Pharmacovigilance

Definición

The science and activities relating to the detection, assessment, understanding, and prevention of adverse drug effects. Pharmacovigilance continues throughout a drug's entire market life and includes spontaneous reporting systems (like FDA MedWatch), signal detection, and risk management.

Ejemplo

Post-marketing pharmacovigilance detected the link between rofecoxib (Vioxx) and heart attacks, leading to its withdrawal in 2004.

Términos Relacionados

Adverse Drug Reaction ADR Drug Recall Clinical Trial Phases

Mencionado en Guías

Common vs. Rare Side Effects

Learn how drug side effects are classified by frequency, what 'common' and 'rare' mean in clinical terms, and how to …
Skin Reactions from Medications

Drug-induced skin reactions range from mild rashes to life-threatening conditions. Learn to recognize different types, understand when they are dangerous, …
How to Report Side Effects (FDA MedWatch)

Reporting medication side effects helps keep everyone safer. Learn how to use the FDA MedWatch system, what to report, and …
Drug Recalls: What You Need to Know

What triggers a drug recall, how recalls are classified, and exactly what you should do if a medication in your …
Drug Safety After Approval (Post-Marketing)

FDA approval is not the end of drug safety evaluation — it is the beginning of a new phase. Learn …
How to Check If Your Drug Has Been Recalled

A practical, step-by-step guide for checking whether a specific medication in your home is subject to an active FDA recall …