Related Experiment Video

Updated: Apr 21, 2026

Evaluating the Effectiveness of Cancer Drug Sensitization In Vitro and In Vivo
09:19

Evaluating the Effectiveness of Cancer Drug Sensitization In Vitro and In Vivo

Published on: February 6, 2015

8.3K

Adverse reactions to oncologic drugs: spontaneous reporting and signal detection

Marco Tuccori1, Sabrina Montagnani, Alice Capogrosso-Sansone

  • 1Tuscan Regional Centre of Pharmacovigilance, Pisa, Italy.

Expert Review of Clinical Pharmacology
|November 4, 2014
PubMed

Insights

Monitoring anticancer drug safety is crucial. Many serious adverse drug reactions (ADRs) in oncology drugs are not initially reported, highlighting the need for robust spontaneous reporting systems.

Area of Science:

  • Oncology
  • Pharmacovigilance
  • Drug Safety

Background:

  • Oncology research actively develops new anticancer drugs, necessitating continuous safety monitoring.
  • Cancer patients frequently experience adverse drug reactions (ADRs), leading to selective reporting of severe or unusual events.
  • A recent study found 76 serious ADRs in updated oncologic drug labels, with 50% being potentially fatal.

Purpose of the Study:

  • To provide an overview of spontaneous adverse drug reaction (ADR) reporting for oncologic drugs.
  • To discuss methods for analyzing anticancer drug safety using spontaneous ADR reporting databases.

Main Methods:

  • Review of spontaneous adverse drug reaction (ADR) reporting systems.
  • Analysis of databases containing reported ADRs for oncologic medications.
  • Examination of updated drug labels for serious ADRs.

Main Results:

  • A significant proportion of serious ADRs associated with oncologic drugs were not initially documented in drug labels.
  • Potentially fatal adverse drug reactions (ADRs) are a notable concern in oncology drug safety.
  • Spontaneous reporting systems capture critical safety information over time.

Conclusions:

  • Continuous monitoring and analysis of spontaneous adverse drug reaction (ADR) reports are essential for ensuring the safety of anticancer drugs.
  • Improved methods for analyzing pharmacovigilance data can enhance the detection of serious ADRs.
  • Updating drug labels with newly identified ADRs is critical for patient safety in oncology.
Keywords:
adverse drug reactionantineoplastic agentoncologypharmacovigilancespontaneous reporting

More Related Videos

Potentiation of Anticancer Antibody Efficacy by Antineoplastic Drugs: Detection of Antibody-drug Synergism Using the Combination Index Equation15:04

Potentiation of Anticancer Antibody Efficacy by Antineoplastic Drugs: Detection of Antibody-drug Synergism Using the Combination Index Equation

Published on: January 19, 2019

11.8K
Author Spotlight: Radiotherapy and Clonogenic Assays for Advancing Cancer Research and Personalized Medicine05:39

Author Spotlight: Radiotherapy and Clonogenic Assays for Advancing Cancer Research and Personalized Medicine

Published on: April 5, 2024

1.4K

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...
2.0K
Drug toxicity: Idiosyncratic Reactions01:16

Drug toxicity: Idiosyncratic Reactions

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...
213
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...
116
Drug Toxicity: Overview01:00

Drug Toxicity: Overview

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...
279
Drug Toxicity: Allergic Reactions01:30

Drug Toxicity: Allergic Reactions

Drug-related allergies are immune-mediated responses triggered by the administration of pharmacological agents. These hypersensitivity reactions are classified based on the immune mechanisms involved. The four primary types—Type I, II, III, and IV—are mediated by different immunological pathways and exhibit distinct clinical manifestations.Type I Hypersensitivity/ IgE-Mediated Reactions: Immunoglobulin E (IgE) immediately mediates Type I hypersensitivity reactions. Upon initial...
199
Mutagenicity and Carcinogenicity01:25

Mutagenicity and Carcinogenicity

Mutagenicity and carcinogenicity refer to the ability of drugs to cause genetic defects and induce cancer, respectively. The International Agency for Research on Cancer (IARC) classifies agents into four groups based on their carcinogenic potential. Group 1 agents are known human carcinogens; group 2A agents are probably carcinogenic to humans; group 3 agents lack data to support their role in carcinogenesis; and group 4 includes agents for which data support that they are not likely to be...
2.0K