Midwestern University Chicago College of Pharmacy, Downers Grove, Illinois 60515, USA.
Antimicrob Agents Chemother. 2010 Apr;54(4):1534-40. doi: 10.1128/AAC.01111-09. Epub 2010 Jan 19.
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.
2009 年 4 月，美国食品药品监督管理局（FDA）撤回了一项声明，该声明称头孢曲松和静脉用钙产品不应同时用于任何患者，以防止导致终末器官损伤的沉淀事件。在该声明发布后，我们试图评估该撤回是否合理。我们对 FDA 不良事件报告系统进行了搜索，以确定任何与头孢曲松-钙相互作用导致严重药物不良事件的情况。头孢他啶-钙被用作比较剂。确定了 104 例头孢曲松-钙和 99 例头孢他啶-钙的不良药物事件。根据药物参与的列出描述（主要或次要嫌疑）记录药物不良事件，并将其解释为可能、可能、不太可能或无关。对于头孢曲松-钙相关的不良事件，分别有 7.7%和 20.2%的事件被归类为栓塞的可能和可能。头孢他啶-钙导致的可能栓塞事件较少（4%），但更多的可能栓塞事件（30.3%）。在考虑头孢曲松或头孢他啶和钙作为主要或次要药物的病例中，有 1 例被归类为可能的栓塞事件。该患者接受了头孢曲松-钙治疗并死亡，尽管无法归因于因果关系。我们的分析表明，没有证据支持成人中发生头孢曲松-钙沉淀事件。当前分析的结果加强了 FDA 的修订建议，即>28 天的患者可以顺序接受头孢曲松和钙，并为此类评估提供透明和可重复的方法。
