Midodrine and the FDA

Please bear with me while I talk about midodrine just a little bit more.  This whole situation is complicated, right down to how we are supposed to contact the FDA.  I've been given different answers regarding how to best contact them.  Here are two more official ways we can let the FDA know that the withdrawal of midodrine will have a devastating impact on many thousands of people. We can just totally overwhelm the FDA with letters, emails, and phone calls. :)

Here is a link the the Center for Drug Evaluation and Research.  On this page you will find a link to an online "Contact CDER Form."  This is the form many have used, and they have received a response within two days.

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


Information from DYNA Kids:

I was just given the following web page at DYNA Kids, and it has a very clear description of the situation as it stands currently, and very clear directions for what to do to have your voice heard. They also have an excellent sample letter that can be sent to the FDA. You can find it all here: http://www.dynakids.org/midodrine.jsp


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In my last post I included a sample letter that can be sent to the FDA.  Here is a letter that can be sent to your congressman. 

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). Many people with Orthostatic Intolerance 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 the friend of someone who relies heavily on midodrine in order to function, I am trying to remain hopeful that you, my elected government officials, will advocate on my behalf. I am relying on you to represent the thousands of 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.


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It is very hard for me, and others like me, to keep up with writing, calling, and fighting to have the medicine we need. Life is hard enough as it is, and now we are having to use our precious energy just to keep fighting for the right to use the only medication that has ever been created specifically for us.  Thank you to all of you who are helping us with this huge task!

The Midodrine Battle

People have been asking me if they can contact the FDA about the withdrawal of midodrine from the market.  Yes, you can!  And thank you so much!  I appreciate your effort on my behalf, and on behalf of the many thousands of people who depend on this medication daily.


If you would like to call the FDA, you can use this number: 1-888-463-6332. I am told that you will need to select #4 Speak to a representative, then #3 for Human Drugs, then #1 for Human Drugs (again).


If you would like to send an email to the FDA, please send them to both of the following email addresses.  Just remove the spaces first.  Those are added in to help prevent spam.

norman.stockbridge @ fda . hhs . gov

janet.woodcock @ fda . hhs . gov


If you would like to send a letter through the mail to the FDA, please send it to both addresses below.

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


If you want to contact your congressman, you can find their information here:

http://directory.usayfoundation.org/


Here is a sample letter that can be sent to the FDA.  Feel free to use this, edit as you please, or write your own.

I strongly urge you to reconsider the withdrawal of midodrine from the market. The withdrawal of midodrine was not the result of a safety issue, but rather a procedural argument between the FDA and the makers. While I understand that the FDA has an obligation to enforce its rules and regulations, the decision to withdraw midodrine from the market fails to take into account the 100,000 people who will be left unnecessarily suffering with debilitating symptoms of Orthostatic Intolerance.
 
The FDA is recommending that patients talk to their health-care providers regarding alternative treatments, but at the same time is keenly aware that midodrine is the only FDA approved drug to treat Orthostatic Intolerance. There are no reasonable substitutes for it.

It is completely cost-prohibitive for any of the manufacturers of midodrine to benefit from doing the follow-up studies required, and hence keep the medication on the market. Please take into consideration the fact that thousands of lives will be devastated by the withdrawal of midodrine. 

I ask you to find a solution that allows all involved to benefit--the FDA, the manufacturers, and the patients who rely on midodrine to help them work, care for children, and engage in normal activities of daily living.

Thank you for your time and consideration.
 

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A big thank you to a dear friend who helped me to compose both this blog post and my previous blog post.  Your help has been tremendous on these days when I can barely think and function.  I thank the Lord for you.

Midodrine

There aren’t many medications made for people like me with dysautonomia. Most medicine we use is off label for our condition. However, 14 years ago a medicine came on the market for people just like me! It is called ProAmatine (generic name is midodrine), and it raises blood pressure. Midodrine has been very helpful to me, and to many others with dysautonomia. It is one of the safest medications available, has virtually no side effects, and works immediately.

Just two days ago I was lying flat in bed because my blood pressure was low, and the blood flow to my brain was compromised. My body was tingly all over (similar to the head rush feeling a healthy person might feel), and for half an hour I was on the verge of fainting. The lack of proper blood flow to my brain left me feeling slightly confused and scared. I took 10mg of midodrine, and thirty minutes later I no longer felt like I was going to faint, and my blood pressure came up by 15 points. If I didn’t have midodrine, I don’t know what I would have done.

The Problem:

Two weeks ago the FDA announced that they had decided to pull midodrine off the market, leaving doctors and patients blind-sided. The FDA is pulling midodrine because the follow up studies to test the medications efficacy were not conducted. (It is important to note that they are not concerned with safety issues; the medicine has already been proven to be safe. They are concerned with the proper tests being completed and documented proving that the drug actually works.) Shire, the manufacturer responsible for conducting these studies, said that they have already completed the trials requested by the FDA, but the FDA ruled these trials as inconclusive.

Why can’t Shire, or any other drug manufacturer, just conduct the studies again? The medication trials cost about $25 million dollars. Shire’s annual revenue from selling this medication is $500,000. It all comes down to money. It is not financially worth it for Shire, or any drug company, to conduct such expensive tests.

This is devastating news for me, for many of my closest friends, and for the 100,000 people across the United States who rely on midodrine. Midodrine is literally the only drug ever created and approved to treat low blood pressure. There are no substitutes.

What this means for people with dysautonomia:

- Quality of life will be reduced.

- People will lose their jobs because they cannot function at a normal level without midodrine.

- Many with dysautonomia will have to go on disability for the first time.

- The ability to care for children and a family will be diminished.

What this means for me personally:

- I will have to spend more time lying down.

- I will have more headaches.

- I will have more “coat hanger” pain in my neck and shoulders. This is caused by blood vessels shutting off blood supply to the less vital muscles in order to conserve blood supply to the brain.

- I will have more brain fog (difficulty concentrating due to lack of adequate blood flow to my brain).

- I won’t be able to sit up for as long, making going out in my wheelchair harder.

- I will become even more homebound, and life in general will just be more difficult.

Will midodrine still be available at all?

The FDA does have an expanded-access program, which can allow patients to receive a medication on a case-by-case basis. The patient must have a serious or life-threatening illness that cannot be treated with an alternative medication.

This would make things pretty complicated, and insurance often doesn't cover a drug that would then be considered more 'experimental' than proven. Plus, one of the manufacturers would have to feel that it is worth their time and money to both create an extended access program and continue to manufacture midodrine.

What can be done?

The best action we can take right now is to contact both the FDA and our representatives. This is what our doctors have urged us to do.

My project for the weekend is to write the FDA and write my representatives.

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A big thank you to my dear friend (you know who you are!) for helping me to write this blog post.  I could not have done it without her assistance.

Back from Blogging Hiatus

Hello Friends!  I am back.  It has been a long, hard, busy, and very hot summer.  We are still here, and we are doing well.  Thank you to everyone who commented on my blog or sent me emails to check in with me and see how I was doing.  It is so nice to know that I'm not forgotten.  Thank you for bearing with me as I have been so quiet.  I have been wanting to blog all summer, but fatigue and brain fog have kept me away.  As I am able I will try to keep up with blogging and catch you up on the old news. For now, I am going to give you a quick glimpse into the last couple of months.

In May we went to the Creation Museum for our family vacation. It was really neat, and I am really hoping for energy to blog about the museum and share pictures at a later date.  Later on in the month of May we went to Georgia to visit my family.  It was great to see them again and spend time together.  We were also able to visit with people from our home church in Georgia.  It is always good to see our church family there and reconnect with them.

In June we travelled to Alabama and celebrated my Tante Hanna's 90th birthday!  She travelled over from Germany for the special occasion.

In July William had his face painted like Spider Man. 

I dressed Adelaide up like a ballerina.

William and Adelaide on the 4th of July

We celebrated Independence Day with an indoor picnic.

My mom stayed here and helped us out a lot this summer while Will took several J-term classes.  We couldn't have made it through those long weeks without her help.  She was here for about 3 weeks total helping me with William and Adelaide, and keeping up with the cooking, cleaning, laundry, and shopping.  Is my mom great or what? 

We planted our flower pot garden.  We have enjoyed taking care of the plants, watching the flowers bloom, and eating fresh tomatoes, herbs, and okra.

How are you doing?  How has your summer been?

P.S.  I'm working on updating my blog.  You'll see some things slowly chaning over the next few days/weeks.