Discrepancies in Liver Disease Labeling in the Package Inserts of Commonly Prescribed Medications

Bjõrnsson, Einar; Jacobsen, E; Einarsdóttir, Rannveig; Chalasani, Naga

doi:10.1053/j.gastro.2014.12.007

Cited by 14 publications

(16 citation statements)

References 8 publications

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“…The first aid is represented by the product information or summary of the product characteristics (in United States and Europe, respectively), which however is variable in terms of details and may also substantially differ in the labeling of liver risk[14]. The key information to be checked is the existence of contraindications in patients with pre-existing liver diseases and the presence of specific warnings on the risk of liver damage, with relevant precautions in appropriate monitoring and management.…”

Section: Suspecting and Diagnosing Dili: A Current Dilemmamentioning

confidence: 99%

Drug-induced liver injury: Towards early prediction and risk stratification

Raschi

Ponti

2017

WJH

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Drug-induced liver injury (DILI) is a hot topic for clinicians, academia, drug companies and regulators, as shown by the steadily increasing number of publications and agents listed as causing liver damage (http://livertox.nih.gov/). As it was the case in the past decade with drug-induced QT prolongation/arrhythmia, there is an urgent unmet clinical need to develop tools for risk assessment and stratification in clinical practice and, in parallel, to improve prediction of pre-clinical models to support regulatory steps and facilitate early detection of liver-specific adverse drug events. Although drug discontinuation and therapy reconciliation still remain the mainstay in patient management to minimize occurrence of DILI, especially acute liver failure events, different multidisciplinary attempts have been proposed in 2016 to predict and assess drug-related risk in individual patients; these promising, albeit preliminary, results strongly support the need to pursue this innovative pathway.

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Section: Suspecting and Diagnosing Dili: A Current Dilemmamentioning

confidence: 99%

Drug-induced liver injury: Towards early prediction and risk stratification

Raschi

Ponti

2017

WJH

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“…Product labels (i.e., package inserts) provide some guidance as a part of the prescribing information, but they can be misleading or insufficient and focus largely on the frequency of serum enzyme elevations during therapy . In contrast, clinically significant liver injury from currently available medications is rare, and its frequency and clinical features are not reliably reported in product labels or in general reviews on the efficacy and safety of medications. Most instances of severe hepatotoxicity are first described after the medication is marketed and may be listed in the product label as a post‐marketing reported adverse event of unclear significance or relationship to the drug.…”

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confidence: 99%

Categorization of drugs implicated in causing liver injury: Critical assessment based on published case reports

2015

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An important element in assessing causality in drug-induced liver injury is whether the implicated agent is known to cause hepatotoxicity. We classified drugs into categories based on the number of published reports of convincingly documented, clinically apparent, idiosyncratic liver injury. Drugs described in the website LiverTox (http:// livertox.nih.gov) were classified into five categories based on the number of published cases (category A, 50; category B, 12-49; category C, 4-11; category D, 1-3; category E, none). Case reports in categories C and D were individually reanalyzed using the Roussel Uclaf Causality Assessment Method. Drugs with fatal cases or with rechallenge were noted. Among 671 individual drugs or closely related agents, 353 (53%) were considered convincingly linked to liver injury in published case reports; 48 (13%) were assigned to category A, 76 (22%) were assigned to category B, 96 (27%) were assigned to category C, and 126 (36%) were assigned to category D. Another 7 (2%) were direct hepatotoxins but only in high doses and placed in a separate category (T). The remaining 318 (47%) drugs had no convincing case report of hepatoxicity in the literature (category E). All except one in category A have been available since 1999, 98% had at least one fatal case and 89% a positive rechallenge. In category B, 54% had a fatal case and 41% a rechallenge. Drugs in categories C and D less frequently had instances of fatal (23% and 7%) or rechallenge cases (26% and 11%). Conclusion: Documentation of hepatoxicity in the medical literature is variable, and many published instances do not stand up to critical review. A standardized system for categorizing drugs for hepatotoxicity potential will help develop objective and reliable, computer-based instruments for assessing causality in drug-induced liver injury. (HEPATOLOGY 2016;63:590-603)

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“…In any case, females have been predominately identified in many registries[71,76-79]. As mentioned above, much research has focused on genome-wide studies[114-116,124], and this is an area where we should be focusing our future attention. Environmental factors are poorly understood, with no definitive studies linking diet, or alcohol and coffee consumption to increased DILI risk, again illustrating a need for answers.…”

Section: Risk Factors and Natural Progression Of Dilimentioning

confidence: 99%

“…Liver injury may be caused by most drugs, and labels often carry a warning to lower the dose in the setting of CLD[124], however, there is little evidence to support this reducing the risk for DILI[130]. As such, liver enzyme monitoring has been proposed as an option in all drugs with a high risk of hepatotoxicity[131].…”

Section: Prevention and Treatment Optionsmentioning

confidence: 99%

Drug-induced liver injury: Do we know everything?

Alempijević

Zec

Milosavljević

2017

WJH

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Interest in drug-induced liver injury (DILI) has dramatically increased over the past decade, and it has become a hot topic for clinicians, academics, pharmaceutical companies and regulatory bodies. By investigating the current state of the art, the latest scientific findings, controversies, and guidelines, this review will attempt to answer the question: Do we know everything? Since the first descriptions of hepatotoxicity over 70 years ago, more than 1000 drugs have been identified to date, however, much of our knowledge of diagnostic and pathophysiologic principles remains unchanged. Clinically ranging from asymptomatic transaminitis and acute or chronic hepatitis, to acute liver failure, DILI remains a leading causes of emergent liver transplant. The consumption of unregulated herbal and dietary supplements has introduced new challenges in epidemiological assessment and clinician management. As such, numerous registries have been created, including the United States Drug-Induced Liver Injury Network, to further our understanding of all aspects of DILI. The launch of LiverTox and other online hepatotoxicity resources has increased our awareness of DILI. In 2013, the first guidelines for the diagnosis and management of DILI, were offered by the Practice Parameters Committee of the American College of Gastroenterology, and along with the identification of risk factors and predictors of injury, novel mechanisms of injury, refined causality assessment tools, and targeted treatment options have come to define the current state of the art, however, gaps in our knowledge still undoubtedly remain.

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Discrepancies in Liver Disease Labeling in the Package Inserts of Commonly Prescribed Medications

Cited by 14 publications

References 8 publications

Drug-induced liver injury: Towards early prediction and risk stratification

Drug-induced liver injury: Towards early prediction and risk stratification

Categorization of drugs implicated in causing liver injury: Critical assessment based on published case reports

Drug-induced liver injury: Do we know everything?

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