IEuropean Medicines Agency (EMA) yakaratidza chiratidzo chekuchengetedza zvakapoteredza semaglutide zvinodhaka, zvakadai seOzempic uye Wegovy, uye yakasarudza kuti kamwe kamwe kurasikirwa kwekuona nekuda kweoptic nerve neuropathy inofanira kuiswa mumapakeji avo.
Chinetso chakataurwa hachisi-arteritic anterior ischemic optic neuropathy (NAION), chiitiko chinovhiringidza kuyerera kweropa kune optic nerve uye inogona kukonzera kamwe kamwe, kusingarwadzi, chikamu kana kurasikirwa kwekuona zvachose; mushure me glaucoma, ndicho chimwe chezvikonzero zvinokonzera upofu kune vanhu vakuru.
Izvo EMA yakasarudza uye chii chinochinja
Iyo EMA's Pharmacovigilance Risk Assessment Committee (PRAC) akaongorora data kubva kumakiriniki ekuedzwa, zvidzidzo zvekucherechedza, mabhuku ezvesayenzi uye mishumo yemashure ekutengesa uye yakakurudzirwa kusanganisira NAION semugumisiro wakaipa we semaglutide nehuwandu hwe "zvisingawanzoitiki".
Iyo "isingawanzo" kupatsanura inoisa njodzi pane yakaderera. uye, maererano nemitemo yeEurope, izvi zvakaenzana nemigumisiro inogona kuitika kune 1 muvarwere vane 10.000 voga vanorapwa. Ruzivo rwechigadzirwa ruchashanda kuOzempic, Wegovy, uye Rybelsus.
Nzira yekudzora inoenderera mberiKurudziro yePRAC inofanirwa kutambirwa neKomiti YezveMishonga Yekushandisa Vanhu (CHMP) shanduko idzi dzisati dzanyatsoratidzwa mumapepa epasuru yenyika dzese.
Zvinotaurwa neuchapupu hwesainzi huripo
Nyevero yeEurope yakavakirwa pazviratidzo zvakabudiswa munguva pfupi yapfuuraMuna Chikunguru 2024, JAMA Ophthalmology yakashuma mukana wekuwedzera weNAION kune varwere vanobatwa semaglutide; meta-analysis yakatevera yakasimbisa iyi zano, kunyangwe yakasimbisa kuti humbowo hunoramba hushoma.
Mamwe mabasa akawedzera pfungwa: Chidzidzo cheFebruary 2025 chakabatana semaglutide uye tirzepatide kwete chete kuNAION, asiwo kune paracentral acute medial maculopathy, chirwere chinokanganisa macula.
Zvigumisiro hazvina kufananaOngororo yakarongeka yemiedzo ye78 ine vanopfuura 73.000 vatori vechikamu havana kuwana kushamwaridzana nechirwere cheshuga retinopathy kana mamwe matambudziko emaziso, kunyangwe yakachengetedza mukana wekubatana neNAION.
Nyanzvi dzinokurudzira kungwarira pakududzira dataSezvo endocrinologist Fernando Gerchman akapfupisa, zvakawanikwa zvinonongedza kune chiratidzo chinoda kudzokororwa pamberi peiyo causality isati yatangwa.
Kushanda muSpain uye kuita kwepasirese
MuSpain, iyo AEMPS yakanga yatonyevera nezve njodzi inogona kuitika yekurasikirwa kwekuona kamwe kamwe muvarwere vanobatwa ne semaglutide, kunyange zvazvo kuiswa kwepamutemo muSmPC uye pepa rinomirira chisarudzo chekupedzisira neCHMP.
Iyo Ozempic prospectus yakatosanganisira chirwere cheshuga retinopathy. seyakajairika maitiro akashata, kunyanya mune mamwe makiriniki profiles; yambiro itsva inowedzera NAION sechinhu chisingawanzoitiki.
Zvidzidzo zveepidemiological zvakakura zvakaratidza njodzi yepamusoro ne semaglutide yakaenzaniswa nekusaonekwa, iyo inoshandura, mumashoko akazara, kusvika kune imwe nyaya yekuwedzera pa10.000 munhu-makore ekurapa.
MuUnited States, gakava racho rakapfuura nhandare yemitemo., nemafemu emutemo ari kutevera kirasi-chiito kumatare kubva kuvarwere vanotaura kurasikirwa kwekuona mushure mekushandisa mishonga iyi; mishumo inoratidza kuti nyaya dzinodarika chiuru nemazana masere dziri kumirira.
Zvinokurudzira varwere uye nyanzvi
Shoko rinobva kuvakuru nderokudzikama uye kungwarira.: Kunyange zvazvo chiitiko chacho chisingawanzoitiki, chero kurasikirwa kwekuona kamwe kamwe, kunyange zvishoma uye kusarwadza, kunofanira kukurumidza kubvunzurudzwa kwechiremba.
Kana kuongororwa kweNAION kwakasimbiswa, kurudziro yemitemo ndeyekurega semaglotide uye kufunga dzimwe nzira, nguva dzose pasi pekutongwa kwechiremba uye nekunyatsotariswa.
Pharmacovigilance inosimbiswa, vachikurudzira nyanzvi nevarwere kuti vataure zviratidzo zvekuona uye kufungidzirwa kwakaipa kune masisitimu ehurumende kuti vavandudze kuonekwa.
Iwo mabhenefiti ekurapa eOzempic uye Wegovy anochengetwa mukutonga kwechirwere cheshuga chechipiri uye kuora muviri, asi kushandiswa kwavo kunofanira kuperekedzwa nemashoko akajeka engozi uye kuongororwa kwekliniki.
Iyo EMA yakarongwa yekuvandudzwa kwezvinotarisirwa Chiratidzo chekuchengetedza chinopenya kuti, kunyangwe yakaderera kuwanda, inoda kutariswa: humbowo hunoratidza hukama hunogona kuitika neNAION, zviremera zveSpain zviri kugadzirira shanduko, uye nyanzvi dzinoomerera pakuita chero chiratidzo chechiratidzo pasina kurasikirwa nekuona chokwadi chekuti, nekutarisirwa kwechiremba, chiyero chengozi chinoramba chiri chakanaka.