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A five-year evaluation of reports of overdose with indinavir sulfate
Pharmacoepidemiology and drug safety, 2003-09, Vol.12 (6), p.449-457
Lehman, Heidi P.
Benson, Joan O.
Beninger, Paul R.
Anderson, Charles A.
Blumenthal, Steven J.
Sharrar, Robert G.
2003
Volltextzugriff (PDF)
Details
Autor(en) / Beteiligte
Lehman, Heidi P.
Benson, Joan O.
Beninger, Paul R.
Anderson, Charles A.
Blumenthal, Steven J.
Sharrar, Robert G.
Titel
A five-year evaluation of reports of overdose with indinavir sulfate
Ist Teil von
Pharmacoepidemiology and drug safety, 2003-09, Vol.12 (6), p.449-457
Ort / Verlag
Chichester, UK: John Wiley & Sons, Ltd
Erscheinungsjahr
2003
Quelle
MEDLINE
Beschreibungen/Notizen
Methods Analysis of indinavir overdose reports in Merck & Co., Inc.'s safety database through the first 5 years following US licensure of indinavir. Reports were classified as acute (single high dose in excess of 2400 mg), chronic (multiple extra doses, not exceeding 2400 mg per dose), single extra dose (not exceeding 2400 mg) and dose not reported. Results Seventy‐nine reports of indinavir overdose were reviewed (15 acute, 43 chronic, 13 single extra dose and 8 dose not reported). A total of 52/79 (66%) reports were associated with adverse events. For acute overdose reports with adverse events, indinavir doses ranged from 2.8 g to 48 g (median 6 g; mean 13 g); for acute overdose reports without adverse events, indinavir doses ranged from 4 g to 80 g (median 56 g; mean 45 g). Adverse events following acute and chronic exposures were similar; the most commonly reported adverse events included nausea, vomiting, abdominal pain and nephrolithiasis. Of the 52 patients with adverse events, 39 recovered, 6 had not recovered at the time of reporting and no information regarding outcome was provided in 7 reports. Conclusions Overdose with indinavir was associated with adverse events in the majority of reports. These were most commonly gastrointestinal and renal events, and were generally consistent with the known safety profile of indinavir. The majority of patients recovered. Copyright © 2003 John Wiley & Sons, Ltd.
Sprache
Englisch
Identifikatoren
ISSN: 1053-8569
eISSN: 1099-1557
DOI: 10.1002/pds.868
Titel-ID: cdi_crossref_primary_10_1002_pds_868
Format
–
Schlagworte
Adolescent
,
Adult
,
Adverse Drug Reaction Reporting Systems - utilization
,
adverse event
,
antiretroviral therapy
,
Child
,
Child, Preschool
,
Drug Overdose
,
Drug Therapy, Combination
,
HIV Infections - drug therapy
,
HIV Protease Inhibitors - poisoning
,
Humans
,
Indinavir - poisoning
,
medication error
,
Middle Aged
,
overdose
,
protease inhibitor
,
Suicide
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