The American Food and Drug Administration (FDA) have confirmed that they are allowing Zelnorm to be prescribed under an Investigational New Drug (IND) program. This means that doctors can prescribe the drug to patients who fit certain guidelines – in this case Zelnorm is only being offered to women who are younger than 55, who suffer from IBS or chronic idiopathic constipation, and who do not have pre-existing heart problems.
Zelnorm will only be prescribed if your doctor decides that the drug is “medically necessary”, which presumably means that the IBS or constipation is relatively severe, and that alternatives such as Amitiza cannot produce the same results. Patients also need to sign a consent form.
So – it’s good news that the FDA have issued a press release to confirm that this program exists, and it would be a useful page to print out and take to your doctor if he or she has been dragging their feet, especially as the release contains details of the numbers your doctor should be calling to apply for the program. It’s bad news though if you are over 55 or a man. I guess the age level could be down to increased risk of heart problems in older people, but I’m not sure why they are refusing access to men, although of course with more women than men suffering from IBS it may be that they just have more data on the use of Zelnorm in women.
However, the FDA do say that even for those people who do not qualify for the IND program there may be hope, as an “alternative access option available through the FDA” is mentioned on the Zelnorm homepage, along with a number to call, although this alternative option is only available for patients who have “an urgent need for Zelnorm based on a life-threatening or severely debilitating condition”.
The Zelnorm page also confirms the rather startling information that if you are approved under the IND program, you’ll get the drug for free: “Novartis will provide Zelnorm at no cost to the patient”. Each patient will receive a month’s supply of the drug at a time, with a doctor’s reauthorization needed for each new supply.
I know that some sufferers have been ordering Zelnorm from Mexico, and even traveling there to buy it in person, but even with a bit of bureaucratic hassle I think the IND program has to be the first thing to try. Apart from anything else you will know that you are getting the correct drug, and you will also know that you are using it under proper supervision – and that your use of the drug is being recorded on your medical records.