Zelnorm: Is it worth the Risk?

Baltimore, MDFor the past year, Barbara Truitt took Zelnorm for irritable bowel syndrome. "The crazy part is that Zelnorm does work but it can kill you in the process," she says.

"About a month ago I was surfing the Internet and saw the recall—I freaked out because I had recently had some issues with my heart. I stopped taking it that very night," says 59-year-old Truitt. On March 30th, Novartis, the drug manufacturer, pulled Zelnorm from the market after the FDA determined the risks outweighed the benefits.

Clinical studies revealed that out of more than 11,000 patients taking Zelnorm, 13 had heart attacks, severe chest pain or strokes. Out of 7,000 patients that got the placebo, one had a near stroke. On its [website] Novartis refers to the clinical trial results as " a small imbalance that was statistically significant in the number of cardiovascular ischemic events in patients taking Zelnorm. These events included heart attack, stroke and unstable angina. They occurred primarily in patients who had pre-existing cardiovascular disease and/or cardiovascular risk factors..."

That is a distressing statement for Barbara Truitt and one that gives her cause for concern. "Once I got passed the words 'stroke, and heart attack' I didn't want to read anymore about Zelnorm," she says.

About a week after the recall, she received a letter from Medco, the distributor of Zelnorm. (Truitt orders her prescriptions directly from Medco so she was in their database.)The letter stated the following:

'The FDA has announced that Novartis has agreed to stop selling Zelnorm...it increases a slight risk of serious heart problems...talk to your doctor about alternative therapy as soon as possible. If you have any unused portions of Zelnorm, please contact us.'

"Then I went into shock," says Truitt. "Previously I had symptoms that mirrored MS and now I am not sure what is going on with me. I talked to my doctor a few days later and he suggested I get a brain scan. The scan showed that I had stroke activity or even had a stroke. I don't remember this happening: it could have happened in my sleep, it could have happened anytime...

"So now I am worried about whether or not I will have a full-blown stroke. I asked my doctor if this could have come from taking Zelnorm. He said 'Yes, it could have.' He then put me on Lipitor and aspirin which supposedly will prevent me from having another stroke.

"And I am having difficulty with short-term memory. For instance, I got some meds from the pharmacy yesterday and I couldn't remember what they were for. That has never happened before. It is hard to concentrate, like my brain is struggling to remember anything. I can't balance my checkbook, people's names...I thought these problems would come with age eventually but not suddenly like this --this is scary.

Getting back to the letter from Novartis: Truitt had about half her prescription of Zelnorm leftover so Novartis sent her an envelope with instructions to send any unused Zelnorm back to them with a list of 'out-of-pocket expenses'-- which meant the cost of the unused Zelnorm. "I billed them $45 but now they want an original receipt before I am reimbursed. They also want the number of tablets dispensed and the number being returned," says Truitt. "I had to call Medco and ask them for a receipt—and I am still waiting to get the receipt. They say it will take another 4-6 weeks.

"After Novartis jeopardized my health, this is the kind of treatment I get. I am not happy. Not to mention aggravation and worry. And the doctor's bills—I ended up going to two doctors.

"I figure the only way to be compensated is financially and I am getting legal help. They can't make my brain better. Taking Zelnorm has scared the hell outa me. And to live with this every day, it is psychologically draining. Every day is a constant struggle.

"Zelnorm should never have been on the market; why weren't these side effects discovered earlier? And I wonder how they were discovered—who had to die to have Zelnorm recalled? And how many people have suffered a stroke not knowing Zelnorm could be to blame? Thousands of people thought they were just innocent little pills for bowel problems."