title: Disparities in Discontinuing Rosiglitazone Following the 2007 FDA Safety Alert.
abstract: BACKGROUND
  Responsiveness to the Food and Drug Administration (FDA) rosiglitazone safety alert, issued on May 21, 2007, has not been examined among vulnerable subpopulations of the elderly.
  
  
  OBJECTIVE
  To compare time to discontinuation of rosiglitazone after the safety alert between black and white elderly persons, and across sociodemographic and economic subgroups.
  
  
  METHODS
  A cohort study.
  
  
  METHODS
  Medicare fee-for-service enrollees in 2007 who were established users of rosiglitazone identified from a 20% national sample of pharmacy claims.
  
  
  METHODS
  Outcome of interest was time to discontinuation of rosiglitazone after the May alert. We modeled the number of days following the warning to the end of the days' supply for the last rosiglitazone claim during the study period (May 21, 2007-December 31, 2007) using multivariable proportional hazards models.
  
  
  RESULTS
  More than 67% of enrollees discontinued rosiglitazone within six months of the advisory. In adjusted analysis, white enrollees (hazard ratio=0.90; 95% confidence interval, 0.86-0.94) discontinued rosiglitazone later than the comparison group of black enrollees. Enrollees with a history of low personal income also discontinued later than their comparison group (hazard ratio=0.84; 95% confidence interval, 0.81-0.87). There were no observed differences across quintiles of area-level socioeconomic status.
  
  
  CONCLUSIONS
  White race and a history of low personal income modestly predicted later discontinuation of rosiglitazone after the FDA's safety advisory in 2007. The impact of FDA advisories can vary among sociodemographic groups. Policymakers should continue to monitor whether risk management policies reach their intended populations.
authors.affiliation: *Department of Health Services, Policy & Practice, Brown University School of Public Health, Providence, RI †Optum Epidemiology, Waltham, MA.
authors.forename: Danya M
authors.initials: DM
authors.lastname: Qato
authors.forename: Amal N
authors.initials: AN
authors.lastname: Trivedi
authors.forename: Vincent
authors.initials: V
authors.lastname: Mor
authors.forename: David D
authors.initials: DD
authors.lastname: Dore
mesh_terms: D001741:Black or African American / Q000706:statistics & numerical data*; D000368:Aged; D000369:Aged, 80 and over; D015331:Cohort Studies; D005260:Female; D054625:Healthcare Disparities / Q000706:statistics & numerical data*; D006801:Humans; D007004:Hypoglycemic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D054524:Medicare Part D; D016016:Proportional Hazards Models; D000077154:Rosiglitazone; D056737:Safety-Based Drug Withdrawals / Q000706:statistics & numerical data*; D045162:Thiazolidinediones / Q000009:adverse effects / Q000627:therapeutic use*; D014481:United States; D014486:United States Food and Drug Administration; D044465:White People / Q000706:statistics & numerical data*; D016903:Drug Monitoring
chemical_list: D007004:Hypoglycemic Agents; D045162:Thiazolidinediones; D000077154:Rosiglitazone