ST LOUIS (MD Consult) - On October 16, 2009, American Regent and the US Food and Drug Administration notified health care professionals of updated safety information for Dexferrum (iron dextran injection), an agent used in the treatment of iron-deficiency anemia. Anaphylactic-type reactions, including fatalities, have been reported after the parenteral administration of iron dextran injections. For this reason, the manufacturer has modified the Boxed Warning section of the product label.
Updated instructions for Dexferrum now include a recommendation for administering a test dose of the product before the first therapeutic dose is given. Prescribers should be aware that fatal reactions have also occurred during the period after the uneventful administration of the test dose. The product label states that a test dose of 0.5 mL of Dexferrum should be administered intravenously at a gradual rate over a period of at least 5 minutes. Although untoward reactions to the product are usually evident within a few minutes of exposure, patients should be observed for at least 1 hour. If no signs or symptoms of anaphylactic-type reactions occur, the full therapeutic dose of Dexferrum may be administered.
The Dexferrum label advises prescribers to observe patients receiving the product for signs or symptoms of anaphylactic-type reactions during product administration. Patients with a history of drug allergy or multiple drug allergies may be at increased risk of anaphylactic-type reactions. The manufactuer recommends that resuscitation equipment and personnel trained in the detection and treatment of anaphylactic-type reactions be readily available during Dexferrum administration.
In addition to the aforementioned changes made to the product label, statements have been added to clarify the differences in the chemical characteristics and clinical effects of different iron dextran preparations. The intent of these statements is to help minimize any confusion that may exist between the available products.
The manufacturer advises that Dexferrum be given only to patients in whom clinical and laboratory investigations have established an iron deficient state and whose conditions are not amenable to oral iron therapy.
圣路易斯(MD Consult)—— 2009年10月16日，美国Regent实验室和美国食品药品管理局向医务人员通报了一则关于Dexferrum(右旋糖酐铁注射液)的最新安全性信息，这是一种用于治疗缺铁性贫血的药物。有报告称，右旋糖酐铁注射液静脉给药后出现了过敏反应，甚至导致患者死亡。因此，Dexferrum的生产商修改了产品标签上的黑框警告内容。
Dexferrum的新版说明书建议，在首次给予治疗剂量之前先小剂量试用本品。处方医生应警惕，在给予患者相对安全的试用剂量后也曾出现过致命性不良反应。产品标签指出，应先静脉输注0.5 ml试用剂量的Dexferrum，输注速度应逐渐增加，输注时间不得少于5 min。虽然该药的不良反应通常出现于给药后数分钟内，但仍应坚持观察患者至少1 h。如果没有出现任何提示过敏反应的症状或体征，则可给予治疗剂量的Dexferrum。
Dexferrum产品标签建议，处方医生在本品给药期间应观察患者是否出现了提示过敏反应的症状或体征。既往有药物过敏史或多药过敏史的患者出现过敏反应的风险更高。生产商建议，在Dexferrum给药期间，应备有心肺复苏急救设备，最好还要有曾接受过敏反应诊断与治疗的专业人员在场。
除了上述修改以外，产品标签上还增加了一条声明，阐明不同的右旋糖酐铁制剂在化学特性和临床效果方面存在差异。该声明旨在帮助人们避免混淆几种市面上的同类产品。
生产商还建议，Dexferrum仅用于那些临床和实验室检查均明确提示缺铁状态，且无法采用口服铁剂治疗的患者。
