Enderlein E, Meller S, Rieker J, Ruzicka T, Homey B
Hautklinik, Heinrich-Heine-Universität Düsseldorf.
Hautarzt. 2005 Oct;56(10):937-41. doi: 10.1007/s00105-005-1015-5.
Since their approval, topical calcineurin inhibitors have proven to be effective medications in the treatment of atopic eczema. On March 10, 2005, the Food and Drug Administration (FDA) followed the advice of the Pediatric Advisory Council and issued a "black box warning" for the use of Protopic (Tacrolimus) und Elidel (Pimecrolimus). This FDA alert has caused worldwide uncertainty among parents and patients. Several dermatological societies have issued critical position statements. This report reviews the existing information underlying the warning and places it into the context of current knowledge.
自获批以来,外用钙调神经磷酸酶抑制剂已被证明是治疗特应性皮炎的有效药物。2005年3月10日,美国食品药品监督管理局(FDA)采纳了儿科咨询委员会的建议,对普特彼(他克莫司)和爱宁达(吡美莫司)的使用发布了“黑框警告”。这一FDA警示在全球范围内引起了家长和患者的不安。多个皮肤科协会已发表了批评性的立场声明。本报告回顾了该警告背后的现有信息,并将其置于当前知识背景下进行考量。