Directed by the French Agency for the Safety of Health Products (AFSSAPS), the French pharmacovigilance system is in charge of the surveillance of drugs after they have been provided by AFSSAPS with official marketing authorizations that are in France either 'new drug approval certificates' (AMM) or 'temporary utilization authorizations' (ATU). About 3,700 pharmaceutical products are concerned which are used either for treatment (all drugs and remedies, inclusive plasma-derived blood products), prevention (vaccines, oral contraception), diagnosis (contrast products, ...), or to modify a physiologic function (general or local anesthetics). At the national level, the main actors of the system are AFSSAPS and its National Commission, the 31 Regional Centers of Pharmacovigilance, all the health professionnals, and the pharmaceutical laboratories. Health professionnals are held to notify any suspected serious or unexpected adverse effects as quickly as possible. The analysis of data collected by the national report bank permits alerts and inquiries about drug safety. Furthermore regional centers of pharmacovigilance are responsible for drug information. The French pharmacovigilance system works in cooperation with the European Agency for the Evaluation of Medicinal Products.
Download full-text PDF |
Source |
|---|---|
| http://dx.doi.org/10.1016/s1246-7820(99)80036-6 | DOI Listing |
Publication Analysis
Top Keywords
Similar Publications
[Teratovigilance. Antiepileptics during pregnancy and paternal use].
Rev Med Suisse
January 2025
Swiss Teratogen Information Service, Service de pharmacologie clinique, Département de médecine, Centre hospitalier universitaire vaudois, 1011 Lausanne.
The 2023-2024 updates on teratovigilance, with a focus on antiseizure medications, highlight several key points. American medical societies have revised their recommendations: maintaining effective seizure control is essential for both maternal and fetal health; lamotrigine, levetiracetam, and oxcarbazepine are preferred first-line treatments, whereas valproic acid and topiramate should be avoided if possible. In March 2024, an update on topiramate indicated an increased risk of neurodevelopmental disorders with prenatal exposure.
View Article and Find Full Text PDFLactic acidosis with metformin accumulation in the intensive care units of the Nord Pas de Calais region: A known serious adverse event that can be better prevented.
Therapie
December 2024
CHU Lille, University Lille, Intensive Médecine Reanimation, 59000 Lille, France.
Article Synopsis
- The study focused on identifying situations that lead to metformin-associated lactic acidosis (MALA) in ICU patients and evaluating its preventability.
- A total of 198 MALA cases were assessed, with 19.2% resulting in death; the majority of patients had acute events like dehydration or severe infections that contributed to the condition.
- The findings indicated that MALA is often preventable, highlighting the need for better physician and patient education regarding metformin use during high-risk medical situations.
Quantifying the potential contribution of drugs to the occurrence of acute kidney injury in patients with chronic kidney disease.
Clin Kidney J
January 2025
Pharmacoepidemiology Unit, Department of Clinical Pharmacology, Amiens-Picardie University Medical Center, Amiens, France.
Background: We sought to comprehensively describe drug-related components associated with acute kidney injury (AKI) in patients with chronic kidney disease (CKD), describing the incidence of drug-related AKI, the proportion of preventable AKI, identified the various drugs potentially associated with it, explored the risk factors, and assessed the 1-year incidences of the recurrence of drug-related AKI, kidney failure, and death.
Methods: CKD-REIN is a French national prospective cohort of 3033 nephrology outpatients with a confirmed diagnosis of CKD (eGFR <60 ml/min/1.73 m²).
Intracerebroventricular anaerobic dopamine in Parkinson's disease with L-dopa-related complications: a phase 1/2 randomized-controlled trial.
Nat Med
January 2025
Parkinson's Disease Centre of Excellence, Department of Neurology, Univeristy of Lille, CHU Lille, INSERM U1172-Degenerative & Vascular Cognitive Disorders, Lille, France.
Continuous compensation for cerebral dopamine deficiency represents an ideal treatment for Parkinson's disease. Dopamine does not cross the digestive and blood-brain barriers and is rapidly oxidized. The new concept is the intracerebroventricular administration of anaerobic dopamine (A-dopamine) using an abdominal pump connected to a subcutaneous catheter implanted in the third ventricle, near the striatum.
View Article and Find Full Text PDFWant AI Summaries of new PubMed Abstracts delivered to your In-box?
Enter search terms and have AI summaries delivered each week - change queries or unsubscribe any time!