Hormonálna antikoncepcia: prínosy vs. riziká | Medicínske právo
              

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Hormonálna antikoncepcia: prínosy vs. riziká


 | 16.12.2013 | komentárov: 369

Európska lieková agentúra (EMA) ukončila prehodnotenie bezpečnosti kombinovanej hormonálnej antikoncepcie s dôrazom na riziko vzniku venózneho tromboembolizmu (vznik krvných zrazenín). Prínos vraj prevyšuje nad rizikami užívania.

Obrazok Potvrdila, že používanie HAK všetkých typov mierne zvyšuje riziko krvných zrazenín, avšak toto riziko je podľa EMA nízke. Riziko zapríčinenia infarktu alebo cievnej príhody podľa agentúry nie je potvrdené. Napriek tomu zdôraznila potrebu dostatočnej informovanosti pacientok, ktoré by mali najmä poznať príznaky a vedieť ich rozpoznať. Lekári by mali pri jej predpisovaní pamätať na to, že individuálne faktory žien sa môžu časom meniť.

V súvislosti s prehodnocovaním bezpečnosti používania kombinovanej HAK boli prijaté nasledovné zistenia a závery, ktoré sú dôležité pre pacientky:

•    EMA prehodnocovala pomer prínosov a rizík v súvislosti s používaním kombinovanej HAK, najmä s dôrazom na riziko tromboembolizmu. Záverom hodnotenia je, že prínosy užívania kombinovanej HAK prevládajú nad rizikom vzniku krvných zrazením v žilách. Toto riziko je dlhodobo známe a je veľmi nízke.
•    Ženy, u ktorých sa počas používania kombinovanej HAK neobjavili žiadne problémy, nemusia užívanie prerušiť. Napriek tomu je potrebné, aby si boli vedomé rizika vzniku krvných zrazením, akokoľvek je toto riziko nízke.
•    Riziko vzniku krvných zrazením v žilách sa líši v závislosti od typu gestagénu, ktorý kombinovaná HAK obsahuje. Počet zaznamenaných prípadov sa pohybuje medzi  5 – 12 na 10 000 žien, ktoré kombinovanú HAK užívajú počas doby jedného roka. Pre porovnanie, u žien, ktoré kombinovanú HAK neužívajú, sa riziko pohybuje na úrovni 2 prípadov z 10 000 žien.
•    Ženy, ktoré užívajú kombinovanú HAK, by mali vedieť rozpoznať príznaky vzniku krvných zrazenín. Sú to: silná bolesť alebo opuch dolných končatín, náhla nevysvetliteľná dýchavičnosť, zrýchlené dýchanie alebo kašeľ, bolesť na hrudi, slabosť alebo tŕpnutie tváre, rúk alebo nôh. V prípade výskytu týchto príznakov je nutné okamžite vyhľadať lekára!
•    Pri užívaní kombinovanej HAK je zároveň nutné poznať faktory, ktoré zvyšujú riziko vzniku tromboembolizmu. Ide o fajčenie, nadváhu, vyšší vek, opakované migrény, vrodené predispozície na vznik krvných zrazenín v relatívne nízkom veku (<50 rokov), dlhodobo znížená pohyblivosť (napr. z dôvodu choroby alebo zranenia). Tieto rizikové faktory sa u žien môžu s časom meniť. Riziko vzniku krvných zrazenín v žilách je tiež vyššie počas prvého roka užívania kombinovanej HAK.
•    Kombinovaná HAK je na Slovensku viazaná na lekársky predpis z dôvodu nutnosti pravidelnej kontroly zdravotného stavu ženy, aby bolo minimalizované riziko vzniku možných vedľajších účinkov.
•    Ženy sa majú s lekárom poradiť o tom, ktorý typ antikoncepcie je pre nich najvhodnejší.

O záveroch Európskej liekovej agentúry pri predpisovaní a používaní kombinovanej HAK informoval Štátny ústav pre kontrolu liečiv hlavného odborníka MZ SR pre gynekológiu a pôrodníctvo, Slovenskú gynekologickú spoločnosť, Spoločnosť pre plánované rodičovstvo a Slovenskú lekárnickú komoru. Chceli by sme však dodať, že prehodnotenie sa týkalo možných rizík spojených so vznikom krvných zrazenín, avšak viaceré zdroje poukazujú na ďalšie možné problémy spojené s užívaním HAK. (napríklad pri cukrovke, žlčových kameňoch alebo ochoreniach pečene atď.)


Spracovala: Veronika Miková
Zdroj: http://www.sukl.sk/sk/bezpecnost-liekov/bezpecnostne-upozornenia/ema-ukoncila-prehodnocovanie-bezpecnosti-kombinovanej-hormonalnej-antikoncepcie?page_id=3505
Foto: thefreedigitalphotos.net



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