Tuesday

Posted this in the other thread too, there may be hope: http://www.medicalnewstoday.com/articles/197890.php

"The agency is working with the drug manufacturers to develop an expanded-access program to allow patients who currently receive the drug to continue to receive it. On a case-by-case basis, expanded-access programs allow the use of a drug outside of a clinical trial to treat patients with a serious or immediately life-threatening disease or a condition that has no comparable or satisfactory alternative treatment options."

I just called my cardio, they are going to give me a 90 day supply I can fill all at once. That makes me feel a little better. Don't know what will happen in the mean time.

From here: http://www.medicalnewstoday.com/articles/197890.php

"The agency is working with the drug manufacturers to develop an expanded-access program to allow patients who currently receive the drug to continue to receive it. On a case-by-case basis, expanded-access programs allow the use of a drug outside of a clinical trial to treat patients with a serious or immediately life-threatening disease or a condition that has no comparable or satisfactory alternative treatment options."

Maybe there's hope?

I have no words.

I will not be able to function without this.

I will not be able to hold a job.

Waiting to hear back from my doctor.

This would be absolutely devastating for me. I take 10 mg of midodrine five times a day. It's literally the only thing that keeps me going. I would be unable to work or have a "normal" life without it.

Thanks for posting the info for Shire. I will definitely contact them and voice my opinion.

If they're looking for proof that it works, what say we all just march up there and then stop taking it and let them see what happens?

That ought to be proof enough!

Yeah, hopefully it will just get tied up in red tape and nothing will ever come of it.

I'm on this 5x a day, and it's literally the only thing that keeps me functioning most of the time.

Someone just forwarded me this article and I wanted to share:

http://news.yahoo.com/s/ap/20100816/ap_on_...a_unproven_drug

WASHINGTON ? Federal health regulators are pushing to withdraw a blood pressure drug that has been on the market for 14 years in spite of the manufacturer's failure to submit evidence that it actually helps patients.

The Food and Drug Administration approved Shire Laboratories' drug ProAmatine in 1996 based on promising early results in treating low blood pressure. But the company has never conducted a mandatory follow-up study to actually prove the long-term benefits of the drug.

In letter to the company posted online Monday, the FDA proposes withdrawing the drug from the market and gives Shire an opportunity to schedule a hearing to discuss the matter. The letter marks the first time the FDA has threatened to pull a drug off the market due to missing follow-up data, though it has long held that power.

"This proposal is necessitated by Shire's failure to conduct postmarketing clinical trials that verify and describe the clinical benefit" of ProAmatine, the agency states.

Calls placed to Dublin, Ireland-based Shire seeking comment were not returned Monday afternoon.

Copies of the letter were also sent to five generic drugmakers who manufacture the drug, including Mylan Pharmaceuticals and Sandoz Inc. Those generic products would also be subject to a market withdrawal, unless their manufacturers complete the study requested by the FDA.

Roughly 100,000 U.S. patients received prescriptions for ProAmatine or generic versions last year, according to the FDA. The drug is approved to treat orthostatic hypotension, a type of low blood pressure that causes patients to become dizzy or faint when standing upright.

The letter does not cite any safety or effectiveness problems with the drug, and suggests the action is primarily aimed at enforcing drug approval regulations that have not always been enforced.

ProAmatine is part of a family of heart drugs that help stimulate dangerously low blood pressure. Several companies sell generic versions of the drug phenylephrine, which is used off-label to treat the condition.

For nearly 20 years, the FDA has granted accelerated approval to drugs based on so-called surrogate endpoints, or initial measures that suggest the drug will make real improvements in patient health. In cancer drugs, for example, tumor shrinkage is considered a predictor of increased survival.

Drugmakers favor the program because it helps them get products to market sooner.

But the program has not escaped criticism from government watchdogs.

Last fall the Government Accountability Office issued a report saying the FDA should do more to track whether drugs approved based on preliminary results actually live up to their promise.

The report singled out ProAmatine as a particularly egregious example of missing follow-up data. The government watchdog said that ProAmatine has generated more than $257 million in sales even though "the clinical benefit of the drug has never been established."

According to the GAO, the FDA has never once pulled a drug off the market due to missing or unimpressive follow-up data.

The GAO's September 2009 report found that the FDA had requested 144 follow-up studies for drugs since 1992. Of those about 64 percent had been completed and more than one-third were still pending.

I try to go to the gym a lot, and do a lot of sports. But, sometimes it makes me feel better, and sometimes it makes me feel worse.

I think it's all just up in the air. There is no way to tell when I'm going to feel good and when I'm going to feel bad.

In the end I try to exercise when I can, and rest when I feel like I need to. I don't stress about not pushing myself.

Yeah, my autonomic stuff is worse now, but the doc that I went to (just a walk in clinic) told me that I could be allergic to my meds, so he told me to hold off on them until it clears, then re-introduce them one at a time. My autonomic stuff is bound to be worse without my midodrine and all the rest.

I'll keep an eye on things and start looking for an allergist if it doesn't go away. I've been on Xyzal and Prednisone, and have been taking a Benadryl at night too just to help me sleep. Itch cream and oatmeal baths aren't helping that much

This week I had my first case of hives. It's going on four days now and I'm miserable!

I got to reading and I remember seeing that some people had MCAD as a cause for their dysautonomia. I'm reading everything I can but it's all very overwhelming and I don't know where to start!

What kind of doctor usually diagnoses MCAD? Is it likely that the hives are related, or could it just be a fluke? I have searched the forums and have seen that so many of us have had this problem that I think it's worth checking out, even though this is only the first time I've had it.

Any tips on where to start?

I really appreciate it!

I can remember the most complex things about the field I work in, but I have a hard time remembering all the little day to day things.

I was going to order food for me and my husband the other day. He told me what he wanted, I repeated it to him then turned around to order. As soon as I did I'd forgotten what he wanted! Every morning I have to go back in the house at least a couple times to get things I forgot while I was getting ready.

I feel like a space cadet!

Man, all of these replies sound like I could have written them!

I usually get a string of bad mornings in a row. It's been worse recently with the hot weather!

I'll wake up and feel so tired, dizzy, and completely worn out. My hr went up to 138 the other morning just putting on my makeup!

Whether I rest and take care of myself doesn't seem to matter, so I just do what I can, when I can.

My flares are pretty common. I might have one good week in a month where I feel 'normal' again (whatever that is).

When I wake up and I feel like crap, I'm in a flare. Usually my bp is really low, or the pulse pressure is narrow, which confirms that there's a reason I'm feeling like crap. My hr will be super low (40's-50's) resting, and will skyrocket when I stand up and walk around (130-140+). I get dizzy spells too, sometimes vertigo so bad I can't get up.

Then I have days where I can get up and go to work and feel great.

It tends to be worse in the summertime when it's really hot, or if I'm sick or have been injured.

I'll have a few bad days in a row, sometimes a week. Then I'll feel ok for a few more days and eventually I'll wake up feeling awful again.

I guess everyone's pattern is different though. I used to have more good days than bad, it just seems to be getting worse for me this year.

Thank you! That is very helpful to hear that it is working well for you! It's scary but if it means I will feel better it sounds worth it!

I'm curious about this too since I am waiting to hear if my doctor is going to recommend a pacemaker. My HR is generally in the low 40's and dips down into the 30's during the day (not just at night). I've also got tachycardia, so they want to put me back on a beta blocker but my hr is already too low!

Do you have any advice on whether to go with a pacemaker or try to go without as long as you can? How has your life changed since the pacemaker? What are the disadvantages you have had? What are the benefits?

Thank you!

During allergy season I use it pretty regularly. Maybe not every day but every couple of days when I feel I am starting to get stuffy. You need to use it before you get too bad off for it to work.

I use a neti pot. It's really helpful.

The midodrine can make your hr lower so you may need to watch that. I am wondering if my cardio is going to recommend a pacemaker, I was hoping to hear there might be something else I can do for it

If you're on a beta blocker, do you have the bradycardia too? Does it make your hr go too low? How do you fix that?

My cardio has me on a 30 day monitor to check me for POTS. My HR is going way low and way high, like 30-40 resting sometimes and up to 140 when I just stand up and walk around (or more if its hot outside).

I'm on midodrine and they want to put me on a beta blocker again but last time I tried that I hated it!!! Is there anything else they can give you to regulare your heart beats?

I think my cardio knows some about dysautonomia. I am being checked for POTS now, but I already have mitral valve, NMH, and inappropriate sinus tachy. I don't know what my hr was but it was high, so they tried a beta blocker for the tachy but I hated it!!

Hi Tuesday, welcome.

10mg x5? Wow! That's a lot. A resting 44 is about normal for me now too, but now I usually stay below 120 while "just standing" for less than two minutes. What were your standing and supine heart rates before the Midodrine? Is the doctor who put you on the monitor knowledgeable about dysautonomia?

I take 10 mg of midodrine 5 times a day, so every three hours. But, my hr has been going up and down. Resting hr is around 44, spikes up to 150 when I am outside walking. I am on a 30 day monitor to see what's going on.