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.
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.
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.