The FDA warned consumers
and the medical community this week about the risk of muscle damage and
rhabdomyolysis from highest doses of the cholesterol drug simvastatin. In June 2011, the FDA issued a warning
to doctors about potential side effects of Zocor when used at high doses (80
mg), saying that the cholesterol drug may increase the risk of muscle injury or
myopathy. The warning came after more than a year of FDA experts reviewing
clinical trials on Zocor and other drugs containing simvastatin, which had been
available to the manufacturers for some time. Zocor muscle injury side effects
may hospitalize about 5 out of every 100,000 people
who take the highest dose of the medication. The FDA has urged doctors not to
start new patients on 80 mg Zocor and to only give the high dose to patients
who have taken it for more than a year without side effects.
Doctors have been warned not to start new
patients on 80 mg Zocor (simvastatin) prescriptions and to only use this
highest dose among patients who have been taking 80mg Zocor for at least 12
months and have not experienced any muscle problems. The agency also added new
contraindications and dose limitations when simvastatin is taken with certain
other medications. Until 2005, when generic versions became available, Zocor
(simvastatin) was a top selling drug for Merck and remains popular today. Zocor
or other drugs containing simvastatin, including Vytorin and Simcor, were used
by 2.1 million Americans last year.
Rhabdomyolysis
(often abbreviated as rhabdo) is the most serious form of muscle weakness and
can lead to severe Zocor liver damage, kidney damage, kidney failure, and death. Muscle damage can be caused by a crushing injury, chemical or biological
injuries. 80 mg. Zocor would be considered a chemical injury. The destruction of the
muscle leads to the release of the breakdown of products of damaged muscle
cells into the bloodstream. Damaged muscle cells like myoglobin, a protein, can
damage the kidneys which filters blood out of the body. Kidney damage from rhabdo
can be so severe that patients may develop kidney failure.
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