Statin Information
There are 8 million Americans that use statins, the most
widely prescribed class of drugs for lowering cholesterol.
Statins have been shown to reduce heart attacks and strokes.
Baycol was a statin drug, and although every type of statin
is associated to the very rare condition rhabdomyolysis, rhabdomyolysis
was found to occur more frequently when using Baycol. Statins
lower cholesterol levels by interfering with an enzyme HMG
CoA reductase.
The statin drugs are able to dramatically lower cholesterol
more effectively than other cholesterol lowering drugs, but
all statin drugs are known to cause rhabdomyolysis. Patients
taking Baycol were shown to have a much higher frequency of
rhabdomyolysis cases than the other five statin drugs available.
When reports of rhabdomyolysis surfaced in Baycol patients
it was the first time statins were attributed to causing death
because of rhabdomyolysis. The Baycol link to rhabdomyolysis
led to the statin drug to be recalled on August 8, 2001.
The Baycol
recall prompted many patients to discontinue their use
of alternative statin drugs as well, however there are still
five other statins available on the market. The consumer advocacy
group Public Citizen petitioned the FDA after the Baycol recall
in August 2001 to add a black box warning, the FDA’s
strongest issued warning, to the label of some of the other
statins to warn patients of the possible side
effects, including rhabdomyolysis.
The Public Citizen petition stated that there have been an
additional 50 deaths due to other statin drugs than Baycol.
At the time of the Baycol recall analysts were confident
statins would continue to do well as it was one of the fastest
growing segments of the drug industry. Baycol had been expected
to hit $875 million in 2001. After the Baycol recall, the
manufacture of Baycol, Bayer, has been struggling to survive.
Numerous Baycol lawsuits and class actions have resulted from
the serious and deadly side effects linked to statin use that
has been directly linked to the use of Baycol.
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