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A Prospective Safety Surveillance Study for Bupropion Sustained-Release in the Treatment of Depression
Abstract
BACKGROUND: This prospective 105-site study was conducted to determine the rate of seizures and other serious adverse experiences associated with the therapeutic use of the sustained-release formulation of bupropion (bupropion SR). METHOD: 3100 patients with a DSM-III-R diagnosis of depression without a current or past diagnosis of an eating disorder and with no personal or family history of seizure disorders were treated for up to 8 weeks with bupropion SR in an open-label study. Dosing was initiated at 50 mg b.i.d. and increased to a maximum of 150 mg b.i.d. unless not tolerated. Patients had the option to continue treatment with bupropion SR (50 mg b.i.d. to 150 mg b.i.d.) in a continuation phase lasting up to 1 year. During the acute and continuation phases, patients were evaluated for the occurrence of seizures and other serious adverse experiences. Clinical response to and tolerability of bupropion SR were also evaluated. RESULTS: Three patients each experienced a seizure associated with the therapeutic use of bupropion SR during the acute and continuation phases combined. The observed seizure rate during the 8-week acute phase was 2 seizures in 3094 evaluable patients, or 0.06%. The observed seizure rate for the acute and continuation phases combined was 3 seizures in 3094 patients, or 0.10%. Survival analysis yielded a cumulative seizure rate of 0.08% for the acute phase and 0.15% for both phases combined. Two patients who intentionally overdosed with bupropion SR also experienced seizures; however, these events were not included in calculations of the overall seizure rate. Therapeutic doses of bupropion SR were well tolerated and clinically efficacious. CONCLUSION: The therapeutic use of bupropion SR at total daily doses up to 300 mg/day in depressed patients without predisposition to seizures is associated with a seizure rate that is well within the range observed with other marketed antidepressants.
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“However, with the development of bupropion sustained release (SR), the incidence of seizure was decreased to 0.1% in a study containing 3,094 patients (50–300 mg).51”
From Addressing the Side Effects of Contemporary Antidepressant Drugs: A Comprehensive Review (2018) · cites this paper as [51]
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“1% in a study containing 3,094 patients (50-300 mg).(51) The seizure incidence was similar to that of the general population (0.”
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BackgroundTreating Tobacco Use and Dependence
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“1% for daily doses lower than 450 mg (Dunner et al., 1998).”
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“While at doses up to 300 mg/day of its extended-release formulation bupropion use has been associated with an incidence of seizures comparable to that of other antidepressants (71), higher doses of this agent in its immediate release formulation are associated with a relatively higher risk for seizures (0.”
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BackgroundInfluentialTreatment of nicotine addiction: present therapeutic options and pipeline developments
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“A small risk of seizures has been observed; two large studies reported a seizure incidence of approximately 1 per 1000 [29,30].”
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“Two large studies, 1 of which was specifically for smoking cessation, reported seizure incidences of approximately 1 per 1,000.(37,38) Because of this risk, bupropion is contraindicated for patients with seizure disorders, bulimia, anorexia, and those undergoing alcohol or sedative withdrawal.”
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“1% with bupropion sustained release formulation doses up to 400mg/d (Dunner et al. 1998).”
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“Bupropion is associated with a rare, dose-related risk of seizures.(5,6) Because the risk of seizure appears to be related to peak plasma concentrations, interactions that result in the inhibition of bupropion’s metabolism could increase the likelihood of seizure.”
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“1%.[16] Given these results, it is very important that physicians prescribe bupropion SR in accordance with the manufacturer’s prescribing information.”
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“With the sustained release formulation, the rate is 0.1% at the target dose of 300mg/day (Dunner et al. 1998).”
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“This is in line with the number of events of this kind expected from the 1:1000 incidence of epileptic seizure described in the SmPC [3, 18] and trial data where patients did not have a predisposition to seizure [23].”
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A Case Report of Seizure Induced by Bupropion Nasal Insufflation
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Smoking Cessation Interventions in Clinical Practice
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Bupropion-induced convulsions: Preclinical evaluation of antiepileptic drugs
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“The incidence of seizures is 0.1% at doses up to 300 mg per day of sustained-release bupropion, and 0.4% at doses up to 450 mg per day of the immediate-release formulation (Dunner et al 1998).”
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“1%, however, which is comparable to, or better than, SSRIs and other antidepressants, at least at doses up to 300 mg daily.(97,98) Importantly, on the positive side regarding adverse effects, bupropion is associated with a lower risk of weight gain than other augmenters.”
ResultBupropion, a brief history of seizure risk
Tripp, A. C. (2010) · General Hospital Psychiatry · doi:10.1016/j.genhosppsych.2009.11.004 · Cited by 26
An update on therapeutics for tobacco dependence
Lancaster, T., Stead, L. F., & Cahill, K. (2007) · Expert Opinion on Pharmacotherapy · doi:10.1517/14656566.9.1.15 · Cited by 26
“A much larger, open, uncontrolled, observational, safety-surveillance study conducted by the manufacturers [25] examined 3100 adult patients using slow-release bupropion for 8 weeks for treatment of depression.”
BackgroundSmoking Cessation for Patients with Cardiovascular Disease
Joseph, A. M., & Fu, S. S. (2003) · American Journal of Cardiovascular Drugs · doi:10.2165/00129784-200303050-00005 · Cited by 24
Macaluso, M., Zackula, R., D’Empaire, I., Baker, B., Liow, K. K., & Preskorn, S. (2010) · Journal of Clinical Psychopharmacology · doi:10.1097/jcp.0b013e3181dbe1b4 · Cited by 23
“1% for the sustained release (SR) formulation at 300 mg daily.(2,3) A 1991 study conducted by Johnston et al(4) confirmed the 0.”
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A 60-Year-Old Woman With Mild Memory Impairment
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“In patients with no eating disorder and no prior risk factors for seizure, the seizure risk associated with sustained-release bupropion appears acceptably close to that of other antidepressants.(58)”
BackgroundASHP Therapeutic Position Statement on the Cessation of Tobacco Use
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“1%) when sustained-release bupropion was used in the treatment of depression.(59) For this reason, bupropion should be used with extreme caution in patients with a history of seizures, those who have experienced cranial trauma, and those receiving medications known to lower the seizure threshold or those with underlyi…”
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“Moreover, hydroxybupropion induced seizures more potently than bupropion in rodent experiments [12] and immediate release administration of bupropion was associated with a higher incidence of seizures than a sustained release administration in humans [10,13,14].”
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“…is well known, treatment with bupropion is contraindicated in patients with epilepsy or with a seizure history (Alper et al. 2007; Beyens et al. 2008; Davidson 1989; Dunner et al. 1998; Johnston et al. 1991; Kumlien and Lundberg 2009; Ross and Williams 2005; Starr et al. 2009; Tutka et al. 2005).”
Drug Class Review: Second-Generation Antidepressants
Gartlehner, G., Hansen, R. A., Reichenpfader, U., Kaminski, A., Kien, C., Strobelberger, M., Noord, M. V., Thieda, P., Thaler, K. J., & Gaynes, B. N. (2011) · Cited by 17
Lv, J., Hu, L., Zhuo, W., Zhang, C., Zhou, H., & Fan, L. (2015) · Pharmacogenetics and Genomics · doi:10.1097/fpc.0000000000000190 · Cited by 17
Acute myocardial infarction following bupropion (Zyban)
Patterson, R., & Herity, N. (2002) · QJM · doi:10.1093/qjmed/95.1.58 · Cited by 17
Cocaine-associated stroke: three cases and rehabilitation considerations
Tolat, M. W. O. D. R. D. (2000) · Brain Injury · doi:10.1080/026990500120673 · Cited by 17
“Initial concerns over seizures with bupropion treatment appear to have been over-stated [33] but would still be of some concern in the setting of underlying structural brain damage.”
BackgroundCorreia, M. S., Whitehead, E., Cantrell, F. L., et al. (2018) · Clinical Toxicology · doi:10.1080/15563650.2018.1493205 · Cited by 16
“Doses of up to 300mg daily in patients without epilepsy or notable risk factors for seizures do not appear to increase their incidence in these newer formulations [7].”
BackgroundBupropion for the treatment of seasonal affective disorder
Niemegeers, P., Dumont, G., Patteet, L., Neels, H., & Sabbe, B. (2013) · Expert Opinion on Drug Metabolism & Toxicology · doi:10.1517/17425255.2013.804062 · Cited by 13
“1%, which is similar to other antidepressants [88,89].”
BackgroundPsychopharmacohazardology: major hazards of the new generation of psychotherapeutic drugs
Zetin, M. (2004) · International Journal of Clinical Practice · doi:10.1111/j.1368-5031.2004.0088.x · Cited by 14
Sustained release bupropion: Overdose and treatment
White, R. S., & Langford, J. R. (2002) · The American Journal of Emergency Medicine · doi:10.1053/ajem.2002.31136 · Cited by 14
Bupropion Overdose: Significant Toxicity in Pediatrics
Brown, K. M., & Crouch, B. I. (2017) · Clinical Pediatric Emergency Medicine · doi:10.1016/j.cpem.2017.07.005 · Cited by 12
Psychosis Precipitated by Acetyl-L-Carnitine in a Patient With Bipolar Disorder
Evcimen, H., Mania, I., Matthews, M., et al. (2007) · The Primary Care Companion to The Journal of Clinical Psychiatry · doi:10.4088/pcc.v09n0114d · Cited by 13
Second-generation anti-depressants and risk of new-onset seizures in the elderly
Finkelstein, Y., Macdonald, E. M., Li, P., Mamdani, M., Gomes, T., & Juurlink, D. N. (2018) · Clinical Toxicology · doi:10.1080/15563650.2018.1483025 · Cited by 13
Buchanan, L. M. (2002) · Journal of the American Academy of Nurse Practitioners · doi:10.1111/j.1745-7599.2002.tb00120.x · Cited by 12
Metadata
- Authors
- Dunner, D. L., Zisook, S., Billow, A. A., Batey, S. R., Johnston, J. A., & Ascher, J. A.
- Venue
- The Journal of Clinical Psychiatry
- Publisher
- Physicians Postgraduate Press, Inc
- Published
- 1998-07-15
- Volume
- 59
- Issue
- 7
- Pages
- 366-373
- ISSN
- 0160-6689 (ISSN-L)
- OpenAlex
- W2080593090
- Cited by
- 180
- References
- 0
- Citations by year
- 2025: 2 · 2024: 2 · 2023: 3 · 2022: 5 · 2021: 4 · 2020: 6 · 2019: 3 · 2018: 5 · 2017: 4 · 2016: 5 · 2015: 3 · 2014: 2 · 2013: 6 · 2012: 2
- FWCI
- 3.89
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- The Journal of Clinical Psychiatry (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Pharmacology (medical) › Treatment of Major Depression
- Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Toxicology › Pharmacovigilance and Adverse Drug Reactions
- Health Sciences › Medicine › Psychiatry and Mental health › Electroconvulsive Therapy Studies
- Keywords
- bupropion sustained release, depression, seizures, adverse drug reactions, drug safety, antidepressant efficacy, drug tolerability, drug overdose, seizure risk
- MeSH terms
- Adolescent, Adult, Aged, Delayed-Action Preparations, Depressive Disorder, Drug Administration Schedule, Female, Humans, Male, Middle Aged, Patient Compliance, Product Surveillance, Postmarketing, Prospective Studies, Psychiatric Status Rating Scales, Seizures, Severity of Illness Index, Incidence, Survival Analysis, Bupropion, Treatment Outcome, Adverse Drug Reaction Reporting Systems, Antidepressive Agents, Second-Generation
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