Jove
Visualize
Contact Us
JoVE
x logofacebook logolinkedin logoyoutube logo
ABOUT JoVE
OverviewLeadershipBlogJoVE Help Center
AUTHORS
Publishing ProcessEditorial BoardScope & PoliciesPeer ReviewFAQSubmit
LIBRARIANS
TestimonialsSubscriptionsAccessResourcesLibrary Advisory BoardFAQ
RESEARCH
JoVE JournalMethods CollectionsJoVE Encyclopedia of ExperimentsArchive
EDUCATION
JoVE CoreJoVE BusinessJoVE Science EducationJoVE Lab ManualFaculty Resource CenterFaculty Site
Terms & Conditions of Use
Privacy Policy
Policies

Related Experiment Videos

Assessing potential risks and evaluating expected benefits.

Fadia T Shaya1, Anna Gu

  • 1Pharmaceutical Health Services Research, University of Maryland School of Pharmacy, School of Medicine, Epidemiology and Preventive Medicine, Baltimore 21201, USA. fshaya@rx.umaryland.edu

Managed Care Interface
|June 9, 2005
PubMed
Summary
This summary is machine-generated.

Related Concept Videos

You might also read

Related Articles

Articles linked to this work by shared authors, journal, and citation graph.

Sort by
Same author

Machine Learning Based County Level Phenotypes Related to Diabetes Prevalence.

AMIA Joint Summits on Translational Science proceedings. AMIA Joint Summits on Translational Science·2026
Same author

Hyperlipidemia-associated specific modules and hub genes revealed by integrative methods of WGCNA and MetaDE.

Frontiers in genetics·2025
Same author

Exploring Characteristic Parameters to Inform Continued Recovery Among Parenting Women With Opioid Use Disorder in a Residential Facility.

Substance use & addiction journal·2025
Same author

Cost-effective interventions to prevent prescription drug misuse: a systematic review.

Frontiers in public health·2025
Same author

State-level policies and receipt of CDC-informed opioid thresholds among commercially insured new chronic opioid users.

Journal of opioid management·2024
Same author

Short-term healthcare resource utilization associated with receipt of CDC-informed opioid thresholds among commercially insured new chronic opioid users.

Journal of opioid management·2024
Same journal

Changes in hospital readmissions for diabetes-related conditions. Differences by payer.

Managed care interface·2008
Same journal

Heart disease and managed care.

Managed care interface·2008
Same journal

A conversation with James K. Min, MD.

Managed care interface·2008
Same journal

Acute coronary syndromes.

Managed care interface·2008
Same journal

Improving outcomes in cardiovascular disease.

Managed care interface·2008
Same journal

The effect for oncology of the national coverage determination for erythropoiesis-stimulating agents.

Managed care interface·2008
See all related articles

The rofecoxib withdrawal highlights the complexity of drug risk assessment and the critical role of postmarketing data. Understanding real-world outcomes is essential for informed clinical decisions regarding medication benefits and harms.

Area of Science:

  • Pharmacovigilance and Drug Safety
  • Regulatory Science
  • Health Economics

Background:

  • The withdrawal of rofecoxib underscores significant challenges in drug risk-benefit evaluation.
  • Drug approval considers expected benefits versus risks, with increasing inclusion of cost-effectiveness.
  • Postmarketing surveillance is crucial for revealing actual therapeutic outcomes.

Purpose of the Study:

  • To analyze the implications of the rofecoxib withdrawal on societal risk assessment.
  • To examine the complex scientific and regulatory aspects of drug evaluation.
  • To discuss the integration of postmarketing evidence into clinical decision-making.

Main Methods:

  • Review of the rofecoxib case study and its market withdrawal.
  • Analysis of drug approval processes, including risk-benefit and cost-effectiveness.

Related Experiment Videos

  • Discussion of the role of postmarketing data in understanding treatment outcomes.

    • Main Results:

    • The rofecoxib experience demonstrates the intricate nature of drug safety and efficacy assessment.
    • Postmarketing data provides vital insights into a drug's real-world performance.
    • Current frameworks struggle to reconcile postmarketing evidence with clinical decision-making.

    Conclusions:

    • Societal approaches to drug risk assessment require re-evaluation following events like the rofecoxib withdrawal.
    • Balancing pre- and post-approval data is essential for robust drug safety monitoring.
    • Further development is needed to effectively link real-world evidence to clinical practice.