In February of 2009, I wrote a blog post about a medication I started taking to increase my blood pressure when standing and sitting. I titled the post Magic Midodrine because the medication has been so life-changing for me. Every 3 1/2 hours the little alarm on my phone buzzes to let me know it's time to take another dose of my magic midodrine.
Last week news broke that the FDA has decided to pull midodrine off the market, leaving doctors and patients blind-sided. I've been feeling very sad and devastated by this news.
This news came on the tails of an increase in my Rocephin dose by my PCP (without consulting me first), that has left me even more crashed out. I've been able to get the dose lowered again, but not before the higher dose pushed me past my 'tolerable' limit. I was still herxing enough from the increase in mid-July! I'm also in the midst, as I mentioned in my previous blog post, of trying to find a new Lyme doctor and pursuing other options for treatment. I'll try to write separate blogs when I am able, but it's been hard to keep up with any sort of communication these days.
Back to the midodrine: Here is what we know so far, what it means for patients like me, and what can be done to try to help. People have been asking me a lot of questions in response to this news, and I have tried to answer them as well as possible.
The 'technical' stuff is first, and the 'emotional' and 'personal' stuff is last...so you can choose what you want to read!
Why is the FDA pulling midodrine off of the market?
ProAmatine (the name brand of midodrine) was approved in 1996 via the FDA's accelerated approval process. The FDA requires companies who receive this type of approval to conduct follow-up studies indicating the drug's efficacy.
However, the FDA has NEVER actually enforced this rule. Until last week, that is, when they decided to withdraw ProAmatine (and subsequently its generics) from the market for failure to provide adequate follow-up studies.
Shire, the drug company who manufactures ProAmatine, argues that they did conduct follow-up studies but the FDA found them to be inconclusive.
Apparently, the Government Accountability Office called out the FDA on its failure to enforce the rules regarding follow-up studies for drugs approved on the fast-track program. It specifically cited ProAmatine as an example.
It is incredibly important to note that midodrine has NEVER been called out for safety issues. In fact, it is incredibly well-tolerated and safe. This is part of what makes this action by the FDA so frustrating for those of us who rely on this medication.
Why won't Shire or those who manufacture the generics (five companies) do more follow-up studies instead of pulling the drug off of the market?
The short answer is money. Low blood pressure isn't a big money maker.
Even before the FDA announced its withdrawal of ProAmatine from the market, Shire had apparently notified them in November of 2009 that they would stop manufacturing ProAmatine effective September 30, 2010.
The FDA made its official announcement regarding the withdrawal of ProAmatine from the market for failing to conduct follow-up studies on August 17th. The generic companies have 30 days to respond to the FDA's actions but I don't think any of us expect those manufacturers to decide to take on the follow-up studies either.
It would cost Shire $25 million dollars to conduct the studies the FDA requires. Shire makes $500,000 a year off of ProAmatine. This is 0.1% of their profits.
About 100,000 people rely on midodrine to control symptoms of low blood pressure upon standing.
So, why in the world would they spend the money to do the studies for such a small group of patients? They wouldn't, and I completely understand that.
Will midodrine be available from other countries?
Nothing is known at this point. The drug is available and manufactured in Canada and Europe. At issue is whether any of the manufacturers of the generic would want to continue manufacturing the drug in those countries, when it can't be available in the U.S. It is hard to imagine there being enough demand for the drug if it isn't FDA approved in the U.S.
Even if the drug is available, it is extremely expensive. For me, a month's supply would cost about $800. Obviously, this is not sustainable over the long-term.
Will the drug 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 now be considered more 'experimental' than proven. Plus, one of the manufacturers has 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 all take right now is to contact both the FDA and our representatives. I will follow up this blog post with contact information as well as sample letters (that is my next project!). Even Dr. ANS emphasized this as the best thing we can do right now. Remember to remind the FDA and your representatives that this decision was a political one, and not about patients.
How much longer will I be able to get midodrine?
Shire will stop manufacturing ProAmatine on September 30th. I have a wonderful pharmacist who is willing to stockpile as much midodrine as she can for me, as long as it continues to be available through her supplier. I am the only patient at my pharmacy who uses this medication (surprise, surprise!). The supply likely won't run out immediately, but we have no idea now long it will be available.
The other problem is that, even if she can stockpile six months or so of midodrine, my insurance my stop paying for it once they figure out that the FDA has pulled ProAmatine off of the market.
So, things are very up in the air.
Right now, I'm continuing to take midodrine as I do every day. Every 3 1/2 hours, four times a day. I'm trying to take it one day at a time, knowing that the only thing I can do is enjoy it while I have it.
Why is the withdrawal of midodrine so devastating?
Midodrine is literally the only drug ever approved to treat Orthostatic Intolerance (low blood pressure upon standing, which is a huge part of my ANS issues).
No substitutes exist.
At this point all of the other drugs used to treat those of us with ANS dysfunction are used off-label (SSRIs, beta-blockers, etc.), but none have the very special mechanism that midodrine does.
Over the years, I have tried almost 70 medications to treat my various conditions or the symptoms of them. When I started midodrine at the beginning of last year, I felt that I had finally found the closest thing to a magic pill I have ever found.
When I was not on treatment for Lyme last summer, we were able to go on outings and I could sit up for longer periods of time. I had a major change in all of my symptoms (which I wrote about extensively in that first post, so I won't repeat it here).
For those of us who take this medication, we are looking at a huge change in the quality of life that midodrine gives us. For some members of the forum I am on, midodrine has given them the ability to lead an almost 'normal' life--they work, raise a family, participate in hobbies. Without midodrine they cannot function.
Even though I'm not going on outings now, midodrine has been one of the major tools we have used to help me tolerate the Lyme treatment. The more intense the antibiotic therapy the more problems I have with blood pressure.
One of the biggest and scariest questions is whether or not I will be able to tolerate the treatment for Lyme if I do not have midodrine.
Midodrine has helped me to get through both an endoscopy and my surgery to insert my port without my blood pressure crashing out.
If I really think about what will happen when midodrine is no longer available, I feel sad, devastated, angry and terrified. I really can't even imagine life without this medication. And I'm so very sad along with my other friends who rely on this medication too. I really don't know what I will do without this medication.
I feel like each time we think we'll get a little breather from the constant medical battles (for home care, for lexapro, etc.) something else comes up. The last thing I feel like I have energy for right now is writing more letters and using more energy to fight, fight, fight for this medication. But it is what has to be done. And I will do it.
When will we find a way to make healthcare about the patient and not about politics and money? Why pick on a medication that has not viable alternatives for those it helps? Why make it so impossible for Shire or the other manufacturers to do follow-up studies?
Photos: We've been trying to get out for short StRolls as often as possible in the evenings. I'm usually feeling quite ill, but we make the effort even if it is just to the corner and back! On Sunday evening, the rain streamed down through the sunlight. I knew this meant it was 'rainbow weather'. And sure enough, when we went out for our StRoll there was a GORGEOUS rainbow. I also snapped a photo of the evening sky on our way back home. And a photo of Asher, all ready to go for our StRoll. I haven't been able to take many photos lately, so I had to use a lot of similar ones in this post! :P
When we go out for our StRolls I definitely think about how the combination of midodrine and having The Rolls has made outings of any sort possible.