Zelnorm, we hardly knew ye!
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I'm guessing it will be back, but with limitations - aka thalomid or 2mg Lamictal.
More like an orphan drug. For those it works on, it works great. But...it doesn't work for very many & the market probably won't sustain its presence in the general retail level.
More like an orphan drug. For those it works on, it works great. But...it doesn't work for very many & the market probably won't sustain its presence in the general retail level.
Pergolide, too, though we had to more to befriend it.
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so i dont have to call doctor's office to tell them to do PA's anymore
the FDA asked them to stop selling it...
from forbes.com:
A relatively small number of patients had heart problems, including chest pain, heart attacks and stroke, while on Zelnorm, but it appeared there was a large increase in risk when all 19,000 patients who got either Zelnorm or placebo were compared.
Of more than 11,000 patients treated with Zelnorm, 13 had serious and life-threatening cardiovascular side effects, according to the FDA. Four patients had a heart attack, and one died. Six had heart chest pain, or angina, that could lead to a heart attack. Three had strokes. Among the 7,000 people taking a placebo, only one had symptoms suggesting the beginning of a stroke; they went away without a problem.
from forbes.com:
A relatively small number of patients had heart problems, including chest pain, heart attacks and stroke, while on Zelnorm, but it appeared there was a large increase in risk when all 19,000 patients who got either Zelnorm or placebo were compared.
Of more than 11,000 patients treated with Zelnorm, 13 had serious and life-threatening cardiovascular side effects, according to the FDA. Four patients had a heart attack, and one died. Six had heart chest pain, or angina, that could lead to a heart attack. Three had strokes. Among the 7,000 people taking a placebo, only one had symptoms suggesting the beginning of a stroke; they went away without a problem.
Thanks for the info! I just heard about this...it does work really well for some people, I wonder if it will come back with a black box warning.
Oh God, here come the trial lawyers.
However, if you look directly at the Novartis site:
It was due to a retrospective analysis of data from more than 18,000 pts. The cardiac events were MI, stroke & unstable angina & these events occurred in 13 pts in the treated group & in 1 case in the placebo group.
"All pts affected had pre-existing CV disease &/or CV risk factors."
The rate of CV ischemic events seen in Zelnorm-treated patients in controlled trials corresponds approximately with the expected rates for such events in the general population.
On independent cardiologist who reviewed the data said, "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."
Thus - discussions are ongoing with the FDA to evaluate the best way to continue to make Zelnorm available to appropriate pts.
I'm guessing it'll be back......
It was due to a retrospective analysis of data from more than 18,000 pts. The cardiac events were MI, stroke & unstable angina & these events occurred in 13 pts in the treated group & in 1 case in the placebo group.
"All pts affected had pre-existing CV disease &/or CV risk factors."
The rate of CV ischemic events seen in Zelnorm-treated patients in controlled trials corresponds approximately with the expected rates for such events in the general population.
On independent cardiologist who reviewed the data said, "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."
Thus - discussions are ongoing with the FDA to evaluate the best way to continue to make Zelnorm available to appropriate pts.
I'm guessing it'll be back......
Does anyone know the mechanism by which Zelnorm might possibly cause this increased risk? I can't find that info anywhere 😕
The point here is - there may not be an increased risk, but the marketability to the whole population may not be worth the exposure.
Since it was a retrospective post-marketing survelliance study, no mechanisms were looked at or speculated.
