Drug products: Clarithromycin Aurobindo, Clarithromycin HEC, Clarithromycin HEC Pharm, Clarithromycin Hexal, Clarithromycin Krka, Clarithromycin Ranbaxy, Clarithromycin Teva, Klacid, Klaritromycin Abacus Medicine, Klaritromycin Ebb, Klaritromycin STADA, Nexium® HP
ATC code: A02BD06, J01FA09
Clarithromycin is associated with QT-prolongation on ECG and thus a risk of potentially fatal arrhythmias of the type Torsade de Pointes ventricular tachycardia. No difference in risk between men and women has been shown for clarithromycin but a known risk factor for Torsade de Pointes is female sex. A systematic review found the resistance of Helicobacter pylori to clarithromycin to be higher in women.
Pharmacokinetics and dosing
No studies with a clinically relevant sex analysis regarding pharmacokinetics or dosing of clarithromycin have been found.
Several studies report differences in Helicobacter pylori antibiotic resistance between men and women. A systematic review of 31 studies, published worldwide 2006-2009, found that overall, primary clarithromycin resistance was more common among women than men (20.5% vs. 15.5%). Also, clarithromycin resistance rate varied widely between different populations. High resistance was reported from Spain and Japan while low resistance was found in Sweden, the Netherlands and Malaysia . Similarly, in a German study analyzing positive Helicobacter pylori urease tests in 2015-2018 (929 men, 917 women, 5 unknown), female sex was associated with carrying clarithromycin-resistant H. pylori (adjusted OR 2.3, 95%CI 1.6-3.4) . In a retrospective observational cohort study, patients (44 men, 59 women) with severe asthma or bronchiectasis were treated with clarithromycin or azithromycin in addition to their standard treatment. Men with bronchiectasis were more likely to respond (symptom score) to treatment with macrolides than women, 53% vs. 27% .
Clarithromycin has been associated with prolonged QT-interval and a risk of Torsades de Pointes ventricular tachycardia [4, 5]. Among the known risk factors of drug-induced ventricular arrhythmias are female sex, hypokalemia, bradycardia, and base line QT-prolongation .
Reproductive health issues
Regarding teratogenic aspects, please consult Janusmed Drugs and Birth Defects (in Swedish, Janusmed fosterpåverkan).
Date of litterature search: 2021-02-09
- De Francesco V, Giorgio F, Hassan C, Manes G, Vannella L, Panella C et al. Worldwide H pylori antibiotic resistance: a systematic review. J Gastrointestin Liver Dis. 2010;19:409-14. PubMed
- Bluemel B, Goelz H, Goldmann B, Grüger J, Hamel H, Loley K et al. Antimicrobial resistance of Helicobacter pylori in Germany, 2015 to 2018. Clin Microbiol Infect. 2020;26(2):235-239. PubMed
- Coeman M, van Durme Y, Bauters F, Deschepper E, Demedts I, Smeets P et al. Neomacrolides in the treatment of patients with severe asthma and/or bronchiectasis: a retrospective observational study. Ther Adv Respir Dis. 2011;5:377-86. PubMed
- Shaffer D, Singer S, Korvick J, Honig P. Concomitant risk factors in reports of torsades de pointes associated with macrolide use: review of the United States Food and Drug Administration Adverse Event Reporting System. Clin Infect Dis. 2002;35:197-200. PubMed
- Clarithromycin Aurobindo (clarithromycin). Summary of Product Characteristics. Swedish Medical Products Agency. [updated 2021-11-30, cited 2021-02-09]
- Roden DM. Drug-induced prolongation of the QT interval. N Engl J Med. 2004;350:1013-22. PubMed
- Statistikdatabas för läkemedel. Stockholm: Socialstyrelsen. 2020 [cited 2021-03-10.] länk
Reviewed by: Diana Rydberg
Approved by: Karin Schenck-Gustafsson