WinRho SDF Linked to Intravascular Hemolysis and Death: FDA
A “black box” warning has been added to Baxter Healthcare and Cangene Corporations’ platelet deficiency drug, WinRho SDF, after the FDA determined the drug has caused a condition in some patients that led to lethal cases of anemia and multi-organ failure.
The FDA, Cangene and Baxter alerted health care professionals on Wednesday that some patients being treated for immune thrombocytopenic purpura (ITP) have died after taking WinRho SDF due to complications from intravascular hemolysis (IVH).
IVH can cause severe anemia, failure of the kidneys and other organs, and respiratory distress. WinRho SDF side effects have proven lethal in some patients, particularly those over the age of 65 with other life-threatening conditions.
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Learn MoreITP is a syndrome in which the patient has a decreased number of blood platelets due to the immune system attacking them with antibodies, which can lead to bleeding, easy bruising, or the leaching of blood from capillaries into the skin and mucous membranes. WinRho SDF was first approved in the U.S. by FDA in 1995, and is made from human plasma.
The black box warning, the most stringent labele warning that the FDA can mandate for a drug, warns health care professionals that patients should be closely monitored in a health care setting for at least eight hours after being put on the drug. It also recommends several urine analyses be performed over several hours.
The warning also includes a list of symptoms that patients should be aware of, which could indicate the onset of IVH, including:
- Back pain
- Shaking and chills
- Fever
- Discolored urine
If symptoms arise, a battery of post-laboratory tests should be performed. A lack of symptoms in the first few hours does not mean that IVH will not occur at a later time. The drug carried a warning against IVH previously, but now that warning will be placed prominently on the label with a black border on all WinRho SDF packaging.
If symptoms arise, a battery post-laboratory tests should be performed. A lack of symptoms in the first few hours does not mean that IVH will not occur at a later time. The drug carried a warning against IVH previously, but now that warning will be highlighted by a black border on all WinRho SDF packaging.
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4 Comments
MarySeptember 9, 2011 at 6:54 am
In March 2008, I developed ITP. After spending 3 days in ICU with my platelets between 1000-4000, I was transferred to a hospital that had a hematollgist. We had tried high-dose steroids and packed platelet without much success so he suggested we try Win-Rho. After a few days, my platelets were up enough to go home. However, a week later, they began to drop again and the doctor gave me another[Show More]In March 2008, I developed ITP. After spending 3 days in ICU with my platelets between 1000-4000, I was transferred to a hospital that had a hematollgist. We had tried high-dose steroids and packed platelet without much success so he suggested we try Win-Rho. After a few days, my platelets were up enough to go home. However, a week later, they began to drop again and the doctor gave me another round of Win-Rho. With the first injection in the hospital, I did okay without too many side effects. However, after the second infusion, I became extremely ill. Mostly fever, short of breath, EXTREME fatigue, and an overall feeling of ill-health. I could barely lift my arms to turn over in bed and had to have help to get to the bathroom only 5 feet away. I felt so bad that I really did not think I would survice the night. However, I slowly began to get better. Then, about 10 days later, the platelets once again began to drop. My surgeon advised we do an immediate splenectomy before they dropped too low. Approximately a week later, I was rushed to the hospital due to severe shortness of breath where I was diagnosed with multiple blood clots in both lungs. My PCP told me later that there was no good medical explanation for why I survived. After 11 days in the hospital on Heparin and Coumadin, my Coumadin levels finally reached the point where I could leave the hospital. It has been 3-1/2 years and I am on chronic Coumadin at a level of 13 mg a day. I still have problems with my breathing, my strength has never returned to what it was before the Win-Rho and the PE's, and for the last year I have been suffering with unexplained muscle pain and muscle weakness that is slowly increasing in severity. I have had multiple tests but the doctors are baffled as to the cause. This is the first time that I have heard of other people having similar problems and I would like to find out more.
SamarMarch 10, 2011 at 12:06 am
My mom had Leukemia CLL, went through a cycle of chemo, did ok for a a about a month, but her platelets weren't going up and didn't know why. Her dr tried different injections to bring platelets up, didn't work. Then, the dr. ended up giving her winrho on Feb 19, 2010 in the morning and sent her home after that. . Her dr. called and said to bring her back to emergency asap, we brought her back[Show More]My mom had Leukemia CLL, went through a cycle of chemo, did ok for a a about a month, but her platelets weren't going up and didn't know why. Her dr tried different injections to bring platelets up, didn't work. Then, the dr. ended up giving her winrho on Feb 19, 2010 in the morning and sent her home after that. . Her dr. called and said to bring her back to emergency asap, we brought her back to the hospital in an ambulance with all the symptoms listed above. Within a few hours, she went into septic shock, respiratory failure developed ITP, and hemolysis and was on life support for 6 days. Sadly, she passed away March 13, 2010 a day after this warning was published.
SuzanneNovember 4, 2010 at 2:28 pm
I was diagnosed with ITP in September of 2006. I had no platelets for a while, and my hema started me on an "extremely high dose" of win-rho after rituxan didn't work. I wound up in ER with very bad headache. I was anemic and needed blood transfussions. I fired that doctor and eventually had my spleen removed. After my spleenectomy I had multiple PE's in my lungs. I survived but it was a clo[Show More]I was diagnosed with ITP in September of 2006. I had no platelets for a while, and my hema started me on an "extremely high dose" of win-rho after rituxan didn't work. I wound up in ER with very bad headache. I was anemic and needed blood transfussions. I fired that doctor and eventually had my spleen removed. After my spleenectomy I had multiple PE's in my lungs. I survived but it was a close call. Now, three years later, I still have a clotting condition and have to take 15 mgs. of coumadin every day for the rest of my life. I'd like to know if anyone has had a similar experience. I'm wondering if it's the win-rho that made me clot and if it has long term side effects that are still contributing to my clotting condition. I had the surgery about a month after my last win-rho treatment and I'm now reading that I should have waited at least 3 months???
ChristieOctober 8, 2010 at 4:10 pm
My son was hospitalized for ITP in October 2008. He was administered WinRho and within hours had a severe hemolytic reaction to the drug. He had all of the symptoms listed above that are now on the black box warning and was hospitalized for 5 days. Since his remission, he has had other strange symptoms occur including the onset of nervous tics. I am currently researching to see if his reaction w[Show More]My son was hospitalized for ITP in October 2008. He was administered WinRho and within hours had a severe hemolytic reaction to the drug. He had all of the symptoms listed above that are now on the black box warning and was hospitalized for 5 days. Since his remission, he has had other strange symptoms occur including the onset of nervous tics. I am currently researching to see if his reaction was recorded with the FDA or Baxter/Cangene. I have notified the hospital and the physician to receive this information. What I want to know is if the warnings were in place in October of 2008 because I was not given prior notice of the side effects or symptoms to watch for before he was given the treatment.