What's the problem with generic antiepileptic drugs? A call to action

Neurology

Volumn 68, Issue 16, 2007, Pages 1245-1246

  Berg, Michel J ^a  

^a STRONG MEMORIAL HOSPITAL   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ANTICONVULSIVE AGENT; GENERIC DRUG; ZONISAMIDE;

AREA UNDER THE CURVE; COST BENEFIT ANALYSIS; DRUG APPROVAL; DRUG MARKETING; DRUG SURVEILLANCE PROGRAM; EDITORIAL; EPILEPSY; FOOD AND DRUG ADMINISTRATION; HUMAN; MEDICAL LITERATURE; PRIORITY JOURNAL; UNSPECIFIED SIDE EFFECT;

ANTICONVULSANTS; COST-BENEFIT ANALYSIS; DRUG APPROVAL; DRUGS, GENERIC; EPILEPSY; HUMANS; PRODUCT SURVEILLANCE, POSTMARKETING; RECURRENCE; RISK ASSESSMENT; THERAPEUTIC EQUIVALENCY; TREATMENT OUTCOME; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 34247223819     PISSN: 00283878     EISSN: None     Source Type: Journal    
DOI: 10.1212/01.wnl.0000262876.37269.8b     Document Type: Editorial

References (9)

1. Approved drug products with therapeutic equivalence evaluations (Orange Book), 27th ed. 2007. http://www.fda.gov/cder/ob/. Accessed February 25, 2007.
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3. Henney JE. Review of generic bioequivalence studies. JAMA 1999;282: 1995.
4. Nightingale SL. Therapeutic equivalence of generic drugs: letter to health practitioners. January 28, 1998. http://www.fda.gov/cder/news/ nightgenlett.htm. Accessed February 25, 2007.
5. Liow KK, Barkley GL, Pollard JR, Harden C, Bazil CW. Position statement on the coverage of anticonvulsant drugs for the treatment of epilepsy. Neurology 2007;68:1249-1250.
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7. 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.
8. Berg MJ, Gross R. Physician and patients perceive that generic drug substitution of antiepileptic drugs can cause breakthrough seizures: results from a US survey. Epilepsia 2006;47 (suppl 4):155. Abstract.
9. Crawford P, Feely M, Guberman A, Kramer G. Are there potential problems with generic substitution of antiepileptic drugs? A review of issues. Seizure 2006;15:165-176.