ST LOUIS (MD Consult) - On March 10, 2010, the US Food and Drug Administration issued a notice to health care professionals about a safety issue associated with the use of WinRho SDF, an intravenous immune globulin (human).

Cases of intravascular hemoloysis (IVH) and its complications, including fatalities, have been reported in patients treated with WinRho SDF for immune thrombocytopenic purpura (ITP). Intravascular hemolysis can lead to clinically-compromising anemia and multisystem organ failure including acute respiratory distress syndrome. Serious complications, including severe anemia, acute renal insufficiency, renal failure, and disseminated intravascular coagulation, have also been reported. Fatal outcomes associated with IVH and its complications have occurred most frequently in patients of advanced age (>65 years) with comorbid conditions.

Accordingly, a Boxed Warning has been added to the label for WinRho SDF, which strengthens the warnings related to the risk of developing IVH in the patients with ITP. The information provided includes the following:

 

·         Patients should be closely monitored in a health care setting for at least 8 hours after administration of WinRho SDF.

·         A dipstick urinalysis should be performed at baseline, 2 hours, and 4 hours after product administration as well as before the end of the monitoring period.

·         Patients should be alerted to and should monitor themselves for signs and symptoms of IVH, including back pain, shaking chills, fever, and discolored urine or hematuria. (However, absence of these signs and/or symptoms of IVH within 8 hours of product administration does not indicate IVH cannot subsequently occur.)

·         If signs and/or symptoms of IVH are present or if IVH is suspected after WinRho SDF administration, post-treatment laboratory testing should include urinalysis as well as measurements of plasma hemoglobin, haptoglobin, L-lactate dehydrogenase, and plasma bilirubin (direct and indirect).

圣路易斯(MD Consult)——2010年3月10日，美国食品药品管理局(FDA)就使用WinRho SDF(一种人体静脉注射用免疫球蛋白)相关的安全性问题向医护人员发布了一则通告。

在使用WinRho SDF治疗免疫性血小板减少性紫癜(ITP)患者中已经有发生血管内溶血(IVH)和死亡等并发症的病例报告。血管内溶血可导致临床上危重贫血的发生和多系统器官功能衰竭，其中包括急性呼吸窘迫综合征。此外，还有重度贫血、急性肾功能不全、肾衰竭以及弥散性血管内凝血等严重并发症的报告。与IVH及其并发症有关的致死性结局常发生于有伴发疾病的高龄患者(>65岁)。

据此，WinRho SDF的说明书中添加了一个黑框警告，着重强调与ITP患者IVH发病风险有关的警告。信息内容如下：

 

·         在医疗机构中，患者在WinRho SDF用药后应接受至少8 h的密切监护。

·         在基线、给药后2 h及4 h，以及监护期结束前应使用试纸条进行尿液分析。

·         患者应警惕并自行监测IVH的体征和症状，其中包括背痛、寒战、高热以及尿液无色或血尿[然而，在用药后8 h内无上述症状和(或)体征并不意味着随后不会发生IVH]。

·         在应用WinRho SDF后，若出现IVH的症状和(或)体征或者疑似IVH时，应进行治疗后实验室检查，其中包括尿液分析以及血浆血红蛋白、结合珠蛋白、L-乳酸脱氢酶以及血浆胆红素(包括直接及间接胆红素)的测定。