[Drug surveillance and adverse reactions to drugs. The literature and importance of historical data].
The authors highlight the essential role of pharmacovigilance and the need for a simple, efficient and low-cost system of adverse reaction (AR) reporting which could cover the whole population and all marketed drugs, and suggest that the only one presently viable is based on spontaneous reporting. To support their proposal the authors provide a definition of AR and of the different monitoring system, and list as many drugs as possible to find in the literature that have been associated with a specific AR, together with the active molecule, the therapeutic indication, the features of the AR and the regulatory actions (withdrawal from the market, restriction of use). Moreover, by describing the "history" behind some of these drugs the authors highlight the contribution that pharmacovigilance and spontaneous reporting have had to the development of regulations for approval and marketing of new drugs. It is also highlighted how some of these unexpected events (thalidomide, DES) have had a significant and important contribution to pharmacological and toxicological knowledge.
Mariani
L
L
Dipartimento di Farmacologia, Chemioterapia e Tossicologia Medica, Università degli Studi di Milano.
Minora
T
T
Ventresca
G P
GP
D004305:Dose-Response Relationship, Drug; D064420:Drug-Related Side Effects and Adverse Reactions; D006801:Humans; D007558:Italy; D004364:Pharmaceutical Preparations / Q000008:administration & dosage; D011358:Product Surveillance, Postmarketing / Q000706:statistics & numerical data
D004364:Pharmaceutical Preparations