The findings and conclusions of this study are those of the authors and do not necessarily reflect the views of the Food and Drug Administration.
Version of Record online: 14 FEB 2003
Copyright © 2003 John Wiley & Sons, Ltd.
Pharmacoepidemiology and Drug Safety
Volume 13, Issue 1, pages 29–34, January 2004
How to Cite
Manda, B., Drinkard, C. R., Shatin, D. and Graham, D. J. (2004), The risk of esophageal obstruction associated with an anti-allergy medication (Claritin-D® 24-Hour—original formulation). Pharmacoepidem. Drug Safe., 13: 29–34. doi: 10.1002/pds.816
Findings of this study were presented at the Annual Meeting of the Academy for Health Services Research and Policy, June 2001, Atlanta.
- Issue online: 24 DEC 2003
- Version of Record online: 14 FEB 2003
- Manuscript Accepted: 22 NOV 2002
- Manuscript Revised: 19 AUG 2002
- Manuscript Received: 22 MAR 2002
- US FDA Cooperative Agreement. Grant Number: FD-U-001643-01/02
- post-marketing drug surveillance;
- adverse drug events;
- anti-allergy medication
To investigate a possible increased risk of esophageal obstruction among users of loratadine and pseudoephedrine (Claritin-D® 24-Hour ‘C-D 24’, the original, round, extended-release formulation) compared to two other tablet formulations of loratadine.
Pharmacy data of 12 managed care plans were screened to identify users in the three groups from 1 September 1996 to 31 December 1998. Users with a medical claim following their first loratadine prescription (Index prescription) indicating an esophageal obstruction or endoscopic procedure were considered claims-identified cases. Medical records were reviewed to validate case status.
There were 233 901 users (61% female) and 245 claims-identified cases occurring within 30 days after the first prescription. The incidence rate per 10 000 users of claims-identified cases occurring on the Index prescription date was higher among C-D 24 users (IR = 1.4) than Claritin® Regular (C-R) users (IR = 0.07; p < 0.002) or Claritin-D® 12-Hour (C-D 12) users (IR = 0.3; p > 0.05). Medical record review of 15 claims-identified cases confirmed two cases of acute esophageal obstruction, both among C-D 24 users.
Claims-based analysis suggested an increased risk of endoscopic procedures on the Index date among C-D 24 users compared to C-R users. However, after medical record review, the study did not provide conclusive evidence of an association between C-D 24 use and esophageal obstruction. This study highlights the importance of validating findings from claims data using medical records. Copyright © 2003 John Wiley & Sons, Ltd.