Loss of response after switching from brand name to generic formulations: Three cases and a discussion of key clinical considerations when switching

International Clinical Psychopharmacology

Volumn 25, Issue 3, 2010, Pages 180-182

  Margolese, Howard C ^a   Wolf, Yaël ^a   Desmarais, Julie Eve ^a   Beauclair, Linda ^a  

^a Allan Memorial Institute   (Canada)

Author keywords

Adverse effects; Biological availability; Brand name drug; Generic drug; Generic switching; Relapse; Therapeutic equivalency

Indexed keywords

AMFEBUTAMONE; DIAZEPAM; FLUOXETINE; GENERIC DRUG; IMIPRAMINE; MIRTAZAPINE; OLANZAPINE; PROCYCLIDINE; RISPERIDONE; TRAZODONE; VALPROATE SEMISODIUM;

ADULT; ARTICLE; BIOEQUIVALENCE; CASE REPORT; DEPRESSION; DETERIORATION; DIAGNOSTIC AND STATISTICAL MANUAL OF MENTAL DISORDERS; DRUG FORMULATION; DRUG SUBSTITUTION; ENERGY; EVENING DOSAGE; FEMALE; HUMAN; MAJOR DEPRESSION; MALE; MENTAL CONCENTRATION; MOOD; OBSESSIVE COMPULSIVE DISORDER; PARANOID SCHIZOPHRENIA; PHARMACIST; PRIORITY JOURNAL; PSYCHOTHERAPY; SUICIDAL IDEATION; TREATMENT OUTCOME; TREATMENT RESPONSE;

DRUGS, GENERIC; FEMALE; FLUOXETINE; HUMANS; MALE; MIANSERIN; MIDDLE AGED; RECURRENCE; THERAPEUTIC EQUIVALENCY; VALPROIC ACID;

EID: 77950942361     PISSN: 02681315     EISSN: None     Source Type: Journal    
DOI: 10.1097/YIC.0b013e328337910b     Document Type: Article

References (24)

1. Blier P (2007). Generic medications: another variable in the treatment of illnesses. J Psychopharmacol 21:459-460.
2. Borgherini G (2003). The bioequivalence and therapeutic efficacy of generic versus brand-name psychoactive drugs. Clin Ther 25:1578-1592.
3. Canadian Generic Pharmaceutical Association (2006). Brand name drugs versus generic drugs: what's the difference? http://www.canadiangenerics.ca/en/ resource/BrandvsGeneric-What%27stheDifference.pdf
4. Chenu F, Batten LA, Zernig G, Ladstaetter E, Hebert C, Blier P (2009). Comparison of pharmacokinetic profiles of brand-name and generic formulations of citalopram and venlafaxine: a crossover study. J Clin Psychiatry 70:958-966.
5. Crawford P, Feely M, Guberman A, Kramer G (2006). Are there potential problems with generic substitution of antiepileptic drugs? A review of issues. Seizure 15:165-176.
6. Cutler NR (2001). Pharmacokinetic studies of antipsychotics in healthy volunteers versus patients. J Clin Psychiatry 62 (Suppl 5):10-13.
7. Davies G (2001). Changing the salt, changing the drug. Pharm J 266:322-323.
8. Duh MS, Andermann F, Paradis PE, Weiner J, Manjunath R, Cremieux PY (2007). The economic consequences of generic substitution for antiepileptic drugs in a public payer setting: the case of lamotrigine. Dis Manag 10:216-225.
9. Duh MS, Cahill KE, Paradis PE, Cremieux PY, Greenberg PE (2009). The economic implications of generic substitution of antiepileptic drugs: a review of recent evidence. Expert Opin Pharmacother 10:2317-2328.
10. European Agency For The Evaluation Of Medicinal Products (2000). Evaluation of medicines for human use. Note for guidance on the investigation of bioavailability and bioequivalence. http://www.emea.europa.eu/pdfs/human/qwp/ 140198en.pdf
11. Food and Drug Administration (2001). Center for Drug Evaluation and Research (CDER). Guidance for industry: statistical approaches to establishing bioequivalence.
12. Food and Drug Administration (2002). The FDA's drug review process: ensuring drugs are safe and effective. http://www.fda.gov/Fdac/features/2002/ 402-drug.html
13. Food and Drug Administration (2005). Frequently asked questions on patents and exclusivity. http://www.fda.gov/Drugs/DevelopmentApprovalProcess/ ucm079031.htm#How%20 many%20years%20is%20a%20patent% 20granted%20for? Health Canada.
14. Health Products and Food Branch (2005). Guidance for industry- bioequivalence requirements: comparative bioavailability studies conducted in the fed state. Guideline A, guideline B and report C. http://www.hc-sc.gc.ca/ dhp-mps/prodpharma/applic-demande/guide-ld/bio/fedstate-sujetsjeun-e.html
15. Kumet R, Gelenberg AJ (2005). The effectiveness of generic agents in psychopharmacologic treatment. Essent Psychopharmacol 6:104-111.
16. Lam YW, Ereshefsky L, Toney GB, Gonzales C (2001). Branded versus generic clozapine: bioavailability comparison and interchangeability issues. J Clin Psychiatry 62 (Suppl 5):18-22. (Pubitemid 32295160)
17. Layton S, Barbeau M (2004). Generic replacement of clozapine: a simple decision model from a Canadian perspective. Curr Med Res Opin 20:453-459.
18. LeLorier J, Duh MS, Paradis PE, Lefebvre P, Weiner J, Manjunath R, Sheehy O (2008). Clinical consequences of generic substitution of lamotrigine for patients with epilepsy. Neurology, 70:2179-2186.
19. Meibohm B, Beierle I, Derendorf H (2002). How important are gender differences in pharmacokinetics? Clin Pharmacokinet 41:329-342.
20. Nador A, Szweras M (2002). Comparing canadian notice of compliance (NOC) regulations for patented medicines with corresponding United States and European Union provisions. Bereskin and Parr (Ed). http://www.bereskinparr.com/English/ publications/art-html/bio-noc-regul-nador.html
21. Shi S, Morike K, Klotz U (2008). The clinical implications of ageing for rational drug therapy. Eur J Clin Pharmacol 64:183-199.
22. Steinhoff BJ, Runge U, Witte OW, Stefan H, Hufnagel A, Mayer T, Kramer G (2009). Substitution of anticonvulsant drugs. Ther Clin Risk Manag 5:449-457.
23. Treur M, Heeg B, Moller HJ, Schmeding A, Van Hout B (2009). A pharmaco-economic analysis of patients with schizophrenia switching to generic risperidone involving a possible compliance loss. BMC Health Serv Res 9:32.
24. Van Ameringen M, Mancini C, Patterson B, Bennett M (2007). Symptom relapse following switch from Celexa to generic citalopram: an anxiety disorders case series. J Psychopharmacol 21:472-476.