The Return Of Zelnorm… Sort Of
6 CommentsBy Ed Silverman // July 27th, 2007 // 8:29 am
The Novartis drug for irritable bowel syndrome, which was withdrawn in March due to a high risk of developing heart attacks, strokes and chest pain, will become available in the US again, but as part of a restricted access program. (Please see “Irritable Heart Syndrome”).
The program is for women in the US under 55 years of age who suffer from IBS with constipation or chronic idiopathic constipation, and for whom no other treatment has provided satisfactory relief, or patients who had satisfactory improvement of their symptoms with prior Zelnorm treatment.
Novartis and the FDA are moving forward with this program because of requests from docs and patients following the “marketing suspension,” according to a statement from the drugmaker.
But “these patients must meet strict criteria and have no known or pre-existing heart problems and be in critical need of this drug,” says Steve Galson, who directs the FDA’s Center for Drug Evaluation and Research, in a statement. “Zelnorm will remain off the market for general use.”
The withdrawal was based on a review of a new retrospective analysis of pooled clinical trial data which showed the incidence of cardiovascular ischemic events was higher in patients taking Zelnorm than those taking placebo. However, Novartis continues to maintain that no causal relationship between Zelnorm and cardiovascular ischemic events has been demonstrated.
Chris
Interesting timing vis-a-vis FDA March 2008 review on methylnaltrexone, Wyeth/Progenics’ drug for opioid induced constipation. Different cause of the constipation perhaps, although I understand IBS is caused by a variety of things. It is a particularly nasty and debilitating condition, so this is good news for patients, and good timing for Novartis.
Maria Smith
I am so happy that Zelnorm is returning to the market. For the months that this “miracle” drug was off the market, I have been miserable with serious constipation. When you dont’ go to the bathroom for months and you find something “actually works”, you are elated. I praise God that this is returning and am on the phone with doctor ordering me a prescription.
Thank you Novartis for fighting for your patients.
Hank
I appreciate people’s rights to weight risks and benefits if they are appropriately and accurately informed. However, history strongly suggests that this kind of “controlled approval” almost always fails. The drug is prescribed much more widely than the guidelines suggest. In the meantime, it is impossible to do a genuine screen to rule out pre-existing heart disease.
In the long run, my prediction is that Zelnorm will go the way of Propulsid. Down the tubes.
I.M. Annoyed
I was just reading through the various posts on this site and couldn’t help but notice what was said above: “Thank you Novartis for fighting for your patients” Huh? Did I miss something here? When did we become the patients of Pharma? I am a patient of my doctor and I take the drugs he prescribes because he is qualified to do so. If we can be called anything, we can be called subscribers. As one who works in the industry I can tell you that “inside” you are not referred to as patients - you are merely an economical unit. Bringing Zelnorm back to the market is not “fighting for patients”. It was all about returning profits for this drug. It has nothing to do with patients.
Caveat Emptor….
Hypocrisy rules
Zelnorm is a good drug if used properly for the right patient. However when Novartis came up with it be research etc. they right away declared it to be the next mega-drug that will bring in billions, yes with “b”, per year in sales and enormous profits for the company. Thye got approved a quite a nerrow indication IBS in Women. This did not stop them to promote it via their multiple sales forces for as many indications as possibly exist and some more in any and every patient. “You got constipation. Use Zelnorm the super expensive lexative”. Of curse they got in trouble but unlike Merck they quickly took it of the market and now they will rebrand it and return it to the market. In fact, the will do the type of promotion that they should have mdone initially if the did not make fallse claims and off label promo.
That is your “most admired company”.
ps. Keep an eye on Novartis’ version of VIOXX - Prextige now on market and indicated ONLY for pain of osteoarthritis in the knees. I bet any money their reps are pushin it for ANY pain anywhere in the human body. My own doc Rxed it for me for the pain in my shoulder. It was like takin nothing and I switched to aspirin and it worked. I told the doc it was only for the knees, he said not to worry Novartis said it was OK for anything. What next for this once great Co?
S A
I took Zelnorm for 2 1/2 years. It was the best thing that ever happened for me. I was constantly miserable and using worthless antispasmodics that constantly had unpleasant side effects. One I tried made me tired for 2 days with one dose and the other caused severe bladder spasms. The side effects were worse than the misery so I rarely took the medication. I had constant problems with air trapping, pressure build up in the abdomen and chest to the point I thought I was having an asthma attack. It took prescription strength pain medicine to stop the terrible pain. Nothing OTC worked I was happy when I finally found a doctor willing to prescribe Zelnorm. The pain and problems stopped almost immediately and I remained on it non-stop until it was pulled off the market. I found out in early April. I was concerned about the cardiac side effects but later learned I had no lasting harm from the medication. I remember Propulsid like someone above mentioned. I was on it two months and it cause permanent irreversible heart murmurs and mitral valve leakage that requires yearly checks with cardiology.
After the recall my doctor wanted to put me on another new barely tested medication Amitiza. I was not willing. After the Zelnorm fiasco I went with something that has been around a long time and requires no prescription, Miralax. It has worked just as well as expensive Zelnorm for me.