Effects of safety warnings and risk management plan for Thiazolidinediones in Taiwan.

View Abstract

PURPOSE

To evaluate changes in thiazolidinedione use and quality of prescription following safety warnings for thiazolidinediones and cardiac risk in 2007, Risk Management Plan (RMP) policy for rosiglitazone in 2010, and warning for pioglitazone and bladder cancer risk in 2010 in Taiwan.

METHODS

We obtained 2003-2011 claims data from Taiwan's National Health Insurance Research Database. Using an interrupted time series design and segmented regression, we estimated changes in monthly prescribing rates for thiazolidinediones among all and prevalent diabetes patients with and without cardiovascular disease history (CV history). We also compared time to prescription of thiazolidinediones among new diabetes patients with CV history before and after each regulatory action using survival analysis.

RESULTS

Among prevalent patients with and without CV history, the prescribing rates of rosiglitazone decreased 36.88% and 28.92% after safety warnings in 2007 respectively. Pioglitazone prescriptions increased 13% among patients with CV history, but no changes were detected among patients without CV history. After rosiglitazone's RMP policy in 2010, large reductions in prescriptions were observed in patients with CV history (-101.67%) and those without CV history (-88.04%). Among new diabetes patients with CV history, cardiac safety warnings in 2007 significantly delayed the prescription of rosiglitazone, but no significant change was found for pioglitazone.

CONCLUSIONS

The Taiwan FDA regulatory actions for thiazolidinediones communicated possible risks of cardiac events and bladder cancer. Different safety regulatory actions had differential impacts on the use of rosiglitazone and pioglitazone and the quality use of these drugs among the high-risk patients.

Abbreviation
Pharmacoepidemiol Drug Saf
Publication Date
2015-08-06
Volume
24
Issue
10
Page Numbers
1026-35
Pubmed ID
26251229
Medium
Print-Electronic
Full Title
Effects of safety warnings and risk management plan for Thiazolidinediones in Taiwan.
Authors
Hsu JC, Cheng CL, Ross-Degnan D, Wagner AK, Zhang F, Kao Yang YH, Liu LL, Tai HY, Chen KH, Yang PW, Lu CY