CHRU-Nancy, Department of Clinical Pharmacology, Toxicology and Pharmacovigilance, Regional University Hospital of Nancy, Université de Lorraine, Nancy, France.
Université de Lorraine, CNRS, IMoPA, Nancy, France.
Fundam Clin Pharmacol. 2021 Oct;35(5):792-807. doi: 10.1111/fcp.12653. Epub 2021 Mar 8.
Worldwide, the consumption of dietary supplements for the enhancement of sexual performance is common. Consumers are generally fond of these products because they often want to avoid drugs, preferring "natural" than "chemical" solutions. This is challenging, as many of these supplements labelled "herbal" or "natural" are actually adulterated with drugs, mainly phosphodiesterase-5 inhibitors. This phenomenon is facilitated by fewer demanding regulations for marketing supplements. Thus, consumers may be widely exposed to serious adverse events, such as acute liver injury, kidney failure, pulmonary embolism, stroke or even death. We aim to warn physicians about this issue. This multidisciplinary review simultaneously deals with clinical consequences of this phenomenon, analytical toxicology and regulation. Indeed, after outlining this worldwide issue and highlighting that a drug-adulterated dietary supplement is actually a falsified drug, we discuss its main contributing factors. Then, we describe some examples of adverse events of which a case of sildenafil-tadalafil-induced ischaemic stroke that benefited medical care in our hospital. Furthermore, we present some means to avoid adulteration and discuss their limitations that may be explained by the heterogeneity of the regulation of dietary supplements between countries. Doing so, we point out the requirement of a global harmonization of this regulation for an efficient eradication of this public health threat. Meanwhile, dietary supplements should be considered adulterated until proven otherwise. Thus, we encourage physicians to investigate these products in the drug histories of their patients, especially when clinical conditions cannot be explained by classical aetiologies.
在全球范围内，人们普遍使用膳食补充剂来增强性功能。消费者通常喜欢这些产品，因为他们更倾向于选择“天然”而非“化学”解决方案，避免使用药物。然而，这一做法存在挑战，因为许多标有“草本”或“天然”标签的补充剂实际上都掺杂了药物，主要是磷酸二酯酶-5 抑制剂。由于对补充剂营销的监管要求较低，这种现象更加普遍。因此，消费者可能会广泛接触到严重的不良事件，如急性肝损伤、肾衰竭、肺栓塞、中风甚至死亡。我们旨在就这一问题向医生发出警告。本文是一次多学科的综述，同时涉及了这一现象的临床后果、分析毒理学和监管问题。实际上，在概述了这一全球性问题并强调了掺杂药物的膳食补充剂实际上是一种伪造药物之后，我们讨论了其主要的促成因素。然后，我们描述了一些不良事件的例子，包括我们医院一起西地那非-他达拉非引起的缺血性中风病例，该病例得益于医疗护理。此外，我们还介绍了一些避免掺杂的方法，并讨论了其局限性，这些局限性可能是由于各国对膳食补充剂监管的异质性造成的。通过这样做，我们指出了需要对这一监管进行全球协调，以有效消除这一公共卫生威胁。同时，应将膳食补充剂视为掺杂药物，除非有相反证据。因此，我们鼓励医生在患者的药物史中调查这些产品，特别是当临床情况无法用经典病因解释时。
