April 2007 Archives

If you have been affected by the recent Zelnorm/Zelmac recall then I would encourage you to register your complaint. This post contains the contact details that you will need to do just that - many thanks to Jeff Roberts at the IBS Self-Help Group who has provided these names and numbers.

The best thing to do is to either contact Novartis, the manufacturers of the drug, or the Food and Drug Administration (FDA), the drug regulators who actually took the thing off the market. Or, of course, you can contact both.

I would keep your messages fairly short and focused, perhaps describing your life with IBS before Zelnorm, during Zelnorm, and after Zelnorm! I would also describe how IBS interferes with any aspects of your daily life such as holding down a job or raising a family, and also how many other treatments you had tried before finding Zelnorm.

Making your voice heard really is a worthwhile thing to do - IBS sufferers previously campaigned for the return of the IBS-diarrhea drug Lotronex after it had been pulled by the FDA, and were successful, so these kind of patient-led campaigns really can work.

I don't want to minimize the experience of anyone who has experienced side effects from Zelnorm, and of course we should all be concerned about the safety of the drugs we are taking. But I do think we should make it clear how many patients have been helped by this drug, and how sparse the alternatives are for people with long-term, chronic IBS.

It's also worth pointing out that we don't necessarily have to ask for a complete reintroduction of the drug. At the moment the FDA has entirely removed the drug from the market, making it inaccessible to everyone, but it would be possible for them to make the drug available to a more restricted group of patients, and the FDA have said they are going to consider this. We need to make sure that they do!

So, these are the details to use (all USA contact details)...

For the manufacturers Novartis, you can call 1-800-742-2422, or call the Novartis Customer Interaction Center at 888-NOW-NOVA (888-669-6682).

For the FDA, you can write to:

Dr. Stephen K Galson, M.D., M.P.H.
Director, Center for Drug Evaluation and Research
U.S. Food and Drug Administration
5600 Fishers Lane, Rockville MD 20857-0001

and/or

Douglas Throckmorton, M.D.
Deputy Director, Center for Drug Evaluation and Research
U.S. Food and Drug Administration
5600 Fishers Lane, Rockville MD 20857-0001

After the recall of Zelnorm, which now extends to Canada and Australia as well as the United States, there are a lot of IBS-constipation sufferers who have been left in the lurch. I've had a number of really quite distressing messages from sufferers who don't know what to do without Zelnorm, and so I thought I should write a post about what possible alternatives to Zelnorm there are, and what people have been telling me they are using already.

Long-term sufferers may have tried a lot of these before, but I hope I can offer at least one new suggestion. This post comes with the usual warning message that I am not medically qualified in any way, and you should check with your doctor before trying any of these treatments.

Some of the medications may not be available in Australia and Canada (all are available in the USA), so ask your doctor about your options.

Amitiza is a fairly new medication which was designed for chronic constipation rather than IBS, but is being used by a number of IBS sufferers. There does seem to be a side effect of nausea in some people, although that might be lessened if it is taken with a meal. Reviews of Amitiza so far have been mixed, but that will usually be the case with most drugs as individuals and symptoms can vary so widely. Some people have found it helpful.

Miralax is an osmotic laxative ("osmotic" just means it draws water into the bowel) which used to be prescription-only in the USA but is now over-the-counter. Miralax does seem to be a fairly powerful laxative and there are some positive reviews on my IBS treatment website.

Magnesium supplements are available from most healthfood stores and are used by quite a number of IBS-C sufferers with good results. Magnesium oxide and magnesium citrate seem to be the forms of magnesium with the best results (I take magnesium citrate myself), and the dose is usually around 400mg a day to start off with, perhaps one tablet in the morning and one or two at night, and then alter the dose as needed.

Milk of magnesia is a fairly mild laxative, but one that does seem to be gentle on the stomach and not cause pain. Not to be confused with plain magnesium tablets.

The IBS Audio Program 100 is famous in the online IBS community for being effective and safe, and I've read many messages from people who have used this program with good results. It's a simple self-hypnosis program (hypnotherapy has at least a dozen clinical trials to show it works for IBS) which you listen to at home. It comes on CD, and can be delivered worldwide.

A gluten-free or a dairy-free diet (or both combined) do seem to help a number of sufferers. It's probably fine to test this on yourself for a few weeks or so by cutting out all dairy and gluten and seeing what happens, but if you are going to do this for a longer period of time then I would ask a doctor or qualified nutritionist/dietician for advice on how to replace the foods you have excluded.

And if anyone does try any of these treatments, or has any other Zelnorm/Zelmac alternatives which they are using, please do post your views in the comments section to help fellow IBS sufferers.