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The risk of esophageal obstruction associated with an anti‐allergy medication (Claritin‐D® 24‐Hour—original formulation)
Author(s) -
Manda Bharati,
Drinkard Carol R.,
Shatin Deborah,
Graham David J.
Publication year - 2004
Publication title -
pharmacoepidemiology and drug safety
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.023
H-Index - 96
eISSN - 1099-1557
pISSN - 1053-8569
DOI - 10.1002/pds.816
Subject(s) - medicine , loratadine , medical prescription , medical record , incidence (geometry) , pharmacy , pediatrics , family medicine , anesthesia , pharmacology , physics , optics
Purpose 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. Methods 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. Results 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. Conclusions 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.