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New Message on Pituitary Chat
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From: PTResearcher2
Message 6 in Discussion
Dostinex (cabergoline), a dopamine agonist, was included in the study of 3
dopamine agonists showing increased chance of heart valve problems. MGH sent a
letter (hard copy - I could not find the information on their website, either)
to their patients previously or currently on Dostinex. They are recommending
that every patient currently or previously on a high dose (3mg/daily (6
pills/daily); 21mg/week (42 pills/week)) of Dostinex should have an
echocardiogram (noninvasive ultrasound of the heart) as a precaution. They also
recommend discussing having an echocardiogram with your physician if you have
been or are currently taking Dostinex (any dose) if you wish to have your heart
checked as a precaution. MGH may be the only neuroendocrine center "on the
ball," as it were. They are being cautious & thorough. Has anyone else been
contacted by their doctor(s) about Dostinex & the recent studies done?
(I was in a similar situation, I was on "Zelnorm," which was recently taken off
the market for cardiac events. I called my GI and told them about it and then
asked them what I should do. They did not know about it. Physicians need to
stay informed so they can inform their patients. We cannot rely on them, so we
must inform ourselves.)
FDA Public Health Advisory
Pergolide (marketed as Permax)
The FDA is notifying you that the companies that manufacture and distribute
pergolide have agreed to withdraw this drug from the market due to the
potential for heart valve damage. Two new studies showed that patients with
Parkinsons disease who were treated with pergolide had an increased chance of
serious damage to their heart valves when compared to patients who did not
receive the drug. Pergolide is a member of a class of drugs known as dopamine
agonists and is used with levodopa and carbidopa to manage the signs and
symptoms (tremors and slowness of movement) of Parkinsons disease.
Patients with Parkinsons disease who are taking pergolide should: Contact
their healthcare professional to discuss alternate treatment options.
NOT stop taking Pergolide without consulting their healthcare professional,
since stopping pergolide too quickly can be dangerous and several other
effective treatments are available.
Healthcare professionals who prescribe pergolide should consider the following:
Assess the patients need for dopamine agonist (DA) therapy. If
continued treatment with a DA is necessary, another DA should be substituted
for pergolide. There are other dopamine agonists approved for the treatment of
Parkinsons disease that are not associated with heart valve damage. Published
transition regimens describe the conversion from one DA to another. If
treatment with a DA is to be discontinued, pergolide should not be stopped
abruptly, because rapid discontinuation of all dopamine agonist therapies can
be dangerous. Instead, gradually decrease the dose of pergolide. Patients
who will be taken off pergolide should be told that other effective options for
treatment exist, including three other DAs that are not associated with damage
to heart valves.
In 2006, a boxed warning regarding the risk of serious heart valve damage was
added to the labeling for pergolide. The two recent studies, published in The
New England Journal of Medicine in January 2007, confirm earlier studies that
also described this problem. Pergolide is marketed by Valeant under the trade
name Permax and sold and manufactured as the generic drug pergolide by Par and
Teva.
In light of this additional safety information and the availability of
alternative treatments for Parkinsons disease that do not have comparable
safety problems, the companies that manufacture and sell pergolide have stopped
shipping pergolide for distribution and will, in cooperation with FDA, work to
remove from the market both the name brand Permax (pergolide) and the generic
versions of pergolide. The effect of this voluntary withdrawal on supplies of
pergolide currently in pharmacies will not be immediate. This delay will allow
time for healthcare professionals and patients to discuss appropriate treatment
options and to change treatments.
One of the drugs that was included in the recent studies showing increased
chance of heart valve problems is Dostinex (cabergoline), another dopamine
agonist. This drug is approved in the U.S. for the treatment of
hyperprolactinemic disorders (conditions in which there are elevated levels of
prolactin in the blood). Dostinex is not approved in the U.S. for the
treatment of Parkinsons disease. For hyperprolactinemic disorders, a
considerably lower dose of Dostinex is used. At these lower doses of Dostinex,
there appears to be little chance of heart problems; therefore, Dostinex will
remain on the US market for the treatment of hyperprolactinemic disorders.
The FDA is working with the manufacturers of pergolide to determine if it is
possible to make the drug available to those few patients who are currently
taking pergolide where previous efforts to switch to a different treatment have
been unsuccessful, or where efforts subsequent to this advisory to switch
therapies are also unsuccessful. In the interim, healthcare professionals and
patients should consider all treatment options with the understanding that in
the future, the drug may no longer be available.
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