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Fda Withdrawing Proamatine/midodrine?!


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I also sent an email to Public Citizen Health Research Group. Their MD thought the FDA removing the drug was a good idea. I emailed them to tell them why they are wrong. It is one more place that people might want to contact. The issue with the drug is not safety or effectiveness: it is politics of our healthcare system!!!

Louise

Thank you for contacting Public Citizen.

I understand that you do not want the FDA to withdraw the approval for midrodrine. I will forward your email to our researchers.

Again, thank you for contacting Public Citizen.

Sincerely,

Ben Weaver

Consumer Correspondent

Public Citizen Health Research Group

Health Research Group

Public Citizen

202-588-1000

hrg1@citizen.org

http://www.citizen.org/hrg

http://www.worstpills.org

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I can't sleep this morning, so I called the FDA and left a message. I received a call back within half an hour. The lady I spoke to, Misu, said that my call would be counted, but that I also needed to submit something in writing. She said the way to do that was with the online comment form at www.regulations.gov. So I went there and submitted my comment, but I'm not sure if she was correct about this being the best way to contact the FDA. Has anyone else been told to use this form?

Every time a new way is posted for how to contact the FDA regarding the midodrine issue, I do it. I just wish the FDA would decide how they want us to contact them!

I have sent messages to every email address listed in this topic, and through the CDER contact form, but I have yet to get a reply from any of the messages I have sent. Has anyone else not heard back?

Rachel

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I also sent an email to Public Citizen Health Research Group. Their MD thought the FDA removing the drug was a good idea. I emailed them to tell them why they are wrong. It is one more place that people might want to contact. The issue with the drug is not safety or effectiveness: it is politics of our healthcare system!!!

I can't find anything about midodrine on Public Citizen. apparently, they listened to you.!!

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Interesting reading on the stock price rise for Chelsea Theraputics, one of the generic producers of midodrine, and soon to be the make of newly approved droxidopa. Unfortunately, droxidopa will not work for me--I make too much norepinephrine as it is... my issue is low blood volume and GI pooling.

Nina

http://www.smallcapnetwork.com/Chelsea-Therapeutics-still-set-to-run-higher/s/article/view/p/mid/5/id/77/

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Yeah, Chelsea Theraputics stands to gain a lot from midodrine being off the market.

Will and I have been reading up on droxidopa, and though it might work for some of us, but it certainly won't work for all of us. Also, because it crosses the blood/brain barrier, children and pregnant women aren't allowed to take it. I don't know at what point someone is no longer considered a "child" as far as the medication goes, but the woman, Leslie, who my husband talked to at the FDA today said that the teenage girls who get POTS won't be able to take it.

We definitely still need midodrine. It is safe both for children and for pregnant women, and it works for a broader range of people.

On a brighter note, when my husband talked with Leslie at the FDA today, she said that they have really been overwhelmed with phone calls, emails, and letters about midodrine. They are so overwhelmed that they need to do something fast because they can hardly get any other work done. We've frozen up their website on more than one ocassion due to submitting so many letters online. :) They had no idea that we could put up such a fight! Or that when we can't, our friends and family will fight on our behalf.

Rachel

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This is the letter I sent last week. Thanks for the sample letters posted earlier in the thread.

Unfortunately I received a generic form letter from one of my Senators in return, which doesn't have anything to do with anything. :(

I haven't heard from NORD, the (USA) National Organization for Rare Disorders. I also haven't had a reply from OrphaNet, a worldwide portal for rare diseases and orphan drugs.

I am writing to urge the FDA to reconsider the announced withdrawal of ProAmatine (midodrine hydrochloride) from the market.

I suffer from Orthostatic Intolerance due to Ehlers Danlos Syndrome, an incurable rare genetic condition that affects my vascular system, which causes another rare disease, Postural Orthostatic Tachydardia Syndrome as a secondary condition. Taking ProAmatine has significantly improved my quality of life.

While the FDA has recommended that patients talk to their health-care providers regarding alternative treatments, the FDA must be aware that ProAmatine is the ONLY FDA-approved drug for the treatment of Orthostatic Intolerance and that there are NO reasonable substitutes for it.

In addition, ProAmatine has no central nervous system side-affects, unlike the psychoactive drug Northera / Droxidopa, which Chelsea Therapeutics COINCIDENTALLY is trying to bring to market for neurogenic orthostatic hypotension. I am unsure if this drug will even treat patients like me, who suffer from non-neurogenic orthostatic intolerance.

Why has the FDA chosen to withdraw a medication that, since it was first approved in 1996, has NEVER been identified with any safety issues?

The FDA has made it cost-prohibitive for the manufacturers of ProAmatine to benefit from complying with the follow-up studies the FDA are now requires after 15 years, and so these manufacturers have instead chosen to discontinue making the medication as of September 2010 instead of spending the millions of dollars necessary to become compliant with the FDA paperwork.

The FDA must take into consideration the fact that 100,000 lives like mine will be devastated by the withdrawal of ProAmatine. It needs to find a reasonable solution that allows ALL involved to benefit--the FDA, the manufacturers, and the patients who count on ProAmatine to enable them to stand upright without fainting, so they can engage in normal activities of daily living.

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Can I just say how proud I am that despite us being a tiny, tiny group of patients with a rare diagnosis, we've caused the FDA commentary website to seize up a few times. Good for all of you who took the time to make a stand. In this post, I'm going to try to summarize the methods of contact, for those inclined to do so (certainly a personal choice).

To call the FDA to lodge my opinion, I called:

1-888-463-6332, select #4 Speak to a representative, #3 Human Drugs, #1 Human Drugs.

regaring Public docket (FDA-2007-N-0475)

Then I emailed re: Public docket (FDA-2007-N-0475) to druginfo@fda.hhs.gov

the other way I contacted them was via a webform on the CDER here:

http://www.accessdata.fda.gov/scripts/email/cder/comment.cfm

And lastly, although probably late for now is to write directly using the old fashioned paper and envelope method here;

FDA-2007-N-0475

Division of Dockets Management (HFA-305)

Food and Drug Administration

5630 Fishers Lane, Room 1061

Rockville, MD 20852

* Entitle your letter: A Response to the FDA proposed withdrawal of Midodrine

(FDA-2007-N-0475)

* Clearly and efficiently state your concern and ask your questions.

* Be sure to provide your contact information.

* Save a copy for your records.

Dr. Janet Woodcock

Director FDA/CDER

10903 New Hampshire Ave

Silver Spring MD 20993.

Dr. Norman Stockbridge

Director Division of Cardiovascular and Renal Drugs

10903 New Hampshire Ave

Silver Spring MD 20993

and I welcome anyone to copy/paste my letter, or use it as a base and alter it to meet your own personal requirements.

I am very concerned by the decision of the FDA to withdraw the marketing approval for Shire Development Inc.'s midodrine hydrochloride product, Proamatine. The FDA is requiring that Shire conduct additional testing, which will cost millions of dollars, and apparently the company would rather stop producing the drug at all than go through with this testing. This is *NOT* a safety issue, but rather a procedural argument between the FDA and the makers.

The problem is that this drug and all generic versions are also now at risk of no longer being available at all in the US, or only possibly on a very limited basis. The generic makers have been given a few weeks beyond the limit for Shire, late September, to provide the FDA with additional testing results. However, this is cost prohibitive and it is likely there will soon be *NO* source for this medication in the US.

Midodrine is a prescribed drug for the conditions that result in low blood pressure, such as Orthostatic Intolerance (POTS [postural orthostatic tachycardia syndrome], NCS [neurocardiogenic syncope] in particular). I have a genetic collagen defect that resulted in a diagnosis of POTS, NCS and global dysautonomia (dysfunction of the autonomic nervous system). I also have been the volunteer administrator of a medical support group at DINET.org (Dysautonomia Information Network) for the past six years. I have come to know more than 6000 active members with this condition, many of whom depend upon this drug for quality of life and the ability to function independently by stabilizing blood pressure; without access to this drug, hundreds of thousands of US patients are facing the prospect of losing their jobs, their ability to care for family, participate in daily life, and function without disability.

There is no substitute drug for midodrine. Midrodine is not a widely prescribed drug in the general population, except that is is the primary first line of intervention for patients with low blood pressure, so it is not in the economic interest of the manufacturer (Shire) to conduct extensive additional testing. A recent email from Shire indicates their intention to cease production rather than comply with the FDA for financial reasons. I am imploring you to work with the FDA regulators to keep this drug available in the US, as there is no other similar option in the marketplace. Midodrine (ProAmatine) has more than a decade of safe use in the United States.

As someone who relies heavily on prescription medication in order to function, to work full time with children with autism, and teach part time to prepare new teachers to serve children with severe disabilities, I am trying to remain hopeful that you, my elected government officials, will advocate on my behalf. I am relying on you to represent me, and the thousands or other NJ patients who will likely be unable to work, and possibly become completely disabled and fully reliant on others for daily needs if this drug is withdrawn from market.

http://www.ashp.org/import/news/HealthSystemPharmacyNews/newsarticle.aspx?id=3387

Okay, hope that provides help to those of you who've been trying to work on this issue (I know it's not everyone's issue, but for those who want to take a stand, I'm hoping to just give you a one-stop-shopping post).

Nina

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I've written to everyone that I can write to, but I haven't received any responses. Maybe the shear volume of letters will make the FDA rethink their plans for pulling midodrine. If I needed a medication for hypotension I couldn't use droxipoda anyway as I have hyper POTs and don't need an increase in norepinephrine.

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Interesting! Thank you so much for the update. I'm really glad to hear that they are moving forward with trials for midodrine. I hope that it is proven to be beneficial. I know that it has been beneficial for me, and I don't want to have to go back to life without midodrine!

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