| Title | The risk of esophageal obstruction associated with an anti-allergy medication (Claritin-D 24-Hour--original formulation). | | Author(s) | Manda B, Drinkard CR, Shatin D, Graham DJ | | Institution | Center for Health Care Policy and Evaluation, UnitedHealth Group, 12125 Technology Drive, MN002-0260, Minneapolis, MN 55344-7302, USA. bharati_s_manda@uhc.com | | Source | Pharmacoepidemiol Drug Saf 2004 Jan; 13(1):29-34. | | MeSH | Adolescent
Adult
Aged
Airway Obstruction
Anti-Allergic Agents
Child
Comparative Study
Deglutition
Delayed-Action Preparations
Drug Combinations
Ephedrine
Esophagus
Female
Humans
Loratadine
Male
Medical Records
Middle Aged
Product Surveillance, Postmarketing
Research Support, U.S. Gov't, P.H.S.
Retrospective Studies
| | Abstract | 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. | | Language | eng | | Pub Type(s) | Journal Article
| | PubMed ID | 14971120 |
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