Crow Posted September 4, 2010 Report Share Posted September 4, 2010 http://www.nytimes.com/2010/09/04/health/policy/04fda.html?_r=4&pagewanted=print Quote Link to comment Share on other sites More sharing options...
Rachel Posted September 4, 2010 Report Share Posted September 4, 2010 Wahoo!!!! We won!Thank you for sharing this article!It will take me forever to fall asleep tonight because I am so excited! Quote Link to comment Share on other sites More sharing options...
DancingLight Posted September 4, 2010 Report Share Posted September 4, 2010 I'm in shock!!! And soooo excited! Is this too good to be true???? Quote Link to comment Share on other sites More sharing options...
Chaos Posted September 4, 2010 Report Share Posted September 4, 2010 YEAH!!! Such good news for so many of us. THANK YOU to all who helped by contacting the FDA, your representatives, and all your friends and families and helped bring about this change. Special thanks to all of you who helped on this who don't even use the drug. Those of us who do are indebted to all of you! Quote Link to comment Share on other sites More sharing options...
cnm1 Posted September 4, 2010 Report Share Posted September 4, 2010 I can not stop crying!!! I am so happy!!! Wow. My daughter has been having a hard time with her move. Heat and idiots who don't follow through on promises to help have really taken a toll on her. I too far away to help and it is torturing me. At least this worry is done. I AM SO PROUD OF US!!!!!Louise Quote Link to comment Share on other sites More sharing options...
Noreen Posted September 4, 2010 Report Share Posted September 4, 2010 http://www.nytimes.com/2010/09/04/health/policy/04fda.html?_r=4&pagewanted=print Great news. Thanks for posting.One question, are we all teenage drug seekers -"Midodrine treats a condition known as postural orthostatic tachycardia syndrome, or Pots. Such patients suffer a severe drop in blood pressure when they stand because blood pools in their legs when vessels fail to constrict. Symptoms range from dizziness to fainting, and the condition is most common among teenage girls." Quote Link to comment Share on other sites More sharing options...
firewatcher Posted September 4, 2010 Report Share Posted September 4, 2010 I wouldn't relax yet, Shire may not continue to sell Midodrine and it may be only the generics. Until we know that one of the generics will continue (despite the small profits...) we need to keep squeaking! Quote Link to comment Share on other sites More sharing options...
maggie Posted September 4, 2010 Report Share Posted September 4, 2010 Congrats to all those who took the time to express the needs to all those who makes these types of decisions. It shows that concerns are heard and that prayers are answered. I'm so glad for all who use this drug, one less worry! Who would have ever thought such determination who win the day? Maggie Quote Link to comment Share on other sites More sharing options...
Noreen Posted September 4, 2010 Report Share Posted September 4, 2010 we need to keep squeaking!That was sort of my point. That was the first article the NY Times had on midodrine and they got it wrong.Perhaps now would be the time to raise awareness about dystonia riding on the FDA issue. Quote Link to comment Share on other sites More sharing options...
Rachel Posted September 4, 2010 Report Share Posted September 4, 2010 Firewatcher, according to the article, Shire has changed their position too and will continue to make ProAmatine."On Friday, Dr. Jeffrey Jonas, Shire?s senior vice president of research and development, said the company had changed its stance and would appeal. ?There is substantial evidence the drug does work,? Dr. Jonas said." Quote Link to comment Share on other sites More sharing options...
firewatcher Posted September 4, 2010 Report Share Posted September 4, 2010 Firewatcher, according to the article, Shire has changed their position too and will continue to make ProAmatine."On Friday, Dr. Jeffrey Jonas, Shire?s senior vice president of research and development, said the company had changed its stance and would appeal. ?There is substantial evidence the drug does work,? Dr. Jonas said."Rachel,I guess I'm just cynical, but that could simply be a "canned response" brought on by the bad press and pressure. Since they decided to stop selling the drug a year before the FDA "withdrew" it, I'm guessing that they are looking to unload the rights to someone else. This is a political move and politicians (even MDs) will say ANYTHING you want to hear. Actions are completely different. The NY times got several factual elements about POTS wrong for the sake of brevity and completely excluded the other uses for Midodrine like dialysis and the elderly, so I question the context of the quote from Dr. Jonas at Shire. They could be appealing to save face and still not continue to manufacture the drug. Until we know that the drug will continue to be manufactured by some company, I wouldn't stop squeaking. Quote Link to comment Share on other sites More sharing options...
cnm1 Posted September 4, 2010 Report Share Posted September 4, 2010 While I agree that some cynicism is appropriate; there is also reason for optimism. I will continue to monitor the situation but I am still celebrating!!! Quote Link to comment Share on other sites More sharing options...
Stace915 Posted September 4, 2010 Report Share Posted September 4, 2010 Canned response or not, at this point they can't say it is staying on the market and then pull it? Right?!?? I guess that is the article that Debbie from Dynakids called me about yesterday, she wanted to send a NY times reporter to my house to take my photo for the story, except I don't live in NY anymore. Wooo-hooo!!!! This is fantastic news!!!!!!!!!!!!!!!!!! Quote Link to comment Share on other sites More sharing options...
Mary P Posted September 4, 2010 Report Share Posted September 4, 2010 What with all the disappointments we endure with visits to the doctors, this is indeed great news. Now I can tell my pharmacist that she can once again get midodrine. I know she felt badly when time after time she couldn't supply my needs. Does anyone here recall that snappy tune, 'Happy Days Are Here Again'? I think I heard it ages ago by Mitch Miller and his band. At any rate, this is at least one happy reason to believe that someone cares. Quote Link to comment Share on other sites More sharing options...
wareagle Posted September 4, 2010 Report Share Posted September 4, 2010 Great news!! I will feel much better about the whole thing when the FDA makes some sort of announcement. I've been searching their website but haven't seen anything about this. The article said that the FDA "announced" it would keep Midodrine on the market...I wonder where we can go to view this?All and all, I'm very proud of the effort everyone put in to right this wrong!! Let's hope this decision stands. Quote Link to comment Share on other sites More sharing options...
Noreen Posted September 4, 2010 Report Share Posted September 4, 2010 This is a political move and politicians (even MDs) will say ANYTHING you want to hear. Actions are completely different. The NY times got several factual elements about POTS wrong for the sake of brevity and completely excluded the other uses for Midodrine like dialysis and the elderlyOne of my letters to congressional reps focused on dialysis use of midodrine. Dialysis is covered by the Federal gov.'t under a law signed in 1972 by Pres. Nixon. I pointed out that if they withdrew the drug, how many portable dialysis machines would they have to provide dialysis patients? I also pointed out that the gov't is currently paying for clinical trials of midodrine with spinal cord injuries as VA hospitals. Of course, let's not leave out NASA's use of the drug as astronauts re-enter the atmosphere. If anyone is studied and documented it is definitely the astronauts (bet they got name brand and not generic, too).It is strictly a matter of no one in government being willing to gather the information they have. My recollection is that the VA trials have endpoints identical to what the FDA required of Shire (use of TT to measure BP at timed intervals, etc.) It is absolutely ridiculous that no one at the FDA could do a survey of the literature to ascertain the information. The FDA has lost all credibility in my opinion. Going after midodrine as a first line after the GAO got on them for lack of paperwork is glaring in the total lack of regard for the American people. Quote Link to comment Share on other sites More sharing options...
nmorgen Posted September 5, 2010 Report Share Posted September 5, 2010 I agree with you Reen. I think they just said hey let'spick a drug with one of the lowest usage rates and we will go after them, no one will notice. Not even taking into consideration that there is no alternative. They didn't think that everyone taking the drug would bombard them, the media and their representatives with letters and complaints. Without that attention, midodrine would probably be on it's way out. Quote Link to comment Share on other sites More sharing options...
MightyMouse Posted September 5, 2010 Report Share Posted September 5, 2010 I'm still doing a happy dance that our rag tag little crew of medically disabled folks brought the FDA to it's knees... or at least to where ever they had to stoop to reboot their server after we crashed it with our emails. Seriously folks, here we are, a bunch of folks who have major medical problems, some who cannot function well without help and some like me who scrape along just enough to make it through a work day before completely melting at home, and we STILL were able to pull off a miracle. I'm so grateful to be a part of this place and to call you my friends.Nina Quote Link to comment Share on other sites More sharing options...
yogini Posted September 5, 2010 Report Share Posted September 5, 2010 I think we have to take it one step at a time. It's amazing that the FDA changed its mind so quickly about midodrine. If that can be accomplished, then the rest should be easier. I don't think the NYT article was necessarily wrong in its description about POTS. At least years ago, when I first developed POTS, the literature said it was more common among young women, although anyone can get it. Quote Link to comment Share on other sites More sharing options...
sandymbme Posted September 7, 2010 Report Share Posted September 7, 2010 I just came across an article about the possibility of Midodrine being withdrawn and had a near panic attack! I am currently taking 10mg 3x a day and STILL having issues with keeping my BP sufficiently high! I will be following this issue very closely, because without the Midodrine I am headed right back for an in-patient stay at my local hospital, only with no clear resolution!Sandy Quote Link to comment Share on other sites More sharing options...
Crow Posted September 7, 2010 Author Report Share Posted September 7, 2010 Associated Press article:FDA relents from midodrine withdrawal planhttp://www.google.com/hostednews/ap/article/ALeqM5gFyddT4zNHRqivlzZUw5OcHVjGIwD9I2HME00 Quote Link to comment Share on other sites More sharing options...
Crow Posted September 8, 2010 Author Report Share Posted September 8, 2010 Chelsea Therapuetics investors still hoping FDA pulls midodrine; other catalyst on tap this monthhttp://www.smallcapnetwork.com/CHTP-investors-still-hoping-FDA-pulls-midodrine-other-catalyst-on-tap-this-month/s/article/view/p/mid/5/id/79/ Quote Link to comment Share on other sites More sharing options...
cnm1 Posted September 8, 2010 Report Share Posted September 8, 2010 http://www.theheart.org/article/1119697.doMore confirmation of the FDAs decision Quote Link to comment Share on other sites More sharing options...
Chaos Posted September 9, 2010 Report Share Posted September 9, 2010 Chelsea Therapuetics investors still hoping FDA pulls midodrine; other catalyst on tap this monthhttp://www.smallcapnetwork.com/CHTP-investors-still-hoping-FDA-pulls-midodrine-other-catalyst-on-tap-this-month/s/article/view/p/mid/5/id/79/I'm glad this drug is doing so well for people with Parkinson's related neurogenic hypotension. However, many of us here do NOT have low Norepi levels and to think that Midodrine, a drug that works for many of us, should be withdrawn because this other drug may soon be available is just crazy. It's like all the people saying that there should be mandated limits on how much salt people are allowed to consume. HELLO!!! Obviously not everyone is alike and to try to force one solution on everyone is ridiculous... not to mention ANNOYING AS ALL GET OUT!!! YEESH! Quote Link to comment Share on other sites More sharing options...
MightyMouse Posted September 9, 2010 Report Share Posted September 9, 2010 Another story, this one in Bloomberg's summary of this week in healthcare...skim down 2 or 3 headlines to find the FDA/Midodrine onehttp://www.businessweek.com/lifestyle/content/healthday/642874.html Quote Link to comment Share on other sites More sharing options...
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