Baycol
Death
Baycol,
also called cervistatin, was released on the American
market back in February of 1998. During its short lived
life on the American market, there were 31 Baycol deaths
in this country and over 40 world wide. Of the 31 Baycol
deaths in the U.S., 12 occurred with patients who were
also taking the drug gemfibrozil. Gemfibrozil is a Lopid,
another cholesterol-lowering drug. Bayer cooperated
in the FDA action on Wednesday the 8th of
August, announcing it would stop sales of Baycol in
all countries with the exception of Japan where gemfibrozil
is not available and Baycol is not prescribed in such
high dosages.
Baycol
was taken off the market on August 8th, 2001
at the urging of the FDA and other public advocacy groups
such as Citizen Group. Baycol was manufactured by Bayer
AG and prescribed to nearly 700,000 Americans.
Baycol
is a statin, a cholesterol-lowering drug that was originally
marketed in order to help reduce the incidence of heart
attacks and strokes. Very simply put, statins block
an enzyme that creates cholesterol. Baycol is one of
the lesser known of the statin drugs currently available
on the U.S. market. Other statins include Zocor, Mevacor,
Pravachol, Lipitor, and Lescol.
Every
statin has been linked to the medical condition known
as Rhabdomyolysis, a debilitating muscle disease that causes deterioration
in muscle tissues that can cause severe pain. In severe
cases, the patient can experience kidney failure and
die. This is what happened to 31 patients who were taking
Baycol and experienced fatal outcomes. Symptoms of Rhabdomyolysis
include muscle pain, weakness, tenderness, darker-than-normal
urine, nausea and even vomiting. While there is concern
regarding patients developing Rhabdomyolysis through
the use of statins, only patients taking Baycol have
died from complications.
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Concern over Baycol
Death
There
was significant concern regarding the prescription drug
Baycol once the link between it and fatal cases of Rhabdomyolysis
were reported. Although the Food and Drug Administration
was worried by the dangers associated with the drug,
including Baycol death, it was in England that the first
steps to protect the public were first enacted. England
regulatory officials placed limits on the dosage amount
that patients could be prescribed.
Another
strong response came from Public Citizen, a consumer
advocacy group that monitors health issues in the United
States. The group claimed that statins (Baycol is a
type of statin) were responsible for many additional
deaths over and beyond what had been linked to Baycol.
Public Citizen focused their grievances on the Food
and Drug Administration, which is a regulatory agency
that approves and monitors pharmaceuticals and drugs
in the United States. They urged FDA, as well as Bayer
AG, to pull Baycol off the market because it was a health
risk to certain populations of patients. At the very
least, the group wanted to require Bayer and other makers
of statins to place warning labels that discussed the
potentially fatal outcomes to patients in plain, easy-to-understand
language.
Even
with Baycol off the market, Public Citizen is urging
the government to require patients who are filling their
prescriptions for statins to receive a special sheet
known as a medical guide that outlines potential side
effects. The FDA recently reported that although they
will review the petition by Public Citizen dealing with
statins, the agency has no immediate plans to review
this class of drugs.
For
more information on Baycol death and other serious side
effects, please contact
us to confer with a Baycol recall lawyer.
FDA
and Baycol Recall
Much
of Public Citizen and other groups concerns have been
more far reaching than simply protesting Baycol. In
the last four years, a dozen prescription drugs have
been taken off the U.S. market after causing serious
side effects and deaths. According to critics of the
FDA, the agency has brought drugs to market too quickly,
not allowing for enough time to properly test the effects
of the drug, as well as how the drugs interact with
other prescribed or over-the-counter drugs. FDA’s policy
of “fast tracking” certain drugs to market is, according
to their critics, based on pressure they receive from
powerful pharmaceutical and drug companies. Often times,
these drugs have limited patents on them and drug companies
rush them to market in order to recoup their investments
that often run into the hundreds of millions of dollars.
The
FDA did not fast track Baycol, which was reviewed by
the agency for 11 months.
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High Risk Groups
for Baycol Deaths
The
risk of Baycol death deals with three general population
groups. The first are those patients taking Baycol in
combination with another cholesterol-lowering drug,
gemfibrozil. The introduction of these two drugs together
seems to significantly heighten the incidence of Rhabdomyolysis.
In fact, 12 of the 31 fatalities that have occurred
in this country involved patients taking these two drugs
together. The second group is more older patients. The
third and final group is anyone on a high dosage of
Baycol. Baycol remains available in Japan, where gemfibrozil
is not available and the drug is prescribed in lower
dosages.
Bayer
AG
Bayer
is a German owned company that makes products ranging
from Aspirin to chemicals for industry and fragrances
for perfumes. The recall came at an unfortunate time
for the drug and pharmaceutical giant. The company claimed
that this withdrawal would hurt earnings in the coming
quarters. Bayer has recently stated that its profits
during 2001 will be lower than last year and well below
its initial estimates. Bayer executives said they will
continue to market Baycol in Japan where gemfibrozil
is not available and Baycol is not available in high
doses.
What
to know if you take Baycol or another Statin
If
you were on the prescription drug Baycol, contact your
doctor or physician about switching to one of the other
available statin. For those individuals taking another
statin such as Zocor, Mevacor, Pravachol, Lipitor, and
Lescol, you should not be overly concerned. Many of
these drugs have proved very safe for the vast majority
of patients. However, if you are taking a statin, talk
with your physician about what to be looking for as
far as side effects. If you are on one of these statins
together with gemfibrozil, speak with your doctor about
the potential health risks, particularly muscular disorders.
Spokesmen
for the FDA said that the agency will not require more
stringent warning labels on other statins based on the
lack of significant adverse heath effects.
For
more information on Baycol death and other serious side
effects, please contact
us to confer with a Baycol recall lawyer.
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