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Hi susieqj:
Thanks for posting an information link. The issue isn't just about people having seizures when starting Ampyra; that was already known. The significant point is that postmarketing data led the FDA to acknowledge the potential for the underreporting of adverse events and to, therefor, evaluate the risk of seizures in MS patients taking Ampyra. They have updated the recommendations for prescribing and managing Ampyra based on the risk.
The FDA document reported that, in postmarketing experience, the majority of seizures reported occurred at the recommended dose, within days to weeks of starting therapy, and in patients without a history of seizures (in contradiction to the belief that the risk of seizures is low in people with no history of them). It emphasizes that Ampyra should not be prescribed for patients who have ever had a seizure or for patients who have impaired kidney function, which can cause insufficient metabolism of the drug and lead to seizures.
hello all, I was on 4-AP when i had a seizure and allmost died,that was before AMYPRA was on the market,and i had NEVER had a seizure before,i knew the risk but was willing to try it anyway, i was over 12 hrs in ICU with my family around me,at lest i dont remember all of it, and lets not talk about what i can remember,and because of the risk i took 4-AP just like the Doctor ordered.mark
Hi susieqj:
Thanks for posting an information link. The issue isn't just about people having seizures when starting Ampyra; that was already known. The significant point is that postmarketing data led the FDA to acknowledge the potential for the underreporting of adverse events and to, therefor, evaluate the risk of seizures in MS patients taking Ampyra. They have updated the recommendations for prescribing and managing Ampyra based on the risk.
The FDA document reported that, in postmarketing experience, the majority of seizures reported occurred at the recommended dose, within days to weeks of starting therapy, and in patients without a history of seizures (in contradiction to the belief that the risk of seizures is low in people with no history of them). It emphasizes that Ampyra should not be prescribed for patients who have ever had a seizure or for patients who have impaired kidney function, which can cause insufficient metabolism of the drug and lead to seizures.
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