Grünenthal GmbH, Aachen, Germany.
Adv Ther. 2018 Jan;35(1):12-30. doi: 10.1007/s12325-017-0654-0. Epub 2017 Dec 21.
Tapentadol is a centrally acting analgesic that has been available for the management of acute and chronic pain in routine clinical practice since 2009.
This is the first integrated descriptive analysis of post-marketing safety data following the use of tapentadol in a broad range of pain conditions relating to the topics overall safety, dose administration above approved dosages, administration during pregnancy, serotonin syndrome, respiratory depression, and convulsion. The data analyzed pertain to spontaneous reports from healthcare and non-healthcare professionals and were put in the context of safety information known from interventional and non-interventional trials.
The first years of routine clinical practice experience with tapentadol have confirmed the tolerability profile that emerged from the clinical trials. Moreover, the reporting of expected side effects such as respiratory depression and convulsion was low and no major risks were identified. The evaluation of available post-marketing data did not confirm the theoretical risk of serotonin syndrome nor did it reveal unexpected side effects with administration of higher than recommended doses.
More than 8 years after its first introduction, the favorable overall safety profile of tapentadol in the treatment of various pain conditions is maintained in the general population.
Grünenthal GmbH.
盐酸他喷他多是一种中枢作用镇痛药，自 2009 年以来，已在常规临床实践中用于治疗急性和慢性疼痛。
这是首次对盐酸他喷他多在广泛的与总体安全性、批准剂量以上的剂量管理、妊娠期间使用、血清素综合征、呼吸抑制和惊厥相关的疼痛状况的上市后安全性数据进行综合描述性分析。分析的数据来源于医疗保健和非医疗保健专业人员的自发报告，并结合了来自干预性和非干预性试验的安全性信息。
盐酸他喷他多在常规临床实践的最初几年证实了从临床试验中得出的可耐受性特征。此外，报告的预期副作用（如呼吸抑制和惊厥）发生率较低，未发现任何重大风险。对现有上市后数据的评估并未证实理论上的血清素综合征风险，也未发现高于推荐剂量给药时出现意外的副作用。
在首次引入 8 年多后，盐酸他喷他多在治疗各种疼痛状况的总体安全性良好，这一情况在普通人群中得到维持。
Grünenthal GmbH。
