{"id":120305,"date":"2026-11-05T00:23:10","date_gmt":"2026-11-04T23:23:10","guid":{"rendered":"https:\/\/www.infokuryr.cz\/n\/?p=120305"},"modified":"2026-11-04T12:53:13","modified_gmt":"2026-11-04T11:53:13","slug":"zavazne-vedlejsi-ucinky-roky-varovnych-signalu-ema-nyni-toto-antidepresivum-prezkoumava","status":"publish","type":"post","link":"https:\/\/www.infokuryr.cz\/n\/2026\/11\/05\/zavazne-vedlejsi-ucinky-roky-varovnych-signalu-ema-nyni-toto-antidepresivum-prezkoumava\/","title":{"rendered":"Z\u00e1va\u017en\u00e9 vedlej\u0161\u00ed \u00fa\u010dinky, roky varovn\u00fdch sign\u00e1l\u016f: EMA nyn\u00ed toto antidepresivum p\u0159ezkoum\u00e1v\u00e1"},"content":{"rendered":"
<\/div>\n

Deanxit je v Evrop\u011b schv\u00e1len ji\u017e v\u00edce ne\u017e p\u016fl stolet\u00ed. Nyn\u00ed Evropsk\u00e1 agentura pro l\u00e9\u010div\u00e9 p\u0159\u00edpravky (EMA) vy\u0161et\u0159uje zpr\u00e1vy o z\u00e1va\u017en\u00e9m a trval\u00e9m neurologick\u00e9m po\u0161kozen\u00ed. V kv\u011btnu 2025 varoval belgick\u00fd \u00fa\u0159ad pro regulaci l\u00e9\u010div p\u0159ed t\u011bmito probl\u00e9my. V Indii byl l\u00e9k zak\u00e1z\u00e1n o deset let d\u0159\u00edve. EMA zah\u00e1jila celoevropsk\u00fd p\u0159ezkum a\u017e nyn\u00ed, v \u0159\u00edjnu 2026.<\/span><\/strong><\/p>\n

Evropsk\u00e1 agentura pro l\u00e9\u010div\u00e9 p\u0159\u00edpravky (EMA) zah\u00e1jila <\/span>bezpe\u010dnostn\u00ed p\u0159ezkum l\u00e9ku Deanxit<\/span><\/a> . L\u00e9\u010divo vyr\u00e1b\u011bn\u00e9 d\u00e1nskou farmaceutickou spole\u010dnost\u00ed Lundbeck se pou\u017e\u00edv\u00e1 k l\u00e9\u010db\u011b stav\u016f, jako je deprese a \u00fazkost.<\/span><\/p>\n

Vy\u0161et\u0159ov\u00e1n\u00ed bylo zah\u00e1jeno na z\u00e1klad\u011b 23 podez\u0159el\u00fdch p\u0159\u00edpad\u016f z\u00e1va\u017en\u00fdch neuropsychiatrick\u00fdch ne\u017e\u00e1douc\u00edch \u00fa\u010dink\u016f, kter\u00e9 belgick\u00fd regula\u010dn\u00ed \u00fa\u0159ad pro l\u00e9\u010div\u00e9 p\u0159\u00edpravky obdr\u017eel v letech 2024 a\u017e 2026. Jak <\/span>30. \u0159\u00edjna informovala agentura Reuters<\/span><\/a> , o\u010dek\u00e1v\u00e1 se, \u017ee vy\u0161et\u0159ov\u00e1n\u00ed bude dokon\u010deno do b\u0159ezna 2027. Mo\u017en\u00e9 d\u016fsledky sahaj\u00ed od dal\u0161\u00edch varov\u00e1n\u00ed a omezen\u00ed registrace a\u017e po \u00fapln\u00e9 sta\u017een\u00ed registrace l\u00e9ku.<\/span><\/p>\n

Mo\u017enost nevratn\u00e9ho po\u0161kozen\u00ed<\/span><\/h3>\n

Deanxit kombinuje dv\u011b \u00fa\u010dinn\u00e9 l\u00e1tky: antipsychotikum flupentixol a antidepresivum melitracen. V Evrop\u011b byl poprv\u00e9 schv\u00e1len 13. ledna 1971 v Rakousku. Dnes je l\u00e9k st\u00e1le schv\u00e1len v sedmi \u010dlensk\u00fdch st\u00e1tech EU, v\u010detn\u011b Rakouska, Belgie a \u0160pan\u011blska.<\/span><\/p>\n

Podle <\/span>ofici\u00e1ln\u00edho dokumentu, s n\u00edm\u017e Belgie po\u017e\u00e1dala o p\u0159ezkum agenturou EMA<\/span><\/a> , se u posti\u017een\u00fdch osob vyvinuly mimo jin\u00e9 p\u0159\u00edznaky podobn\u00e9 Parkinsonov\u011b chorob\u011b, poruchy pohybu a kognitivn\u00ed poruchy. P\u0159\u00edznaky se pohybovaly od mimovoln\u00edch pohyb\u016f a hyperkineze (motorick\u00fd neklid) a\u017e po ztr\u00e1tu pam\u011bti a n\u011bkdy p\u0159etrv\u00e1valy i po vysazen\u00ed l\u00e9ku. To nen\u00ed p\u0159ekvapiv\u00e9: Flupentixol blokuje dopaminov\u00e9 receptory. Skute\u010dnost, \u017ee tyto l\u00e9ky mohou zp\u016fsobovat extrapyramidov\u00e9 poruchy pohybu, je zn\u00e1ma ji\u017e des\u00edtky let.<\/span><\/p>\n

N\u011bkolik pacient\u016f bylo l\u00e9\u010deno kombinovan\u00fdm l\u00e9kem Deanxit po mnoho let, v n\u011bkter\u00fdch p\u0159\u00edpadech a\u017e 25 let \u2013 a to i p\u0159esto, \u017ee se ji\u017e objevily neurologick\u00e9 vedlej\u0161\u00ed \u00fa\u010dinky. N\u011bkte\u0159\u00ed jedinci nakonec skon\u010dili v nemocnici; v n\u011bkter\u00fdch p\u0159\u00edpadech byly p\u0159\u00edznaky tak z\u00e1va\u017en\u00e9, \u017ee byly provedeny testy na Parkinsonovu chorobu nebo demenci. <\/span>N\u011bkter\u00e9 p\u0159\u00edznaky p\u0159etrv\u00e1valy i po ukon\u010den\u00ed l\u00e9\u010dby. Belgick\u00e9 \u00fa\u0159ady se nyn\u00ed ob\u00e1vaj\u00ed, \u017ee po\u0161kozen\u00ed m\u016f\u017ee b\u00fdt nevratn\u00e9.<\/span><\/strong><\/p>\n

Agentura si tak\u00e9 klade ot\u00e1zku, zda kombinace obou \u00fa\u010dinn\u00fdch l\u00e1tek ve fixn\u00edch d\u00e1vk\u00e1ch nab\u00edz\u00ed v\u016fbec n\u011bjak\u00fd p\u0159\u00ednos. D\u016fkazy o \u00fa\u010dinnosti kombinovan\u00e9ho l\u00e9ku poch\u00e1zej\u00ed ze star\u00fdch klinick\u00fdch studi\u00ed s pochybnou platnost\u00ed. Byl l\u00e9k schv\u00e1len\u00fd v roce 1971 za tehdej\u0161\u00edch regula\u010dn\u00edch podm\u00ednek po cel\u00e1 desetilet\u00ed pou\u017e\u00edv\u00e1n p\u0159ev\u00e1\u017en\u011b nekriticky?<\/span><\/p>\n

Tato kombinace byla v Indii zak\u00e1z\u00e1na ji\u017e v roce 2014<\/span><\/h3>\n

V kv\u011btnu 2025 zve\u0159ejnila Belgick\u00e1 agentura pro l\u00e9\u010div\u00e9 p\u0159\u00edpravky bezpe\u010dnostn\u00ed upozorn\u011bn\u00ed t\u00fdkaj\u00edc\u00ed se p\u0159\u00edpad\u016f symptom\u016f podobn\u00fdch Parkinsonov\u011b chorob\u011b a kognitivn\u00edho po\u0161kozen\u00ed spojen\u00fdch s p\u0159\u00edpravkem Deanxit. Varovala tak\u00e9 p\u0159ed mo\u017enou chybnou diagn\u00f3zou v d\u016fsledku symptom\u016f a v\u00fdznamn\u00fdm zhor\u0161en\u00edm kvality \u017eivota.<\/span><\/p>\n

Navzdory tomuto varov\u00e1n\u00ed byl l\u00e9k nad\u00e1le pod\u00e1v\u00e1n a byly obdr\u017eeny dal\u0161\u00ed zpr\u00e1vy. To je znepokojiv\u00e9, proto\u017ee nap\u0159\u00edklad <\/span>v Indii<\/span><\/a> byla distribuce l\u00e9ku pozastavena ji\u017e v roce 2013 a l\u00e9k byl zak\u00e1z\u00e1n v roce 2014. Kritika l\u00e9ku tedy nen\u00ed v \u017e\u00e1dn\u00e9m p\u0159\u00edpad\u011b nov\u00e1. Nicm\u00e9n\u011b teprve 16. \u0159\u00edjna 2026 byl na \u017e\u00e1dost Belgie zah\u00e1jen evropsk\u00fd p\u0159ezkumn\u00fd postup \u2013 zhruba 17 m\u011bs\u00edc\u016f po n\u00e1rodn\u00edm ozn\u00e1men\u00ed o bezpe\u010dnosti. A dlouho pot\u00e9, co se v Indii diskutovalo o \u00fa\u010dinnosti l\u00e9ku, jeho bezpe\u010dnosti a pochybn\u00fdch \u00fadaj\u00edch.<\/span><\/p>\n

Bude zaj\u00edmav\u00e9 sledovat, zda EMA p\u0159esto dosp\u011bje k z\u00e1v\u011bru, \u017ee p\u0159\u00ednosy l\u00e9ku p\u0159eva\u017euj\u00ed nad riziky\u2026<\/span><\/p>\n

\"\"<\/p>\n

 <\/p>\n","protected":false},"excerpt":{"rendered":"

Deanxit je v Evrop\u011b schv\u00e1len ji\u017e v\u00edce ne\u017e p\u016fl stolet\u00ed. Nyn\u00ed Evropsk\u00e1 agentura pro l\u00e9\u010div\u00e9…<\/p>\n","protected":false},"author":2,"featured_media":120306,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":[],"categories":[7],"tags":[11979,132,1020,21],"_links":{"self":[{"href":"https:\/\/www.infokuryr.cz\/n\/wp-json\/wp\/v2\/posts\/120305"}],"collection":[{"href":"https:\/\/www.infokuryr.cz\/n\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.infokuryr.cz\/n\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.infokuryr.cz\/n\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.infokuryr.cz\/n\/wp-json\/wp\/v2\/comments?post=120305"}],"version-history":[{"count":0,"href":"https:\/\/www.infokuryr.cz\/n\/wp-json\/wp\/v2\/posts\/120305\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.infokuryr.cz\/n\/wp-json\/wp\/v2\/media\/120306"}],"wp:attachment":[{"href":"https:\/\/www.infokuryr.cz\/n\/wp-json\/wp\/v2\/media?parent=120305"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.infokuryr.cz\/n\/wp-json\/wp\/v2\/categories?post=120305"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.infokuryr.cz\/n\/wp-json\/wp\/v2\/tags?post=120305"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}