Abe Andrew M, Hein Darren J, Gregory Philip J
Andrew M. Abe, Pharm.D., is Assistant Professor, Pharmacy Practice, and Drug Information Specialist, School of Pharmacy, The University of Kansas, Lawrence. Darren J. Hein, Pharm.D., is Assistant Professor, Pharmacy Practice; and Philip J. Gregory, Pharm.D., M.S., FACN, is Associate Professor, Pharmacy Practice, Center for Drug Information and Evidence-Based Practice, School of Pharmacy and Health Professions, Creighton University, Omaha, NE.
Am J Health Syst Pharm. 2015 Jun 1;72(11):966-71. doi: 10.2146/ajhp140574.
Dietary supplement regulatory alerts published by the Food and Drug Administration (FDA) and Health Canada were evaluated and characterized.
FDA MedWatch and Health Canada websites were reviewed to identify regulatory alerts regarding dietary supplements from January 1, 2005, through December 31, 2013. Alerts were analyzed to identify product characteristics that may be predictive of product quality issues and potential patient harm.
A total of 1560 dietary supplement-related regulatory alerts were identified. Of those, 1287 (83%) were identified through Health Canada, and 273 (18%) were identified through FDA MedWatch. The country of origin of dietary supplements associated with regulatory alerts was not provided in most regulatory alerts; however, when their origin was provided, the United States was the most common. Dietary supplements intended for sexual enhancement were the subject of 33% of all regulatory alerts identified. Products purchased online were the most likely to be associated with a regulatory alert. Dietary supplements intended for sexual enhancement, weight loss, and bodybuilding or athletic performance appeared to pose the greatest risk for patient harm due to product contamination with a pharmaceutical such as a phosphodiesterase-5 inhibitor or sibutramine.
Analysis of Canadian and U.S. regulatory alerts concerning dietary supplements revealed that more than 80% of the composite alerts were issued by Health Canada. The most common intended uses of supplements for which alerts were issued were sexual enhancement, weight loss, and bodybuilding or athletic performance. The most common reason for alerts was the presence of a pharmaceutical contaminant.
对美国食品药品监督管理局（FDA）和加拿大卫生部发布的膳食补充剂监管警示进行评估和特征描述。
查阅FDA MedWatch和加拿大卫生部网站，以确定2005年1月1日至2013年12月31日期间有关膳食补充剂的监管警示。对警示进行分析，以确定可能预示产品质量问题和潜在患者伤害的产品特征。
共识别出1560条与膳食补充剂相关的监管警示。其中，1287条（83%）通过加拿大卫生部识别，273条（18%）通过FDA MedWatch识别。大多数监管警示未提供与监管警示相关的膳食补充剂的原产国；然而，当提供其原产国时，美国是最常见的。用于性增强的膳食补充剂是所有识别出的监管警示的33%的主题。网上购买的产品最有可能与监管警示相关。由于产品被磷酸二酯酶-5抑制剂或西布曲明等药物污染，用于性增强、减肥以及健美或运动表现的膳食补充剂似乎对患者造成伤害的风险最大。
对加拿大和美国有关膳食补充剂的监管警示的分析表明，超过80%的综合警示由加拿大卫生部发布。发布警示的补充剂最常见的预期用途是性增强、减肥以及健美或运动表现。警示的最常见原因是存在药物污染物。
