Recommendations of the LICE study group regarding the use of generic antiepileptic drug products;Raccomandazioni del gruppo di studio LICE in merito all'utilizzo di prodotti generici di farmaci antiepilettici

Bollettino - Lega Italiana contro l'Epilessia

Volumn , Issue 135, 2008, Pages 33-39

  Perucca, Emilio ^a   Albani, Fiorenzo ^b   Capovilla, Giuseppe ^c   Dalla Bernardina, Bernardo ^d   Michelucci, Roberto ^e   Zaccara, Gaetano ^f  

^a UNIVERSITY OF PAVIA   (Italy)

^b UNIVERSITY OF BOLOGNA   (Italy)

^c CARLO POMA HOSPITAL   (Italy)

^d UNIVERSITY OF VERONA   (Italy)

^e BELLARIA HOSPITAL   (Italy)

^f SANTA MARIA ANNUNZIATA HOSPITAL   (Italy)

Author keywords

[No Author keywords available]

Indexed keywords

ANTICONVULSIVE AGENT; GENERIC DRUG; PHENYTOIN;

EPILEPSY; FOOD AND DRUG ADMINISTRATION; HUMAN; MEDICAL SOCIETY; PRESCRIPTION; REMISSION; REVIEW;

EID: 41349085183     PISSN: 0394560X     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

References (47)

1. American Academy of Neurology. Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology. Assessment: Generic substitution for antiepileptic medication. Neurology 1990;40:1641-1643.
2. American Medical Association. Featured Report: Generic Drugs (A-02), 2002. www.ama-assn.org/ama/pub/category/print/15279.html (ultimo accesso 2 gennaio 2006)
3. Argumosa A, Herranz, JL. lmpacto clinico y economico de los farmacos genéricos en el tratamiento de la epilepsia. Rev Neurol 2005;41:45-49.
4. Besag FMC. Is generic prescribing acceptable in epilepsy? Drug Safety 2000;23:173-182
5. Bochner F, Hooper WD, Tyrer JH, Eadie MJ. Factors involved in an outbreak of phenytoin intoxication. J Neurol Sci 1972;16:481-487.
6. Brown ES, Shellhorn E, Suppesh T. Gastrointestinal side effects after switch to generic valproate. Pharmacopsichiatr 1998;31:114.
7. Burkhardt RT, Leppik IE, Blesi K, Scott S, Gapany SR, Cloyd JC. Lower phenytoin serum levels in persons switched from brand to generic phenytoin. Neurology 2004;63:1494-1496.
8. Chappell B. Not what the doctor ordered. Queen's University Belfast., 1993, pp. 71-80 (citato da Crawford et al, 1996)
9. Committee for Proprietary Medicinal Products (CPMP) of the European Agency for Evaluation of Medicinal Products (EMEA) Note for Guidance for the Investigation of Bioavailability and Bioequivalence. 26 July 2001, EMEA, London. www.eudra.org/emea.html (ultimo accesso 2 gennaio 2006)
10. Crawford P, Hall WW, Chappell B, Collings J, Steward A. Generic prescribing for epilepsy. Is it safe? Seizure 1996;5:1-5.
11. Finestone AJ, Williams FF. Generic substitution resulting in toxicity. Pa Med 1985:88:34.
12. Gatti G, Furlanut M, Perucca E. Interindividual variability in the metabolism of antiepileptic drugs and its clinical implications. In: Pacifici GM, Pelkonen O, eds., Interindividual Variability in Human Drug Metabolism. London: Taylor and Francis Ltd., 2001:157-180
13. Gilman JT, Alvarez LA, Duchowny M. Carbamazepine toxicity resulting from generic substitution. Neurology 1993;42:2696-2697.
14. Gonzalez de Dios J, Ochoa-Sangrador C, Sempere AP. Farmacos genericos en el tratamiento de la epilepsia. Rev Neurol 2005;41:676-683.
15. Graves NM, Holmes GB, Leppik IE. Compliant populations: variability in serum concentrations. Epilepsy Res Suppl 1988;1:91-99
16. Guberman A, Corman C. Generic substitution for brand name antiepileptic drugs: A survey. Can J Neurol Sci 2000;27:37-43.
17. Hartley R, Alexandrowicz J, Ng PC, McLain B, Browmer CJ, Forsythe WI. Breakthrough seizures with generic carbamazepine: A consequence of poorer bioavailability? Brit J Clin Pract 1990;44:270-273.
18. Haskins LS, Tomaszewski KJ, Crawford P. Patient and physician reactions to generic antiepileptic substitution in the treatment of epilepsy. Epilepsy Behav 2005;7:98-105.
19. Henney, JE, Commissioner, Food and Drug Administration. Lettera a Ratcliffe Anderson E, Jr, Executive vice President and Chief Executive Officer, American Medical Association, 27 giugno, 2000 (citato da American Medical Association, 2002).
20. Hodges S, Forsythe WI, Gillies D, Remington H, Cawood A. Bioavailability and dissolution of three phenytoin preparations for children. Develop Med Child Neurol 1986;28:708-712.
21. Jain KK. Investigation and management of loss of efficacy of an antiepileptic medication using carbamazepine as an example. J Roy Soc Med 1993;86:133-136.
22. Jumao-as A, Bella I, Craig B, Lowe J, Dasheiff RM. Comparison of steady-state blood levels of two carbamazepine formulations. Epilepsia 1989;30:67-70.
23. Koch G, Allen JP. Untowards effects of generic carbamazepine therapy. Arch Neurol 1987;44:578-579.
24. Krämer G, Schneble H, Wolf P, Ad-hoc-Kommission der Deutschen Sektion der Internationalen Liga gegen Epilepsie. Risken der neuen Aut-idem-Regelung für die behandlung mit Antiepileptika. Akt. Neurol 2002;29:115-122.
25. Leppik IE, Cloyd JC, Sawchuk RJ, Pepin SM. Compliance and variability of plasma phenytoin levels in epileptic patients. Ther Drug Monit 1979;1:475-483.
26. Manson JI, Beal SM, Magarey A, et al. Bioavailability of phenytoin from various pharmaceutical preparations in children. Med J Aust 1975;2:590-592.
27. McDonald JT. Breakthrough seizure following substitution of Depakene capsules (Abbott) with a generic product. Neurology 1987;37:1885.
28. Meyer MC, Straughn AB, Jarvi EJ, et al. The bioinequivalence of carbamazepine tablets with a history of clinical features. Pharm Res 1992;9:1612-1616.
29. Meyer MC, Straughn AB. Biopharmaceutical factors in seizure control and drug toxicity. Am J Hosp Pharm 1993; 50 (suppl. 5):S17-S22.
30. Mikati M, Bassett N, Schachter S. Double-blind randomized study comparing brand-name and generic phenytoin monotherapy. Epilepsia 1992;33:359-365.
31. National Institute of Clinical Excellence. Newer drugs for epilepsy. Technology Appraisal 76, National Institute of Clinical Excellence, London, 2004. www.nice.org.uk/TA076guidance (ultimo accesso 2 gennaio 2006)
32. National Institute of Clinical Excellence. Newer drugs for epilepsy in children. Technology Appraisal 79, National Institute of Clinical Excellence, London, 2004. www.nice.org.uk/TA079guidance (ultimo accesso 2 gennaio 2006)
33. Pedersen SA, Dam M. Karbamazepin: er synonim-praeparater ens. Ugerskr. Laeg 1985;147:2676-2677
34. Richens A. Impact of generic substitution of anticonvulsants on the treatment of epilepsy. CNS Drugs 1997;8:124-133.
35. Rosenbaum DH, Rowan AJ, Tuchman L, French JA. Comparative bioavailability of a generic phenytoin and Dilantin. Epilepsia 1994;35:656-660.
36. Sachdeo RC, Belendiuk G. Generic versus branded carbamazepine. Lancet 1987;1:1432.
37. Sansom LN, O'Reilly WJ, Wiseman CW, Stern LM, Derham J. Plasma phenytoin levels produced by various phenytoin preparations. Med J Austr 1975;2:593-595.
38. Scottish Intercollegiate Guidelines Network. Diagnosis anmd management of epilepsy in adults. Guideline No. 70, 2003. www.sign.ac.uk/sign.ac.uk/pdf/ sign70.pdf (ultimo accesso 2 gennaio 2006)
39. Scottish Intercollegiate Guidelines Network. Diagnosis anmd management of epilepsies in children and yoing people. Guideline No. 81, 2005. www.sign.ac.uk/pdf/sign81.pdf (ultimo accesso 2 gennaio 2006)
40. Soryal I, Richens A. Bioavailability and dissolution of proprietary and generic formulations of phenytoin. J Neurol Neurosurg Psychiatry 1992;55:688-692
41. Stewart MJ, Ballinger BR, Devlin EJ, Miller AY, Ramsay AC. Bioavailability of phenytoin. A comparison of two preparations. Eur J Clin Pharmacol. 1975;9:209-212.
42. Tammisto P, Kauko K, Viukari M. Bioavailability of phenytoin. Lancet 1976;1;254-255.
43. Vadney VJ, Kraushaar KW. Effects of switching from Depakene to generic valproic acid on individuals with mental retardation. Ment Retard 1997;35:468-476.
44. Van Emmerink F. Bureau urges continuity in antiepilepsy treatment. BMJ 2005;331:720.
45. Welty TE, Pickering PR, Hale BC, Arazi R. Loss of seizure control associated with generic substitution of carbamazepine. Ann Pharmacother 1992;26:775-777.
46. Wilner AN. Therapeutic equivalency of generic antiepileptic drugs: Results of a survey. Epilepsy Behav 2004;5:995-998.
47. Wyllie E, Pippenger CE, Rothner AD. Increased seizure frequency with generic primidone. JAMA 1987;258:1216-1217.