Generic antiarrhythmics are not therapeutically equivalent for the treatment of tachyarrhythmias11∗Disclosure: This study was not written with support from or discussion with any pharmaceutical manufacturer.

Reiffel, James A.; Kowey, Peter R.

doi:10.1016/s0002-9149(00)00715-3

Cited by 41 publications

(3 citation statements)

References 11 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…In most cases, arrhythmia control was re-established when the patients were switched back to the trade-name drug [ 2 , 3 ]. These results can be attributed partly to differences in drug absorption as BE studies were performed in healthy volunteers while these older studies enrolled some post-myocardial patients in whom gastrointestinal absorption is altered [ 134 ].…”

Section: Generic Substitution Of Brand-name Aads With a Narrow Timentioning

confidence: 99%

Narrow therapeutic index drugs: a clinical pharmacological consideration to flecainide

Tamargo

Heuzey

Mabo

2015

Eur J Clin Pharmacol

192

141

View full text Add to dashboard Cite

PurposeThe therapeutic index (TI) is the range of doses at which a medication is effective without unacceptable adverse events. Drugs with a narrow TI (NTIDs) have a narrow window between their effective doses and those at which they produce adverse toxic effects. Generic drugs may be substituted for brand-name drugs provided that they meet the recommended bioequivalence (BE) limits. However, an appropriate range of BE for NTIDs is essential to define due to the potential for ineffectiveness or adverse events. Flecainide is an antiarrhythmic agent that has the potential to be considered an NTID. This review aims to evaluate the literature surrounding guidelines on generic substitution for NTIDs and to evaluate the evidence for flecainide to be considered an NTID.MethodsA review of recommendations from various regulatory authorities regarding BE and NTIDs, and publications regarding the NTID characteristics of flecainide, was carried out.ResultsRegulatory authorities generally recommend reduced BE limits for NTIDs. Some, but not all, regulatory authorities specify flecainide as an NTID. The literature review demonstrated that flecainide displays NTID characteristics including a steep drug dose–response relationship for safety and efficacy, a need for therapeutic drug monitoring of pharmacokinetic (PK) or pharmacodynamics measures and intra-subject variability in its PK properties.ConclusionsThere is much evidence for flecainide to be considered an NTID based on both preclinical and clinical data. A clear understanding of the potential of proarrhythmic effects or lack of efficacy, careful patient selection and regular monitoring are essential for the safe and rational administration of flecainide.Electronic supplementary materialThe online version of this article (doi:10.1007/s00228-015-1832-0) contains supplementary material, which is available to authorized users.

show abstract

Section: Generic Substitution Of Brand-name Aads With a Narrow Timentioning

confidence: 99%

Narrow therapeutic index drugs: a clinical pharmacological consideration to flecainide

Tamargo

Heuzey

Mabo

2015

Eur J Clin Pharmacol

192

141

View full text Add to dashboard Cite

show abstract

“…On the other hand, in a study about propafenone, Amit et al [ 1 ] reported that the generic formulation was found to be at least as safe and effective as the brand formulation with regard to atrial fibrillation recurrence, emergency room and hospital admissions, and necessity for concomitant therapy [ 5 ]. Another report evaluated the risk of thyroid dysfunction between patients using brand name versus generic formulations of amiodarone and found no difference in terms of incidence of thyroid dysfunction [ 6 ]. In general, however, there is little evidence of important clinical differences between generic and brand-name drugs in cardiovascular disease [ 7 ].…”

Section: Discussionmentioning

confidence: 99%

Appearances of Premature Atrial and Ventricular Contractions After Switching From Brand Name to Generic Cibenzoline

Oguri¹,

Fujiu²,

Oshima³

et al. 2023

Cureus

View full text Add to dashboard Cite

In antiarrhythmic drugs, the therapeutic window is narrower than in other drugs. Brand name and generic drugs do not use the same inactive ingredients and binder substances. We report a 78-year-old male patient who had been treated for asymptomatic atrial fibrillation and atrial/ventricular premature contractions. Brand name cibenzoline had completely suppressed all arrhythmias. When the medication was changed to the generic drug, the patient showed frequent palpitations and arrhythmias. After restarting the brand-name drug, the arrhythmias were completely suppressed again. These results showed clear differences between brand name and generic cibenzoline in a specific patient. This report is the first case to describe the diminished effectiveness of generic oral cibenzoline.

show abstract

“…Using the Naranjo probability scale, we documented an association between the generic drug and the development of atrial fibrillation, and we demonstrated in this case that a switch from the generic formulation of atenolol to the Tenormin ® -based therapy resulted in the improvement of symptoms, with an increase in plasma atenolol values. As other articles have suggested a difference in the clinical efficacy of the generic drug with respect to the brand formulations,[ 13 14 15 16 ] in recent times, a retrospective study performed in Italy has reported that off-patent generic drugs have the same efficacy as the brand formulation. [ 17 ]…”

Section: Discussionmentioning

confidence: 99%

Recurrence of atrial fibrillation after switching from brand to generic atenolol

Gallelli¹,

Maida²,

Staltari³

et al. 2015

Journal of Pharmacology and Pharmacotherapeutics

View full text Add to dashboard Cite

show abstract

Generic antiarrhythmics are not therapeutically equivalent for the treatment of tachyarrhythmias11∗Disclosure: This study was not written with support from or discussion with any pharmaceutical manufacturer.

Cited by 41 publications

References 11 publications

Narrow therapeutic index drugs: a clinical pharmacological consideration to flecainide

Narrow therapeutic index drugs: a clinical pharmacological consideration to flecainide

Appearances of Premature Atrial and Ventricular Contractions After Switching From Brand Name to Generic Cibenzoline

Recurrence of atrial fibrillation after switching from brand to generic atenolol

Contact Info

Product

Resources

About