期刊
ANTIMICROBIAL AGENTS AND CHEMOTHERAPY
卷 54, 期 4, 页码 1534-1540出版社
AMER SOC MICROBIOLOGY
DOI: 10.1128/AAC.01111-09
关键词
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资金
- Midwestern University Chicago College of Pharmacy (MWU CCP)
- MWU CCP Faculty Research Stimulation
- Society of Infectious Diseases Pharmacists: Infectious Diseases Pharmacotherapy Residency Award
- U.S. National Cancer Institute [1R01CA 10271301, 1K01CA134554-01]
- NATIONAL CANCER INSTITUTE [R01CA102713, K01CA134554] Funding Source: NIH RePORTER
In April 2009, the FDA retracted a warning asserting that ceftriaxone and intravenous calcium products should not be coadministered to any patient to prevent precipitation events leading to end-organ damage. Following that announcement, we sought to evaluate if the retraction was justified. A search of the FDA Adverse Event Reporting System was conducted to identify any ceftriaxone-calcium interactions that resulted in serious adverse drug events. Ceftazidime-calcium was used as a comparator agent. One hundred four events with ceftriaxone-calcium and 99 events with ceftazidime-calcium were identified. Adverse drug events were recorded according to the listed description of drug involvement ( primary or secondary suspect) and were interpreted as probable, possible, unlikely, or unrelated. For ceftriaxone-calcium-related adverse events, 7.7% and 20.2% of the events were classified as probable and possible for embolism, respectively. Ceftazidime-calcium resulted in fewer probable embolic events (4%) but more possible embolic events (30.3%). Among cases that considered ceftriaxone or ceftazidime and calcium as the primary or secondary drug, one case was classified as a probable embolic event. That patient received ceftriaxone-calcium and died, although an attribution of causality was not possible. Our analysis suggests a lack of support for the occurrence of ceftriaxone-calcium precipitation events in adults. The results of the current analysis reinforce the revised FDA recommendations suggesting that patients >28 days old may receive ceftriaxone and calcium sequentially and provide a transparent and reproducible methodology for such evaluations.
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