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 Concept Videos

Pharmacovigilance01:19

Pharmacovigilance

2.0K
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
Effects of Chemicals: Overview01:27

Effects of Chemicals: Overview

2.4K
Drugs, encompassing various chemical compounds from natural sources, lab synthesis, or genetic engineering, elicit different biological responses in living organisms. Some of these responses are desirable or therapeutic, while others are undesirable. The primary goal of administering a drug is to achieve a therapeutic effect, that is, to address a specific disease or health condition. Any concurrent effects outside of this therapeutic outcome are considered undesirable. These undesirable...
2.4K
The Placebo Effect01:54

The Placebo Effect

5.9K
The placebo effect occurs when people's expectations or beliefs influence or determine their experience in a given situation. In other words, simply expecting something to happen can actually make it happen.
5.9K
Modified-Release Drug Delivery Systems: Site-Targeted01:24

Modified-Release Drug Delivery Systems: Site-Targeted

164
Site-targeted drug delivery systems enhance therapeutic efficacy while minimizing systemic toxicity and treatment costs. Unlike conventional methods, these systems ensure precise drug delivery, improving bioavailability and reducing side effects. Targeted drug delivery is classified into three levels. First-order targeting directs drugs to the capillary beds of specific organs or tissues. Second-order targets specific cell types, such as tumor cells, using receptor-mediated interactions.
164
Drug Regulation01:25

Drug Regulation

3.0K
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...
3.0K
Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches01:23

Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches

627
Biopharmaceutical studies constitute a vital field aiming to enhance drug delivery methods and refine therapeutic approaches, drawing upon diverse interdisciplinary knowledge. In research methodologies, the choice between controlled and non-controlled studies significantly influences the study's reliability and accuracy.
Non-controlled studies, commonly employed for initial exploration, lack a control group, rendering them susceptible to biases and external influences. In contrast,...
627

You might also read

Related Articles

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

Sort by
Same author

[Current and future therapeutic options for COVID-19].

Nederlands tijdschrift voor geneeskunde·2022
Same author

Change in Hematoma Size after Dexamethasone Therapy in Chronic Subdural Hematoma Subtypes: A Prospective Study in Symptomatic Patients.

Journal of neurotrauma·2022
Same author

Reference intervals of urinary kidney injury biomarkers for middle-aged men and women determined by quantitative protein mass spectrometry.

Annals of clinical biochemistry·2022
Same author

Opioid prescribing patterns after arthroplasty of the knee and hip: a Dutch nationwide cohort study from 2013 to 2018.

Acta orthopaedica·2022
Same author

Valid Evidence for Diagnosis and Treatment of Infections in the Intensive Care Unit: Beyond Randomized Control Trial Study Design (Trial Emulation and Machine Learning).

Journal of clinical medicine·2022
Same author

Association between prescription opioid use and unplanned intensive care unit admission and mortality in the adult population of the Netherlands: a registry study.

British journal of anaesthesia·2022

Related Experiment Video

Updated: Apr 29, 2026

Meta-Analysis of the Effectiveness and Safety of Shugan Jieyu Capsules for the Treatment of Insomnia
04:34

Meta-Analysis of the Effectiveness and Safety of Shugan Jieyu Capsules for the Treatment of Insomnia

Published on: February 17, 2023

1.9K

[Pill matters: targeted research into side effects necessary].

Frits R Rosendaal1

  • 1Leids Universitair Medisch Centrum, afd. Klinische Epidemiologie, Leiden.

Nederlands Tijdschrift Voor Geneeskunde
|May 22, 2014
PubMed
Summary

Hormonal preparations with cyproterone acetate, used for acne and hirsutism, pose risks like venous thrombosis. A Dutch study found voluntary reporting insufficient for detecting common side effects from these widely used contraceptives.

Area of Science:

  • Pharmacovigilance
  • Endocrinology
  • Dermatology

Background:

  • Hormonal preparations containing cyproterone acetate are prescribed for acne and hirsutism but also used off-label as oral contraceptives.
  • Reports of fatal venous thrombosis linked to these drugs, particularly Diane-35, have prompted regulatory scrutiny.
  • Concerns regarding the safety of cyproterone acetate have been documented since 2001, yet usage persisted.

Purpose of the Study:

  • To analyze side effect reports received by Lareb (The Netherlands Pharmacovigilance Centre) concerning cyproterone acetate-containing hormonal preparations.
  • To evaluate the effectiveness of the current pharmacovigilance system in detecting adverse events associated with these medications.
  • To highlight the discrepancy between licensed indications and actual usage patterns of cyproterone acetate.

More Related Videos

Author Spotlight: Integrating Traditional Chinese Medicine with Modern Pharmacology and Genomics for Assessing Postmenopausal Osteoporosis in Mice
07:20

Author Spotlight: Integrating Traditional Chinese Medicine with Modern Pharmacology and Genomics for Assessing Postmenopausal Osteoporosis in Mice

Published on: August 23, 2024

1.2K
Drug Repurposing Hypothesis Generation Using the "RE:fine Drugs" System
05:10

Drug Repurposing Hypothesis Generation Using the "RE:fine Drugs" System

Published on: December 11, 2016

9.6K

Related Experiment Videos

Last Updated: Apr 29, 2026

Meta-Analysis of the Effectiveness and Safety of Shugan Jieyu Capsules for the Treatment of Insomnia
04:34

Meta-Analysis of the Effectiveness and Safety of Shugan Jieyu Capsules for the Treatment of Insomnia

Published on: February 17, 2023

1.9K
Author Spotlight: Integrating Traditional Chinese Medicine with Modern Pharmacology and Genomics for Assessing Postmenopausal Osteoporosis in Mice
07:20

Author Spotlight: Integrating Traditional Chinese Medicine with Modern Pharmacology and Genomics for Assessing Postmenopausal Osteoporosis in Mice

Published on: August 23, 2024

1.2K
Drug Repurposing Hypothesis Generation Using the "RE:fine Drugs" System
05:10

Drug Repurposing Hypothesis Generation Using the "RE:fine Drugs" System

Published on: December 11, 2016

9.6K

Main Methods:

  • Analysis of spontaneous adverse event reports submitted to Lareb.
  • Review of reports following media attention and regulatory actions related to cyproterone acetate.
  • Assessment of the timeliness and source of reported side effects (patients vs. physicians).

Main Results:

  • Lareb received hundreds of reports, with over half originating from patients, often detailing long-past side effects.
  • A significant number of women in the Netherlands continued using these potentially unsafe oral contraceptives.
  • The study identified that voluntary reporting systems are inadequate for detecting increased frequencies of common side effects.

Conclusions:

  • The pharmacovigilance system relying on voluntary reports is insufficient for identifying risks associated with widely used hormonal preparations like cyproterone acetate.
  • Physician and patient reporting alone may not capture the true incidence of adverse events, especially for common side effects.
  • There is a need for more robust pharmacovigilance strategies to ensure patient safety with medications used off-label.