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AHA responds to petition
of
FDA to change statin labels
August 22, 2001 -HeartCenterOnline
The American Heart Association (AHA) issued a press release
yesterday following Public Citizen's recent petition to the FDA,
which called for stronger label warnings for all statins, a type
of cholesterol-reducing drug. Public Citizen, a Washington, DC
based consumer advocacy group, filed the petition in the wake of
Bayer Pharmaceutical's voluntary withdrawal of its statin Baycol (cerivastatin)
due to reports of a potentially fatal side effect called
rhabdomyolysis.
Rhabdomyolysis is a rare but
potentially fatal condition in which muscle cells break down,
releasing their contents into the bloodstream. Some patients
report no symptoms, but in rare cases rhabdomyolysis can lead to
kidney or other organ failure and death. At the time of the Baycol
recall, the FDA issued a press release stating that while all
statins have been associated with rare cases of rhabdomyolysis,
fatal cases associated with Baycol have been significantly more
common than with other approved statin drugs.
Symptoms of rhabdomyolysis
include:
* Muscle pain, weakness and/or tenderness
* Fever
* Dark urine
* Nausea and/or vomiting
* Malaise (a general feeling of illness or discomfort)
The AHA press release quoted its
Chief Science Officer Sidney Smith, MD, in the following
statement. "We know that the FDA looks carefully at adverse
drug reactions to determine if special warnings or labels are
warranted. After careful review of the available information on
the statin class of drugs, the FDA should be in the best position
to determine whether special labeling will be effective."
"The key to controlling
negative side effects caused by any medicine is an open dialogue
between the physician and the patient," continued Dr. Smith's
statement. "Doctors should warn their patients to be on the
watch for potential side effects of any medication. And patients
need to take the initiative and call their physician if they
experience an unusual side effect. Appropriate labels can also be
a valuable tool in patient education."
The AHA release went on to
acknowledge that statins and other cholesterol-reducing
medications play a large role in the management of blood
cholesterol levels and the overall decrease of the risk of heart
disease or stroke. However, the AHA also stressed the importance
of lifestyle choices such as diet and exercise as the foundation
for cholesterol- lowering strategies.
According to the original FDA
press release regarding the Baycol withdrawal, patients
experiencing any symptoms of rhabdomyolysis were advised to stop
taking the medication and consult their physician immediately.
Other patients were advised consult with their physicians
regarding switching to an alternate cholesterol-reducing
medication. In the AHA release, Dr. Smith stressed that patients
should discuss their concerns and options with their physicians.
"In general, we don't think
that patients should stop taking medications without talking to
their physician," Dr. Smith stated in the AHA release.
"If a patient is experiencing side effects, the physician can
often switch the patient to a different statin or other medicine
that will continue to manage their cholesterol without the side
effects."
Statins are considered the first
line of treatment for most patients with high cholesterol (hypercholesterolemia).
They block the production of specific enzymes used by the body to
make cholesterol. They are particularly effective at lowering
levels of LDL ("bad") cholesterol and, to a lesser
degree, triglycerides. More information about statins and other
cholesterol medications can be found in the HeartCenterOnline
article Cholesterol-Reducing Drugs or on the HeartCenterOnline The
Cholesterol Center.
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