Urgent Call to Action:

The U.S. Food and Drug Administration (FDA) proposes the withdrawal of Midodrine / ProAmatine from the market.

DYNA Youth Members ask the public to "Please Stand By Me!"

August 19, 2010

To: DYNA Members, Families and Friends

From: Debbie Dominelli
President

Re: Requested Action -
Response to FDA Proposed Withdrawal of Midodrine/ProAmatine

This is a direct and urgent request for DYNA members to take action regarding the FDA's proposed withdrawal of Midodrine/ProAmatine, which it announced this past Monday, August 16, 2010.

Please know that the brand ProAmatine and the generic versions of Midodrine have NOT been found to be unsafe for use by the FDA. Rather, the FDA is enforcing for the first time ever a regulatory technicality on the brand pharmaceutical corporation, which will also impact the generic providers. The result imminently endangers the continued availability of this drug. There is no alternative to this drug currently available.

Many, if not most, people diagnosed with orthostatic intolerance conditions utilize this drug as a mainstay to remain functional. Most of our membership utilizes this drug.

On behalf of our membership, the DYNA organization is monitoring this situation carefully and communicating with all interested parties on a timely basis to advocate for the best possible outcome. Additionally, the DYNA Medical Advisory Board is actively participating on our behalf.

Now is the time for our members to participate. Follow the instructions below to be advocates for our DYNA members and for all people who will be devastatingly impacted by this FDA action. This affects most of our members now. Whether it affects your family now or not - please act to help fellow members and yourself or your family members who may need this drug at some other time.

I have spoken with leadership at the FDA regarding this action. The FDA welcomes consumer input regarding this matter - and, in fact, will consider it in their continued assessment of the situation. They need to hear from us to make an informed decision. As most of us are aware, our medical conditions are not well known even among the medical community. We cannot expect a large, over-burdened government agency to know our stories. We have to tell them.

Please do the following at your earliest opportunity:

1. Call the FDA's Office of Drug Information at: 888-463-6332. You will be given selection options so listen to them carefully. You will want to select #4 Speak to a Representative, # 3 Human Drugs, #1 Human Drugs. You may have to leave your name and contact information on a recording. Be sure to speak very clearly and repeat your name and phone number for clarity. Tell them that you are responding to the FDA proposed withdrawal of Midodrine / ProAmatine and that you wish to object. Inform them of how this drug and the lack of it will impact your life. Voice your concern. Ask questions. They keep count of calls. (These calls should be made by adults over the age of 18.) Be sure to make note of the time of your call, the individual you spoke to and the details of the conversation.
2. Write the FDA. Written correspondence to FDA may be posted to the public docket (FDA-2007-N-0475). Include 4 copies of your letter.

Send to:
FDA-2007-N-0475
Division of Dockets Management (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, MD 20852

• Entitle your letter: A Response to the FDA proposed withdrawal of Midodrine / Proamatine.
• Clearly and efficiently state your concern and ask your questions.
• Be sure to provide your contact information.
• Include 4 copies when you mail it and be sure to save a copy for yourself.
• Sample Letter
  This letter was provided by a DYNA Youth Ambassador. Please feel free to download it. Please make sure that you mail 4 copies of your final letter (do not staple them together).
3. Inform your family, friends, physicians and anyone who cares and will help. Concerned citizens may contact the FDA in the above manner.
4. Donate to the cause that serves you (whatever Dysautonomia organization that may be). The Dysautonomia community needs your financial support to continue to advocate on your behalf. Funding is essential. Donate to www.dynakids.org via the link on our main web site.
5. Watch for continued updates on this matter.
6. Remain calm. Together, we will work this out.

Please act now. This is a matter of vital importance and time is of the essence.

Download FDA Docket no. FDA-2007-N-0475.