ArticleNeurology2016
Switching generic antiepileptic drug manufacturer not linked to seizures: A case-crossover study.
Article in Neurology, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers, 2 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
11 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- Effects of generic exchange of solid oral dosage forms in neurological disorders: a systematic review.International journal of clinical pharmacy · 2020Pooled it
- Nocebo in Biosimilars and Generics in Neurology: A Systematic Review.Frontiers in pharmacology · 2019Pooled it
- Commentary: Consensus Guidelines on the Appropriate Use of Brand-Name and Generic Anti-Seizure Medication for the Management of Epilepsy in the Gulf Region.Neurology and therapy · 2023Article
- Attitudes towards the switching of anti-epileptic medications in pharmacies: the patients' perspective.Postepy psychiatrii neurologii · 2023Article
- Assessment of Variation in State Regulation of Generic Drug and Interchangeable Biologic Substitutions.JAMA internal medicine · 2021Article
- Considerations over a Case of Suspected Therapeutic Failure in Pediatric Patients after Switching Valproate Manufacturers.Innovations in pharmacy · 2020Article
- A Survey of Patients' Perceptions of Pill Appearance and Responses to Changes in Appearance for Four Chronic Disease Medications.Journal of general internal medicine · 2019Article
- Evaluation of Switching Patterns in FDA's Sentinel System: A New Tool to Assess Generic Drugs.Drug safety · 2018Article
- Advocacy for children with epilepsy: Leveraging the WHA resolution. Advocacy Task Force, Commission of Pediatrics, International League Against Epilepsy.Epilepsia open · 2018Review
- Risk-Based Bioequivalence Recommendations for Antiepileptic Drugs.Current neurology and neuroscience reports · 2017Review
- Safety of switching from brand-name to generic levetiracetam in patients with epilepsy.Drug design, development and therapy · 2017Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors.
Funding
Abstract
objectiveWith more antiepileptic drugs (AED) becoming available in generic form, we estimated the risk of seizure-related events associated with refilling generic AEDs and the effect of switching between different manufacturers of the same generic drug.
methodsWe designed a population-based case-crossover study using the Medicaid Analytic eXtract and a US commercial health insurance database. We identified 83,001 generic AED users who experienced a seizure-related hospital admission or emergency room visit between 2000 and 2013 and assessed whether they received a refill of the same AED from the same manufacturer or a different manufacturer. Patients served as their own controls and conditional logistic regression was used to compare exposure to a refill during the hazard period, defined as days 2-36 preceding the seizure-related event, to exposure during the control period, defined as days 51-85 preceding the seizure-related event.
resultsGeneric AED refilling was associated with an 8% increase in the odds of seizure-related events (odds ratio [OR] 1.08; 95% confidence interval [CI] 1.06-1.11). The OR following a switch to a different manufacturer of the same AED was 1.09 (95% CI 1.03-1.15); however, after adjusting for the process of refilling, there was no association between switching and seizure-related hospital visits (OR 1.00; 95% CI 0.94-1.07).
conclusionsAmong patients on a generic AED, refilling the same AED was associated with an elevated risk of seizure-related event; however, there was no additional risk from switching during that refill to a different manufacturer. Generic AEDs available to US patients, with Food and Drug Administration-validated bioequivalence, appear to be safe clinical choices.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.