What could have been done to avoid the
current claims for Rhabdomyolysis made by
The Food and Drug Administration (FDA) approved Baycol in 1997 following
the testing of the drug on approximately 3,000 people by Bayer.
Prior to its release, related drugs known as
statins had already been seen to cause problems such as those
endured by Rhabdomyolysis sufferers, but on
a hugely inferior scale than suffered by Baycol victims.
The main method of prevention would have been more extensive
The base of people on whom
the drug was tested were very clustered and so the effects on a wider
range of people were merely estimated. Had
further tests been administered, it would have been discovered that the
elderly were much more at risk for Rhabdomyolysis
from the drug than younger people and that a combination of Baycol and
gemfibrozil was particularly dangerous.
Many of the worst injuries were suffered by Baycol victims who
took Baycol and Lopid (Baycol and
Could the FDA have prevented so many Baycol
Many Rhabdomyolysis problems would have also
been averted had the FDA made more of an effort to clarify the dangers
that it was concerned about. The screening
process at the time was less stringent as the FDA was under pressure to
approve more products from the pharmaceutical industry, at the time
worth more than $100 billion to the economy.
Was there a problem with
taking Baycol and Gemfibrozil together?
Yes -- together they can increase the risk of
Gemfibrozil (often sold as Lopid) is
a lipid regulating agent.
Gemfibrozil is used with diet changes
(restriction of cholesterol and fat intake) to reduce the amount of
cholesterol and certain fatty substances in your blood.
Accumulation of cholesterol and fats along the walls of your
arteries (a process known as atherosclerosis) decreases blood flow and
therefore, the oxygen supply to your heart, brain, and other parts of
your body. Lowering your blood level of
cholesterol and fats may help to prevent heart disease, angina (chest
pain), strokes, and heart attacks. Together,
the drugs caused a breakdown of the myoglobin
which harmed the ability of the kidneys to function.
When did they discover
that you should not take Baycol and Lopid
Lopid alone was not a problem, but when the
combination of Baycol and Lopid was
prescribed, Rhabdomyolysis problems occurred
even more frequently.
Gemfibrozil and Baycol were taken together by at least 12 Baycol
victims who died as a result of their usage of Baycol and
drug is another agent that performs a similar task to Baycol, limiting
the usefulness of lipids. The danger of using
Gemfibrozil and Baycol (or other
statins) was well documented prior to Baycol
ever being released.
sufficent warnings given about using Baycol
and Gemfibrozil (Lopid)
Unfortunately, it was seen as sufficient to label bottles of
statins with relevant warnings, as opposed
to banning the concurrent supply of Baycol and
Lopid to the same patient. The
enthusiasm of doctors to provide a high a dosage of the drug as possible
also may have had a large part in the Baycol victim's deaths or other
Baycol claims. Many of the Baycol and
cases became widespread following the introduction of the 0.8 mg Baycol
tablet, as doctors were keen to move patients straight to this increased
dosage from the previous, safer 0.4 mg tablets.
Do I have a Baycol and Lopid or
Baycol and Gemfiborzil case?
Do I have a case for Rhabdomyolysis?