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 I just recently discovered that Zelnorm was withdrawn from the market, so I have not had time to contact the FDA.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.
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.
posted by Angela at
12:45 PM
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