Lipitor
Lawsuits Claim Pfizer Failed to Warn of Cholesterol Drug's Rare
Dangers
June
9, 2006 – Lawsuits filed this week claim that drug-maker
Pfizer has failed to
warn doctors and patients about serious possible side effects
of the
cholesterol-lowering drug.
The
two lawsuits claim that Lipitor caused lasting, debilitating
muscle and nerve problems -- including memory loss. Mark Jay
Krum, a lawyer based in New York and Philadelphia, last Wednesday
filed the suits in New York State Supreme Court on behalf of
patients in New York and Atlanta.
Charles
M. Wilson, a 60-year-old Atlanta man, says taking Lipitor damaged
his nervous system. Three years after he stopped taking Lipitor,
the suit says, his feet and hands burn, his balance is lost,
and he suffers bouts of fatiguefatigue and memory loss.
The
suit filed by Michael Mazzariello, a 47-year-old New Yorker,
says his use of statins -- the family of cholesterol-lowering
drugs to which Lipitor belongs -- left him with debilitating
muscle damage and extensive memory loss.
"The
complaint alleges that Pfizer promoted Lipitor as a safe drug
with minimal health risks while failing to warn doctors and
patients about Lipitor's more dangerous side effects,"
Krum tells WebMD. "No one is saying Lipitor does not work
in reducing cholesterol. In most people it may be safe. But
there are side effects such as those in the complaints filed
on June 7. People are entitled to know."
With
annual sales of about $12 billion, Lipitor is the world's best-selling
medicine.
It's the most popular of the cholesterol-lowering drugs called
statins.
Other statins include Zocor, Crestor, Mevacor, Pravachol, and
Lescol.
A statin drug called Baycol was removed from the market in 2001
because it
caused far more cases of muscle damage than other members of
its class.
Pfizer: Lipitor Safe, Allegations False
Pfizer:
Lipitor Safe, Allegations False
Pfizer
spokesman Bryant Haskins says that while Lipitor is among the
world's
safest drugs, it can -- rarely -- cause serious side effects.
And the company,
he says, makes these risks perfectly clear to doctors and to
patients.
"This
is an extremely safe drug. It is the most studied drug in the
world,"
Haskins tells WebMD. "It has been studied in over 400 clinical
trials with 80,000
patients. More than 20 million patients have taken the drug
since it entered the
market about a decade ago. Any potential side effects, any significant
adverse
events are on the drug's label, in our advertisements, and on
our web site.
To say we have hidden information on this drug is absolutely
false."
Lipitor
has two major kinds of side effects, says Richard Milani, MD,
head of preventive cardiology
at the New Orleans-based Ochsner Clinic Foundation. A prominent
cardiologist, Milani serves on the speakers' bureau for Pfizer
and other companies that make statin drugs but has no other
ties to the companies.
"Statins
are one of the most studied classes of drugs ever to occur in
medicine," Milani tells WebMD. "There are only two
safety issues. One is liver-related issues, and the other is
muscle damage."
Patients
taking Lipitor and other statins get regular blood tests that
look for liver problems. These, Milani says, can be easily spotted
before the drugs cause any damage.
Muscle
damage can be lasting, but patients usually experience muscle
aches as an early warning sign, Milani says.
"I
tell patients there is a small chance they can develop muscle
aches," he says. "It is only a small chance, but all
they have to do is discontinue the drug and give us a call.
I tell them the truth; I would not expect this to happen. These
are infrequent side effects."
And
Lipitor, Milani says, doesn't cause side effects any more often
than other statins.
Lipitor
Nerve Damage?
The
lawsuits prominently claim that Lipitor caused nerve damage
in the plaintiffs.
"Some
of the ailments they claim to have from Lipitor have been studied
in clinical trials -- and there has been no scientific link
established," Pfizer's Haskins says.
However,
there are reports in the scientific literature suggesting that
statins may be linked to a form of nerve damage called peripheral
neuropathyperipheral neuropathy.
According
to a 2006 report from the Statin Safety Assessment Conference
of the National Lipid Association, the risk of this happening
is 12 nerve-damage events per year for every 100,000 people
who take statins. And the report notes that the link between
statins and peripheral neuropathyneuropathy is "putative."
On
the other hand, the report says, statin drugs every year "avert
several hundred deaths and several hundred cases each"
of strokestroke and heart attackheart attack for every 100,000
high-risk patients taking the drugs.
"Sometimes
these news stories about lawsuits scare people. What you don't
want to do is say these medicines are dangerous," Milani
says. "I am talking about the many people having no problem
while taking these drugs."
By
Daniel DeNoon, WebMD Medical News Reviewed By Louise Chang,
MD on Friday, June 09, 2006
SOURCES:
News release, PRNewswire, June 8, 2006. Pfizer statement on
Lipitor, June 9, 2006. Guyton, J.R. American Journal of Cardiology,
April 17, 2006; vol 97: pp 95C-97C. Mark Jay Krum, private practice
attorney, New York and Philadelphia. Bryant Haskins, director
of corporate media relations, Pfizer, New York. Richard Milani,
MD, section head, preventive cardiology, Ochsner Clinic Foundation,
New Orleans.
Statin
Adverse Effects: Implications for the Elderly
by
Beatrice A. Golomb, M.D., Ph.D.
Geriatric Times May/June 2004 Vol. V Issue 3
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