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Come abbiamo accennato appena ieri, il farmaco dimagrante Acomplia (principio attivo rimonabant) è stato ritirato dal commercio nell’ottobre del 2008 dietro disposizione dell’Agenzia Italiana del Farmaco a seguito della conferma, da parte del comitato per i medicinali per uso umano dell’EMEA (Agenzia Europea per i medicinali), dell’elevatissimo rischio di effetti collaterali a livello psichico dovuti alla sua assunzione. All’epoca il farmaco, in commercio in Europa dal 2006, aveva fatto il proprio ingresso nelle nostre farmacie da soli cinque mesi (nel maggio 2008) e veniva usato dietro controllo medico come terapia aggiuntiva a dieta ed esercizio fisico nel trattamento dell’obesità in presenza di fattori di rischio. Ma qual era il suo meccanismo di azione?

Il rimonabant è una molecola che agisce sul sistema dei cannabinoidi endogeni, recettori localizzati sia a livello cerebrale che periferico, coinvolti nella regolazione dell’appetito e per i quali è stata dimostrata una sovrastimolazione in pazienti obesi con conseguente incontrollata assunzione di cibo e accumulo di grasso. Poichè stimolando i recettori per i cannabinoidi si ha un aumento della fame mentre la loro inibizione ha l’effetto opposto, rimonabant veniva utilizzato per le sue proprietà anoressizzanti che esplicava proprio bloccando l’azione di tali recettori purtroppo però con conseguenze deleterie a livello psichico.

In realtà però già nel 2007 l’americana FDA (Food and Drugs Administration) aveva rilevato disturbi psichiatrici nel 26% dei pazienti trattati con il farmaco e votato all’unanimità contro la sua immissione in commercio mentre la commissione europea aveva chiesto all’EMEA di rivedere il profilo di sicurezza del farmaco, che d’altra parte era già controindicato in pazienti depressi, in base ad alcune segnalazioni circa la sua sicurezza psichiatrica. Dagli studi clinici effettuati è emerso quanto già rilevato negli Stati Uniti e cioè il forte rischio di disturbi psichiatrici quali ansia, depressione, aggressività e persino tendenze suicide, tutto questo a fronte di un’efficacia piuttosto limitata in termini di controllo del rischio cardiovascolare e della perdita di peso.

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