WinRho SDF Linked to Rare Cases of Intravascular Hemolysis in ITP Patients

Yael Waknine

Disclosures

January 06, 2006

Jan. 6, 2006 -- The US Food and Drug Administration (FDA), Cangene Corporation, and Baxter Healthcare Corporation have warned healthcare professionals via letter regarding the rare risk for serious and potentially fatal intravascular hemolysis in patients with immune thrombocytopenic purpura (ITP) receiving intravenous Rho (D) human immune globulin (anti-D; WinRho SDF).

Use of the liquid product has also been linked to falsely elevated glucose readings on some testing systems, according to an alert sent today from MedWatch, the FDA's safety information and adverse event reporting system.

The FDA has received rare postmarketing reports of intravascular hemolysis in ITP patients receiving anti-D. Signs and symptoms included back pain, shaking chills, fever, and discolored urine, occurring most commonly within 4 hours of administration.

Potentially serious complications of the condition, such as clinically compromising anemia, acute renal insufficiency, and disseminated intravascular coagulation (DIC) have also been reported. Very rarely, these resulted in fatality.

According to the letter, the etiology of these events appears to be complex and the effects of age, sex, pretreatment renal function, pretreatment hemoglobin levels, other concomitantly administered blood/blood products, or significant comorbid conditions at DIC onset remain unknown.

ITP patients receiving anti-D should be monitored for signs and/or symptoms of intravascular hemolysis and its complications, including hemoglobinuria, pallor, hypotension, tachycardia, oliguria or anuria, edema, dyspnea, and increased bruising/prolongation of bleeding time.

Patients should also be advised to immediately report symptoms of back pain, shaking chills, fever, discolored urine, decreased urine output, sudden weight gain, fluid retention/edema, and/or shortness of breath.

The FDA also warned of the potential for falsely elevated glucose readings in patients using glucose dehydrogenase pyrroloquinolinequinone (GDH-PQQ)--glucose monitoring systems. Because the GDH-PQQ method is not glucose-specific, readings may be falsely increased by the maltose content of liquid anti-D.

Patients receiving the product should be advised to use glucose-specific testing methods such as glucose dehydrogenase nicotine-adenine dinucleotide, glucose oxidase- or glucose hexokinase-based tests.

Rho-D immune globulin is indicated for the treatment of ITP and suppression of Rh isoimmunization, and is supplied in liquid and lyophilized powder formulations. Additional information regarding use of the product may be obtained by contacting Baxter Medical Affairs at 1-866-424-6724.

Healthcare professionals are encouraged to report adverse events related to use of Rho-D immune globulin to Baxter Healthcare at 1-800-423-090. Alternatively, this information may be reported to the FDA's MedWatch reporting system by phone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, online at http://www.fda.gov/medwatch , or by mail to 5600 Fishers Lane, Rockville, MD 20852-9787.

Reviewed by Gary D. Vogin, MD

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