School of Pharmacy, University of California, San Francisco, USA.
Am J Manag Care. 2010 May 1;16(5):e111-6.
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.
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.
Retrospective electronic medical record (EMR) review.
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.
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.
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.
2007 年 5 月 21 日，媒体和美国食品药品监督管理局（FDA）的 MedWatch 通过广泛传播安全警报，警告人们使用抗糖尿病药物罗格列酮可能会增加缺血性心肌梗死和心血管死亡的风险。
确定 FDA 安全警告通知患者和医务人员是否会影响停止使用罗格列酮治疗的决定，以及对血糖控制的影响。
回顾性电子病历（EMR）审查。
对 552 名 2007 年 5 月 21 日正在使用罗格列酮的初级保健患者的 EMR 记录进行审查，以确定因 FDA 警告通知而停止使用罗格列酮的患者比例。我们确定了停药是由医生还是患者发起的。我们比较了继续使用罗格列酮组和停止治疗组的糖化血红蛋白（A1C）值从基线到随访的变化。
在 552 名患者中，有 344 名（62%）因该警告而停止使用罗格列酮。在 150 例（43.6%）中，停药是由医生发起的，在 155 例（45.1%）中是由患者发起的，在 39 例（11.3%）中原因不明。在继续使用罗格列酮组和停止治疗组之间，从基线到随访的 A1C 值的平均变化没有显著差异。
通知患者和医务人员关于 FDA 的安全警报确实会影响临床决策。大众媒体应与 FDA 合作，以负责任的方式以基于证据、易于理解的方式传达药物安全信息，并量化真实风险。
