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The American Journal of Managed Care September 2013
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FDA Warning and Removal of Rosiglitazone From VA National Formulary
Sherrie L. Aspinall, PharmD, MSc; Xinhua Zhao, PhD; Chester B. Good, MD, MPH; Roslyn A. Stone, PhD; Kenneth J. Smith, MD, MS; and Francesca E. Cunningham, PharmD
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FDA Warning and Removal of Rosiglitazone From VA National Formulary

Sherrie L. Aspinall, PharmD, MSc; Xinhua Zhao, PhD; Chester B. Good, MD, MPH; Roslyn A. Stone, PhD; Kenneth J. Smith, MD, MS; and Francesca E. Cunningham, PharmD
After the FDA warning and removal of rosiglitazone from the VA National Formulary, glucose control may have declined among those discontinuing rosiglitazone without receiving replacement medication.
Although we followed a large patient cohort over time and comprehensively assessed medication data, the study has limitations. Most importantly, the project was observational and uncontrolled. However, these types of safety warnings and policy changes will not allow a controlled intervention study. Second, we may have overestimated the discontinuation rate if patients obtained rosiglitazone outside the VA system. This probably occurred infrequently because providers could switch their patients to pioglitazone without completing a nonformulary request, and rosiglitazone is only available as a brand medication, so the copay is likely higher outside the VA system. Third, the relative effect of the FDA warning may have been underestimated if the rosiglitazone discontinuation rate was increasing prior to April 1, 2007. In our data, the rate was essentially unchanged in April and May, and in the study by Starner and colleagues,11 the average number of rosiglitazone claims per day per 1 million members was stable in January through April 2007. Rosiglitazone use started to decline in May 2007, the month of the FDA warning.11

Fourth, we probably underestimated the proportion of patients categorized as receiving rosiglitazone as a second- or third-line medication. Patients with a previous adverse event or contraindication to metformin or a sulfonylurea would be misclassified as receiving rosiglitazone as a first- or second-line agent. We were not able to obtain this information using administrative databases; however, were such patients categorizedcorrectly, the discontinuation rate among those receiving rosiglitazone as first- or second-line therapy would have been even higher. Fifth, we could not assess insulin doses because the directions are not always updated when a change is made, so we did not know whether the dose was increased after rosiglitazone was stopped. Sixth, we did not know whether other medications were eventually added or changed in those with poor glucose control because we assessed medication changes within a relatively short time frame (60 days after the end of the days of supply of the last rosiglitazone prescription). Finally, we did not assess the long-term effects of this intervention because our follow-up ended in June 2008.

CONCLUSIONS

In conclusion, the rosiglitazone discontinuation rate increased following the FDA warning about a potential increased risk of MI and increased still more following its removal from the VANF. Glucose control may have declined among those who discontinued rosiglitazone without receiving another antidiabetic agent in its place.

Author Affiliations: From VA Center for Medication Safety (SLA, XZ, CBG, FEC), Hines, IL; Center for Health Equity Research and Promotion (SLA, XZ, CBG, RAS), VA Pittsburgh Healthcare System, Pittsburgh, PA; University of Pittsburgh School of Pharmacy (SLA, CBG), Pittsburgh, PA; University of Pittsburgh School of Medicine (CGB), Pittsburgh, PA; University of Pittsburgh Graduate School of Public Health (RAS), Pittsburgh, PA; Division of Clinical Modeling and Decision Sciences (KJS), University of Pittsburgh, Pittsburgh, PA.

Funding Source: There was no funding for this project.

Author Disclosures: The authors (SLA, XZ, CBG, RAS, KJS, FEC) report no relationship or financial interest with any entity that would pose a conflict of interest with the subject matter of this article.

Authorship Information: Concept and design (SLA, XZ, CBG, RAS, KJS, FEC); acquisition of data (FEC); analysis and  interpretation of data (SLA, XZ, CBG, RAS); drafting of the manuscript (SLA, CBG, RAS); critical revision of the manuscript for important intellectual content (SLA, XZ, CBG, RAS, KJS, FEC); statistical analysis (XZ, RAS); administrative, technical, or logistic support (KJS, FEC); and supervision (KJS).

Address correspondence to: Sherrie L. Aspinall, PharmD, MSc, Center for Health Equity Research and Promotion, VA Pittsburgh Healthcare System, 7180 Highland Drive (151C-H), Pittsburgh, PA 15206. E-mail: sherrie .aspinall@va.gov.
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