Bennett Charles L, Adegboro Olatokunbo S, Calhoun Elizabeth A, Raisch Dennis
Jesse Brown VA Medical Center, Chicago, IL, USA;
Drug Healthc Patient Saf. 2010;2:1-5. doi: 10.2147/dhps.s6548. Epub 2010 Feb 16.
Drug- and device-associated hypersensitivity reactions are serious toxicities that can result in respiratory failure or acute cardiac ischemic events, or even severe hypersensitivity syndromes such as Stevens-Johnson syndrome. These toxicities are usually poorly described in the "black box" warnings section of the product labels.
Adverse event reports contained in databases maintained by the Project on Medical Research on Adverse Drug Events and Reports (Med-RADAR), product labels, safety advisories disseminated by pharmaceutical manufacturers, the Food and Drug Administration (FDA), and the Centers for Disease Control and Prevention (CDC) were reviewed.
Adverse event reports identified three health care workers who developed nevirapine-associated Stevens-Johnson syndrome following occupational exposure to HIV-infected blood or blood products; four persons with localized hypersensitivity and fatal cardiac events associated with rapamycin- or paclitaxel-coated coronary artery stent placements; and six persons with breast cancer who developed severe or fatal anaphylaxis after receiving adjuvant chemotherapy with Cremophor-EL containing paclitaxel. Safety advisories from the FDA, CDC, and the relevant pharmaceutical manufacturers were ambiguous in their description in "black box" warning sections of package inserts describing these serious and potentially fatal toxicities.
Improvements are needed in pharmacovigilance and subsequent dissemination of safety advisories for drug/device-associated hypersensitivity reactions.
药物和器械相关的过敏反应是严重的毒性反应，可导致呼吸衰竭或急性心脏缺血事件，甚至引发严重的过敏综合征，如史蒂文斯-约翰逊综合征。这些毒性反应在产品标签的“黑框”警告部分通常描述得很简略。
对药物不良事件医学研究项目（Med-RADAR）维护的数据库中包含的不良事件报告、产品标签、制药商发布的安全建议、美国食品药品监督管理局（FDA）以及疾病控制与预防中心（CDC）的相关内容进行了审查。
不良事件报告中发现，有三名医护人员在职业暴露于感染艾滋病毒的血液或血液制品后出现了与奈韦拉平相关的史蒂文斯-约翰逊综合征；有四人在接受雷帕霉素或紫杉醇涂层冠状动脉支架植入术后出现局部过敏反应并发生致命心脏事件；有六名乳腺癌患者在接受含紫杉醇的聚氧乙烯蓖麻油（Cremophor-EL）辅助化疗后出现严重或致命过敏反应。FDA、CDC以及相关制药商发布的安全建议在包装说明书的“黑框”警告部分对这些严重且可能致命的毒性反应描述含糊不清。
在药物/器械相关过敏反应的药物警戒及后续安全建议传播方面需要改进。
