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Q&A 24 - natalizumab PML, EBV IgM-positive, generic fingolimod
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Q&A 24 - natalizumab PML, EBV IgM-positive, generic fingolimod

I was moved from Gilenya to generic fingolimod tablets last year. I have noticed a worsening of side effects and wonder if it could be a consequence of the new generic version...

Questions

Q1: Natalizumab PML was a known risk once it went to market in 2004/5, and from my reading, it was a shock. Why did nothing come out during the trials? Surely there would’ve been a PML scare during phases 2-3? I can’t see any literature on this, but it seems that this shocked the community when it came to market, so I’m curious why nothing popped up during the trials, and if it did, was it hidden, or they didn’t know?

Q2: Besides having MS, I am regularly (weakly) positive for EBV IgM. What does this mean?

Fingolimod | Accord Healthcare, Generic & Biosimilar Medicines
generic / me-too fingolimod

Q3: I was moved from Gilenya to generic fingolimod tablets last year. Over the past few months, I have noticed a worsening of side effects and wonder if it could be a consequence of the new generic version of the drug. 

The main worsened side effects noticed:

  • Recurrence of warts on fingers and thumb 

  • Sickness / fuzzy / dizziness sensations

  • Occasional blood when going to the toilet

  • Vivid and weird dreams

Do you think these are related to generic fingolimod?

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