Zelnorm yanked. But it might come back?
Zelnorm (tegaserod) has been yanked — not a big surprise in our litigation-happy society. I can understand the CYA-above-all-else policy, but in this case, though, I think patient education and discussion would be a far superior option than removing a novel drug from the shelves entirely. I've seen first-hand several instances where Zelnorm worked when nothing else did. (Lubiprostone just came out, remember.)
But in a recent analysis of 18 000 patients in the entire clinical database, adverse cardiovascular events were seen in 13 out of 11 614 patients (0.11%) on Zelnorm, but in only one patient (0.01%) out of 7031 taking placebo, a statistically significant difference.
I happen to know that these people are willing to deal with this risk to continue to lead healthier lives. When a drug is yanked, it's a no-win situation, especially when it's one-of-a-kind like this. The kicker is whether there's even any meaningful risk at all:
Quoted in a company press release as "an independent cardiologist," Dr Jeffrey L Anderson (University of Utah, Salt Lake City) commented, "My review of the data suggested that a causal relationship is unlikely between tegaserod and the rare cardiovascular ischemic events observed in clinical trials. Furthermore, the data did not show any consistent pattern of event type, time to event, or dose relationship in tegaserod-treated patients."
The FDA is willing to consider letting Zelnorm back into the wild again. I hope they do.
Here's to hoping Amitiza (lubiprostone) can fill Zelnorm's shoes as effectively in the meantime. But knowing drugs like this, it'll probably work for some, but not for others, leaving some left out in the cold. Again.
[tags]Medicine, pharmacy, Zelnorm[/tags]
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I just wanted to say thanks for your write-up. I have had to go the last 2 weeks without Zelnorm and I feel TERRIBLE. I have had a problem for years. I was taking prepulsid many moons ago and it was the only drug on the market at that time that worked. It too was pulled off the shelves. I experience a couple of years with much discomfort and pain until Zelnorm came along. It costs a fortune but it worked. I functioned and most importantly it didn't cause me any pain. I am so frustrated. It feels hopeless.
I do hope something new comes out and SOON! I know first hand how crucial it is for daily functioning. It is significant for those of us young and old (I am 29). My problem is chronic, I just hope my wait for an aid to improve it, won't be.
Sincerely,
Michelle
a neighbour from Canada
Comment by Michelle Sammut — May 20, 2007 @ 8:16 pm