Naslov
ANALIZA SPONTANO PRIJAVLJENIH SUMNJI NA NUSPOJAVE LEVOTIROKSINA U REPUBLICI HRVATSKOJ
(ANALYSIS OF SPONTANEOUSLY REPORTED ADVERSE DRUG REACTIONS OF LEVOTHYROXINE IN CROATIA)

Autori
Koppmann, Ellen Sophie

Vrsta, podvrsta i kategorija rada
Ocjenski radovi, diplomski rad, diplomski

Fakultet
Medicinski fakultet

Mjesto
Split

Datum
09.10

Godina
2019

Stranica
38

Mentor
Modun, Darko

Ključne riječi
tiroksin, nuspojave lijekova, hipotireoza
(thyroxine, drug-related adverse effects, hypothyroidism)

Sažetak
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.

Izvorni jezik
Engleski

Znanstvena područja
Temeljne medicinske znanosti, Kliničke medicinske znanosti

POVEZANOST RADA