Manda B, Drinkard C, Shatin D, Graham D; Academy for Health Services Research and Health Policy. Meeting.
Abstr Acad Health Serv Res Health Policy Meet. 2001; 18: 150.
United Health Group, Center for Health Care Policy and Evaluation, 9900 Bren Rd E. MN008-W109, Minnetonka, MN 55343, Phone: (952) 936-1731, Fax: (952) 936-7270, E-mail: bharati_s_manda@uhc.com
RESEARCH OBJECTIVE: A substantial number of reports to the U.S. Food and Drug Administration's post-marketing drug surveillance system indicated a possible risk of esophageal obstruction associated with the use of the anti-allergy medication Claritin-D 24 Hour (Schering Corporation), leading to the reformulation of this drug. This study investigates the relative risk and incidence rates of this adverse event esophageal/upper-airway obstruction, due to the use of Claritin-D 24 Hour (a large, round, extended release tablet) compared with two smaller formulations of Claritin in a large, managed care population.STUDY DESIGN: A retrospective cohort study design was utilized, with three study groups: one exposed (users of Claritin-D 24 Hour) and two control groups' users of Claritin-D 12 Hour (control group 1) and users of regular Claritin (control group 2). Administrative data were analyzed to identify users in each group during the period 9/1/1996 through 12/31/1998. Subjects were required to have at least 90 days of continuous enrollment prior to and 30 days after their first prescription (Index claim). Outcomes were identified using diagnoses /procedure codes indicating esophageal or upper airway obstruction events. Medical records were reviewed for members with claims-based outcomes within 0 or 1 day of the Index Date (date on Index Claim) to validate case status and obtain information on other potential risk factors/previous history of esophageal disorders.POPULATION STUDIED: Commercial and Medicare members enrolled in 12 UnitedHealth Group-affiliated managed care plans.PRINCIPAL FINDINGS: There were 233,901 users and 432,387 prescriptions (3.1 prescriptions on average per user) for all three formulations combined, with 61% (142,587) female and 39% (91,314) male. The highest proportion of users was in control group 2 (137,585; 59%), followed by control group 1 (61,090; 26%) and the exposed group (35,226; 15%). Claims analysis identified 245 potential cases of esophageal/upper-airway obstruction occurring within 30 days after the Index Date: 42 in the exposed group; 49 in control group 1; and 154 in control group 2. Incidence rates were calculated for shorter time intervals after the Index Date. Comparison of rates across the three study groups showed marginally significant differences only for events occurring on the same day as the Index Date [Incidence rates per 10,000: 1.4, 5 cases (exposed group); 0.3, 2 cases (control group 2); 0.1, 1 case (control group 1)]. Medical record review of 15 presumptive cases that occurred on or one day after the Index Date confirmed only one true case. It is noteworthy that the one confirmed true case was from the exposed group while no true cases were found in either control group.CONCLUSIONS: This study found no evidence of a statistically significant relationship between use of Claritin-D 24 Hour and esophageal/upper airway obstruction events. However, given that the outcome event is not easily identified by diagnosis or procedure codes, medical chart reviews of a larger number of cases may provide better evidence of the true association.IMPLICATIONS FOR POLICY, DELIVERY, OR PRACTICE: The risk of esophageal obstruction associated with the use of an anti-allergy medication (claritin-d 24 hour).PRIMARY FUNDING SOURCE: This research was supported by US FDA Cooperative Agreement Number FD-U-1001643-01. 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
Publication Types:
Keywords:
- Airway Obstruction
- Asthma
- Ephedrine
- Esophageal Diseases
- Esophageal Neoplasms
- Female
- Hypersensitivity
- Hypersensitivity, Immediate
- Incidence
- Loratadine
- Male
- Medical Records
- Rhinitis, Allergic, Seasonal
- Risk Factors
- United States
- utilization
- hsrmtgs
Other ID:
UI: 102273456
From Meeting Abstracts