FDA Warns of Muscle Damage From Zocor

March 19, 2010 -- Based on new
data, the FDA today warned that higher doses of the cholesterol-lowering drug
Zocor, sold generically as simvastatin, carry an increased risk of muscle
injury.


The FDA also warns that mixing
Zocor with certain other drugs also increases patients' risk of muscle injury,
including the rare but serious complication known as
rhabdomyolysis. Rhabdomyolysis can
sometimes result in fatal kidney damage.


The combination products Vytorin
and Simcor also contain simvastatin, the active ingredient in Zocor. Zocor is a
member of the class of drugs known as statins. All statin drugs carry a risk of
muscle damage, but new data suggest that this risk may be particularly high for
the 80 milligram dose of Zocor.


The data come from the SEARCH
study, in which muscle damage was seen in nearly 1% of patients taking the 80
milligram dose of Zocor but in only 0.02% of patients taking the 20 milligram
dose of Zocor.


Rhabdomyolysis was
rare in the SEARCH study. It happened in
only 11 of 6,031 patients (0.02%) in group taking the 80
milligram
dose of Zocor, but was not seen in
patients taking the 20
milligram
dose.


A different study found that
muscle damage was more common in patients taking Zocor doses of more than 20

milligrams
a day who also took the heart rhythm drug
amiodarone (brand names Cordarone, Pacerone). Patients taking another drug,
verapamil (brand names Calan, Covera, Isoptin, Verelan), also should not take
Zocor at doses higher than 20
milligrams
.


And patients taking the
angina/blood pressure drug diltiazem (brand names Cardizem, Cartia, Dilacor,
Diltia, and Tiazac) were also at higher risk of muscle injury if they also
took Zocor at doses higher than 40
milligrams
a day.


New data also suggest that people
of Chinese descent should not take Zocor at the 80
milligram
dose -- and should be careful even when
taking lower doses -- if they also take niacin-containing products.


You should never take Zocor at any
dose if you are taking:



Itraconazole


Ketoconazole


Erythromycin


Clarithromycin


Telithromycin


HIV protease
inhibitors


Nefazodone 



You should never take more than
the 10
milligram
dose of Zocor if you are
taking:



Gemfibrozil


Cyclosporine


Danazol


 





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