Av
Den europeiska läkemedelsmyndigheten, EMA, började i augusti 2011 att utreda bantningsläkemedel som innehåller den aktiva substansen orlistat. Detta efter att ett 30-tal rapporter om allvarliga leverbiverkningar inkommit till myndigheten under det senaste decenniet.
Efter granskningen konstaterar myndigheten att risken för leverskador är för låg för att godkännandet ska dras in, men anser att biverkningen bör stå med i produktinformationen.
I Sverige är finns de orlistatbaserade bantningspreparaten Alli, som marknadsförs av Glaxosmithkline, och Roches läkemedel Xenical. Orlistatbaserade läkemedel är det sista av tre stora bantningsläkemedel som fortfarande finns kvar på marknaden. Tidigare har EMA dragit tillbaka godkännandet för Sanofi-Aventis bantningsläkemedel med den aktiva substansen rimonabant och Abbotts preparat med substansen sibutramin. Detta efter att rimonabant lett till biverkningar i form av depression och sibutramin ökat risken för kardiovaskulära händelser.
Orlistat är en substans som hindrar kroppen från att ta upp fett i maten och istället för ut fettet med avföringen. Xenical godkändes i Sverige 1998 och är ett receptbelagt läkemedel som godkänts för behandling av personer med ett body mass index på 28 och uppåt. Alli däremot säljs receptfritt sedan 2009, något som kritiserats av bland annat specialistläkare inom ätstörningar då deras patienter börjat missbruka läkemedlet.
Efter granskningen konstaterar myndigheten att risken för leverskador är för låg för att godkännandet ska dras in, men anser att biverkningen bör stå med i produktinformationen.
I Sverige är finns de orlistatbaserade bantningspreparaten Alli, som marknadsförs av Glaxosmithkline, och Roches läkemedel Xenical. Orlistatbaserade läkemedel är det sista av tre stora bantningsläkemedel som fortfarande finns kvar på marknaden. Tidigare har EMA dragit tillbaka godkännandet för Sanofi-Aventis bantningsläkemedel med den aktiva substansen rimonabant och Abbotts preparat med substansen sibutramin. Detta efter att rimonabant lett till biverkningar i form av depression och sibutramin ökat risken för kardiovaskulära händelser.
Orlistat är en substans som hindrar kroppen från att ta upp fett i maten och istället för ut fettet med avföringen. Xenical godkändes i Sverige 1998 och är ett receptbelagt läkemedel som godkänts för behandling av personer med ett body mass index på 28 och uppåt. Alli däremot säljs receptfritt sedan 2009, något som kritiserats av bland annat specialistläkare inom ätstörningar då deras patienter börjat missbruka läkemedlet.
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