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I’m sure by now most are aware of the FDA warning on Tecfidera and may want to read it as published. This link is to the FDA’s safety announcement about PML with Tecfidera.
http://www.fda.gov/Drugs/DrugSafety/ucm424625.htm
Of course, this is only one case and it seems related to very low lymphocytes, something certain to be monitored more closely than was done in this tragic case.
JC virus causes PML. This virus is normally kept in check by lymphocytes but when they are insufficient infection may take hold. IMO, this may have been what occurred.
Biogen stated this person had PML but died of pneumonia. Respiratory problems were one of the reasons cited when Europe banned dimethyl fumarate from consumer products in 2009. Several articles can be Googled about that ban.
One thing you really don’t want to do taking Tecfidera is breathe it. Avoid breaking the capsules. The prescribing info cautions as much. Simply said, avoid breathing dimethyl fumarate and you may avoid respiratory problems such as pneumonia.
IMO, those taking Tecfidera and having respiratory problems should be review how they handle the capsule, even though not breaking it open.
For example, although rarely, I have in the past swallowed a supplement capsule that got stuck part way down and opened. I know this because I could smell the contents. If this were to happen with Tecfidera a very serious respiratory problem could occur, IMO.
I believe not every clinician is telling patients why they should avoid breathing Tecfidera but the reasons are obvious if you do a bit of investigation into why dimethyl fumarate was banned in the EU in 2009.
Just something to be aware of.
Tecfidera finally got approval in Europe so apparently dimethyl fumarate is ok in meds but still banned in consumer goods. I believe one primary use was as anti-fungal leather goods (furniture) preservative which China used in exports. It is an extremely inexpensive industrial chemical.
http://www.fda.gov/Drugs/DrugSafety/ucm424625.htm
Of course, this is only one case and it seems related to very low lymphocytes, something certain to be monitored more closely than was done in this tragic case.
JC virus causes PML. This virus is normally kept in check by lymphocytes but when they are insufficient infection may take hold. IMO, this may have been what occurred.
Biogen stated this person had PML but died of pneumonia. Respiratory problems were one of the reasons cited when Europe banned dimethyl fumarate from consumer products in 2009. Several articles can be Googled about that ban.
One thing you really don’t want to do taking Tecfidera is breathe it. Avoid breaking the capsules. The prescribing info cautions as much. Simply said, avoid breathing dimethyl fumarate and you may avoid respiratory problems such as pneumonia.
IMO, those taking Tecfidera and having respiratory problems should be review how they handle the capsule, even though not breaking it open.
For example, although rarely, I have in the past swallowed a supplement capsule that got stuck part way down and opened. I know this because I could smell the contents. If this were to happen with Tecfidera a very serious respiratory problem could occur, IMO.
I believe not every clinician is telling patients why they should avoid breathing Tecfidera but the reasons are obvious if you do a bit of investigation into why dimethyl fumarate was banned in the EU in 2009.
Just something to be aware of.
Tecfidera finally got approval in Europe so apparently dimethyl fumarate is ok in meds but still banned in consumer goods. I believe one primary use was as anti-fungal leather goods (furniture) preservative which China used in exports. It is an extremely inexpensive industrial chemical.
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