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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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Pharmacokinetics in Geriatric Patients: Effect of Age on Drug Absorption01:22

Pharmacokinetics in Geriatric Patients: Effect of Age on Drug Absorption

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As individuals age, their body's physiology evolves, affecting drug pharmacokinetics. The most apparent changes occur in the gastrointestinal tract, where an increase in gastric pH, a delay in gastric emptying, and a reduction in gastrointestinal motility are observed. Remarkably, these changes do not substantially modify the absorption of orally administered drugs, particularly those absorbed via passive diffusion.Transdermal drug delivery emerges as a highly viable method for older adults due...
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Pharmacodynamics in Geriatric Patients: Effects of Age01:27

Pharmacodynamics in Geriatric Patients: Effects of Age

346
Age-related pharmacokinetic changes are extensively documented, but understanding age-related pharmacodynamic alterations is relatively limited. This knowledge gap can be partly attributed to the complexity of developing appropriate measures of drug responses compared to bioanalytical methods for determining drug concentrations.Most information regarding age-related differences in human pharmacodynamics originates from cross-sectional studies. However, these studies assume that observed mean...
346
Pharmacokinetics in Geriatric Patients: Effect of Age on Drug Distribution01:00

Pharmacokinetics in Geriatric Patients: Effect of Age on Drug Distribution

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Drug distribution in the human body is influenced by several factors, including plasma protein concentration, body composition, blood flow, tissue-protein concentration, and tissue fluid pH. Among these, changes in plasma protein concentration and body composition due to aging significantly affect how drugs are distributed within the body. Specifically, aging is associated with a decrease in albumin levels by about 10% and an increase in α1-acid glycoprotein levels. These alterations are...
359
Pharmacokinetics in Geriatric Patients: Effect of Age on Drug Excretion01:18

Pharmacokinetics in Geriatric Patients: Effect of Age on Drug Excretion

334
In geriatric patients, renal physiology undergoes significant changes, including diminished renal blood flow and a lower glomerular filtration rate (GFR), leading to alterations in medication clearance. Drugs such as aminoglycoside antibiotics, lithium, and digoxin, which rely on glomerular filtration for removal from the body, particularly impact pharmacokinetics. These drugs tend to have slower clearance rates in older adults, necessitating careful dosage considerations.Evaluation of renal...
334
Pharmacokinetics in Geriatric Patients: Effect of Age on Drug Metabolism01:18

Pharmacokinetics in Geriatric Patients: Effect of Age on Drug Metabolism

370
Geriatric patients show significant variation in how their bodies process medications, which can change how effective and safe treatments are. The liver is the primary organ where drug metabolism occurs, involving two main types of chemical reactions: phase I and II. Phase I metabolism is driven by the cytochrome P450 enzyme system, which includes key types such as CYP3A, CYP2D6, and CYP2C9. Research indicates that while aging doesn't notably alter the levels or activity of these enzymes, it...
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Age-Dependent Differences in Canakinumab Safety: A Comprehensive Pharmacovigilance Analysis Using the FAERS Database.

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Canakinumab, an anti-interleukin-1β antibody, shows significant safety signals, including infections and gastrointestinal issues in children, and neoplasms in older adults. Postmarketing surveillance is crucial for both short-term and long-term adverse events.

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Area of Science:

  • Pharmacovigilance
  • Immunology
  • Oncology

Background:

  • Canakinumab, an anti-interleukin-1β monoclonal antibody, has established efficacy but limited safety data across age groups.
  • Postmarketing safety evaluation is essential for comprehensive understanding of drug risks.

Purpose of the Study:

  • To evaluate the postmarketing safety profile of canakinumab using real-world adverse event data.
  • To identify specific safety signals and age-related adverse event patterns associated with canakinumab therapy.

Main Methods:

  • Analysis of adverse event (AE) reports from the FDA Adverse Event Reporting System (FAERS) database (2010 onwards).
  • Disproportionality analysis using four algorithms (ROR, PRR, MGPS, BCNN) to detect safety signals.
  • Weibull distribution modeling for temporal risk assessment of AEs.
  • Age-stratified analysis to identify distinct AE profiles in different pediatric and adult populations.

Main Results:

  • 9262 canakinumab-related AE reports were analyzed, revealing significant safety signals.
  • Prominent signals included general disorders, administration site conditions, and infections/infestations.
  • Distinct age-specific AE profiles: gastrointestinal/hepatobiliary disorders in children (<12 years), leukopenia in adolescents (12-17 years), and neoplasms in older adults (≥65 years).
  • Temporal analysis indicated an early failure pattern, with approximately 40% of AEs occurring after one year of treatment.

Conclusions:

  • Canakinumab is associated with significant safety signals, particularly infections and gastrointestinal/hepatobiliary disorders in younger patients, and neoplasms in elderly patients.
  • The observed dual temporal pattern of AEs necessitates both short-term and long-term patient monitoring.
  • Comprehensive pharmacovigilance strategies are required to ensure the safe use of canakinumab across all age demographics.