Clinical consequences of disseminating the rosiglitazone FDA safety warning.

Background: On May 21, 2007, a safety alert was widely disseminated through the media and US Food and Drug Administration (FDA) MedWatch concerning a possible increased risk of ischemic myocardial infarction and cardiovascular death in people receiving the antidiabetic drug rosiglitazone.

Objective: To determine whether notification of patients and providers about an FDA safety warning influenced the decision to discontinue rosiglitazone therapy and the resulting effect on glycemic control.

Study Design: Retrospective electronic medical record (EMR) review.

Methods: EMR documentation review of 552 primary care patients with a prescription for rosiglitazone current on May 21, 2007, was conducted to determine the percentage that had rosiglitazone discontinued as a result of written notification about the FDA alert. We ascertained whether discontinuation was initiated by the physician or patient. We compared the change in glycosylated hemoglobin (A1C) values from baseline to follow-up between the group continuing on rosiglitazone and the group discontinuing therapy.

Results: Of 552 patients, 344 (62%) had rosiglitazone discontinued as a result of the warning. Discontinuation was initiated by the physician in 150 cases (43.6%), by the patient in 155 cases (45.1%), and was undetermined in 39 cases (11.3%). No significant difference was found in the mean change in A1C values from baseline to follow-up between the 2 groups.

Conclusions: Notifying patients and providers about FDA safety alerts does influence clinical decision making. The lay media should partner with the FDA to responsibly communicate drug safety information in evidence-based, understandable terms that quantify real risk.