|
The decision last week by the German company
Bayer AG to withdraw the cholesterol-lowering statin drug
Baycol from the market after it was linked to 31 deaths left
700,000 Americans scrambling to find a new drug. It also left
the millions who are taking other statins wondering whether
the entire class of medications is safe.
Experts expect most
Baycol users to be put on one of the five statins that remain
on the market. But like Baycol, those drugs are
linked to the same rare muscle weakness, known as myositis,
which occurs in about 1 in 1,000 statin users, according to
James Cleeman, director of the National Cholesterol Education
Program at the National Heart, Lung, and Blood Institute.
That condition occasionally progresses
to rhabdomyolysis -- a complete breakdown of muscle cells
that can lead to kidney failure and death. How many cases
occur is not known, because of limited post-market surveillance
by the Food and Drug Administration (FDA).
Even so, Cleeman says the benefits of
statins "far outweigh the risks.
People taking
Baycol need to talk to their doctor about what drug they should
switch to.
And people taking other statins should
continue to take them because they are many, many times more
beneficial" than they are risky.
But the Baycol experience illustrates
the growing potential for medical complications and drug interactions
as Americans increasingly rely on numerous pharmaceuticals
to control chronic conditions such as elevated cholesterol,
high blood pressure, arthritis and diabetes. In about a third
of the Baycol cases, deaths occurred among people who also
took gemfibrozil, a drug used to lower triglyceride levels.
Other reports in the scientific literature
link combinations of statins and other drugs, including warfarin
(used to prevent blood clotting), ketoconazole (an antifungal
drug) and clarithromycin (an antibiotic) to rhabdomyolysis.
Even the experts are struggling to sort
out the extent of the problem. "Who knows what the risks
are?" says pharmacologist and physician Raymond Woosley,
vice president at the University of Arizona's Health Sciences
Center in Tucson. "You can find out on the Internet how
many suitcases are lost in air travel, but who knows how many
people are harmed by drugs?"
Consumer advocate Sidney Wolfe, director
of the Public Citizen Health Research Group, believes statin
complications may be greater than previously thought.
He and his group are reviewing FDA statin data from the past
three years and plan to petition the agency to require all
statin drug labels to feature a more explicit warning about
the side effects.
Until the facts are more clear, here
is what you need to know if you take Baycol -- or any statin:
Any of them
can cause myositis. Some experts
believe that pravastatin (Pravachol) and fluvastatin (Lescol)
may have less potential for drug interactions, but the data
aren't sufficient to declare one drug safer or more dangerous
than the others.
Watch carefully
for muscle tenderness or weakness.
Although muscle weakness occurs only rarely, given the 12
million statin prescriptions written yearly in the United
States, that works out to thousands of cases.
Look
for "feelings of achiness or weakness that
can be localized or diffuse and can occur independent of exercise,"
says Sidney Smith, chief science officer of the American Heart
Association. Fever can be another symptom of muscle weakness.
Seek immediate medical attention if your urine turns brown
-- a symptom of muscle proteins' being excreted through the
kidneys.
Ask about
getting a blood test. Liver
function blood tests are routinely performed before statins
are started and again 10 to 12 weeks later to ensure no problem
is emerging. But you need another blood test -- either creatine
kinase (CK) or creatine phosphokinase (CPK) -- to monitor
whether muscle cells are breaking down.
Experts say this test should be performed
if any muscle weakness is experienced. Some also believe that
the test should be used routinely to screen for muscle weakness,
but this remains controversial.
Tell your
doctor what other medications you take.
You've heard this before, but it's absolutely crucial with
the statins. Deaths have been reported not only in people
who also took Baycol with gemfibrozil, but in those who took
other statins with other drugs, including cyclosporin.
Don't forget to tell your doctor if you
take any over-the-counter medications, dietary supplements
or herbal or botanical substances.
For more information on statins: please
see the related links below.
Washington
Post August 14, 2001; Page HE03
| 