6MP/Mercapt. NOT approved for IBD!!! Just like LDN....then what's the difference?!

[Sea_Star]

I just researched and it turns out the FDA has not approved it for IBD!! It's "off-label"....exactly how LDN is!! Holy cannoli. Check it out!!

Read in the blue box: http://www.fda.gov/Drugs/DrugSafety/ucm250913.htm

Section 5.5: http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205919s000lbl.pdf

Excuse the enthusiasm, but now we have a point to tell doctors who refuse LDN saying it's not approved, to show them that neither is 6MP/AZA!!

I'm sorry if you all know this already lol....or if I'm missing something...

 

[nogutsnoglory]

There are a few drugs used off label for crohns but the clinical trials have demonstrated efficacy. It takes a lot of money and time to get approval. The research simply isn't there for LDN in terms of what the medical community is seeking. I hope research is conducted but most doctors will dismiss the small research done.

 

[Sea_Star]

oh :x Oopsies. So the FDA is not always looked at by Drs as the deciding factor, when it comes to clinical trials...gotcha So i wonder why they won't approve it, if multiple trials prove efficacy...

 

[DustyKat]

Unfortunately you will find that IBD is the poor cousin to most other auto-immune diseases so other than the 5ASA’s nothing that is specific to IBD has been developed and approved.

Most of the drugs we have are via the trickle down effect from diseases such as Rheumatoid Arthritis. So whilst not developed for IBD they are at least in the realm of auto-immune. That is why it isn’t an issue for docs in prescribing them off label. As these drugs are prescribed more frequently the studies as to their efficacy and issues that may arise in IBD then follows. So it is basically catch up research.

Imuran is the oldest drug, in the immunosuppressant class, in use for IBD so you will find a multitude of studies regarding its use, some extending over 30 years or more.

LDN for use in Crohn’s is a much more recent phenomena.

Dusty. xxx

 

[Kev]

Yes... LDN is a relative baby. First study published in the American Journal of Gastro-Enterology in the summer of 2007. By Dr Jill Smith out of Penn State University. So, as of now... 7 years. The Norwegian documentary shows an 11 plus year usage for varied diseases in Norway and Ireland. So, between 7 and 11 years in use here and in Europe.

I 'DIDN'T' know about 6MP/AZA... AZA almost killed me. LDN gave me remission for the past 7 years (well, 6 and 1/2).. and with absolutely no appreciable risk to me as well..


I really don't think there is any need for me to emphasize the obvious arguments here..