The risk of esophageal obstruction associated with an anti-allergy medication (Claritin-D 24-Hour--original formulation).

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.

Incidence of idiopathic acute liver failure and hospitalized liver injury in patients treated with troglitazone.

OBJECTIVE: Troglitazone, a thiazolidinedione antidiabetic agent, was withdrawn from the U.S. market in March, 2000, after 94 cases of acute liver failure (ALF) were reported with its use. Based on a literature review, the estimated background rate of hospitalization for idiopathic acute liver injury is 22 per million person-years and for idiopathic ALF, less than 1 per million person-years. This study was conducted to estimate the incidence rates of hospitalized idiopathic acute liver injury and ALF among troglitazone-treated patients. METHODS: An observational retrospective inception cohort of patients treated with troglitazone was assembled using claims data from a large multistate health care organization. Patients with at least 90 days of health plan enrollment before their first troglitazone prescription between April, 1997 and December, 1998 were enrolled. Hospitalized cases of potential troglitazone-induced acute liver injury or ALF were identified from claims data based on International Classification of Diseases, 9th Revision, coding. Primary medical records were reviewed for case validation, and incidence rates of acute liver injury were calculated using person-years of troglitazone exposure as the denominator. RESULTS: A total of 7568 patients contributed 4020 person-years of troglitazone exposure. Of these, five were hospitalized with acute liver injury attributed to the drug and not explained by other causes. Incidence rates (95% CI) per million person-years of acute idiopathic liver injury were as follows: hospitalization (n = 5), 1244 (404, 2900); hospitalized jaundice (n = 4), 995 (271, 2546); and ALF (n = 1), 240 (6.3, 1385). CONCLUSIONS: Troglitazone use was associated with a marked increase in risk of hospitalized acute idiopathic liver injury and ALF.

A study of compliance with FDA recommendations for pemoline (Cylert).

OBJECTIVE: To assess compliance with product labeling recommendations to use pemoline as second-line therapy for attention-deficit/hyperactivity disorder (ADHD) and to obtain baseline and biweekly liver enzyme tests. METHOD: Retrospective cohort study using administrative claims data to identify first-line therapies and liver enzyme tests among pemoline users between January 1, 1998, and March 31, 2000. Prescriptions for first-line therapy were searched for 90 days prior to the first pemoline claim. Liver enzyme testing (baseline and follow-up) was compared between two groups (the prerecommendation cohort October 1,1998, to March 31, 1999, and the postrecommendation cohort October 1,1999, to March 31,2000). RESULTS: 1,308 patients received at least one pemoline prescription during the study period; 76% of patients < or = 20 years were male. ADHD was the claims-identified indication for 688 patients (52%). Despite the labeling recommendation for use as second-line therapy, only 237 ADHD patients (34%) received a first-line therapy prior to pemoline. Only 12% and 11% of the pre- and post-cohort patients, respectively, received baseline liver enzyme tests; 9% in the pre- and 12% in the post-cohort received at least one liver enzyme follow-up test. CONCLUSIONS: Compliance with product labeling was low for both recommendations. Understanding the reasons for this finding could help improve risk management strategies.

Ambulatory use of psychotropics by employer-insured children and adolescents in a national managed care organization.

OBJECTIVE: To provide a description of the ambulatory use of psychotropic medications by children and adolescents in a large, geographically diverse employer-insured population. DESIGN: This retrospective observational study used administrative claims data for 1995-1999 for members under age 20 in 6 Independent Practice Association health plans affiliated with UnitedHealth Group. We calculated the prevalences of use for 4 major therapeutic drug classes: central nervous system stimulants (CNSSs), selective serotonin reuptake inhibitors (SSRIs), tricyclic antidepressants (TCAs), and other antidepressants (OADs). Changes over time by age, gender, geographic region, and prescriber specialty were analyzed across drug classes. RESULTS: The prevalence of CNSS, SSRI, and OAD use steadily increased over the 5-year period, whereas TCA use decreased. The prevalence of use of the most commonly used classes, the CNSS and SSRI classes, increased from 23.8 to 30.0 per 1000 and 7.9 to 12.8, respectively. There was variability across and within geographic regions. Pediatricians were the most frequent first prescribers of CNSS, and psychiatrists were most likely to prescribe SSRIs. CONCLUSION: Acceleration of use of psychotropic medications is slower in an employer-insured national population. Since primary care physicians are frequent prescribers of psychotropics, their training and expertise are crucial.