Fda Withdrawing Proamatine/midodrine?!

[Tuesday]

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.

[nmorgen]

Wow, I hope that doesn't happen. I know quite a few of you here are on midodrine and I'm sure it would cause you major problems if it were no longer available. I'll be praying the FDA doesn't just pull the drug, and the pharm co get those studies into them asap.

[Tuesday]

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.

[Noreen]

That is not good news.

Why do they start on the one drug many of us benefit from?

l

FDA link http://www.fda.gov/NewsEvents/Newsroom/Pre...s/ucm222580.htm

[Tuesday]

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!

[Noreen]

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!

I am with you there. If anyone wants to urge them to address this ASAP -

The contact information for the Shire is:

USA

For all Shire Specialty Pharmaceuticals customer inquiries or to report an adverse experience with a specific Shire product, please call 800-828-2088.

Shire Specialty Pharmaceuticals customers may also contact us by email:

Medical Information

Please email medinfoglobal@shire.com

Customer Services

Please email CustomerService@shire.com

[desiree942]

Soooo frustrating. Wonder how long we have to stockpile before they pull it??!!

[mkoven]

does anyone know what we might do? I also would be devastated. is there some action we might take as individuals, collectively, through our docs, etc.?

[iheartcats]

Well this is bad and scary news.

This one really helps me function and get going in the morning. I really thing it's integral in me being able to work, too.

Any ideas how long this could take to be 'pulled?' I can't believe they'd pull a drug out from people who really need it. It's only used by 100k people? Then of course it's very small and going to be used for very specific conditions in a small amount of people.

[iheartcats]

The LA Times has a write-up too:

http://www.latimes.com/health/boostershots...6,0,53066.story

It says the FDA will revoke approval if it does not hear from Shire in 15 days and the generic manufacturers in 30 days.

Devastating to us POTS folk...I really won't know what to do!

[MightyMouse]

Wow. That's really unfortunate for those taking midodrine here in the US. I wonder if it will be possible to import from other locations such as Canada, Mexico or Europe in the event that the FDA withdraws approval?

[houswoea]

aww man! I kinda like standing.

But what should we do? How can we get as much as we can before it goes away?? :'(

[iheartcats]

It's so costly I can't afford it outside of insurance - and my refill isn't due until in September. I guess I'll get as much use out of what I have. I don't know any alternatives yet but maybe others can share what they do (if they don't use Midodrine) and talk to my original doctor who placed me on Midodrine.

[Chaos]

Thanks Reen and Cat Lady for posting the email address for Shire so we can let them know how much the drug has helped us. It may not change anything but it certainly can't hurt.

This is a real BUMMER!! I know it hasn't helped everyone, but for those of us who have benefited from it, this is a major setback.

[emadden514]

This would be a setback. Unfortunately, I'm only seeing it licensed for use in the US. I checked Inhouse Pharmacy where a lot of folks with Gastroparesis get their meds not available in the US. They don't have it. this would be unfortunate.

Elizabeth

[Tuesday]

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.

[Stace915]

Ahhh me to... I take it every 3 hours.... What are we supposed to do????????? (Panicking!!)

[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.

[Stace915]

I already get it in 90 supplies... did your cardio have any other info?? I feel like we should all put emergency calls into Dr.Grubbs office, not that he can do anything but I am at a loss for ideas.

[Tuesday]

I just talked to the nurse, I don't know if they have even heard about this yet. Didn't sound like she knew anything. I am waiting for my doctor or the nurse practitioner to call me back for more info.

[Noreen]

Link to contact the FDA.

http://www.fda.gov/AboutFDA/CentersOffices...DER/default.htm

[iheartcats]

I just wrote the FDA. From my understanding, there is no other drug that really does what Midodrine does!

[Mary P]

I live in Canada and used the generic brand, Midodrine, for 2 years and then suddenly couldn't get it anymore. So the pharmacist gave me Amatine and I think by the time I need a refill, this name drand will no longer be availabe either. For 2 1/2 years I was taking 10mg/3xday. When I began to realize that neither generic or brand would be available, I cut back little by little until I'm now on 5mg/2xday.

Honestly, I don't feel any different than when I was on the higher dosage compared to now. Perhaps I need to cut back to 5 mg/1x day and see what happens.

As I prepared for a virtual colonoscopy, I was on a 3 day liquids only regime with 2 cans of broth (Sodium) a day included in the 12-14 cups of fluid I drank. I never felt as well or walked as well or had as much energy. I'm guessing that it was the extra liquid, water and gatorade, along with the extra salt in the broth. I took only 5mg Amatine on those days.

I haven't been able to drink as much now that I'm eating again. I wish you all well, and hope that the Amatine or Midodrine will always be available to all whom it has helped in any way. I will write to our Minister of Health in both Toronto and Ottawa.

[iheartcats]

I have a feeling many insurance companies won't cover a drug on clinical trial (the expanded access program). It also says if there is not enough supply it can go into lottery.

http://www.fda.gov/ForConsumers/ByAudience...s/ucm176098.htm

Basically, it's gamble if anyone can get it at that point or not so yet another stress for many of us.

[firewatcher]

Press Release (same as before EXCEPT that it mentions the generic manufacturers)

Perhaps if all of you write or email to the generic manufacturers, they may continue to make the drug. They have longer to respond to the FDA and could do their own study. It only has to prove that Midodrine positively effects your quality of life. Since Shire won't do it, maybe one of the generics will...it is worth a shot!