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Related Concept Videos

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.
This process, termed pharmacovigilance, aims to detect, evaluate, and minimize harmful effects related to medication use. The data collection for pharmacovigilance depends on spontaneous reporting systems, where healthcare professionals or patients voluntarily report suspected ADRs.
In some cases, there...
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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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Therapeutic Drug Monitoring: Overview and Classification01:16

Therapeutic Drug Monitoring: Overview and Classification

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Therapeutic Drug Monitoring (TDM) is a clinical practice that measures specific drug levels in a patient's blood at designated intervals to ensure the drug concentration stays within a therapeutic range. This monitoring is crucial for optimizing individual dosage regimens, enhancing therapeutic efficacy, and minimizing drug-related toxicity. TDM is vital for drugs with narrow therapeutic windows, significant variability in pharmacokinetics, and a clear correlation between plasma levels and...
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FDA Approved Drugs: Changes to Approved Drugs01:26

FDA Approved Drugs: Changes to Approved Drugs

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Post-approval, manufacturers may modify an approved new or generic drug product. Such modifications can encompass alterations in the Active Pharmaceutical Ingredient (API), manufacturing process, formulation, batch size, manufacturing site, and container closure system (FDA Guidance for Industry, April 2004). Often, a drug product may undergo multiple changes.These modifications require careful evaluation to determine their potential impact on the drug product's identity, strength, quality,...
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Pharmacokinetics: Overview01:10

Pharmacokinetics: Overview

9.7K
Pharmacokinetics is a scientific discipline that focuses on the journey of a drug within the body, encompassing four key stages: absorption, distribution, metabolism, and elimination. The first stage, absorption, involves the drug's transfer into the bloodstream. Several factors dictate the extent and speed of this process. For example, the liver often metabolizes oral drugs before they reach systemic circulation, leading to only partial absorption. In contrast, intravenous (IV)...
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Pharmaceutical Poisoning: Potential Scenarios01:26

Pharmaceutical Poisoning: Potential Scenarios

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Pharmaceutical poisoning can occur through various channels, impacting an estimated 2 million hospitalized patients in the U.S. annually with serious adverse drug responses. These scenarios encompass both therapeutic uses, such as drug toxicity, where even standard dosages can lead to severe central nervous system depression, and non-therapeutic exposures, including accidental ingestion by children, and environmental and occupational exposures.Unintentional poisonings often involve exploratory...
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Updated: May 2, 2026

Multiplex Therapeutic Drug Monitoring by Isotope-dilution HPLC-MS/MS of Antibiotics in Critical Illnesses
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[Pharmacovigilance update].

Léonore Diezi1, Delphine Renard2, Laura E Rothuizen2

  • 1Département des laboratoires CHUV, Lausanne. leonore.diezi@chuv.ch

Revue Medicale Suisse
|February 25, 2014
PubMed
Summary
This summary is machine-generated.

Key 2013 pharmacovigilance updates highlight drug safety concerns. Nitrofurantoin, dabigatran, azithromycin, zolpidem, roflumilast, retigabine, telaprevir, rituximab, fingolimod, tolvaptan, and nicotinic acid/laropiprant all had significant safety or efficacy revisions.

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Area of Science:

  • Pharmacovigilance and Drug Safety
  • Clinical Pharmacology
  • Regulatory Affairs

Background:

  • The year 2013 saw significant updates in drug safety profiles and regulatory actions.
  • Continuous monitoring of pharmaceutical products is essential for public health.
  • Emerging adverse event data necessitates prompt reassessment of drug risks and benefits.

Purpose of the Study:

  • To review and summarize critical pharmacovigilance updates from 2013.
  • To inform healthcare professionals about revised drug safety information and recommendations.
  • To highlight changes in drug efficacy, contraindications, and risk management strategies.

Main Methods:

  • Review of pharmacovigilance reports and regulatory communications from 2013.
  • Analysis of updated drug information concerning efficacy, adverse events, and contraindications.
  • Identification of specific drugs with revised safety profiles or usage guidelines.

Main Results:

  • Nitrofurantoin: reduced efficacy and increased adverse events with creatinine clearance < 60 ml/min.
  • Dabigatran: contraindicated in patients with mechanical heart valves.
  • Azithromycin: associated with QT prolongation and increased mortality risk.
  • Zolpidem: recommendations for lower dosages.
  • Roflumilast: avoid in patients with or at risk for mood disorders.
  • Retigabine: restricted to last-line use due to pigmentary changes.
  • Telaprevir and rituximab: linked to severe mucocutaneous reactions.
  • Fingolimod: rare cases of progressive multifocal leucoencephalopathy.
  • Tolvaptan: potential for hepatotoxicity.
  • Nicotinic acid/laropiprant: marketing authorization suspended due to unfavorable risk-benefit balance.

Conclusions:

  • The 2013 pharmacovigilance updates underscore the dynamic nature of drug safety.
  • Healthcare providers must stay informed about evolving drug risks to ensure patient safety.
  • Regulatory actions reflect the ongoing effort to optimize therapeutic interventions and minimize harm.