Branded versus Generic Clozapine for Treatment of Schizophrenia

Makela, Eugene H.; Cutlip, William D.; Stevenson, James; Weimer, Jason; Abdallah, Ehab; Akhtar, Raja S; Aboraya, Ahmed; Günel, Erdoǵan

doi:10.1345/aph.1c069

Cited by 21 publications

(13 citation statements)

References 7 publications

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“…Therefore, it is extremely unlikely that our design merely failed to detect a small increase in utilization. The lack of an increase in utilization is consistent with previous reports by Makela et al (2003) and Stoner et al (2003) demonstrating that patients switched to generic clozapine did not show a deterioration in clinical status 2-4 months after the switch. Further, Sajbel, Carter, and Wiley (2001) showed a lack of leucopenia or a need to change clozapine dosages when patients were switched to Zenith Goldline Pharmaceuticals clozapine, which is also consistent with our data.…”

Section: Discussionsupporting

confidence: 91%

Clinical Equivalence of Generic Clozapine

Healy

Taylor

Goldman

et al. 2005

Community Ment Health J

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Section: Discussionsupporting

confidence: 91%

Clinical Equivalence of Generic Clozapine

Healy

Taylor

Goldman

et al. 2005

Community Ment Health J

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“…Most of this data is in the form of case reports, however several of these agents have been examined in a randomized cross-over studies (Lam et al, 2001;Kluznik et al, 2001;Kumet and Gelenberg, 2005) and have indicated a increased risk of symptom relapse when switched to generic. Other studies of clozapine and carbemazepine have not shown a significant deterioration in clinical symptoms following a switch to the generic preparation (Makela et al, 2003;Silpakit et al, 1997). The small literature on this issue to date is, therefore, inconclusive on the matter of bioequivalency between generic and brand name preparations.…”

Section: Discussionmentioning

confidence: 97%

Symptom relapse following switch from Celexa to generic citalopram: an anxiety disorders case series

et al. 2007

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Generic agents do not require large clinical trials of safety and efficacy to enter the market, although they must demonstrate both pharmacological and bioequivalence to the brand name drug. Bioequivalence is attained when the extent of absorption of the generic falls within an FDA predefined range relative to the brand name drug. This potential variation in bioequivalence is not thought to be clinically meaningful, however, there are reports of a lack of therapeutic equivalence between some generic medications and the brand name. This study examines the potential risks posed by a switch from Celexa to generic citalopram. Twenty patients at an Anxiety Disorders Clinic who were unknowingly switched to generic citalopram, from Celexa (Lundbeck, Montreal, Quebec, Canada) and experienced a re-emergence of their anxiety symptoms or development of new adverse events are described in this case series report. The mean time for re-emergence of symptoms or development of adverse events was 3.4 +/- 1.6 weeks (range 0.5-8 weeks). All patients reestablished previous treatment response with a change back to Celexa in a mean time of 3.8 +/- 2.6 weeks (range 0.7-12 weeks). Given these results, it is important for clinicians to be aware of the potential for loss of treatment effect or symptom re-emergence posed by a switch to a generic agent. Randomized, double blind, controlled investigations would likely provide useful information as current bioequivalence and pharmacological equivalence do not necessarily translate into clinical equivalence.

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“…Makela et al 52 conducted an observational study of 20 Clozariltreated outpatients with schizophrenia who were switched to generic clozapine. All were reported as being stable on brand-name clozapine for several months.…”

Section: Literature Reviewmentioning

confidence: 99%

Converting from brand-name to generic clozapine: A review of effectiveness and tolerability data

Bobo

Stovall

Knostman³

et al. 2010

American Journal of Health-System Pharmacy

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Available literature supports the effectiveness and safety of generic clozapine formulations in patients who previously were stable during treatment with brand-name clozapine. The risk of poor outcome after conversion to a generic clozapine formulation appears to be low but difficult to predict. Patients should be closely monitored during the first one to three months after conversion from one formulation to another.

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Branded versus Generic Clozapine for Treatment of Schizophrenia

Cited by 21 publications

References 7 publications

Clinical Equivalence of Generic Clozapine

Clinical Equivalence of Generic Clozapine

Symptom relapse following switch from Celexa to generic citalopram: an anxiety disorders case series

Converting from brand-name to generic clozapine: A review of effectiveness and tolerability data

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