Increased risk of suicide under intrathecal ziconotide treatment? – A warning

@article{Maier2011IncreasedRO,
  title={Increased risk of suicide under intrathecal ziconotide treatment? – A warning},
  author={Christoph Maier and H Gockel and Kai Gruhn and Elena K. Krumova and Marc-Andreas Edel},
  journal={PAIN{\textregistered}},
  year={2011},
  volume={152},
  pages={235-237}
}
Despite some other known psychiatric adverse effects, ziconotide is recommended for intrathecal pain treatment with a good efficacy and safety. Although some hints in previous studies are apparent, a higher suicidality has not been accepted as a treatment risk of ziconotide treatment by the investigators in the former randomized controlled trials so far. We present two cases supporting the suspicion of ziconotide-induced suicidality. Both showed no depressive symptoms at the time of treatment… Expand
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Administering ziconotide and monitoring patients treated with ziconotide: expert opinions.
TLDR
The maximum recommended dosing and titration schedule provided in the prescribing information may be too aggressive for some patients, and experience has demonstrated that ziconotide is better tolerated with slower titration to a lower maximum dose. Expand
Intrathecal Ziconotide: A Review of Its Use in Patients with Chronic Pain Refractory to Other Systemic or Intrathecal Analgesics
TLDR
Intrathecal ziconotide provides a treatment option for patients with severe, unremitting pain who have failed to respond to other intensive analgesic regimens and for enhancing its efficacy and tolerability. Expand
A safety review of approved intrathecal analgesics for chronic pain management
TLDR
This review will evaluate the pivotal trials that established the use of morphine and ziconotide as first-line IT therapy for patients with chronic pain, as well as safety and efficacy data generated from various retrospective and prospective studies. Expand
Ziconotide: a clinical update and pharmacologic review
TLDR
Ziconotide is a safe and effective strategy to treat chronic pain, although limitations remain, including a small therapeutic window, and low starting doses and slow incremental increases and long titration intervals may improve tolerability. Expand
The Relationship Between the Mechanisms of Action and Safety Profiles of Intrathecal Morphine and Ziconotide: A Review of the Literature.
TLDR
Potentially severe and clinically relevant adverse events (AEs) associated with IT morphine include respiratory depression, tolerance, and granuloma formulation, whereas IT ziconotide is associated with neuropsychiatric AEs, such as cognitive impairment, hallucinations, and changes in mood or consciousness, particularly with high doses and rapid titration. Expand
Do the potential benefits outweigh the risks? An update on the use of ziconotide in clinical practice
TLDR
This paper provides a concise, up‐to‐date and clinically‐oriented summary of the use of ziconotide in clinical practice, not least concerning safety and dosage issues. Expand
Integrated risk assessment of suicidal ideation and behavior in drug development.
TLDR
An industry consensus framework for risk assessment and decision making of SIB during drug development is presented based on chemical and pharmacological similarities of compounds with clinical evidence of suicidal intent, target or indication classes associated with high incidence of S IB. Expand
Near-resolution of persistent idiopathic facial pain with low-dose lumbar intrathecal ziconotide: a case report
TLDR
This is the first case report identifying the novel use of low-dose lumbar intrathecal ziconotide to successfully treat PIFP with nearly complete resolution of pain and minimal to no side effects and may supplant multimodal medication management and/or invasive orofacial surgical intervention for PifP. Expand
Validation Study of UPLC Method for Determination of Morphine, Ropivacaïne and Ziconotide in Combination for Intrathecal Analgesia
TLDR
A new analytical method by simple liquid chromatographyultraviolet spectrometry method was developed and validated for the simultaneous quantification of three analgesic drugs (morphine, ropivacaine and ziconotide) and can be considered as a stability indicating method. Expand
Expert opinion on emerging drugs: chronic low back pain
TLDR
The epidemiology, rationale for mechanism-based treatment, competitive environment and market trends, and the preclinical and clinical evidence supporting over 15 different classes of analgesic medications studied for CLBP or related pain conditions are discussed. Expand
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