I left out in my last post that my letter includes the plea to the FDA to schedule the public advisory committee meeting that they said they would have so that everyone has a chance to voice just how much they are being affected by this decision.

Here is a copy of my letter, I encourage others to share their story here and also use my letter as an example of the information that everyone should put in their own letter for the meeting. My condition is not IBS so I cannot personally speak about the severity of that condition so I urge those with IBS to document their trials as well. This medicine should not be denied to anyone where the benefits outweigh the risks. It is up to us to explain why the benefits do outweigh the risks.

I am a 26 year old women. I have nerve damage from a spinal fusion surgery that prohibits my body from any peristaltic movement. The drug zelnorm is the only medication or treatment that treats this problem with my nerves. Without it my digestive system is stagnant. I cannot eliminate without this medicine. There are simply no other options for me. Without this medication I have no quality of life. I cannot get out of bed, I cannot eat, I cannot take care of my child. To just survive without this medicine I have to spend a couple of hours a day giving myself painful enemas that only give the slightest relief but do nothing for my ability to function in any normal way. And this will not prevent my inevitable physical decline. My digestive system does not work on it’s own. One of the most basic of bodily functions is dependent on this medicine. When this drug was recalled so was my life. I do not respond to anything else. Imagine for a second if everything you put in your body had no way to digest. Imagine all of the food just sitting in your body fermenting until you became feverish and so distended that you couldn’t sit up. Imagine the pain along with the fear that your intestines will burst. Now imagine ignoring hunger pains because you simply can’t put anymore food in your body because to do so is killing you. Please imagine this because that is my life without zelnorm. I am in chronic pain because of a spinal injury. I have suffered so much as it is. To this day I can still not work because of the chronic pain in my spine from this injury. On top of this without zelnorm my digestive system is useless. I cannot go to the bathroom without this medication. It is as simple as that. A basic bodily function that is taken for granted by most is completely hindered for me without this miracle medication. Every day I thanked god for this medicine. I am pleading for this medicine to be returned to me. Without it I cannot function in this world. I don’t have to spend my life in bed sick and miserable there is a medicine that works for me. Please bring it back. Without it I am in serious trouble. My digestive system ceases to function without this medication. The digestive system is a crucial component of the physical body and I do not see me living very long without it. This medicine was recalled before all of the facts were gathered. The FDA made a decision that the risks outweighed the benefits without doing the proper research. Because lives do depend on this drug. I know there are others like me. If the magnitude of this situation was considered before the recall like it should have been I am certain the medicine would not have been pulled from everyone. This is blatant misconduct on the part of the administration to rip medicine away from people without getting all of the facts. Until this drug is back in the hands of people like me whose lives depend on it there will be casualties and they will be the fault of the FDA who recalled a medication before finding out that there are people who depend on it to live. If the research was competent it would have been apparent that there are people with nerve damage that categorically depend on this medicine and will slowly be poisoned to death without it. This is an outrage and it must be righted sooner than later. I need to live.

Everyone please send in letters to the people listed below explaining how much you need this medication and urge for the public advisory committee meeting to be scheduled. This is the meeting where we get to plead our case. Mention that the FDA claimed in their press release that they would have this meeting to discuss a "limited return" of the drug. The more letters the better so also have your family and friends send in letters as well if you are so inclined. Also I am urging everyone to contact their congressional representives and let them know what the FDA is doing to their constituents. Political pressure is the best kind of pressure.

Dr. Stephen K Galson, M.D., M.P.H.Director, Center for Drug Evaluation and ResearchU.S. Food and Drug Administration5600 Fishers Lane , Rockville MD 20857-0001

and/orDouglas Throckmorton, M.D.Deputy Director, Center for Drug Evaluation and ResearchU.S. Food and Drug Administration5600 Fishers Lane , Rockville MD 20857-0001

Zelnorm Withdrawl and Response

As any visitor to this website probably knows, the drug Zelnorm was voluntarily recalled by its manufacturer, the Swiss pharmaceutical company Novartis. The withdrawl was issued at the request of the Food and Drug Administration after the results of tests conducted by Novartis were released that showed an increased risk of cardiac problems. The studies a total of more than 11,000 Zelnorm users. Of those tested, thirteed Zelnorm users had cardiac problems, versus only one in the control group.

Although the tests do indicate that Zelnorm poses a risk of increased cardiac problems, the FDA has simply not taken into consideration the importance of this drug in the lives of many Americans, primarily women. It is important for patients to be informed of the risks of medication, but to require the manufacturer to pull the drug without allowing users to continue taking the medication after a consultation with their doctor is a gross overreaction to the test results.

The primary purpose of this blog is to inform former Zelnorm users about the steps that we can take to push for the return of this important medication. My immediate goal is to find out more information about the potential for a "limited return" of the drug for those where the benefit outweighs the risks that the FDA discussed in its press release. I just recently discovered that Zelnorm was withdrawn from the market, so I have not had time to contact the FDA. As soon as I find out the date of the FDA's public meeting to discuss Zelnorm I will post that here. I live in the DC metro area, so I will be able to attend the meetings, whenever they are.

Many people depend on this medication and our very sick without it. If you are one of those people or are a family member or friend of one of those people get involved. If we make it known how crucial this medication is for some people we may be able to get a return of this drug.


THE MOST IMPORTANT THING I NEED FROM YOU: Please send me letters, via email is fine, but signed letters sent through the mail are even better. I would like to collect as many personal stories as I can so that I can present them at the public hearing. We can work together to bring this drug back.

If you would like to submit a letter you can email me at angelad621@yahoo.com. If you like to submit a letter through the postal service, contact me at the email address above and we can make arrangements for you to send the letter. I also welcome you to post your story here. I will add my personal story shortly. It might be helpful to share our experiences as we go through this trying time.