Bayer Slow to Remove Baycol from Market
November 23, 2004
An upcoming article in the Journal of the American Medical
Association (JAMA) reports that drug maker Bayer was slow to report
the health risks associated with Baycol. The findings, based in part
on internal company documents revealed in a recent court case,
indicate Bayer knew the dangers of Baycol 4 months after its release
on the market in February, 1998.
Baycol, a cholesterol-lowering drug, was removed from the market in
2001 due to dangerous side effects, including a sometimes fatal
muscular disorder, rhabdomyolysis.
Bayer received seven
reports between February and June 1998 that Baycol users had
developed rhabdomyolysis, according to internal company documents
cited in the JAMA report.
The problems occurred most frequently when Baycol was taken with
Lopid, produced by Pfizer Inc., which is used to lower a type of fat
in the blood known as triglycerides. Fibrates, as such drugs are
called, often are prescribed along with statins. Bayer began
revising its labeling in July 1998 to address the findings, but it
wasn't until December 1999 that the company announced in a letter to
healthcare providers that Baycol's labeling would explicitly warn
about the risk of taking it with Lopid.
Later findings by Bayer on the link between Baycol and Lopid and the
muscular disorder were never ''published, reported to regulatory
authorities, physicians or patients,''
Finally, in 2001 Bayer withdrew Baycol from the U.S. market.
The recently released internal company documents, and recent reports
indicate Bayer knew the dangers of Baycol but did not alert the
regulatory officials or public soon enough.
If you took Baycol and experienced any adverse reactions you may
have a valid legal claim.
Sales of Baycol (generic name cerivastatin) were projected to reach
$800 million in 2001, but the German manufacturing company, Bayer
A.G., took Baycol off the market after 31 patients on the drug had
died suspiciously of rhabdomyolysis.
Rhabdomyolysis is classed as a disorder rather than a disease. In
rhabdomyolysis, muscle cells break down, flooding the kidneys with
cellular waste. Death occurs when the kidneys are overwhelmed and
shut down.
As early as December 1999, with the original reports of muscle
problems and deaths linked to Baycol, both Bayer and the Food and
Drug Administration warned doctors to take precautions when
prescribing it. As the problem continued, Baycol had to be taken off
the market.
BAYCOL LAWYERS /
ATTORNEYS
If you or a loved one have
suffered from the dangerous side effects of Baycol, you should
consider receiving a free legal evaluation from an experienced
Baycol
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BAYCOL NEWS & LAWYER UPDATES
Drug maker slow to remove Baycol, researchers say
Miami Herald - 11/23/2004
The makers of Baycol, a cholesterol-lowering drug withdrawn
from the market in 2001, were slow to report its risks, a report said. A
medical journal proposed a new office to monitor drug safety.
Bayer lower amid medical journal article on Baycol risk
CBS MarketWatch - 11/23/2004
Bayer (BAY) (DE:575200) shares were 1 percent worse in Frankfurt amid an
article in the Journal of the American Medical Association saying it may
have known about the muscle risks caused by its Baycol drug before it warned
of that risk.
Doctors: Baycol yanked too late
Indianapolis Star - 11/23/2004
New reports accuse another drug company of being too slow to pull a
dangerous medication from the market and question the ability of the federal
Food and Drug Administration to protect the public from such risks.
This time it's Baycol, a cholesterol-lowering medicine that Bayer AG
withdrew in 2001 after some people who took it developed a severe and
sometimes fatal muscle disorder. A new study found that the risks were far
greater than had been believed.
Baycol's risks possibly concealed
News-Leader - 11/23/2004
Another pharmaceutical company may have concealed safety information about a
dangerous drug, this time Bayer and its once-popular cholesterol medication
Baycol, according to a report in a prominent medical journal.
Baycol was pulled from the market in 2001, but an analysis published Monday
in the Journal of the American Medical Association argues that there were
strong indications of its dangers three months after the drug's introduction
in 1998.
Bayer lagged on warnings: study
CBS MarketWatch - 11/23/2004
In the wake of Merck's arthritis drug Vioxx being pulled from the market, a
study now points a finger at Bayer AG, charging that the firm held back
evidence of a deadly side effect of its cholesterol drug Baycol.
Ten scientists on Monday released a report that suggests that Bayer knew of
Baycol's risks long before it warned the public.
Set to be discussed in several papers in the Dec. 1 in the Journal of the
American Medical Association, the study showed that Baycol -- taken off the
market in 2001 -- had a 10-fold higher risk of causing a serious and
sometimes fatal muscle disorder known as myopathy, compared with other
statin drugs.
Bayer was quick to defend its action on the drug, generically known as
cerivastatin.
Can Some Cholesterol Lowering Drugs Lead to Muscle Disorder?
Three years ago, the cholesterol lowering drug Baycol was taken off the
market because it caused some people to develop a serious muscle disorder.
Baycol is known as a statin type drug. Its chemical name is cerivastatin.
And it brought up the question-- what about the other statins?
Cardiovascular disease is the country's most lethal health problem and drugs
to lower cholesterol are one way to fight it. Almost one billion
prescriptions for cholesterol lowering drugs were sold in the U.S. in 2002.
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