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Pharmacovigilance01:19

Pharmacovigilance

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Post-marketing surveillance is a critical component of pharmaceutical regulation, often uncovering unanticipated adverse drug reactions (ADRs) once a drug is widely used over an extended period.
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Drug Toxicity: Risk factors01:24

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Adverse Drug Reactions (ADRs) are potential complications that arise during pharmacotherapy, influenced by multiple risk factors. Age plays a significant role; both neonates and the elderly are at heightened risk due to their respective immature and diminished metabolic and elimination processes. Gender also impacts ADRs, with females experiencing a 1.5 to 1.7-fold greater risk than males, which may be linked to pharmacokinetic, pharmacodynamic, and hormonal differences. Notably, neonates, the...
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Drug Toxicity: Overview01:00

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Drug toxicity quantifies the harm a compound causes to an organism, varying by dose and potentially impacting whole systems or specific organs like the liver. Toxic reactions may arise from venomous insect or spider bites, with effects ranging from mild symptoms to severe outcomes such as brain damage or death. Common forms of acute poisoning include ethanol intoxication and overdose of pain or fever medications, with substances like GHB and heroin being particularly lethal at doses close to...
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Drug toxicity: Idiosyncratic Reactions01:16

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Idiosyncratic drug reactions represent abnormal chemical responses that vary significantly among individuals, ranging from extreme sensitivity to low doses to insensitivity to high doses. These reactions often occur due to the drug's covalent binding with serum proteins, forming a foreign hapten that triggers an immunotoxicological response. The variability in drug reactions has a strong pharmacogenetic foundation, with genetic differences crucial in how individuals metabolize drugs. For...
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Therapeutic Drug Monitoring: Affecting Factors01:29

Therapeutic Drug Monitoring: Affecting Factors

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Therapeutic Drug Monitoring (TDM) is the clinical practice of measuring specific drug levels in a patient's blood or body tissues to manage and optimize therapy. TDM is crucial for drugs with narrow therapeutic windows, like warfarin and phenytoin, where incorrect doses can lead to treatment failure or severe side effects. This monitoring ensures the dosage administered is within a safe and effective range. The factors affecting therapeutic drug monitoring include:Patient-Specific Factors:a.
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Effect of Hepatic Disease on Pharmacokinetics: Pathophysiologic Assessment and Liver Function Test01:22

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In clinical practice, the direct measurement of hepatic blood flow to evaluate liver function presents significant challenges due to the intricate and specialized nature of the necessary techniques. Consequently, healthcare professionals often rely on empirical estimates derived from thorough patient examinations and liver function tests to gauge liver health. Among the tools at their disposal, the Child–Pugh and MELD scoring systems stand out for their ability to categorize and assess...
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Quantification of the Immunosuppressant Tacrolimus on Dried Blood Spots Using LC-MS/MS
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Prospective, systematically recorded mycophenolate safety data in Graves' orbitopathy.

M Riedl1,2, A Kuhn2, I Krämer3

  • 1Departments of Medicine I, Johannes Gutenberg University Medical Center, Mainz, Germany.

Journal of Endocrinological Investigation
|February 18, 2016
PubMed
Summary
This summary is machine-generated.

Mycophenolic acid (MPA) treatment showed good tolerance in Graves' orbitopathy (GO) patients, with most adverse events being mild and manageable. This study systematically analyzed adverse events during MPA treatment for GO, finding it well-tolerated.

Keywords:
Graves’ orbitopathyICH guidelineMedical dictionary for regulatory activities (MedDRA)MycophenolateSafety

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Area of Science:

  • Endocrinology
  • Ophthalmology
  • Pharmacology

Background:

  • Graves' orbitopathy (GO) is an autoimmune condition affecting the eyes.
  • Mycophenolic acid (MPA) exhibits antiproliferative properties, suggesting potential therapeutic benefits in GO.
  • Systematic analysis of adverse events (AEs) is crucial for evaluating MPA's safety in GO patients.

Purpose of the Study:

  • To systematically analyze for the first time adverse events (AEs) associated with mycophenolic acid (MPA) treatment in patients with Graves' orbitopathy (GO).

Main Methods:

  • Prospective longitudinal study conducted at an academic tertiary referral center.
  • Fifty-three consecutive patients with active, moderate-to-severe GO received MPA 0.720 g once daily for 24 weeks.
  • Adverse events were documented, coded using MedDRA, and assessed for seriousness and causality.

Main Results:

  • 36 patients (68%) reported at least one AE; 88 AEs were documented in total.
  • Most frequent AEs included insomnia, fatigue, and optic neuropathy; 12 patients (23%) experienced at least one side effect (SE).
  • All reported SEs were within MPA's known safety profile, and no patient discontinued MPA due to drug-induced SEs.

Conclusions:

  • MedDRA-coded data confirm the good tolerance of a moderate MPA dose in GO patients.
  • MPA demonstrates a favorable safety profile for managing Graves' orbitopathy.
  • The findings support MPA as a potentially beneficial treatment option for GO with manageable adverse events.