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Related Concept Videos

Pharmacovigilance01:19

Pharmacovigilance

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...
Therapeutic Drug Monitoring: Affecting Factors01:29

Therapeutic Drug Monitoring: Affecting Factors

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.
Therapeutic Drug Monitoring: Overview and Classification01:16

Therapeutic Drug Monitoring: Overview and Classification

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...
FDA Approved Drugs: Changes to Approved Drugs01:26

FDA Approved Drugs: Changes to Approved Drugs

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,...
Pharmacokinetics: Overview01:10

Pharmacokinetics: Overview

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) administration...
Pharmaceutical Poisoning: Potential Scenarios01:26

Pharmaceutical Poisoning: Potential Scenarios

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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Related Experiment Video

Updated: May 14, 2026

Multiplex Therapeutic Drug Monitoring by Isotope-dilution HPLC-MS/MS of Antibiotics in Critical Illnesses
11:17

Multiplex Therapeutic Drug Monitoring by Isotope-dilution HPLC-MS/MS of Antibiotics in Critical Illnesses

Published on: August 30, 2018

[Pharmacovigilance update].

F Livio1

  • 1Division de pharmacologie clinique, Département des laboratoires, CHUV, 1011 Lausanne. francoise.livio@chuv.ch

Revue Medicale Suisse
|February 2, 2013
PubMed
Summary
This summary is machine-generated.

Key 2012 pharmacovigilance updates highlight risks with dabigatran, dual renin-angiotensin-aldosterone system blockade, and drug interactions. Dose reductions and monitoring are advised for several medications.

Related Experiment Videos

Last Updated: May 14, 2026

Multiplex Therapeutic Drug Monitoring by Isotope-dilution HPLC-MS/MS of Antibiotics in Critical Illnesses
11:17

Multiplex Therapeutic Drug Monitoring by Isotope-dilution HPLC-MS/MS of Antibiotics in Critical Illnesses

Published on: August 30, 2018

Area of Science:

  • Pharmacovigilance and Drug Safety
  • Clinical Pharmacology
  • Regulatory Science

Context:

  • Review of major pharmacovigilance findings and safety updates from 2012.
  • Focus on adverse drug reactions and interactions reported for various pharmaceutical agents.
  • Highlights the importance of post-marketing surveillance in identifying drug risks.

Purpose:

  • To summarize critical pharmacovigilance updates from 2012 for healthcare professionals.
  • To inform prescribers about newly identified risks and updated safety recommendations.
  • To enhance patient safety by disseminating crucial drug safety information.

Summary:

  • Dabigatran poses bleeding risks in elderly patients with renal failure.
  • Dual renin-angiotensin-aldosterone system blockade with aliskiren is contraindicated.
  • Incretins show a low risk of acute pancreatitis.
  • Fusidic acid and statin interactions increase rhabdomyolysis risk.
  • Boceprevir/telaprevir interactions with antiretrovirals are complex but manageable.
  • Citalopram and ondansetron maximum doses reduced.
  • Atomoxetine can increase blood pressure and heart rate.
  • Agomelatine is associated with elevated liver enzymes.
  • Fingolimod requires strengthened cardiovascular monitoring due to risks of bradycardia and heart blocks.

Impact:

  • Informed clinical decision-making regarding medication prescribing and patient monitoring.
  • Potential reduction in adverse drug events and improved patient outcomes.
  • Facilitated updates to drug labeling and clinical guidelines based on emerging safety data.