ArticleCMAJ : Canadian Medical Association journal = journal de l'Association medicale canadienne2011
Amiodarone-induced thyroid dysfunction: brand-name versus generic formulations.
Article in CMAJ : Canadian Medical Association journal = journal de l'Association medicale canadienne, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers, 1 of them a synthesis that pooled it.
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Who cites it
9 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Pooled it
- [Type 2 amiodarone-induced thyrotoxicosis: prevalence, time and predictors of development].Problemy endokrinologii · 2023Article
- Appearances of Premature Atrial and Ventricular Contractions After Switching From Brand Name to Generic Cibenzoline.Cureus · 2023Article
- Explainable Machine Learning Techniques To Predict Amiodarone-Induced Thyroid Dysfunction Risk: Multicenter, Retrospective Study With External Validation.Journal of medical Internet research · 2023Article
- Methodological Considerations for Comparison of Brand Versus Generic Versus Authorized Generic Adverse Event Reports in the US Food and Drug Administration Adverse Event Reporting System (FAERS).Clinical drug investigation · 2017Article
- Amiodarone-related thyroid dysfunction.Internal and emergency medicine · 2014Article
- Using fractional polynomials to model the effect of cumulative duration of exposure on outcomes: applications to cohort and nested case-control designs.Pharmacoepidemiology and drug safety · 2014Article
- Incidence and pattern of thyroid dysfunction in patients on chronic amiodarone therapy: experience at a tertiary care centre in oman.The open cardiovascular medicine journal · 2013Article
- The backlash against bioequivalence and the interchangeability of brand-name and generic drugs.CMAJ : Canadian Medical Association journal = journal de l'Association medicale canadienne · 2011Article
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10 authors.
Funding
Abstract
backgroundAmiodarone is associated with dysfunction of the thyroid. Concerns have arisen regarding the potential for adverse effects with generic formulations of amiodarone. We evaluated and compared the risk of thyroid dysfunction between patients using brand-name versus generic formulations of amiodarone and identified risk factors for thyroid dysfunction.
methodsWe conducted a retrospective cohort study of patients with atrial fibrillation aged 66 years and older. We used administrative databases that linked information on demographics and clinical characteristics, claims for prescription drugs and discharges from hospital. We estimated thyroid dysfunction using person-year incidence.
resultsOf the 60,220 patients in the cohort, 2804 (4.7%) used the brand-name formulation of amiodarone and 6278 (10.4%) used the generic formulation. Baseline characteristics between these two groups were comparable. The median maintenance dose of amiodarone was 200 mg/d for both groups. The total incidence rate for thyroid dysfunction was 14.1 per 100 person-years for both formulations. The mean time to clinical dysfunction of the thyroid was 4.32 years for the brand-name formulation and 4.09 years for the generic formulation. In a multivariate analysis, there was no significant difference in the incidence rates of thyroid dysfunction between the generic and brand formulations (hazard ratio 0.97, 95% confidence interval 0.87-1.08). Factors associated with an increased risk of thyroid dysfunction were being a woman, increasing age and having chronic obstructive pulmonary disease.
interpretationIn this population-based study, we saw no difference between brand-name and generic formulations of amiodarone in terms of incidence of thyroid dysfunction.
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