Adverse drug reaction: pomalidomide-induced liver injury

Ward, Stephen; Yum, Kendra; Abramovitz, Rebecca B; Isola, Luis; Jagannath, Sundar; Parekh, Samir

doi:10.1016/s0140-6736(14)61030-8

Cited by 11 publications

(2 citation statements)

References 5 publications

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“…Among the first detected hepatotoxins in 2014, we selected the first post-marketing report by pomalidomide, the latest immunomodulating drugs approved by the FDA for multiple myeloma. The causal association was based on the temporal association with drug exposure and the exclusion of other causes [41] . Notably, DILI occurred despite dose titration and monitoring of liver function.…”

Section: Spontaneous Reporting Systems and Case Series/reportsmentioning

confidence: 99%

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

Raschi

Ponti

2015

WJH

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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.

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Section: Spontaneous Reporting Systems and Case Series/reportsmentioning

confidence: 99%

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

Raschi

Ponti

2015

WJH

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“…lesions [7], de novo or recurrent viral hepatitis [8], de novo or recurrent autoimmune disease [9], and drug toxicity [10]. The pathogenesis of chronic liver allograft dysfunction has not been fully elucidated.…”

Section: Introductionmentioning

confidence: 99%