Drug- and herb-induced liver injury: Progress, current challenges and emerging signals of post-marketing risk

Abstract

Drug-induced liver injury (DILI) and herb-induced liver injury is a hot topic for clinicians, academia, drug companies and regulators, as shown by the steadily increasing number of publications in the past 15 years. This review will first provide clues for clinicians to suspect idiosyncratic (unpredictable) DILI and succeed in diagnosis. Causality assessment remains challenging and requires careful medical history as well as awareness of multifaceted aspects, especially for herbs. Drug discontinuation and therapy reconciliation remain the mainstay in patent's management to minimize occurrence of acute liver failure. The second section will address novel agents associated with liver injury in 2014 (referred to as "signals"), especially in terms of clinical, research and drug development implications. Insights will be provided into recent trends by highlighting the contribution of different post-marketing data, especially registries and spontaneous reporting systems. This literature scrutiny suggests: (1) the importance of post-marketing databases as tools of clinical evidence to detect signals of DILI risk; and (2) the need for joining efforts in improving predictivity of pre-clinical assays, continuing post-marketing surveillance and design ad hoc post-authorization safety studies. In this context, ongoing European/United States research consortia and novel pharmaco-epidemiological tools (e.g., specialist prescription event monitoring) will support innovation in this field. Direct oral anticoagulants and herbal/dietary supplements appear as key research priorities.

Food Sustainability Challenges in the Developing World

“…In many instances, especially in countries where stringent rules are not imposed, the safety and quality of products can be highly compromised, thus undermining the sustainability agenda. A wealth of literature is available on the risks associated with health supplements (Raschi and De Ponti 2015;Reid et al 2015;Wallace 2015;Willers et al 2014). In fact, a set of regulations on dietary supplements has been proposed by the US Food and Drug Administration (2015), which should be of immense practical help.…”

A Case Report of Liver and Renal Function Changes in Stroke Patients Taking Long-term Herbal Medicine

“…Figure 3 depicts a variety of theories related to the pathogenesis of HILI. The overlap is mostly with those for DILI in host, herb-drug supplements (HDS), and environment factors [16,51]. Up to date, a large portion of medicines used in developing countries are herb drugs.…”

Research Advances on Hepatotoxicity of Herbal Medicines in China

“… Figure 3 depicts a variety of theories related to the pathogenesis of HILI. The overlap is mostly with those for DILI in host, herb-drug supplements (HDS), and environment factors [16, 51]. …”