Fda Withdrawing Proamatine/midodrine?!

[shanying418]

I agree with Mightymouse's post. i was on midodrine till a few days ago and was taken off it when I phoned my cardiologist about the FDA issue. My cardio doctor was surprised about the news and replied in an honest way that this will make the situation tricky. Although I'm facing the same problem of not knowing what to do next (I'm currently off meds), I also think it is important to remain hopeful and probably see if there are other options for back up. I can see that my cardiology doctor is also a bit puzzled by what to do and I won't doubt that he'll consult other professionals about this situation. It might be for our best interest to wait for a collaborate decision on the medical professions. I know it sounds a bit hard and something must be done, but keeping up the hope might also be as important in the crisis.

[Noreen]

Shari-

I am a bit confused why you were taken off now. The drug is still on the market - it is not a safety or efficacy issue really - it's a paperwork reporting issue mostly. If you were deriving benefit from it you could still get it.

I was due for my next three month supply on the 17th and called the cardio's office. His nurse called it in to the drugstore - I never did talk to her as a partial supply was available at the pharmacy yesterday. That by itself is not unusual as they usually don't have 270 on hand.

[MightyMouse]

Reen is correct, it's NOT a safety issue. If it were safety related, the drug would have been black boxed (restricted use to last resort) or removed entirely from US market.

[DancingLight]

Were our doctors even aware of the impending withdrawal of midodrine before the announcement by the FDA this week?

I was just curious if they are left scrambling as much as we all are? I had just spoken to my ANS specialist last week about my midodrine Rx and he didn't mention anything about it possibly being taken off of the market. He's one of the top specialists in the country, so either he didn't know or he was trying not to cause me panic before everything shook down.

The news hits for ProAmatine and its withdrawal are numerous and not very encouraging!

Please keep us posted if anyone knows what we can do to help keep this drug available. Nina, it sounds like you have inside scoop?

[Michelle Sawicki]

As far as I know the doctors were just as surprised as we were. The ones I am in contact with did not know of this ahead of time.

Michelle

[MightyMouse]

Inside only so much as Michelle and I are within the email loop/cc list for a good sized group of doctors who were blind sided with this last week and now strategizing on what would be the most likely way of getting patients what they need. I haven't heard anything new today.

[shanying418]

Shan-

I am a bit confused why you were taken off now. The drug is still on the market - it is not a safety or efficacy issue really - it's a paperwork reporting issue mostly. If you were deriving benefit from it you could still get it.

I was due for my next three month supply on the 17th and called the cardio's office. His nurse called it in to the drugstore - I never did talk to her as a partial supply was available at the pharmacy yesterday. That by itself is not unusual as they usually don't have 270 on hand.

Sorry for the confusing statement. I was taken off from the medication NOT because of safety issues. I was having headache (without high blood pressure) with midodrine and my HR is not controlled either. That's the reasons that my cardio doctor took it off. What I was trying to say is, my doctor was surprised by the news and he even stated that "No one ever contact us about this!"

[Chaos]

You just got to love dealing with government agencies. I emailed the FDA and got the typical response about how they approved the drug in an accelerated manner, they are removing it because the studies weren't done and then they include the sentence about how "in the case of Midodrine there are no alternative treatments...." Then in the very next sentence they say I should talk to my healthcare provider about treatment options. HELLO????? Is he somehow going to be able to snap his fingers and make another drug appear???

It's not bad enough that we've all gone through **** to get to a doctor that knew enough to prescribe something that actually helped us? Now we have to fight the government to try to keep a drug that at least has allowed some of us to return to a somewhat functional level??? AAARRRRGGGGHHHH!!!!

[cnm1]

My feelings exactly, Chaos.

You just got to love dealing with government agencies. I emailed the FDA and got the typical response about how they approved the drug in an accelerated manner, they are removing it because the studies weren't done and then they include the sentence about how "in the case of Midodrine there are no alternative treatments...." Then in the very next sentence they say I should talk to my healthcare provider about treatment options. HELLO????? Is he somehow going to be able to snap his fingers and make another drug appear???

It's not bad enough that we've all gone through **** to get to a doctor that knew enough to prescribe something that actually helped us? Now we have to fight the government to try to keep a drug that at least has allowed some of us to return to a somewhat functional level??? AAARRRRGGGGHHHH!!!!

[MomtoGiuliana]

I wrote to both FDA and my congressman. I am not sure the latter would be that effective. And apparently the manufacturer was looking at discontinuing production anyway? I just skimmed everyone's messages so not sure I got all completely correct.

This is what I wrote:

I am very concerned by the decision of the FDA to withdraw the marketing approval for Shire Development Inc.'s midodrine hydrochloride product, Proamatine. This will require the company to conduct additional testing in the millions of dollars, and apparently the company would rather stop producing the drug at all than go through with this testing. The problem is that this drug and all generic versions are now at risk of no longer being available at all in the US, or only possibly on a very limited basis. Midodrine is a highly prescribed drug for the conditions of Orthostatic Intolerance (POTS, NCS in particular). I have POTS and through a support group have come to know many others with this condition, many of whom depend upon this drug for quality of life/function; without access to this drug, hundreds of thousands of patients are facing the prospect of losing their jobs, their ability to care for family, participate in hobbies, and function without disability. As far as I understand, there is no substitute drug that would work as well. Midrodine is not a widely prescribed drug, so it is not in the economic interest of the manufacturer to conduct extensive additional testing. I am not sure what role congress can play in this issue, but I wanted to bring this to your attention. http://www.ashp.org/import/news/HealthSystemPharmacyNews/newsarticle.aspx?id=3387

[cnm1]

I also contacted my congresswoman today

Louise

I wrote to both FDA and my congressman. I am not sure the latter would be that effective. And apparently the manufacturer was looking at discontinuing production anyway? I just skimmed everyone's messages so not sure I got all completely correct.

This is what I wrote:

I am very concerned by the decision of the FDA to withdraw the marketing approval for Shire Development Inc.'s midodrine hydrochloride product, Proamatine. This will require the company to conduct additional testing in the millions of dollars, and apparently the company would rather stop producing the drug at all than go through with this testing. The problem is that this drug and all generic versions are now at risk of no longer being available at all in the US, or only possibly on a very limited basis. Midodrine is a highly prescribed drug for the conditions of Orthostatic Intolerance (POTS, NCS in particular). I have POTS and through a support group have come to know many others with this condition, many of whom depend upon this drug for quality of life/function; without access to this drug, hundreds of thousands of patients are facing the prospect of losing their jobs, their ability to care for family, participate in hobbies, and function without disability. As far as I understand, there is no substitute drug that would work as well. Midrodine is not a widely prescribed drug, so it is not in the economic interest of the manufacturer to conduct extensive additional testing. I am not sure what role congress can play in this issue, but I wanted to bring this to your attention. http://www.ashp.org/import/news/HealthSystemPharmacyNews/newsarticle.aspx?id=3387

[MightyMouse]

Katherine, you got the information correct as far as my understanding goes. Also, you've provided nice, concise, well written explanation and request for support. Well done.

Nina

I wrote to both FDA and my congressman. I am not sure the latter would be that effective. And apparently the manufacturer was looking at discontinuing production anyway? I just skimmed everyone's messages so not sure I got all completely correct.

This is what I wrote:

I am very concerned by the decision of the FDA to withdraw the marketing approval for Shire Development Inc.'s midodrine hydrochloride product, Proamatine. This will require the company to conduct additional testing in the millions of dollars, and apparently the company would rather stop producing the drug at all than go through with this testing. The problem is that this drug and all generic versions are now at risk of no longer being available at all in the US, or only possibly on a very limited basis. Midodrine is a highly prescribed drug for the conditions of Orthostatic Intolerance (POTS, NCS in particular). I have POTS and through a support group have come to know many others with this condition, many of whom depend upon this drug for quality of life/function; without access to this drug, hundreds of thousands of patients are facing the prospect of losing their jobs, their ability to care for family, participate in hobbies, and function without disability. As far as I understand, there is no substitute drug that would work as well. Midrodine is not a widely prescribed drug, so it is not in the economic interest of the manufacturer to conduct extensive additional testing. I am not sure what role congress can play in this issue, but I wanted to bring this to your attention. http://www.ashp.org/import/news/HealthSystemPharmacyNews/newsarticle.aspx?id=3387

[DADofPotsSon]

I sent an email to my Ohio Congressman this weekend & the FDA. Also son#2 is trying to stock up on proamatine but not have good luck with his method.

DADofPotsSon

[MightyMouse]

I have also written to my congressman (Christopher Smith) and the FDA. I'll let you know if I get anything more than a form letter back.

[doctorguest]

Below is the letter I received today in response to my letter to Shire.

Page 1

August 24, 2010

Ref: US10-010211

Subject: ProAmatine

Dear Dr.________:

Thank you for your recent medical information inquiry regarding ProAmatine. We

understand that you have requested information on the discontinuation of ProAamatine.

Shire will be discontinuing the sale of the branded drug, ProAmatine effective September

30, 2010. Shire acquired ProAmatine as a part of the acquisition of Roberts Pharma in

1999 and Shire conducted and completed the post marketing trials that the FDA

required. The FDA, however, viewed these trials as inconclusive and required that

additional trials be conducted for ProAmatine to maintain its marketing authorization. As

a result, Shire elected to withdraw the product effective September 30, 2010 and notified

the FDA in November 2009 and healthcare professionals earlier this year of this

decision. Shire's withdrawal of the NDA was not related to any concerns regarding the

safety of ProAmatine.

We are sorry that this action may be affecting your patient?s treatment plan. As of this

time, there are generic forms of midodrine hydrochloride tablets are available in the US

that you may consider, as well as other therapies for treating orthostatic hypotension.

The following is a short list of the manufacturers of generic midodrine hydrochloride:

Mylan Labs

Sandoz

Apotex

Upsher-Smith

Impax Labs

We regret any inconvenience that this may cause you and your patieints and hope that

alternative therapies or options can be found.

This enclosed information is supplied as a professional courtesy in response to your

inquiry. It is intended to provide pertinent data that will assist you in forming your own

conclusions and making your own decisions. This information is not intended to

Page 2

advocate any indication, dosage, or other claim that is not covered in the enclosed

package insert.

Should you have any questions or need additional information, please contact us directly

at 1-800-828-2088.

Sincerely,

Medical Affairs Associate

[Tuesday]

Several people on Facebook are trying to get consumer advocate Erin Brockovich to help take over this case, and petition the FDA to get the drug back on the market. If you're on Facebook, search for "Join Lynn & Erin Brockovich for proamatine/midodrine."

You can email Erin Brockovich from her website, just click the big yellow HELP button: http://www.brockovich.com/index.html

Make sure you mention ProAmatine/Midodrine.

[Angelika_23]

I have written my congressman as well. Let's deluge them with letters!

[Tuesday]

Here is a link to Lynn's site with information about contacting Erin Brockovich: http://delivermeministries.org/node/136

[DancingLight]

Thank you to everyone who has already written to the FDA and their representatives! That is definitely my project for this week.

I was fortunate enough to be in contact this week with my ANS doctor and he suggested that the best thing we can do at this time is make ourselves heard by contacting the FDA and our representatives.

Otherwise, I don't think the doctors know too much else either. He said midodrine may still be available on a case by case basis.

Make sure the FDA and your representatives know this was a political decision, and did not take into account patients.

I know Nina was also waiting to hear from doctors on her board, and may have some more information than I do.

I haven't been on the board for a long time, and I hope that I am not stepping on any toes to post this. Just wanted to share what I had heard, because I know a lot of us feel that our lives and the quality of them depend on this medication.

The best thing we can do right now is speak up!

emily

[MightyMouse]

If you're inclined to contact the FDA on this issue, here is a direct link to the correct department for your commentary/complaint:

http://www.fda.gov/AboutFDA/CentersOffices/CDER/ContactCDER/default.htm

To find your congressman you can try looking here:

http://directory.usayfoundation.org/

my congressman's page also double checked that I had the correct person by asking for my zipcode plus 4 to make sure I was in his district.

Nina

[sue1234]

Doctorguest showed a copy of a letter he received from the manufacturer. It says that the generic versions are still available from the listed companies. Is the generic not a good replacement? (I don't take the med, just want to keep informed for any future need).

[MightyMouse]

Sue, the letter from Shire regarding the generics is misleading. The generics are also at risk presently. The generic makers were given the same ultimatum from the FDA, with a few additional weeks past the deadline given to Shire. So, the generics have until the end of September to provide the FDA with an response.

I've also contact my local legislators (State senator and assemblymen). Here's what I wrote them:

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

Nina C. Wilde

[sue1234]

Now I see--the letter doesn't tell all story! Hope y'all get it to remain available for those that are in need of it!

[nmorgen]

Can someone write a generic letter stating the problem that we could all copy and paste and send to legislators? I agree that this is political and has nothing to do with the drug itself. I think the FDA just picked a drug with limited distribution to see if they could get a way with it.

[kjd111]

Hi everyone. I haven't posted a lot (dedicated lurker) but my daughter has been diagnosed with NMH and possibly PAF - rather than POTS. She was prescribed Midodrine and it has definitely helped a lot, so this has been really shocking news. We saw our doctor today and he was completely blindsided..........and not too happy. He's been prescribing it for years and describes it as a "lifesaver". I wrote to the FDA and am in the process of writing to our state senators(we are in Texas). I received my response from the FDA this afternoon. I was very (underline very) sharp with them in my email about not coming back to me with a standard line of "seek alternative treatments" since they know full well there aren't any. It does seem they paid a bit more attention in the response i am copying below, but based on the tone, it seems to me that they are digging in their heels. This definitely smells politically motivated.

"Thank you for your message to the Division of Drug Information at the Center for Drug Evaluation and Research (CDER), within the Food and Drug Administration (FDA).

We appreciate the time that you have taken to contact us and we are certainly sensitive to your situation and to those who have similarly contacted us on this issue. At this time, we do not have any additional information, but should new information become available, it will be posted on our website:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm222640.htm

ProAmatine was approved in the United States in September 1996 under the FDA's Accelerated Approval program. This program allows for the approval of drugs (or new drug indications) on the basis of an effect on a surrogate endpoint considered reasonably likely to predict a clinical benefit, if the disease to be treated is serious or life-threatening, and if the available data suggest that it will provide a benefit over established therapies. In the case of ProAmatine, there are no alternative approved treatments for orthostatic hypotension.

Accelerated Approval, however, has certain requirements that must be met as conditions of approval. Specifically, the manufacturer of the drug must conduct post-marketing studies to confirm the expected clinical benefit. Because neither the original (innovator) sponsor of ProAmatine-Shire Pharmaceuticals-nor anyone else has conducted the required post-marketing studies that confirm clinical benefit, which was a condition of approval under Accelerated Approval, this drug will be removed from the U.S. market.

FDA realizes the importance of patient access to the treatments they need. FDA will work with any drug sponsor willing to develop an expanded access program, so that patients who are currently using this drug and receiving benefit from it can continue to get it. We cannot, however, mandate that this be done.

We strongly encourage patients taking this drug to talk to their healthcare professionals if they are concerned or have any questions. We also encourage professional societies to talk to their members to communicate this important information. We want healthcare professionals to be prepared and to discuss alternative treatment strategies for this important patient group.

Best regards,

Drug Information BLS

Division of Drug Information

Center for Drug Evaluation and Research

Food and Drug Administration

For up-to-date drug information, follow the FDA's Division of Drug Information on Twitter at FDA_Drug_Info