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Safety profile of oxcarbazepine: results from a prescription-event monitoring study

Safety profile of oxcarbazepine: results from a prescription-event monitoring study
Safety profile of oxcarbazepine: results from a prescription-event monitoring study
Purpose: To monitor safety of oxcarbazepine, prescribed in primary care in England, using prescription-event monitoring (PEM). Methods: Postmarketing surveillance using observational cohort technique of PEM. Exposure data were obtained from dispensed British National Health Service prescriptions issued by general practitioners (GPs) March 2000–July 2003. Demographic, drug utilization, and clinical event data were collected from questionnaires posted to GPs at least 6 months after first prescription date for each patient. Incidence densities (IDs) (number of first reports per 1,000 patient-months of treatment) were calculated and differences for events reported in month 1 (ID1) and months 2–6 (ID2–6) (99% confidence intervals) were examined for changes in event rates. Follow-up and causality assessment of medically significant events were undertaken. Results: The cohort comprised 2,243 patients [mean age 40.4 years; range 2–99 years; standard deviation (SD) 18.8; 46.3% (n = 1,038) male]. Most frequently reported primary indications were epilepsy, convulsion (n = 1,111; 49.5%, n = 209; 9.3%, respectively). GPs recorded 932 reasons for stopping medication in 698 (31.1%) patients; most frequent clinical reason “drowsiness/sedation” (n = 57; 2.5% of cohort). Clinical events (excluding indication) associated with starting treatment (lower 99% CI > 0) included: “drowsiness/sedation” (ID1-ID2–6 = 14.2), “nausea/vomiting” (ID1-ID2–6 = 13.0), and dizziness (ID1-ID2–6 = 11.6). Events followed up and assessed as probably related to oxcarbazepine use included rash (7 of 11) and hyponatremia (15 of 38). Discussion:  There were no serious adverse drug reactions reported during this study. Results of the study should be taken in context with other epidemiologic studies.
0013-9580
818-829
Buggy, Y.
b3ad4b24-fde8-47c1-a728-96e4b9df6b3b
Layton, D.
ffe4fa31-837c-46bf-aa15-fe28cbf0ca7f
Fogg, Carole
42057537-d443-462a-8944-c804252c973b
Shakir, S.
0cb615ce-d9db-4f7d-bba9-5a95c4a6144b
Buggy, Y.
b3ad4b24-fde8-47c1-a728-96e4b9df6b3b
Layton, D.
ffe4fa31-837c-46bf-aa15-fe28cbf0ca7f
Fogg, Carole
42057537-d443-462a-8944-c804252c973b
Shakir, S.
0cb615ce-d9db-4f7d-bba9-5a95c4a6144b

Buggy, Y., Layton, D., Fogg, Carole and Shakir, S. (2010) Safety profile of oxcarbazepine: results from a prescription-event monitoring study. Epilepsia, 51 (5), 818-829. (doi:10.1111/j.1528-1167.2009.02489.x).

Record type: Article

Abstract

Purpose: To monitor safety of oxcarbazepine, prescribed in primary care in England, using prescription-event monitoring (PEM). Methods: Postmarketing surveillance using observational cohort technique of PEM. Exposure data were obtained from dispensed British National Health Service prescriptions issued by general practitioners (GPs) March 2000–July 2003. Demographic, drug utilization, and clinical event data were collected from questionnaires posted to GPs at least 6 months after first prescription date for each patient. Incidence densities (IDs) (number of first reports per 1,000 patient-months of treatment) were calculated and differences for events reported in month 1 (ID1) and months 2–6 (ID2–6) (99% confidence intervals) were examined for changes in event rates. Follow-up and causality assessment of medically significant events were undertaken. Results: The cohort comprised 2,243 patients [mean age 40.4 years; range 2–99 years; standard deviation (SD) 18.8; 46.3% (n = 1,038) male]. Most frequently reported primary indications were epilepsy, convulsion (n = 1,111; 49.5%, n = 209; 9.3%, respectively). GPs recorded 932 reasons for stopping medication in 698 (31.1%) patients; most frequent clinical reason “drowsiness/sedation” (n = 57; 2.5% of cohort). Clinical events (excluding indication) associated with starting treatment (lower 99% CI > 0) included: “drowsiness/sedation” (ID1-ID2–6 = 14.2), “nausea/vomiting” (ID1-ID2–6 = 13.0), and dizziness (ID1-ID2–6 = 11.6). Events followed up and assessed as probably related to oxcarbazepine use included rash (7 of 11) and hyponatremia (15 of 38). Discussion:  There were no serious adverse drug reactions reported during this study. Results of the study should be taken in context with other epidemiologic studies.

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e-pub ahead of print date: 22 April 2010
Published date: 1 May 2010

Identifiers

Local EPrints ID: 437014
URI: http://eprints.soton.ac.uk/id/eprint/437014
ISSN: 0013-9580
PURE UUID: 6889576b-ab6a-4bfa-9fa8-a09f605ecc30
ORCID for Carole Fogg: ORCID iD orcid.org/0000-0002-3000-6185

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Date deposited: 15 Jan 2020 17:30
Last modified: 27 Jan 2020 13:58

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Contributors

Author: Y. Buggy
Author: D. Layton
Author: Carole Fogg ORCID iD
Author: S. Shakir

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