Avatar of heather


July 24, 2009 in Uncategorized

The most serious adverse reactions reported during Kuvan administration was gastritis, spinal cord injury,streptoccal infection, testicular carcinoma, and UTI. Mild to moderate neutropenia was also noted. This was found on and but only if you click under the healthcare professionals section. I have sent an E-mail asking why we are not able to view these reactions and noone has replied. My nutritionist is looking into this as well.

5 Reviews of FYI

  1. Registered: Jul 22, 2009

    Posts: 0

    Fairhaven, Massachusetts

    I am very interested in this as well.

    One thing to remember is that ALL events must be reported during these studies and they will be all documented…even thought they might have nothing to do with the drug. So, if one of the subjects is diagnosed with a UTI or cancer, it will be reported without finding out if it is related or not. The spinal cord injury could have been a car accident. But, it will still be reported. The UTI could be a regular occurrence for that person.

    I think that is why they are not reported to us. Not that I am saying that is right. I remember going to a PKU Town Meeting and I believe that was how some of these serious events were described.

    While a little (or a lot) alarming, I think it is good to report everything. It would be helpful if these were explained more fully.

    Thanks for pointing me in the right direction. I get the inserts all the time and have stopped reading them. My husband is a pharmacist so he gets the medical inserts and I haven’t looked at it in a long time.

  2. Registered: Jan 16, 2009

    Posts: 0

    louisville, Kentucky

    Biomartin contacted me to day and told me that the FDA requires them to list everything. The spinal cord injury was not related to the Kuvan. They investigated it, and came with that conclusion. Sorry if i scared anyone i was just very concerned and confused, but they helped answer my questions. I thought i could help someone with the same concern. Thanks

  3. Registered: Sep 12, 2006

    Posts: 0

    Franklin, Wisconsin

    When any medication is being studied for safety ALL adverse effects must be reported to a doctor. This means that those who were involved in the studies to test the safety and side effects of Kuvan had to report anything that was not normal while they were on Kuvan.

    When I began taking Kuvan while the clinical trials were still going on. When I started my doctor and dietitian wanted to know right away if something was not normal. They had to know about every little sniffle, sneeze, and cough, because FDA needed to know.

    This does not necessarily mean these issues were caused by Kuvan. It just means that while someone was taking Kuvan during the clinical trials they experienced these problems such as gastritis, spinal cord injury etc. For example the spinal cord injury could have been caused by something such as a car accident, but because the person who suffered spinal cord injury was taking Kuvan at the time they were required to report that as an adverse effect.

    Someone correct me if I am wrong, but this is my understanding about why adverse effects are listed for medications. 

  4. Registered: Jul 22, 2009

    Posts: 0

    Fairhaven, Massachusetts

    Thanks for talking to BioMarin and posting their explanation. It would be nice if they could explain that more in their inserts but I guess they have too much info in there already! I think it is great to post any questions about Kuvan just like this. The more info, the more power. Take care.

  5. Registered: Feb 20, 2009

    Posts: 0

    , North Carolina

    I am surprised to hear this. I did a review of the new Kuvan information which was sent to me and then a rep talked to me about the information that I received. I found tucked in the back was exactly the information you were made aware of. It’s all there, but I don’t think most people even go looking for that type of info. The person interviewing me was a bit surprised that I found and read that info.

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