FDA Has Safety Concerns about New Medication – Vedolizumab

bustin the eskimo look a few days ago

bustin the eskimo look a few days ago

Hey UC’ers,

Quick but important message regarding a very recent FDA ( Food and Drug Administration) review.

Takeda is a massive pharmaceutical company headquartered in Japan, maybe you’ve heard of them before.  And they have been hoping to bring forward their new blockbuster medication called Vedolizumab which I wrote a previous post on in August 22 (here’s the link to that story – old story).  In speaking to some immunologist doctor friends of mine in San Diego a few months ago about this, it sounded like it had some serious promise for many UC’ers (and I hope it still does even though I’m pretty anti-medications myself.)

Yesterday the FDA announced it is concerned that this new treatment from Takeda may put a small percentage of patients at risk of a deadly brain infection.

The FDA will be meeting again on December 9th, 2013 to discuss further the potential dual licenses for this treatment.  Takeda is seeking a license to distribute/sell this medication to people with ulcerative colitis who have:

“adult patients with moderately to severely active ulcerative colitis who have had an inadequate response to, have lost response to, or were intolerant to either conventional therapy or a tumor necrosis factor-alpha (TNFα) antagonist.”  (direct quote from the FDA website: http://www.fda.gov/AdvisoryCommittees/Calendar/ucm371059.htm )

I know there are many of you who are searching for some new treatment to help your UC symptoms get under control.  So just do me a favor and keep up on the latest news with new medications.  The best case scenario is that your GI doctor’s are keeping up on all of this as well, but that’s not always the case.  So staying educated is key, and hopefully that can minimize any unwanted surprises down the road.

Best of luck to all of you, and here are a few links to some other stories regarding this news:

http://www.fiercebiotech.com/story/fda-questions-safety-takedas-blockbuster-hopeful-bowel-disease-drug/2013-12-05

http://www.medpagetoday.com/Gastroenterology/InflammatoryBowelDisease/43295

 

In good health,

 

-Adam Scheuer

founder of iHaveUC & Colitis Patient

One Response to “FDA Has Safety Concerns about New Medication – Vedolizumab”

  1. bevDecember 7, 2013 at 3:24 pm #

    First…the eskimo look becomes you! It’s fealin’ cold up here in Canada at the moment. Records are being busted…

    Second…I cannot stress enough that the drugs used to treat UC are BAD NEWS.

    Always have been….hopefully, won’t always be because new treatments will be all natural, the way it should be.

    Thank you Adam. Scary stuff, but necessary knowledge.

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