Safety Alerts & Recalls

What does this mean?

WinRho SDF is used to treat very serious conditions. For most patients, the benefits of WinRho SDF will continue to outweigh the risks of IVH. That said, this is a good reminder to review the patient information about WinRho SDF and discuss any concerns with your doctor.

If you experience any of the following symptoms after receiving WinRho SDF, you should seek medical attention immediately:

- shaking chills, fever or back pain

- discolored or darkened urine

- decreased urine production

- swelling

- shortness of breath

If you have additional questions or concerns about WinRho SDF, please follow up with your doctor.

Black Box Warning for WinRho SDF Warns About Potentially Life Threatening Reaction

Cangene, Baxter and the FDA notified healthcare professionals that cases of intravascular hemolysis (IVH) and its serious complications, including death, have been reported in patients treated for immune thrombocytopenic purpura (ITP) with WinRho SDF. IVH is a potentially life threatening reaction in which a large number of red blood cells are destroyed while in the blood stream. In the patients who experienced this reaction, most had symptoms within 4 hours of receiving WinRho SDF.

The Boxed Warning informs healthcare professionals that: 1) Patients should be closely monitored in a health care setting for at least eight hours after administration, including taking multiple urine samples (also called urinalysis) during the monitoring period.

2) Patients should be alerted to monitor for signs and symptoms of IVH, including back pain, shaking, chills, fever, and discolored urine (also called hematuria). Although it is most common to see IVH symptoms within 4 hours of receiving WinRho SDF, IVH and its symptoms can occur outside of this time period.

WinRho SDF is an immune therapy that is used to treat people with the bleeding disorder called immune thrombocytopenic purpura (ITP). ITP is a bleeding disorder caused by an abnormally low number of platelets. WinRho SDF is also used to protect against the development of antibodies in a person with Rh-negative blood who is given Rh-positive blood, and in pregnancy to prevent an Rh-negative mother's immune system from harming an Rh-positive baby's red blood cells. This safety update only applies to patients receiving WinRho SDF for ITP.

For more information, please visit: more information here

To read the WinRho Information for Patients Leaflet, please visit: more information here

Source: Manufacturer
Publication Date: 2010-03-11
Last Updated: 2010-03-11

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