Healthy Skepticism Library item: 16363

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Publication type: Journal Article

Wilkinson JJ, Force RW, Cady PS.
Impact of safety warnings on drug utilization: marketplace life span of cisapride and troglitazone.
Pharmacotherapy 2004 Aug; 24:(8):978-86
http://www.ncbi.nlm.nih.gov/pubmed/15338846

Abstract:

STUDY OBJECTIVE: To evaluate the impact of safety alerts on the volume of cisapride and troglitazone usage. DESIGN: Retrospective database analysis. SETTING: University research center. MATERIAL: Idaho Medicaid claims data from January 1994—July 2000. MEASUREMENTS AND MAIN RESULTS: Monthly counts of total and new prescriptions filled for cisapride and troglitazone were analyzed graphically over time as a function of all prescriptions. New prescriptions were defined as those filled by patients who had not received the drug within the previous year. A binomial comparison of the 5 months before and after each safety alert was conducted by Poisson distribution. Overall and new cisapride usage increased after the first alert, which occurred in February 1995 (p<0.05). After the second alert, in September 1995, growth in new prescriptions ended but total prescriptions continued to grow (p<0.05). After the third alert, in June 1998, growth in total use ended and the number of new prescriptions declined (p<0.05). The final two alerts (June 1999 and January 2000) were met with significant declines (p<0.05 for both). Troglitazone was the subject of two alerts in October and December 1997. After these, overall usage increased (p<0.05), whereas the number o new prescriptions decreased (p<0.05). The third alert, in July 1998, caused no change as total prescription use continued to grow (p<0.05), whereas the number of new prescriptions decreased (p<0.05). A fourth alert, in June 1999, resulted in a decrease of overall usage and new prescriptions (p<0.05 for both). CONCLUSION: Numerous safety alerts were required for each drug before drug usage declined. The decline in overall use was slower than the decline in new prescriptions, possibly indicating a need for increased assessment of refilled prescriptions after the release of new safety data.

Keywords:
Chromans/adverse effects*nCisapride/adverse effects*nDatabases, FactualnDrug Labeling*nGastrointestinal Agents/adverse effects*nHumansnHypoglycemic Agents/adverse effects*nPharmacoepidemiologynProduct Surveillance, Postmarketing/methods*nRetrospective StudiesnThiazolidinediones/adverse effects*nUnited StatesnUnited States Food and Drug Administration*