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~~~~~~~~~~~~~~~~~~
Bayer
Voluntarily Withdraws Baycol
FDA Talk Paper - August 8, 2001
WASHINGTON (Reuters) - Bayer AG's cholesterol-fighting
drug Baycol, which the German drug giant
pulled from the market Wednesday, was linked
to 31 U.S. deaths from a muscle-related
side effect, health officials said.
~~~~~~~~~~~~~~~~~~
FDA
says Withdrawn Bayer Drug Linked to 31 Deaths
Reuters News Service - August 8, 2001
FDA today announced that Bayer Pharmaceutical
Division is voluntarily withdrawing Baycol
(cerivastatin) from the U.S. market because
of reports of sometimes fatal rhabdomyolysis,
a severe muscle adverse reaction from this
cholesterol-lowering (lipid-lowering) product.
The FDA agrees with and supports this decision.
~~~~~~~~~~~~~~~~~
Drug's
Problems Raise Questions on Warnings
New York Times - August 21, 2001, By
Philip J. Hilts
When Baycol, a cholesterol-lowering
drug, was approved in 1997, it appeared
to be a potentially lifesaving drug with
few side effects. It had been tested on
more than 3,000 patients, and no serious
problems had turned up. ...
~~~~~~~~~~~~~~~~
If you took Baycol
and experienced any adverse reactions you
may have a valid legal claim.
Baycol,
a 'statin' drug sold for lowering cholesterol,
was approved by the FDA in 1997. Prior
to its release, it had been tested on more
than 3,000 patients. Statins are powerful
anti-cholesterol drugs that save lives by
prevention of heart attacks and strokes.
Six statins are left on the market in the
United States, and about 12 million people
take them.
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.
Doctors
were sent advisories to:
- not
start patients on the highest dose
- not
to give patients both cerivastatin and
Lopid, or gemfibrozil, a nonstatin drug
that lowers blood triglyceride levels
and cholesterol. These drug combinations
seem to increase risk.
Many doctors
deny receiving such advisories.
In
the United States, Public Citizen's Health
Research Group, a medical watchdog organization
in Washington, said it had found 81 reports
of deaths from rhabdomyolysis linked to
statin drugs other than cerivastatin since
the late 1980's.
Government
statisticians have calculated that there
were probably about 10 cases of side effects
for each case reported to the F.D.A.
Product liability
laws and medical malpractice or negligence
laws are guided by personal injury law. The
primary aim of personal injury law is to
provide relief through compensation to
injured parties for the damages incurred.
Among the types of recoverable damages are:
loss of earning capacity, pain and
suffering, and reasonable medical expenses.
Damages include both present and future
expected losses.
- Product
Liability: Defective products
such as prescription drugs which are not
properly labeled as to interactions or
other contraindications. Your attorney
can evaluate your legal rights and advise
you of possible compensation.
- Professional
Malpractice: Medical malpractice
or negligence may involve delay in treatment
or incorrect treatment or missed diagnosis.
Your lawyer can protect your rights and
represent your interests.
- Wrongful
death: Fatal injuries
due to negligence or other liability may
bring compensation to heirs or estate.
Seek legal counsel before the statute
of limitations becomes an issue.
If you have rhabdomyolysis and kidney failure
after or during use of a statin drug,
the maker of Baycol, Bayer Corporation,
or another manufacturer of another statin
drug may be liable for compensation. Your
lawyer can counsel you as to your
right to recover damages to help defray
the costs of treatment and provide compensation
for your pain and suffering.
Drug litigation can be complex. It
is best to seek the counsel of a personal
injury attorney with experience in this
field of law.
If you feel that you are having a reaction
to a statin drug, stop the drug immediately
and call your physician.
Symptoms of Rhabdomyolysis :
- abnormal urine color (dark, red, or
cola colored)
- muscle tenderness
- weakness of the affected muscle(s)
- generalized weakness
- muscle stiffness or aching (myalgia)
- weight gain (unintentional)
- seizures
- joint pain
- fatigue
Signs And Tests for Rhabdomyolysis :
- An examination reveals tender or damaged
skeletal muscles.
- A urinalysis may reveal casts and hemoglobin
without formed red blood cells.
- A urine myoglobin test is positive.
- A serum myoglobin test is positive.
- A CPK is very high.
- A serum potassium may be very high (potassium
is released from cells into the bloodstream
when there is cell breakdown).
- creatinine - urine
- creatinine
- CPK isoenzymes
Prior to accepting
an insurance settlement, it is wise to speak
with a personal injury lawyer to evaluate
your situation and to ensure that your interests
are protected. Most personal injury
attorneys provide free initial consultations
and most will only be paid if you win your
case and receive a judgment.
Most
frequently, personal injury attorneys will
receive a percentage of the settlement awarded
to you. Legal advice can save
you time, trouble and money and can insure
that you are treated fairly.
Personal
Injury Attorney Web Links
Consultwebs.com
can assist in making recommendations if
desired.
Arthur
M. Blue Law Office, P.A., Personal Injury
lawyers, Carthage & Southern Pines,
North Carolina - (910) 947-1500
Brady, Nordgren, Morton & Malone, Estate
Planning, Wills & Trusts, Probate, Raleigh,
NC - (919) 782-3500
Breakstone,
White-Lief & Gluck, Personal Injury,
Medical Malpractice, Boston, MA - (617)
723-7676
Brinkley Walser, PLLC, Estate Planning,
Personal Injury, Real Estate, Workers
Compensation, Wrongful Death, Elder Law,
Banking Law, Traffic Law, Criminal Law,
Employment Law, Medical Malpractice, Family
Law, Lexington, NC - (336) 249-2101
Coover &
Barr, LLC, Business, Commercial &
Corporate Litigation, Family Law, Real
Estate, Columbia, MD - (410) 997-7600
Robert B.
Corris, S.C., Complex Business
Litigation, Fraud, Contacts - Milwaukee,
Wisconsin - 414-272-8000
Crouse
Law Offices, James T. Crouse - Aviation
Disaster & Personal Injury Attorneys,
Raleigh, NC - (919) 861-0503
Neil A. Davis, Family Law,
Personal Injury Law,
Troy, Michigan - (248) 244-9677
Martin
Ganderson, Estate Planning, Trusts,
Elder Law, Norfolk, VA - (757) 622-0505
Garlin
Driscoll & Murray, Personal Injury, Business Litigation,
Louisville / Boulder, CO - (303) 926-4222
Glenn,
Mills & Fisher, P.A., Personal Injury,
Professional Malpractice, Employment
Discrimination, Civil Rights, Wills and
Estates, Durham, NC, 919-683-2135
Belluck
Fox,
New York lawyers
practicing Medical Malpractice & Personal
Injury such as
Meridia,
Kava,
Mesothelioma,
Asbestos,
Silicosis,
Crestor -
New York, NY - 1-866-6ACTION
Ted
A. Greve & Associates, Auto &
Truck Accidents, Wrongful Death, Mass Torts,
Social Security Disability, Workers'
Compensation, Immigration, North Carolina
& South Carolina - (800) 984-7383
Jeremy
Howe & Partners in Mediation, Attorney
at Law, Mediation, Newport, Rhode Island -
(401) 841-5700
Kohn
& Rath, Personal Injury lawyers,
Hinesburg, Vermont - (802) 482-2905
Kraft & Associates,
Social Security
Disability,
Dog Bites,
Truck Wrecks,
Auto Accidents,
Personal Injury lawyers, Dallas,
Texas - (800) 999-9999
The Offices of George W. Lennon,
Workers Compensation,
Social Security Disability, Personal Injury,
Wrongful Death, Raleigh, NC - (919) 856-9000
Lichtenstein, Fishwick & Johnson, PLLC -
Personal Injury, Employment Law, Medical
Malpractice and Negligence, Family Law,
Roanoake, VA - (540) 463-6233
Marks & Harrison, Personal Injury
Lawyers,
Truck Accidents,
Wrongful Death, Social Security Disability,
Workers' Compensation, Consumer Fraud,
Richmond, Petersburg, Charlottesville, VA -
(800) 283-2202
MedLaw Legal Team, Medical Malpractice,
Personal Injury,
Nursing Home Abuse,
Cancer MisDiagnosis, Drugs - Serving the
U.S., Offices in Baltimore MD, Washington
DC, Philadelphia PA - (410) 653-9030
MGM Law
Offices - Personal Injury, Bankruptcy
Lawyers, Debt Solutions, Credit Card
Consolidation Attorneys, Traffic Accidents,
Milwaukee, Wisconsin, Chicago, Illinois,
Indiana - (800) 850-0398
Mineo &
Mineo, Aviation Disaster & Personal
Injury Attorneys, Raleigh, NC - (919)
861-0500
Munley,
Munley & Cartwright - Personal Injury
Lawyers, Workers Compensation, Social
Security - Scranton / Wilkes-Barre - All of
Pennsylvania - (800) 346-7401
The New
York Bar Association's -
Law Practice
Management Forum - New York, New York
New York Medical Malpractice Lawyers -
Oshman & Mirisola handles
medical malpractice /
negligence,
accident &
injury claims;
New York Personal
Injury cases including,
prescription drug
litigation, brain injury and
birth injury lawsuits including Erb’s Palsy
and Cerebral Palsy - 1 (800) 400-8182
Orange County Personal Injury Lawyers - Southern California - U.S.,
Nielsen & Associates,
Personal Injury and Disability, including
Auto Accidents,
Social Security Disability,
Workers Compensation,
Neck Injuries,
Dog Bites,
Back Injuries,
Spinal Cord Injuries,
Premises Liability,
Lemon Law, Orange County, Southern
California (866)-815-2616
Poyner
& Spruill, L.L.P., Multi-disciplinary,
Raleigh, Charlotte & Rocky Mount, North
Carolina - (919) 783-6400
Raleigh
Personal Injury Lawyers – Hardison &
Associates: North Carolina Attorneys
handling
Car Accidents,
Personal Injury,
and
Workers Compensation.
1(800)434-8399
Rosen
& Rosen,
Medical Malpractice,
Personal Injury, Workers Compensation,
Nursing Home Abuse, Hollywood, FL - (954)
981-1852
Smith,
Debnam, Personal Injury lawyers, Raleigh,
North Carolina - (919) 250-2000
Teague & Glover, Personal Injury
lawyers, Elizabeth City, North Carolina
- (252) 335-0878
Teddy & Meekins, Personal Injury
Attorneys, Shelby, NC - serving Cleveland,
Rutherford and Lincoln counties - Phone
704-487-1234
Twiggs,
Beskind, Strickland & Rabenau, P.A.,
Personal Injury lawyers, Raleigh, North
Carolina - (919) 828-4357
Warfield
Meredith & Darrah, P.C., Personal
Injury lawyers, Severna Park, Maryland
Paul
L. Whitfield, Personal Injury lawyer,
Charlotte, North Carolina - (704) 372-8322
Law
Offices of John C. Wunsch,
Erb's Palsy,
Cerebral Palsy,
Birth Personal Injury, Chicago, IL - (312)
977-9900
The Yarborough Law Firm,
Construction Law,
Administrative Law, Personal Injury cases,
Real Estate Matters, Corporate and Business
matters, Employment Law and Collections,
Fayetteville, NC, 910-433-4433
Other state
listings are listed
above
State Listings - Lawyers
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BAYCOL General
Interest Web Links
Baycol
(Cerivastatin) Information -
from the FDA.
Baycol
FDA.com -
informational news service helping those
affected by Baycol and rhabdomyolysis.
Baycol.com
- This is the official Bayer site.
Baycol see Cerivastatin
(Systemic)
Baycol - Hmg-Coa
Reductase Inhibitors (Systemic)
Bayer
Voluntarily Withdraws Baycol
Bayer
Voluntarily Withdraws Baycol From Market
Biology
of the Kidneys and Urinary Tract
CNN.com
- Bayer: Baycol anti-cholesterol
drug linked to ...
Cerivastatin
(Baycol) Drug for Cholesterol: Use, Side
Effects ...
Kidney
Failure
For
comments, corrections or additions, please
contact:
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