Related Experiment Video

Updated: Jun 16, 2026

Use of Rabbit Eyes in Pharmacokinetic Studies of Intraocular Drugs
10:02

Use of Rabbit Eyes in Pharmacokinetic Studies of Intraocular Drugs

Published on: July 23, 2016

[Pharmacovigilance update]

F Livio1, A Ivanyuk, J Biollaz

  • 1Division de pharmacologie et toxicologie cliniques, Département de médecine CHUV, 1011 Lausanne. francoise.livio@chuv.ch

Revue Medicale Suisse
|February 23, 2010
PubMed

Insights

In 2009, drug safety alerts highlighted risks like progressive multifocal leukoencephalopathy (PML) with efalizumab, leading to its market withdrawal. Other drugs showed risks including PML, aplastic anemia, and pancreatitis.

Area of Science:

  • Pharmacovigilance and Drug Safety
  • Clinical Pharmacology
  • Regulatory Science

Context:

  • Review of major pharmacovigilance signals and alerts from 2009.
  • Focus on newly identified or reinforced drug safety concerns.
  • Analysis of post-marketing surveillance data for adverse events.

Purpose:

  • To summarize critical drug safety information released in 2009.
  • To highlight drugs with significant adverse event profiles.
  • To inform healthcare professionals and regulatory bodies about emerging risks.

Summary:

  • Efalizumab withdrawn due to progressive multifocal leukoencephalopathy (PML) and efficacy concerns.
  • Ongoing PML reports with rituximab and natalizumab; rare pure red cell aplasia with mycophenate.
  • Gastrointestinal, dermatologic, and ocular events with erlotinib; skin reactions with etravirine; renal and pancreatic issues with exenatide and sitagliptin.

Impact:

  • Informed clinical decision-making regarding drug selection and patient monitoring.
  • Contributed to regulatory actions and updated drug safety labeling.
  • Enhanced awareness of potential drug-induced adverse events, including PML and pancreatitis.

More Related Videos

Multiplex Therapeutic Drug Monitoring by Isotope-dilution HPLC-MS/MS of Antibiotics in Critical Illnesses11:17

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

Published on: August 30, 2018

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...
Drug Regulation01:25

Drug Regulation

Drug regulation encompasses the management of drug usage by evaluating its safety and efficacy through assessments conducted by regulatory authorities. Regrettably, the history of drug regulation is marred by several catastrophic events. One such incident is the Elixir Sulfanilamide tragedy, in which the toxic compound diethyl glycol was included in a sweet-tasting medication, leading to numerous fatalities. This event prompted the enactment of the Food, Drug, and Cosmetic Act in 1938. Under...
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,...
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...
Impact of Pharmacokinetic–Pharmacodynamic Models: Regulatory Decisions01:15

Impact of Pharmacokinetic–Pharmacodynamic Models: Regulatory Decisions

PK–PD modeling has significantly influenced FDA regulatory decisions, particularly drug approval, dosage optimization, and labeling. These models integrate pharmacokinetics (PK) and pharmacodynamics (PD) to predict drug behavior and effects, aiding in optimizing dosing regimens and enhancing the probability of clinical trial success.One notable example is Nesiritide (Natrecor®), a recombinant human brain natriuretic peptide for treating acute decompensated congestive heart failure (CHF).