The Titanic has become a metaphor for the disastrous consequences of an unqualified belief in the safety and invincibility of new technology.
Similarly, the thalidomide tragedy stands for all of the « monsters » that can be inadvertently or negligently created by modern medicibne.
Thalidomide, once banned, nhas returned to the center of contoversy with the Food and Drug Administration's (FDA's) nouncement that thalidomide will be placed on the market for the treatment of erythema nodosum leprosum, a severe dermatological complication of Hansen's disease.
Although this indication is very restriceted, thalidomide will be available for off-label uses ocnce it is on the market.
New laws regarding abortion and a new technology, ultrasound, make reasonanble the approval of thalidomide for patients who suffer from serious conditions it can alleviate.
In addition, the FDA and the manufacturer have proposed the most stringent postmarketing monitoring ever used for a prescription drug, including counseling, contraception, and ultrasonography in the event of pregnancy.
The Titanic/thalidomide lesson for the FDA and public health is that rules and guidelines alone are not sufficient to guarantee safety.
Continuous vigilance will be required to ensure that all reasonable postmarketing mo itoring steps are actualy taken to avoid predictable and preventable teratogenic disasters.
Mots-clés Pascal : Homme, Thalidomide, Toxicité, Historique, Foetus pathologie, Tératogène, Pharmacovigilance, Recommandation, Etats Unis, Amérique du Nord, Amérique
Mots-clés Pascal anglais : Human, Thalidomide, Toxicity, Case history, Fetal diseases, Teratogen, Pharmacovigilance, Recommendation, United States, North America, America
Notice produite par :
Inist-CNRS - Institut de l'Information Scientifique et Technique
Cote : 99-0082802
Code Inist : 002B02U10. Création : 31/05/1999.