MS patient on Tecfidera for over 4 years develops PML, dies of pneumonia

[agate]

This is not good news for Tecfidera, I'm afraid. Someone with MS who had taken Tecfidera for over 4 years has died of PML.

Actually the person died of pneumonia but it seems to have been associated with the PML. A clear link between the PML and Tecfidera hasn't been established.

And the patient had had a "severe prolonged" lymphopenia, which would have meant a risk of PML. You have to wonder why this wasn't being addressed.Only registered and activated users can see links., Click Here To Register...

[Lazarus]

Thanks for the article. I have been on rituxan for probably four years and do test positive for the JC virus which is the risk factor for PML.. But, my test score is low, so to speak, and I have chosen to go on with the treatment. My neuro is always concerned but I am living a real life with rituxan. Perhaps the patient who died was making informed decisions about the level of risk she was willing to take...maybe that is the answer to your question.

[Cherie]

I just got off the International Organization of MS Nurses website. there had been no JCV titre done on her (nor have any been requested for patients beginning tecfidera). She had never been on immunosuppressants like IV steroids, Cytoxan, methotrexate or Immuran as most patients with PML have had.

There was concern when Tecfidera came to market that there were already 4 cases of PML with this drug in the dermatologic community (it had been used to treat an aggressive skin disorder).

6 MS Nurses who are on Research and teaching faculties and are policy setters in the MS Community are meeting today to draw guidelines for not only the FDA but also for treating personnel in the MS Community to make them aware that this is another drug which will have a black box warning on it most likely and will ultimately require JCV testing before going on and at intervals during treatment with Tecfidera.
Personally, I would recommend that all who are on this medication already open dialogue with your neurologist about being tested or, if positive, looking into alternative therapies that may be less risky for you.