Background Oral anticoagulants are established drugs of choice for the prevention and treatment of thromboembolic events. However, monitoring their safety remains warranted. Objective The aim was to analyze spontaneous reports of adverse drug reactions related to oral anticoagulants in the Czech Republic. Setting Retrospective observational pharmacovigilance study. Methods Adverse drug reaction reports were obtained from the State Institute for Drug Control between January 2005 and November 2017. Reports related to warfarin, dabigatran, apixaban, and rivaroxaban received from healthcare professionals and patients were analyzed. Main outcome measure Frequency and nature of adverse drug reactions reported to oral anticoagulants. Results In total, 297 reports containing 672 adverse drug reactions were received; 269 reports were sent by healthcare professionals (85% by physicians). In 65% of all reports, reactions were due to direct oral anticoagulants. A higher total number of adverse drug reactions was associated with direct oral anticoagulants than with warfarin [reporting odds ratio (ROR): 10.76; confidence interval (CI): 8.70-13.32; p < 0.001]. Along with the increasing utilization of direct oral anticoagulants, the reporting rate gradually declined over time, especially for rivaroxaban and apixaban. Fatal outcomes were reported in 7%, mostly for dabigatran. Hemorrhagic reactions were the most frequently reported adverse drug reactions (37% associated with dabigatran, 28% with apixaban, 24% with warfarin, and 23% with rivaroxaban), and compared to warfarin, they were significantly more often associated with direct oral anticoagulants (ROR: 14.36; CI: 9.57-21.54; p < 0.001). Conclusion The number of adverse drug reaction reports related to oral anticoagulants in the Czech Republic was relatively low, compared to other studies, but 96% of the cases were serious. Data from spontaneous adverse drug reactions reporting should be further analyzed in order to obtain additional information on the safety profile of oral anticoagulants.
- MeSH
- antikoagulancia škodlivé účinky MeSH
- aplikace orální MeSH
- cévní mozková příhoda * farmakoterapie MeSH
- dabigatran škodlivé účinky MeSH
- fibrilace síní * farmakoterapie MeSH
- lidé MeSH
- nežádoucí účinky léčiv * diagnóza epidemiologie MeSH
- retrospektivní studie MeSH
- warfarin terapeutické užití MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- časopisecké články MeSH
- Geografické názvy
- Česká republika MeSH
- MeSH
- chinolony * MeSH
- Evropská unie MeSH
- fluorochinolony * MeSH
- kontrola léčiv a omamných látek MeSH
- lidé MeSH
- postmarketingový dozor * MeSH
- systémy pro sběr zpráv o nežádoucích účincích léků MeSH
- Check Tag
- lidé MeSH
- Geografické názvy
- Evropa MeSH
Článek uvádí doporučení, jak hodnotit riziko léčiv užívaných matkou pro její kojené dítě. Možné riziko určitého množství léčiva, obsaženého v mateřském mléce, je vždy třeba porovnávat s přínosy kojení. Vzhledem k tomu, že kojení má velký význam nejen pro zdraví, správný růst a vývoj dítěte, ale také pro zdraví matky, nemělo by být nikdy doporučeno jeho předčasné ukončení kvůli léčbě matky, aniž by byly stanoveny závažné důvody. Při posuzování možného rizika je třeba prostudovat co nejvíce údajů o přestupu léčiva do mateřského mléka, o farmakokinetice daného léčiva v organismu dítěte a o jeho doložených či potenciálních nežádoucích účincích u kojených dětí. Rovněž je třeba posoudit celkový zdravotní stav konkrétního dítěte.
The article aims at recommendations how to assess the risk of drugs, taken by the mother, to her breastfed child. Some amount of drug present in breast milk always carries possible risks for an infant, however, these risks should be weight to benefits of breastfeeding itself. Breastfeeding offers big advantages for health state, healthy growth and development of the child, but also for the health of the mother. Therefore, it should not be prematurely terminated due to mother´s therapy without any concrete serious reason. During the assessment of possible risks for the infant it is necessary to study all available data on the transfer of the drug into breast milk, on pharmacokinetics in the infant and on the documented or suspected adverse reactions in breastfed infants. The general health state of the infant should be taken into consideration as well. The basic source of information is the Summary of Product Information for the concrete medicinal product which contains well documented and approved data. However, for majority of medicinal products there is not enough of well-documented data on drug use during breastfeeding. Therefore, any further data should be searched in scientific literature. A physician who prescribes a medicine to a breastfeeding woman should always explain her all the possible risks and instruct her on the possible manifestation of adverse reactions and on the need to consult in time a paediatrician. During the treatment of the mother the physician should be with her in close contact and should carefully follow conditions of the breastfed child.
