Tuesday, August 31, 2010

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!

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