The effects of brand-generic substitution in antiepileptic treatment

Beata Tyszko,

Anna Staniszewska


The chronic character of the disease has a significant impact on expenses borne by individual patients and by the health care system. Patients diagnosed with epilepsy need a long-term treatment, which is often expensive. In order to minimize the costs, doctors are increasingly turning to prescribing cheaper generic drugs. On the one hand, from an economic perspective, such a solution is cost-effective; on the other hand, the choice of an inadequate treatment may have serious consequences for the patient’s health. Patients using drugs with a narrow therapeutic index should be careful because of differences in bioequivalence of medicinal products. An inadequate alteration of the treatment for epilepsy, either by replacing the original drug with a generic one or by replacing one generic drug with another,  may adversely affect the patient’s condition. It is important, then, that therapeutic decisions should not be guided chiefly by considerations of cost reduction for the patient, but first of all by possible future health effects.

Słowa kluczowe: padaczka, leczenie, leki przeciwpadaczkowe, leki generyczne

Skrzypczak Z., Haczyński J., Światowy rynek farmaceutyczny dobie kryzysu gospodarczego, “Problemy Zarządzania” 2012; 11, 1 (41); 2: 128–145.

Skrzypczak Z., Haczyński J., Struktura rynku farmaceutycznego wg rodzaju sprzedawanych leków, “Problemy Zarządzania” 2012; 11, 1 (41); 2: 138 – 145.

Gidal B., Tobjorn T., Substitution of generic drugs in epilepsy: Is there cause for concern?, “Epilepsia” 2008; 49 (Suppl. 9): 56–62.

Rascati K., Richards K., Johnsrud M., Effects of Antiepileptic Drug Substitutions on Epileptic Events Requiring Acute Care, “Pharmacotherapy” 2009; 29 (7): 769–774.

Lewek P., Kardas P., Generic drugs: The benefits and risks of making the switch, “The Journal of Family Practice” 2010; 59 (11): 634–640.

Staniszewska A., Co warto wiedzieć lekach generycznych, “Medycyna Pasje” 2010; 4 (9): 14–19.

Grochowska M., Przebieg badań klinicznych leków, “Biomedical” 2011,; accessed: 19.12.2015.

Żukowski P., Badania biorównoważności ich monitorowanie, in: Walter M. (ed), Badania kliniczne – organizacja, nadzór, monitorowanie, Onipharma, Warszawa 2004: 291–294.

Stańczak A., Leki oryginalne, czy leki generyczne, “Aptekarz Polski” 2011; 63 (41),; accessed: 19.12.2015.

Kaczmarek Ł., Innowacyjne generyki przyszłością gospodarki, “Laboratorium” 2012; 5–6: 6–9.

Wkład innowacyjnego przemysłu farmaceutycznego rozwój polskiej gospodarki, Raport PwC, 2011,; accessed: 23.12.2015.

Grzywińska D., Grzywińska A., Rynek leków generycznych Polsce, “Manager Apteki” 2010; 5,; accessed: 22.12.2015.

Kramer G., Biraben A., Carreno M., Current approaches to the use of generic antiepileptic drugs, “Epilepsy & Behavior” 2007; November: 46–52.

Gauthier-Lewis M., Smith J., Pharacologic Management of Epilepsy, “Louisiana Drug Utilization Review Education” 2011; Jan/Feb: 10–19.

Barnes N., Rascati K., Switching of Antiepileptic Drug Formulations, “The Journal of Pediatric Pharmacology and Therapeutics” 2010; 15: 64–65.

Evans J., Generic and Brand-Name AEDs Bioequivalent, “Internal Medicine News” 2010; June: 18.

MacDonald J.T., Breakthrough seizure following substitution of Depakene capsules (Abbott) with generic product, “Neurology” 1987; 37: 1885.

Berg M., Gross R., Tomaszewski K., Generic substitution in the treatment of epilepsy, “Neurology” 2008; 71: 525–530.

Fitzgerald C., Mercedes J., Generic Substitution of Levetiracetam Resulting in Increased Incidence of Breakthrough Seizures, “The Annals of Pharmacotherapy” 2011; 45: 27.

LeLorier J., Duh M., Paradis P., Clinical consequences of generic substitution of lamotrigine for patients with epilepsy, “Neurology” 2008; 70: 2179–2186.

Bialer M., Midha K., Generic products of antiepileptic drugs: perspective on bioequivalence and interchangeability,
“Epilepsia” 2010; 51 (6): 941–950.

Kesselheim A., Stedman M., Bubrick J., Seizure outcomes following the use of generic versus brand-name antiepileptic drugs: systematic review and meta-analysis, “Drugs” 2010; 70 (5): 605–621.

Bialer M., Generic products of antiepileptic drugs (AEDs): is it an issue?, “Epilepsia” 2007; 48 (10): 1825–1832.

Berg M., What’s the problem with generic antiepileptic drugs?: call to action, “Neurology” 2007; 68 (16): 1245–1246.

Andermann F., Gosselin A., Paradis P., Compulsory generic switching of antiepileptic drugs: high switchback rates to brand compounds compared to other drug classes, “Epilepsia” 2006; 48: 464–469.

Haskins L., Tomaszewski K., Crawford P., Patient and physician reactions to generic antiepileptic substitution in the treatment of epilepsy, “Epilepsy” 2005; 7: 98–105.

The Pharmaceutical Industry in Figures, Raport Europejskiej Federacji Stowarzyszeń Przemysłu Farmaceutycznego,; accessed: 02.01.2016.

Jak się prowadzi badania kliniczne, Badania kliniczne Polsce,; accessed: 05.03.2014.

Mendyk A., Leki oryginalne odtwórcze, “Puls Medycyny” 2008,,63366,leki-oryginalne-i-odtworcze; accessed: 23.12.2015.