Fluoroquinolone-associated suicide

Kommalapati, Anuhya; Wallam, Sara; Tella, Sri Harsha; Qureshi, Zaina P.; Bennett, Charles L.

doi:10.1016/j.ejim.2018.07.012

Cited by 14 publications

(5 citation statements)

References 2 publications

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“…116 Moreover, though several SONAR/RADAR investigators and collaborators published clinical findings contrary to corporate interests, no documented threats or intimidation acts could be identified after the findings were published. [153][154][155][156][157][158][159][160][161][162] Our study has limitations. There might be whistle-blowers who have been publicly threatened by corporations and were not identified by our search methodology.…”

Section: Discussionmentioning

confidence: 99%

Davids versus Goliaths: Pharma and academia threats to individual scientists and clinicians

Bennett

Olivieri

Hoque

et al. 2022

The Journal of Scientific Practice and Integrity

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Background We previously described experiences of clinicians who published adverse drug reaction reports. We now report on threats and intimidations leveled against clinicians and scientists who received publicly documented threats after communicating safety, efficacy, or data integrity findings contrary to corporate interests. Methods Data on threats and intimidations were obtained from transcripts of governmental hearings or agencies, university-affiliated reports, media interviews, and investigative journalism articles. Content and timing of threats and intimidation, subsequent harms, numbers of persons seriously injured or who died from individual toxicities, financial payments from sponsors related to safety, efficacy, or data integrity concerns, and civil settlements and criminal findings were evaluated. Findings Twenty-six individuals who communicated safety, efficacy, or data integrity concerns were targets of threats and intimidation from corporate employees (twenty-three individuals) or regulatory personnel (three). Seventeen individuals identified instances where pharmaceutical sponsors submitted fraudulent data in support of regulatory approval of a drug or device. Scientist and clinician communications were followed by drug/device withdrawals (fourteen drugs/devices), black box warnings (six drugs), withdrawal of a sponsor’s application for regulatory approval (one device), and delay of approval of a sponsor’s application for regulatory approval (one drug). Actions mainly occurred after persons communicated with pharmaceutical employees (fourteen). Intimidation efforts by corporate personnel included threats of lawsuits (eighteen individuals), hiring private investigators (nine), and public disparagement at conferences (eleven). Related intimidation efforts carried out by academia or regulatory agency superiors included threats of: loss of positions (six), loss of grant funding (two), delays in decisions regarding tenure (two); or reassignment to a low-level position (one). Academic harms included lost: hospital or university appointments (nine and six, respectively), grant funding (two), chairperson title of an international clinical trial group (one), and journal editorial board position (one). Corporate harms included payment of $1 million to defense attorneys in three cases filed against clinicians. Interpretation Threats and intimidation carried out by corporate employees and/or academic supervisors followed public communication of concerns regarding patient safety, drug efficacy, or data integrity, including instances where sponsors were identified as having submitted fraudulent data to regulatory or government agencies. Consideration should be given to filing criminal charges against pharmaceutical executives who are discovered by scientists or clinicians to have knowingly submitted fraudulent data to regulatory or governmental agencies, rather than causing the scientists and clinicians who submit such reports to risk losing their reputations and occupations.

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Section: Discussionmentioning

confidence: 99%

Davids versus Goliaths: Pharma and academia threats to individual scientists and clinicians

Bennett

Olivieri

Hoque

et al. 2022

The Journal of Scientific Practice and Integrity

Self Cite

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“…While this notion alone is already a cause of concern, it is even more relevant when putting FGIDs in the context of FQAD. FQ use is notoriously associated with mood disturbances, including anxiety, depression and even suicidal ideation [57][58][59][60]. With this in mind, the use of FQs should be advised against, or at the very least, FGIDs should be mentioned in the labels for these drugs.…”

Section: Discussionmentioning

confidence: 99%

A New Criterion for Fluoroquinolone-Associated Disability Diagnosis: Functional Gastrointestinal Disorders

et al. 2021

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Background and Objectives: Fluoroquinolones (FQs) are a broad-spectrum class of antibiotics routinely prescribed for common bacterial infections despite recent recommendations to use them only for life-threatening cases. In addition to their antimicrobial properties, FQs act in the central nervous system as GABAA receptor inhibitors, which could potentially affect functionality of the vagus nerve at the forefront of gastrointestinal (GI) tract function. Alterations in neural control of digestion have been shown to be linked to Functional Gastrointestinal Disorders (FGIDs), which are usually diagnosed based on self-reported symptoms. The aim of this study was to assess the incidence of FGIDs following FQ use. Materials and Methods: Self-reports from the FDA Adverse Event Reporting System were analyzed together with ~300 survey responses from a social network derived sample to the Bowel Disease Questionnaire. Results: The results of this study suggested that six different FQs are associated with a wide range of GI symptoms not currently reported in the drugs’ labels. The responses from the survey suggested that ~70% of FQ users scored positive for FGID, with no positive correlation between drug type, duration of administration, dosage and frequency of administration. Conclusions: This study showed that GI disorders other than nausea, vomiting and diarrhea are more common than currently reported on the drug labels, and that FGIDs are possibly a common consequence of FQ use even after single use.

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“…It is suggested that fluoroquinolones use can increase the risk of suicidal behaviour. 20 Fluoroquinolones can also weaken the aortic wall presumably also by damaging collagenous proteins, increasing the risk of its dissection or aneurysm which are life-threatening events. 15 This large collection of irreversible effects has led to the description of a potentiality permanent syndrome called fluoroquinolone-associated disability (FQAD) 21 and a new verb of having been 'Floxed'.…”

Section: General Side-effects Of Systemic Agentsmentioning

confidence: 99%

Fluoroquinolones are a potent form of chemotherapy

Schmid

2021

Clinical and Experimental Optometry

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Fluoroquinolones (sometimes referred to as quinolones) are generally considered the most effective and useful of all the topical ocular antibiotics. With emerging antibiotic resistance becoming an increasing global problem, eyecare providers are told to use these agents judiciously and only for the most severe ocular infections. However, there are additional reasons to limit the use of these agents. There are increasing reports in America of serious adverse effects of these antibiotics particularly from systemic use (oral and intravenous). 1 In addition to the potentially serious health impacts there are also considerable economic implications, 2 and many hundreds of lawsuits against manufacturers in America both underway and settled. 3 As the side-effects are more likely with systemic dosing than topical application, eye-care providers may be unaware of these potential adverse effects. The extent of their effects, including immunomodulatory, pro-apoptotic, antiproliferative and anti-metastatic actions, is highlighted by these agents being repurposed as anti-cancer agents. 4 The purpose of this viewpoint is to describe the unfortunate consequences that can occur in a portion of patients taking systemic fluoroquinolones, and to share the view that eye-care practitioners should consider them cytotoxic and potential anti-cancer treatments.Quinolone is a generic term referring to a class of drugs that include quinines, naphthyridines, fluoroquinolones, quinazolines, and isothiazoloquinolones. The fluoroquinolones (a subset of the quinolones) are a group of broad spectra, bactericidal antibiotics with a similar mode of action that includes inhibiting the replication and transcription of bacterial DNA synthesis by blocking DNA gyrase or topoisomerase-IV. 5 They are commonly used to treat respiratory and urinary tract infections. In Australia ciprofloxacin, moxifloxacin, and norfloxacin are available for systemic use. 6 Australian clinicians, primarily doctors, must obtain authority to prescribe quinolones under the Pharmaceutical Benefits Scheme and can prescribe them only for specific infections. 6 The purpose of these restrictions has been to minimise bacterial resistance to this class of agents. 7 The Australian Medicines Handbook states 'Worldwide resistance to quinolones is increasing. Judicious use may extend their clinical life'. However, it is the serious adverse reactions that have majorly limited their use.Eye-care providers are well aware of the ocular uses of the fluoroquinolones for bacterial corneal infections. In Australia only two second-generation agents, ofloxacin and ciprofloxacin, are available for ocular use. 6 In America this group includes ciprofloxacin, gemifloxacin, levofloxacin, moxifloxacin, norfloxacin, and ofloxacin.

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Fluoroquinolone-associated suicide

Cited by 14 publications

References 2 publications

Davids versus Goliaths: Pharma and academia threats to individual scientists and clinicians

Davids versus Goliaths: Pharma and academia threats to individual scientists and clinicians

A New Criterion for Fluoroquinolone-Associated Disability Diagnosis: Functional Gastrointestinal Disorders

Fluoroquinolones are a potent form of chemotherapy

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