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612876 tn?1355514495

FDA Press Release on ProAmatine/Midodrine

Everyone on Midodrine:

Please take the time to read this and call/email/whatever your dysauto doc/GP/cardiologist to discuss this ASAP in case you will need to consider alternative treatment options.  Please try not to panic; nothing has been decided YET.  Also, if you read the last sentence, it seems that special considerations might be made for those of us already on the drug, but I don't know how this will work.  Hopefully our doctors/pharmacists will be able to get more info?  I don't know if we can find out more by contacting the FDA.  If anyone finds out more, please post here.

Please note, this is not a concern about the SAFETY of midodrine, but rather a problem with the company (companies?) following through with the proper protocols to completely prove through the necessary clinical trials to prove the EFFICACY of the drug.  Which is to say, if you're on it and it's working for you, then you already know it's effective for YOU, so the concern here isn't something different about the drug itself but about the AVAILABILITY of the drug (possibly in the NEAR future if the company/ies don't respond in 15/30 days as the FDA is requiring).

So read this and talk to your doc(s):

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm222580.htm


Sorry to be the bearer of bad (or at least potentially stressful) news.
-Heiferly.
Best Answer
Avatar universal
GOOD NEWS!!!!

The FDA has changed its mind about withdrawing Midodrine :-)
There was much pressure from charities, doctors and patients.
For once patients were listen to.... Yipee!

This is the link to the New York Times article

F.D.A. Backtracks and Returns Drug to Market

http://www.nytimes.com/2010/09/04/health/policy/04fda.html?_r=2
11 Responses
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492869 tn?1285018933
Reading this comment totally and absolutely made my day!  Thank you so much for the update!  I am not taking Midodrine at current, (I have in the past), but I have had Dysautonomia for most of my life.  As you can imagine, I feel quite strongly that more treatments should be made available to treat our condition.  Removing treatment options seemed like such a terrible step backwards.  Thank you again for the great news!
Helpful - 0
Avatar universal
AMO
good    news indeed!
thanks gh for lettiing us know, i wasn't watching:)
amo
Helpful - 0
1323747 tn?1364806882
You may want to post your question as a new question so everyone sees it.

Sometimes at the end of someone else's post  a question gets lost as others have already left the discussion and it doesn't get enough exposure.

I would like to see the answers to your question too!  :)    Marie
Helpful - 0
Avatar universal
I recently started midodrine, do you guys feel that it helps?  I have many syncope episodes and some so severe that i get nerological problems, numbness, ive tried the beta blockers but they don't seem to help.  Does the midodrine help with the migrains and syncope episodes for you?
Helpful - 0
612876 tn?1355514495
You. Made. My. Day.

Seriously, best news EVAR!!!  

Everyone raise a glass of electrolyte beverage (or an IV bag) and toast to that one!!  Cheers!!  L'chaim!!!!
Helpful - 0
560501 tn?1383612740


   Hmmm, I actually was prescibed this and even got the RX filled.
Tried it a couple days and did not like it......perhaps I should have givin it longer but I guess it doesn't matter now anyhow...Lol

~Tonya
Helpful - 0
967168 tn?1477584489
I'm bummed by this news - I was taking it until a couple of months ago when my insurance ran out and was looking forward to restarting it again Nov 1st when my new insurance goes into effect - it helped some with my symptoms - wonder what those of who used it will do
Helpful - 0
612876 tn?1355514495
I've put in messages to both my general practitioner and cardiologist (though the latter is out of town for the next week—bad timing!), so I will let you all know if/when I hear back anything useful on this.  I'm trying not to stress, but this is a big deal to me because I personally don't do very well without midodrine, and I'm on it every 6 hours round-the-clock right now.  Ugh!!  :-(

Maybe we should be putting calls in to the drug manufacturer(s) involved and pleading with them to take whatever action necessary to make things right with the FDA to keep our medication available?  I don't want to be a thorn in anyone's side ... but then again, the squeaky wheel gets the oil ... ugh, I don't know what we're supposed to do!!!
Helpful - 0
Avatar universal
AMO
big  SIGH !
i just begun midodrine a two weeks ago, and i believe i am having good benefits from it...
i do hope the  people needing to do their jobs to keep this on the market.

thank you heiferly, i will   call me cardio if he does not in the next couple days
amo  
Helpful - 0
492869 tn?1285018933
Seriously?  You are nine hours ahead of me?  I so thought I got this first for once!  I love you Heiferly!  I so love you!  You are so awesomely on top of everything!

I am not currently taking Midodrine/ProAmatine myself because I am unable to tolerate some of the side effects, but I used to take it when I was younger, and considered it to be one of the most helpful medications in my daily regime.  So, this is definitely news to be taken seriously by the Dysautonomia Community.

By the way, if you are wondering about how to keep up-to-date on the latest drug information, the FDA website (www.fda.gov) is very helpful.  Also, the Drug Information website, (www.drugs.com), offers a signup for email alert, which is how I obtained this information so quickly.  (Though apparently not quite as quickly as the amazing Heiferly!)
Helpful - 0
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