immediately after ingesting the pill. Fifteen reports specifically noted that the patients did not take the pill or pills with fluids or lay down after taking the pill. However, most reports lacked information on these points. Most patients had no medical history of esophageal problems and were not taking concomitant medications. One patient each took concomitant ibuprofen and clindamycin, which may have contributed to esophageal symptoms.
The mechanism of esophageal injuries seen in our case series is unclear. Naproxen sodium is available as a small, round or oval, blue tablet and has unknown esophageal adherent tendencies [1]. Antibiotics and antiviral drugs have been implicated in at least 60% of reported cases of pill-induced esophageal injury; anti-inflammatory drugs account for approximately 8% of reported cases [2]. Nonsteroidal anti-inflammatory drugs rarely cause esophageal injury; when they do, however, complications such as hemorrhage or stricture are common [2]. Our case series suggests that the naproxen sodium pills were consumed incorrectly, but other causes cannot be dismissed. Further information on patient use of this over-the-counter medication would be helpful in identifying factors contributing to esophageal injury.
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Author and Article Information
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U.S. Food and Drug Administration, Rockville, MD 20857
Disclaimer: Opinions and assertions contained herein are those of the authors and are not to be construed as representing those of the U.S. Food and Drug Administration.
1. Marvola M, Rajaniemi M, Marttila E, Yahervuo K, Sothmann A. Effect of dosage form and formulation factors on the adherence of drugs to the esophagus. J Pharm Sci. 1983; 72:1034-6.
2. Kikendall JW. Pill-induced esophageal injury. Gastroenterol Clin North Am. 1991; 20:835-6.
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