Regulatory Actions on the Off-Label Use of Prescription Drugs: Ongoing Controversy and Contradiction in 2009 and 2010

Fairman, Kathleen A.; Curtiss, Frederic R.

doi:10.18553/jmcp.2010.16.8.629

Cited by 11 publications

(8 citation statements)

References 16 publications

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“…OLDU based on evidence obtained from controlled research trials is a useful medical tool. This case is an example of life-saving treatment with OLDU, and this drug was approved after approximately 2 years for thrombocytopenia due to chronic HCV infection [13]. Currently, eltrombopag is in use in adult patients with HCV with chronic HCV infection for the treatment of thrombocytopenia when the degree of thrombocytopenia severity should be considered while maintaining optimal interferon-based therapy [14].…”

Section: Discussionmentioning

confidence: 99%

Severe thrombocytopenia in a patient with hepatitis C treated with eltrombopag from off-label drug use to on-label drug use: a case report

et al. 2014

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IntroductionOff-label drug use refers to drug use beyond the specifications authorized for marketing. Eltrombopag is a new thrombopoietin receptor agonist which was used successfully in this critical case of thrombocytopenia associated with hepatitis C infection before it became an approved drug for such cases.Case presentationA 56-year-old Kuwaiti woman with hepatitis C virus infection was treated with pegylated interferon α-2a and ribavirin, laboratory test results prior to therapy were within normal values. After 4 weeks of that treatment, she developed neutropenia and severe thrombocytopenia. Her hepatitis C virus treatment was stopped for many years until eltrombopag was used as an off-label drug with an episode of severe thrombocytopenia. Her platelets count returned to normal level when triple therapy for hepatitis C virus was used successfully.ConclusionsAn off-label drug should be used only when it is the best available drug, based on evidence from on-going multicenter trials. It could be life saving for some patients in critical situations. However, clinical use of eltrombopag later confirmed that it is a safe and effective drug for immune thrombocytopenic purpura or thrombocytopenia associated with hepatitis C virus infection.

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Section: Discussionmentioning

confidence: 99%

Severe thrombocytopenia in a patient with hepatitis C treated with eltrombopag from off-label drug use to on-label drug use: a case report

et al. 2014

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“…If supported by scientific evidence, the offlabel use of drugs represents an opportunity to achieve therapeutic advances in clinical practice, particularly when approved treatments have failed, and it can also provide the only available treatment for "orphan" conditions [26,27]. However, most off-label use has been shown to have little or no scientific support [22,28], and it may undermine the incentives for manufacturers to perform rigorous studies [26].…”

Section: Discussionmentioning

confidence: 99%

Bevacizumab in Clinical Practice: Prescribing Appropriateness Relative to National Indications and Safety

et al. 2011

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The aim of this study was to describe the clinical use of bevacizumab in Lombardy (9.5 million inhabitants), Italy, during 2006 -2007 in patients with metastatic colorectal cancer (mCRC) to evaluate compliance with the Italian Medicine Agency (AIFA) indications, the incidence of adverse events, and the survival rate.We performed computerized record linkage among three different Lombardy health care databases: File F registry, Regional discharge database, and Registry Office records. Patients were classified into approved and offlabel uses according to the AIFA indications.Treatment with bevacizumab was administered to 780 patients, of whom 81.7% (n ‫؍‬ 637) had mCRC. Among these, 37.8% (n ‫؍‬ 241) of patients received the drug in observance of AIFA indications. Overall, ϳ10% of patients had serious treatment-related toxicities (fistula, 3.5%; venous thromboembolism, 2.8%; hemorrhage, 1.9%; intestinal perforation and arterial thromboembolism, <1%). The 1-year survival rate was 74.3% and the 2-year survival rate was 39.2%. The median survival time was 20.5 months, and there were no meaningful differences between gender and age groups.There was a gap between the bevacizumab approved indication and clinical practice pattern: overall, less than one half of the patients received bevacizumab in observance with the regulatory indication. The main reason for nonadherence to the indication was use as a second-line or advanced line of therapy. The incidence of serious adverse events and the survival rates of mCRC patients were similar to those reported in clinical trials. The Oncologist 2012;17:117-124

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“…An example is the joint prescription of Olanzapine (an atypical anti-psychotic drug) and Citalopram (a Selective Serotonin Reuptake Inhibitor, or SSRI), which increases the effect of the latter on depression, although pharmaceutical information simply states that the mechanisms of this interaction ''are not fully understood.'' Furthermore, Citalopram is increasingly prescribed ''off-label'' for disorders such as diabetic neuropathy, premenstrual dysphoria, and dysmorphophobia, among others (Fairman and Curtiss 2010;Vijay, Becker, and Ross 2018). Instead of recognizing that little is understood about mind processes and mental disorders (Summerfield 2012), many health workers and professionals treat patients' problems much like sorcerer's apprentices.…”

Section: Hidden Unknownsmentioning

confidence: 99%

“Madness and Despair are a Force”: Global Mental Health, and How People and Cultures Challenge the Hegemony of Western Psychiatry

Beneduce

2019

Cult Med Psychiatry

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The author suggests to consider some important hidden connections in Global Mental Health (GMH) discourse and interventions, above all the political meaning of suffering and symptoms, the power of psychiatric diagnostic categories (both Western and traditional) to name and to occult at once other conflicts, and the implicit criticism expressed by so-called local healing knowledge and its epistemologies. These issues, by emphasizing the importance to explore other ontologies, help to understand the perplexity and resistance that GMH and its agenda meet among many scholars and professionals, who denounce the risks of reproducing and globalizing Western hegemonic values concerning health, illness, and healing. Keywords ''Palimpsest nature'' of psychiatric disorders Á Hegemonic dimensions of psychiatric diagnostic apparatus Á Crypto-racism Á Indocile suffering Á ''Minor'' and ''subjugated'' (healing) knowledge

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Regulatory Actions on the Off-Label Use of Prescription Drugs: Ongoing Controversy and Contradiction in 2009 and 2010

Cited by 11 publications

References 16 publications

Severe thrombocytopenia in a patient with hepatitis C treated with eltrombopag from off-label drug use to on-label drug use: a case report

Severe thrombocytopenia in a patient with hepatitis C treated with eltrombopag from off-label drug use to on-label drug use: a case report

Bevacizumab in Clinical Practice: Prescribing Appropriateness Relative to National Indications and Safety

“Madness and Despair are a Force”: Global Mental Health, and How People and Cultures Challenge the Hegemony of Western Psychiatry

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