{"id":487,"date":"2024-09-12T20:07:59","date_gmt":"2024-09-12T20:07:59","guid":{"rendered":"https:\/\/www.zavislostnakortikoidoch.sk\/?p=487"},"modified":"2024-09-12T21:47:07","modified_gmt":"2024-09-12T21:47:07","slug":"elidel-a-protopic-mozu-sposobovat-rakovinu-varuje-fda","status":"publish","type":"post","link":"https:\/\/www.zavislostnakortikoidoch.sk\/?p=487","title":{"rendered":"Elidel a Protopic m\u00f4\u017eu sp\u00f4sobova\u0165 rakovinu, varuje FDA"},"content":{"rendered":"

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FDA vydala v roku 2006 varovanie pre Elidel aj Protopic kv\u00f4li potenci\u00e1lnemu riziku rakoviny. Toto varovanie je zalo\u017een\u00e9 na \u0161t\u00fadi\u00e1ch na zvierat\u00e1ch, ktor\u00e9 preuk\u00e1zali zv\u00fd\u0161en\u00e9 riziko rakoviny ko\u017ee ako je lymf\u00f3m a melan\u00f3m. \u0160t\u00fadie sa uskuto\u010d\u0148ovali pri d\u00e1vkach vy\u0161\u0161\u00edch, ako be\u017ene pou\u017e\u00edvaj\u00fa pacienti a riziko rakoviny sa pod\u013ea FDA zvy\u0161ovalo so zvy\u0161uj\u00facou sa d\u00e1vkou a trvan\u00edm. \u0160t\u00fadie na \u013eu\u010foch vtedy jednozna\u010dne nepreuk\u00e1zali, \u017ee tieto lieky sp\u00f4sobuj\u00fa rakovinu, no FDA uviedla, \u017ee hoci pr\u00ed\u010dinn\u00e1 s\u00favislos\u0165 nebola stanoven\u00e1, teoretick\u00e9 riziko nemo\u017eno vyl\u00fa\u010di\u0165. Dlhodob\u00e9 \u0161t\u00fadie na \u013eu\u010foch st\u00e1le prebiehaj\u00fa, aby sa lep\u0161ie pochopili potenci\u00e1lne rizik\u00e1. [1]<\/p>\n

\n

Elidel (pimecrolimus) vyr\u00e1ba spolo\u010dnos\u0165 Novartis Pharmaceuticals a Protopic (tacrolimus) vyr\u00e1bala spolo\u010dnos\u0165 Astellas Pharma, spolo\u010dne tieto kr\u00e9my patria do skupiny topick\u00fdch inhib\u00edtorov kalcineur\u00ednu. Tieto produkty neobsahuj\u00fa kortikoidy.<\/strong><\/p>\n<\/blockquote>\n

\u0160t\u00fadie<\/strong><\/p>\n

R\u00f4zne \u0161t\u00fadie sk\u00famali, \u010di dlhodob\u00e9 pou\u017e\u00edvanie t\u00fdchto mast\u00ed skuto\u010dne zvy\u0161uje riziko rakoviny ko\u017ee. V\u00e4\u010d\u0161ina z t\u00fdchto \u0161t\u00fadi\u00ed bola financovan\u00e1 farmaceutick\u00fdmi spolo\u010dnos\u0165ami, \u010do m\u00f4\u017ee vzbudzova\u0165 ur\u010dit\u00fa obozretnos\u0165. Jedna \u0161t\u00fadia trvala 48 mesiacov, \u010do nie je dostato\u010dne dlh\u00e9 obdobie na spo\u013eahliv\u00e9 zhodnotenie rizika rakoviny. T\u00e1to \u0161t\u00fadia uviedla, \u017ee existuje len m\u00e1lo d\u00f4kazov o s\u00favislosti medzi lok\u00e1lnym pou\u017e\u00edvan\u00edm takrolimu alebo pimekrolimu a vznikom rakoviny ko\u017ee alebo lymf\u00f3mu. Pre pou\u017e\u00edvate\u013eov topick\u00e9ho takrolimusu bola miera v\u00fdskytu pre T-bunkov\u00fd lymf\u00f3m zv\u00fd\u0161en\u00e1 a incidencia sa zvy\u0161ovala aj s rast\u00facou kumulat\u00edvnou d\u00e1vkou. Zv\u00fd\u0161en\u00e1 miera sk\u00faman\u00fdch \u00fa\u010dinkov sa vyskytovala aj v skupine jedincov, ktor\u00ed u\u017e\u00edvali s\u00fa\u010dasne so spom\u00ednan\u00fdmi kr\u00e9mami aj topick\u00e9 kortikosteroidy, v skupine bez kortikosteroidov nebol tento v\u00fdskyt tak\u00fd \u010dast\u00fd. \u0160t\u00fadia bola financovan\u00e1 farmaceutickou firmou LEO Pharma, t\u00e1to inform\u00e1cia je uveden\u00e1 aj v z\u00e1vere dokumentu. [2] Leo Pharma k\u00fapila dermatologick\u00fa div\u00edziu Astellas Pharmas za 725 mili\u00f3nov dol\u00e1rov v roku 2015 a pracuje na v\u00fdvoji \u010fal\u0161\u00edch podobn\u00fdch produktov. [3]<\/p>\n

V niektor\u00fdch \u0161t\u00fadi\u00e1ch bola zaznamenan\u00e1 s\u00favislos\u0165 medzi pou\u017e\u00edvan\u00edm topick\u00fdch kalcineur\u00ednov\u00fdch inhib\u00edtorov a zv\u00fd\u0161en\u00fdm rizikom vzniku lymf\u00f3mu, aj ke\u010f riziko vzniku in\u00fdch druhov rakoviny sa nepotvrdilo. [4] Taktie\u017e aj port\u00e1l o lie\u010div\u00e1ch a ich ne\u017eiad\u00facich \u00fa\u010dinkoch Drugs.com uv\u00e1dza podobn\u00fa inform\u00e1ciu, \u017ee u pacientov lie\u010den\u00fdch topick\u00fdmi kalcineur\u00ednov\u00fdmi inhib\u00edtormi, vr\u00e1tane takrolimovej masti, boli hl\u00e1sen\u00e9 zriedkav\u00e9 pr\u00edpady mal\u00edgnych ochoren\u00ed ako rakovina ko\u017ee a lymf\u00f3my. [5]\u00a0\u00a0<\/p>\n

Z\u00e1ver<\/strong><\/p>\n

Je zn\u00e1me, \u017ee aj tieto kr\u00e9my sp\u00f4sobuj\u00fa syndr\u00f3m z\u00e1vislosti a po\u010das obdobia, kedy jedinec kr\u00e9m nepou\u017e\u00edva m\u00f4\u017ee d\u00f4js\u0165 k zhor\u0161eniu stavu ko\u017ee. Poko\u017eka je n\u00e1chyln\u00e1 k infekci\u00e1m, taktie\u017e m\u00f4\u017eu by\u0165 pr\u00edtomn\u00e9 alergick\u00e9 reakcie, za\u010dervenanie a opuch lymfatick\u00fdch uzl\u00edn. Ke\u010f\u017ee tento typ mast\u00ed m\u00e1 schopnos\u0165 potl\u00e1\u010da\u0165 imunitn\u00fd syst\u00e9m, pri dlhodobom pou\u017e\u00edvan\u00ed sa m\u00f4\u017ee u pacienta rozvin\u00fa\u0165\u00a0 n\u00e1dorov\u00e9 ochorenie lymfatick\u00fdch uzl\u00edn, tzv. lymf\u00f3m.\u00a0<\/p>\n

<\/strong><\/p>\n

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\u010co s\u00fa topick\u00e9 inhib\u00edtory kalcineur\u00ednu (TCI)?<\/strong><\/p>\n

Topick\u00e9 inhib\u00edtory kalcineur\u00ednu (TCI) je typ lieku pou\u017e\u00edvan\u00fd na lie\u010dbu atopick\u00e9ho ekz\u00e9mu u dospel\u00fdch a det\u00ed. \u201eTopick\u00e9\u201c znamen\u00e1, \u017ee sa aplikuj\u00fa na poko\u017eku. \u201eInhib\u00edtor kalcineur\u00ednu\u201c znamen\u00e1, \u017ee blokuj\u00fa kalcineur\u00edn, prote\u00edn, ktor\u00fd prispieva k z\u00e1palu pri atopickom ekz\u00e9me. Existuj\u00fa dva typy TCI: mas\u0165 Protopic (takrolimus) na lie\u010dbu stredne \u0165a\u017ek\u00e9ho a\u017e \u0165a\u017ek\u00e9ho ekz\u00e9mu a kr\u00e9m Elidel (pimekrolimus) na mierny a\u017e stredne \u0165a\u017ek\u00fd ekz\u00e9m.\u00a0 TCI sa m\u00f4\u017eu pou\u017e\u00edva\u0165 na lie\u010dbu aj prevenciu vzplanut\u00ed. M\u00f4\u017eu by\u0165 predp\u00edsan\u00e9 ako lie\u010dba na pou\u017eitie s topick\u00fdmi steroidmi alebo ako alternat\u00edva k topick\u00fdm steroidom.<\/p>\n

Ako funguj\u00fa?<\/strong><\/p>\n

Imunitn\u00fd syst\u00e9m \u013eud\u00ed s atopick\u00fdm ekz\u00e9mom prehnane reaguje na ur\u010dit\u00e9 dr\u00e1\u017ediv\u00e9 l\u00e1tky a alerg\u00e9ny v prostred\u00ed (napr\u00edklad v\u00fdlu\u010dky rozto\u010dov, plesne a pe\u013e). Inhib\u00edtory kalcineur\u00ednu spolupracuj\u00fa s imunitn\u00fdm syst\u00e9mom tak, \u017ee blokuj\u00fa konkr\u00e9tny prote\u00edn naz\u00fdvan\u00fd kalcineur\u00edn, ktor\u00fd zohr\u00e1va \u00falohu pri aktiv\u00e1cii imunitn\u00fdch buniek, ako s\u00fa T-bunky. T-bunky sa podie\u013eaj\u00fa na r\u00f4znych aspektoch atopick\u00e9ho ekz\u00e9mu, vr\u00e1tane z\u00e1palu a svrbenia. [6]\u00a0\u00a0<\/p>\n

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Pou\u017eit\u00e9 zdroje<\/strong><\/p>\n

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    \n
  1. Food and Drug Administration, Office of the Commissioner. Minutes of the Pediatric Advisory Committee meeting. February 14, 2005. Accessed August 24, 2020. [online] <\/span>https:\/\/wayback.archive-it.org\/7993\/20170404062542\/https:\/\/www.fda.gov\/ohrms\/dockets\/ac\/05\/minutes\/2005-4089m1_Minutes.pdf<\/a><\/li>\n
  2. Arana A. et al., Long-Term Risk of Skin Cancer and Lymphoma in Users of Topical Tacrolimus and Pimecrolimus: Final Results from the Extension of the Cohort Study Protopic Joint European Longitudinal Lymphoma and Skin Cancer Evaluation (JOELLE), Clin Epidemiol.<\/em> 2021; 13: 1141\u20131153. https:\/\/www.ncbi.nlm.nih.gov\/pmc\/articles\/PMC8721027\/pdf\/clep-13-1141.pdf<\/a><\/span><\/li>\n
  3. \u00a0About Leo Pharma, Wikipedia [online] https:\/\/en.wikipedia.org\/wiki\/Leo_Pharma<\/a><\/span><\/li>\n
  4. Lam M. et al.,\u00a0 Association Between Topical Calcineurin Inhibitor Use and Risk of Cancer, Including Lymphoma, Keratinocyte Carcinoma, and Melanoma. JAMA Dermatol.<\/em> 2021;157(5):549-558. https:\/\/jamanetwork.com\/journals\/jamadermatology\/fullarticle\/2778024<\/a><\/span><\/li>\n
  5. Protopic Side Effects, Drugs.com<\/span> [online] <\/span>https:\/\/www.drugs.com\/sfx\/protopic-side-effects.html<\/a><\/span><\/li>\n
  6. Topical Calcineurin Inhibitors (TCIs). National Eczema Society [online] https:\/\/eczema.org\/information-and-advice\/treatments-for-eczema\/topical-calcineurin-inhibitors\/#what-are<\/span><\/span><\/span><\/span><\/li>\n<\/ol>\n

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    FDA vydala v roku 2006 varovanie pre Elidel aj Protopic kv\u00f4li potenci\u00e1lnemu riziku rakoviny. Toto varovanie je zalo\u017een\u00e9 na \u0161t\u00fadi\u00e1ch na zvierat\u00e1ch, ktor\u00e9 preuk\u00e1zali zv\u00fd\u0161en\u00e9 riziko rakoviny ko\u017ee ako je lymf\u00f3m a melan\u00f3m. \u0160t\u00fadie sa uskuto\u010d\u0148ovali pri d\u00e1vkach vy\u0161\u0161\u00edch, ako be\u017ene pou\u017e\u00edvaj\u00fa pacienti a riziko rakoviny sa pod\u013ea FDA zvy\u0161ovalo so zvy\u0161uj\u00facou sa d\u00e1vkou a […]<\/p>\n","protected":false},"author":1,"featured_media":504,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_et_pb_use_builder":"on","_et_pb_old_content":"","_et_gb_content_width":"","footnotes":""},"categories":[1],"tags":[],"class_list":["post-487","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-uncategorized"],"yoast_head":"\nElidel a Protopic m\u00f4\u017eu sp\u00f4sobova\u0165 rakovinu, varuje FDA - TSW<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.zavislostnakortikoidoch.sk\/?p=487\" \/>\n<meta property=\"og:locale\" content=\"sk_SK\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Elidel a Protopic m\u00f4\u017eu sp\u00f4sobova\u0165 rakovinu, varuje FDA - TSW\" \/>\n<meta property=\"og:description\" content=\"FDA vydala v roku 2006 varovanie pre Elidel aj Protopic kv\u00f4li potenci\u00e1lnemu riziku rakoviny. 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