Av To Usb Converter Radio Shack

MEDIATOR DRUG WITHDRAWN FROM MARKET

E 'was withdrawn in France, after causing 500 to 1000 deaths.

As we know from research on the Internet, the story that about a month ago in France led to the withdrawal of a drug indicated for the treatment of diabetes and obesity '("Mediator", manufactured by Servier) and reported to be responsible for hundreds of deaths [1] has the paradoxical.


With pharmacovigilance systems, there are many drugs that are withdrawn from circulation each year, or i quali vengono modificate le indicazioni terapeutiche, o aggiunti nuovi “warnings” in merito a possibili effetti collaterali, ma il caso del Mediator fa davvero storia a sè.

Il benfluorex, principio attivo del Mediator, e’ un derivato funzionale della fenfluramina, che riduce l’assorbimento dei grassi e l’iperglicemia.

Impiegato anche nel trattamento dell’obesita’, sulla base di studi centrati sui problemi legati al diabete di tipo 2 e’ stato in commercio anche in Italia fino al 2003, data della rinuncia volontaria da parte della ditta produttrice.
In Spagna e’ stato ritirato nello stesso anno per le segnalazioni di gravi effetti avversi di natura cardiovascolare: pulmonary hypertension and valvular disease.

In France, this drug, yet the subject of bitter controversy in 2005 [2], and 'always been marketed until last month.

But let's see what he says the Food and Drug Administration on fenfluramine [3]. We find that this molecule and 'was recorded in 1973 and the phentermine, often used in combination with the first, even in 1959. The first evidence of adverse reactions are reported in June 1997, it was 24 patients who had developed valvular disease and the particular cases was associated with recruitment of fen-phen (fenfluramine-phentermine). Followed by other reports which confirmed that the cardiovascular risk legato a questa combinazione di farmaci.


Il 15 settembre del 1997 la FDA annunciava l’immediato ritiro della Fenfluramine e Dexfenfluramine [4].
Queste molecole sono quindi state utilizzate per oltre 13 anni, in mercati importanti, pur in presenza di prese di posizione ufficiali da parte di una autorita’ regolatoria di un certo peso quale la FDA.



Alcune semplici considerazioni sulla vicenda:

- quando si dice che la sperimentazione su animali non e’ in grado di garantire la sicurezza di un farmaco e che la vera sperimentazione e’ fatta sui pazienti quanto il farmaco viene immesso sul mercato, si fa forse una semplificazione ma di fatto è esattamente quel che happens;

- the fact that a drug's risk proves important only when tested on hundreds of thousands or millions of people means that the so called "animal model" and 'of no use in highlighting the risks and benefits of a given molecule.

In this case, but not 'the only course, you have to ask' cause, rather than cover unnecessary studies on animal models, will not strengthen the activities seriously 'surveillance and epidemiological studies on drugs. One has to wonder how and 'possible that assessments of dangerousness' of a certain active ingredient are being ignored for decades by other national agencies that have responsibility for monitoring the efficacy and safety of drugs sold and administered by the respective health systems.


SOURCE: The leva.org