TROVAN ® (trovafloxacine)

Fluoroquinolone 3ème génération actif sur le pneumocoque.
Pas encore commercialisé en France.
Voir présentation du produit ci dessous.

Source : Ambassade de France de Washington
Mission Scientifique et Technologique (http://www.france-science.org)
Washington, le jeudi 10 juin 1999

UN ANTIBIOTIQUE RESPONSABLE D'HEPATOTOXICITES SEVERES
La FDA (Food and Drug Administration) vient de prendre une mesure inhabituelle de restriction d'utilisation d'un médicament et d'envoyer un avis de danger aux médecins, leur recommandant de ne pas prescrire sauf en cas d'urgence, un antibiotique très prisé des praticiens: le Trovan.
En effet cet antibiotique produit commercialisé par la firme Pfizer, cause des destructions des tissus hépatiques, et depuis février 1998, 140 cas d'hépatotoxicité ont été observés chez les utilisateurs de Trovan.
Selon le New York Times (NYT), le Trovan est directement impliqué dans 14 cas de sévères atteintes hépatiques et a causé la mort de six personnes. Enfin, trois individus n'ont pu être sauvés que grâce à une greffe de foie.

Pour en savoir plus : Les restrictions d'indication



KIRKLAND, QC -- Jan. 19, 1999 -- Pfizer Canada Inc.’s powerful new antibiotic, Trovan(trovafloxacin)
The drug is expected to play a major role in the treatment of community-acquired pneumonia, a potentially-fatal lung infection which causes 7,000 deaths and affects nearly 360,000 Canadians each year.

Pneumonia can strike at any time, but is particularly prevalent in the winter months and can be devastating for seniors and those with other medical conditions such as chronic bronchitis and heart disease. Community-acquired pneumonia (CAP) is the fifth-leading cause of death for people 65 years of age and over.

"Ninety per cent of all deaths from community-acquired pneumonia occur in patients 60 years of age and over," said Dr. Karl Weiss, attending physician at the department of microbiology and infectious diseases of Hôpital Maisonneuve-Rosemont, in Montreal. "Early aggressive treatment with an antibiotic such as Trovan is essential for these patients in order to prevent the progression of the pneumonia and reduce the severity of the infection and associated mortality. Using the right antibiotic early is crucial."

"In serious infections like pneumonia, it is extremely difficult to determine the bacteria causing the infection at the time a patient presents with symptoms," said Dr. Michel Poisson, assistant-chief at the department of microbiology and attending microbiologist and infectious disease specialist at Hôpital Hôtel-Dieu of Montreal. "We try and make an educated guess, however, most of the time we are treating blind and use combinations of antibiotics to cover all likely suspects. Trovan is an exciting advance because it allows us to use one antibiotic to cover the likely pathogens, including the increasing number of bacteria that have become resistant to traditional antibiotics."

Trovan is a fourth generation quinolone. It is the first antibiotic to have activity against all four classes of pathogens. It is a once-a-day treatment taken as a tablet or administered intravenously. Trovan's ease of use will make it possible for some patients, who would otherwise be hospitalised, to be effectively treated in the community. This may prevent patients from being hospitalised altogether or allow them to be discharged earlier.

wbm@esculape.com
Sommaire FMC