| Abstract | Objectives: Hypothyroidism is a very common disorder and refers to all pathological conditions defined by deficiency of hormones thyroxine and triiodothyronine. The total prevalence, according to previously conducted studies, is around 3%, and of undiagnosed hypothyroidism it is 5%. A gold standard in treatment of this disease is levothyroxine.
Patients and Methods: Levothyroxine oral tablets marketed in Croatia were studied. Adverse drug reaction reports for levothyroxine obtained from 1 January 2006 to 31 December 2018 were included. The following data were analyzed: year, reporter qualification, patient gender and age, seriousness, concomitant therapy and system organic class according to MedDRA.
Results: During period from 2006 to 2018 the total number of levothyroxine adverse drug reaction reports was 146. In year 2018 22.76% of all the reports was obtained. Female gender reported adverse drug reactions predominately, compared to male, 121 vs. 22 reports. In 75.2% of the reports the only involved drug was levothyroxine. Pharmacists most commonly reported adverse drug reactions with 64 reports. Almost 75% of the reports were not classified as serious. Injury, poisoning and procedural complications, General disorders and administration site disorders and Gastrointestinal disorders with 16.9%, 15.3% and 11.2% of the reactions respectively were most commonly reported system organ classes.
Conclusion: During the examined period reports of adverse drug reactions for oral tablets of levothyroxine were classified as not serious. Future studies should involve other countries reports and other drug formulations of levothyroxine in order to improve knowledge of levothyroxine safety profile. |
| Abstract (croatian) | Ciljevi: Hipotireoza je vrlo čest poremećaj, a odnosi se na sva patološka stanja definirana nedostatkom hormona tiroksina i trijodtironina. Prema prethodno provedenim istraživanjima ukupna učestalost u populaciji iznosi oko 3%, a nedijagnosticirane hipotireoze prema procjenama ima oko 5%. Zlatni standard u liječenju ove bolesti je levotiroksin.
Pacijenti i metode: U ovo istraživanje su uključene isključivo tablete za oralnu primjenu levotiroksina koje se nalaze na tržištu u Republici Hrvatskoj. Uključene su sumnje na nuspojave levotiroksina zaprimljene od 1. siječnja 2006. do 31. prosinca 2018. godine. Analizirani su sljedeći podaci: godina prijave, kvalifikacija izvjestitelja, spol i dob pacijenta, ozbiljnost nuspojave, istodobna primjena drugih lijekova u terapiji i organski sustavi prema MedDRA klasifikaciji.
Rezultati: Tijekom razdoblja od 2006. do 2018. godine ukupan broj sumnji na levotiroksin bio je 146. U 2018. godini prijavljeno je 22,76% svih sumnji. Ženski spol pretežno je izvijestio o nuspojavama lijekova, u usporedbi s muškim, 121 prema 22 prijave. U 75,2% prijava jedini lijek bio je levotiroksin. Ljekarnici su najčešće prijavljivali, s 64 prijavljene sumnje na nuspojave levotiroksina. Gotovo 75% sumnji nije klasificirano kao ozbiljno. Ozljede, trovanja i proceduralne komplikacije, Opći poremećaji i poremećaji na mjestu primjene te Gastrointestinalni poremećaji sa 16,9%, 15,3% i 11,2% reakcija najčešće su prijavljeni u sistemskim klasama sustava.
Zaključak: Tijekom ispitivanog razdoblja sumnje na nuspojave lijekova za levotiroksin nisu klasificirane kao ozbiljne. Buduća istraživanja trebaju uključivati podatke drugih zemalja, a i druge formulacije lijekova levotiroksina, kako bi se poboljšalo znanje o sigurnosnom profilu levotiroksina. |
