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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FDA says Withdrawn Bayer Drug Linked to 31 Deaths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.


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Austin Personal Injury Lawyer and Auto Accident Attorneys: Heselmeyer Zinda, represents victims of personal injury, car accident, truck accident, workplace injuries, slip and fall injuries, product liability, and wrongful death in the Austin and Dallas, Texas areas.

Asheville Personal Injury Attorneys - The Elmore Law Firm handling accident claims, medical malpractice, nursing home abuse and other serious injury cases. (828) 253-1492

Austin Felony and Criminal Defense Attorneys – Austin law firm of Minton, Burton, Foster and Collins practices in the areas of personal injuryfederal defensedrug offensesDWIfelony defense, and criminal defense.

Austin, TX Personal Injury Lawyers – Barry & Loewy LLP handling personal injury, accident, and products liability claims throughout Texas. 1(800)892-5044

Austin DWI Attorney – The Austin, TX firm of Minton, Burton, Foster and Collins practices in the areas of DWI OffensesDUI DefenseUnderage DrinkingPublic intoxicationdwi related boating accidents.

Asheville Personal Injury Attorneys - The Elmore Law Firm handling accident claims, medical malpractice, nursing home abuse and other serious injury cases. (828)253-1492

Arthur M. Blue Law Office, P.A., Personal Injury lawyers, Carthage & Southern Pines, North Carolina - (910) 947-1500

Anderson & Anderson Attorneys, LLP, Personal Injury, Social Security Disability, Workers' Compensation, Criminal Law, Traffic & DWI, North Carolina - (888) 895-2962

Belluck & Fox - New York, NY - Motorcycle Accident Attorneys - U.S. - 1-866-6ACTION

Belluck and Fox - New York Mesothelioma Lawyer / New York City Asbestos Attorneys

Belluck and Fox - New York City Asbestos Attorney / New York Mesothelioma Lawyers

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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

Belluck Fox, New York lawyers practicing Medical Malpractice & Personal Injury such as Meridia, Kava, Mesothelioma, Asbestos, Silicosis, Crestor, Vioxx, Lead Paint Lawyers - New York, NY - 1-866-6ACTION

Charles R. Ullman & Associates, Attorneys at Law, Family Law - Divorce, Child Support, Spousal Support, Child Custody, Johnston County & Raleigh, NC, 919-829-1006

California Divorce Attorneys - The Nielsen Law Group handles family law, divorce, and child custody concerns in Southern CA. Orange County Divorce Lawyers, Los Angeles Divorce Attorneys, and San Diego Divorce Lawyers. Contact our California Divorce Attorneys.

California Criminal Defense Lawyers - The Nielsen Law Group offers criminal defense services throughout Southern California: Los Angeles Criminal Defense Lawyers, Orange County Defense Lawyers. Contact our California Criminal Defense Lawyers

California DUI Lawyers - The Nielsen Law Group provides legal services for those accused of DUI/DWI in Southern California. Contact our California DUI Lawyers to speak with our attorneys. Los Angeles DUI Lawyers

California Business Law Attorneys - The Neilsen Law Group provides legal services to the business community in Southern California.

California Injury Lawyers - The Nielsen Law Group provides legal services throughout California for personal injury, workers compensation, social security disability, family law & divorce, DUI, and criminal defense.

Cerebral Palsy Injury - providing CP information for families and those affected by Cerebral Palsy, birth injuries, and medical malpractice; Serving the U.S., Offices in Baltimore MD, Washington DC, Philadelphia PA - 1-888-4-MEDLAW

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Chicago Injury Lawyers – Salvi, Schostock & Pritchard, handling Chicago car accidents, Illinois medical malpractice & birth injury claims, wrongful death in Cook County, Lake County, and Illinois personal injury claims.

Coover & Barr, LLC, Business, Commercial & Corporate Litigation, Family Law, Real Estate, Columbia, MD - (410) 997-7600

Crouse Law Offices, James T. Crouse - Aviation Disaster & Personal Injury Attorneys, Raleigh, NC - (919) 861-0503

Epperly & Follis, P.C., Personal Injury Lawyers, Nursing Home Abuse, Medical Malpractice, Investor Fraud, Workers Compensation, Criminal Defense, Civil Rights - (888) 703-0109

Glenn, Mills & Fisher, P.A., Personal Injury, Professional Malpractice, Employment Discrimination, Civil Rights, Wills and Estates, Durham, NC, 919-683-2135

Indianapolis Personal Injury Lawyer / Indiana Accident Attorney Ken Nunn handling Marion County Car Accidents, Fort Wayne Slips and Falls, Evansville Malpractice Claims, Gary Product Injuries, and IN injury lawsuits including:  Allen County, Evansville, Vanderburgh County, South Bend, Saint Joseph County, Gary, Lake County, Hammond, Bloomington, Monroe County, Muncie, Delaware County, Fishers, Hamilton County, Lafayette, and Tippecanoe.

Knoxville Personal Injury Lawyer and Truck Accident Attorney: Terry, Terry & Stapleton, represent victims of Car Accident, Personal Injury, Truck Accident, Workplace Injuries, Medical Malpractice, Social Security Disability, Wrongful Death and Nursing Home Injury in the Morristown and Knox County, Tennessee area.

Maine Disability Lawyers

Martin Ganderson, Estate Planning, Trusts, Elder Law, Norfolk, VA - (757) 622-0505

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Law Offices of Scott C. Gottlieb & Associates, LLP - Personal Injury, Medical Malpractice, Insurance Settlements, Wrongful Death, Rochester, Syracuse, Watertown, Elmira, NY - (800) 825-5529

Robert B. Corris, S.C., Complex Business Litigation, Fraud, Contacts - Milwaukee, Wisconsin - 414-272-8000

Round Rock Family Lawyer

Round Rock Business Lawyer

Scott C. Gottlieb, Injury Law Attorney, Motor Vehicle Accidents, Medical Malpractice, Wrongful Death, Birth & Brain Injuries, Hunting & Firearms Accidents, Binghamton, NY - (607) 724-7700

 Ted A. Greve & Associates, Auto & Truck Accident, North Carolina Truck Accident, Wrongful Death, Mass Torts, Social Security Disability, Workers' Compensation, Immigration, North Carolina & South Carolina - (800) 984-7383

Ted A. Greve & Associates, Wrongful Death, Mass Torts, Social Security Disability, Workers' Compensation, Auto & Truck Accidents, - (800) 984-7383

Joe Griffith Law Firm – Personal Injury, Criminal Defense, Commercial Litigation, Charleston, South Carolina - (866) 386 – 6460

Harris, Ragan, Patterson & Rodgers, PLLC, Personal Injury, Malpractice and Employment Lawyers - Charlotte, NC - (704) 392-4111

Heselmeyer Zinda, PLLC - Personal Injury, Auto Accidents, Wrongful Death - Dallas / Austin, TX -  (800) 863-5312

Howard, Stallings, From & Huston, P.A., Commercial & Civil Litigation, Employment Law, Personal Injury, Estate Planning, Bankruptcy, Raleigh, NC - (919) 821-7700, New Bern, NC - (919) 633-3006

Law Office of Paul Hogan, LLC, Personal Injury Lawyers - Car Accidents, Truck Accidents, Premises Liabilities, Wrongful Death, Workers Compensation, Mass Tort Drugs, Wichita, KS - (316) 303-1411

Jeremy Howe & Partners in Mediation, Attorney at Law, Mediation, Newport, Rhode Island - (401) 841-5700

Kansas City Missouri Lawyers – Peterson & Associates - injury accidents, prescription litigation lawsuits, and wrongful death claims. 1-877-DRUG-GIANT

Kentucky Personal Injury Lawyer – Frank Jenkins Law Office practices in the areas of wrongful death, car accidents, work related accidents, motorcycle injuries, truck accidents, and social security disability.

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) 989-9999

Law Offices of John C. Wunsch, Erb's Palsy, Cerebral Palsy, Birth Personal Injury, Chicago, IL - (312) 977-9900

Lincoln Injury Attorney & Accident Lawyers - Dyer Law represents the injured and their families in personal injuries, auto accidents, and workplace injuries cases in Lincoln, Omaha, and throughout the state of Nebraska 1-800-393-7529.

Law Office of Brian D. Iton, Family Law, Traffic Law, Real Estate, Englewood Cliffs, Bergen County, NJ - (800) 274-6180.

Lennon & Camak, PLLC, Workers' Compensation, Social Security Disability, Personal Injury, Wrongful Death, Raleigh, NC - 1-(919) 856-9000

Lichtenstein, Fishwick & Johnson, PLLC - Personal Injury, Employment Law, Medical Malpractice and Negligence, Family Law, Roanoake, VA - (540) 463-6233

The Law Office of Laura S. Jenkins, PC, Workers Comp, Social Security, Personal Injury, Business Startups, Raleigh, NC - (919) 846-7766

The Law Offices of John T. Orcutt, Bankruptcy and Debt Relief, Raleigh, NC - 1-888-610-2442

Ft. Lauderdale Personal Injury Lawyer – Rosen & Rosen - Medical Malpractice, Personal Injury, Workers Compensation, Nursing Home Abuse, Hollywood, FL.

Maritime Lawyers – Texas Offshore Accidents  /  Louisiana Maritime Lawyer  / Houston Maritime  /  Gulf Coast Jones Act

Maine Personal Injury Lawyers - Skelton Taintor & Abbott : personal injury, car accidents medical malpractice, and wrongful death claims in Portland, Lewiston, and Auburn.

Maritime Lawyers & Offshore Admiralty Accidents Injury

Marks & Harrison, Personal Injury Lawyers, Truck Accidents, Wrongful Death, Social Security Disability, Workers' Compensation, Consumer Fraud, Richmond, Petersburg, Charlottesville, VA - (800) 283-2202

Maryland Unnecessary Heart Stent Placement Attorneys L / New York Stent Abuse Claim Lawyer / Pennsylvania Stent Fraud Lawyers Contact the Law Offices of Wais, Vogelstein, & Bedigian Online or by phone 1-877-Stent99 (1-877-783-6899).

McEwen Law Firm, Vioxx Personal Injury Lawyers, Inver Grove Heights, MN - (651) 224 – 3833

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, Columbia SC - 1-888-4-MED-LAW

MesotheliomaHelp.net - Asbestos Exposure, Mesothelioma Lawyers, Injury Attorneys - New York, NY - U.S. - (866) 6ACTION

Mineo & Mineo, Aviation Disaster & Personal Injury Attorneys, Raleigh, NC - (919) 861-0500

Missouri Personal Injury Lawyers – Peterson and Associates, P.C. handling accident, medical devices, nursing home abuse, medical malpractice, defective products, toxic chemical exposure and prescription drug injury cases.

Munley, Munley & Cartwright - Train Injuries & Accidents, Personal Injury Lawyers, Workers Compensation, Social Security - Scranton / Wilkes-Barre - All of Pennsylvania - (800) 346-7401

Murray, Craven & Inman, L.L.P. - Bankruptcy, Corporate Law, Construction & Surety, Estate Planning, Litigation, Taxation, Fayetteville, NC - (910) 483-4990

New York Personal Injury Lawyers – Schwartzapfel Partners represent victims of Personal Injuries, Car Accidents, Medical Malpractice, Slip & Fall Cases, and Disability claims in New York, The Bronx, Brooklyn, and Queens.

Naples / Fort Myers Injury Lawyers - Our experienced team is centrally located in Lee & Collier counties and represents those injured in car accidents, workplace injuries, and other serious injury claims.

NC Speeding Ticket Lawyers

North Carolina Academy of Trial Lawyers- Raleigh, North Carolina - (800) 688-1413

New York Motorcycle Accident Lawyers - NY Biker Injury Attorneys, Belluck & Fox. 1-877-LEGAL03

New York Lead Paint Lawyers – Does your child have elevated lead levels? Learn more about your rights, and protecting your family. NY Lead Paint Attorneys

New York Personal Lawyer, NY Accident Attorney: David Resnick & Associates, PC, Car Accidents, Slip & Fall, Pedestrian Injuries - (212) 279-2000.

New York Personal Injury Lawyers - Schwartzapfel Truhowsky Marcus P.C handling accident claims, medical malpractice, product liability, auto accidents, construction injuries, and other injury cases. (800) 966-4999

NJ Personal Injury – Our experienced team handles injury and accident claims throughout New Jersey, including those injured in car accidents, workplace injuries, and other serious injury claims.

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

Oxycontin & Drug Injury Attorneys, Experienced Pharmaceutical Lawyers, Missouri - U.S. - 800-536-HELP

Petersburg VA Personal Injury Lawyers – Cuthbert Law Offices handling motor vehicle accidents, medical malpractice, and social security claims.

Philadelphia Accident Lawyers - Pennsylvania Car & Truck Accident Attorneys. Munley, Munley & Cartwright, P.C. - 1(800) 346-7401

Providence Personal Injury Lawyer, Rhode Island Accident Attorneys – Gemma Law Associates, Inc.

Paul A. Samakow, P.C. - Personal Injury Lawyers, Vienna, VA - (703) 761-4343, Wheaton, MD - (301) 949-1515

Paul J. Tafelski, P.C., Criminal Defense, Bloomfield Hills, MI - (248) 647-0404

Raleigh Personal Injury Lawyers – Hardison & Associates: North Carolina Attorneys handling Car Accidents, Personal Injury, and Workers Compensation. 1(800)434-8399

South Carolina Injury Attorneys – Louthian Law Firm handling serious injury claims throughout SC: Columbia, Richland County, Charleston, Greenville, Florence, Myrtle Beach.

Sacramento Personal Injury Attorneys – Arnold Law Firm practices in the areas of nursing home injury and negligence, car accidents, work related accidents, product safety, wrongful death, personal injury, and denture cream liability.

San Antonio, TX Disability Attorney – Heard & Smith: Probate, Estate Planning, Social Security Disability. 1(800)584-3700

Seattle Injury Lawyers - Brett & Coats Personal Injury Attorneys : Personal Injury, Car Accidents, Motorcycle Injuries, Hit and Run Accidents, Drunk Driver Accidents, and Wrongful Death with claims in Seattle, Tacoma, Everett, and Bellingham.

Seattle Drunk Driving Car Crash - Brett & Coats Personal Injury Attorneys : Drunk Driving Accidents , Car Accidents, Motorcycle Injuries, Hit and Run Accidents and Wrongful Death with claims in Seattle, Tacoma, Everett, and Bellingham.

Seattle Personal Injury Lawyer - Selander O’Brien, PLLC, Protecting the People of Washington: Accident & Injury Claims. 1-800-734-0404

St. Louis Accident Lawyers, Fox Goldblatt and Singer

Texas Truck Accident Lawyers  -  Louisiana Truck Accidents

Tacoma Injury Lawyer – Rush, Hannula, Harkins & Kyler LLP handling injury, accidents, medical malpractice claims throughout Washington state.

Teague & Glover, P.A., Personal Injury, Criminal Defense lawyers, Elizabeth City, North Carolina - 252-335-0878

Teague & Glover, P.A., Personal Injury, Criminal Defense 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

Truck Accident Lawyers - Physician | Nurse Attorneys, Baltimore Maryland, Washington DC, Philadelphia Pennsylvania, Columbia SC - Servicing the U.S. - 1-888-4-MEDLAW

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

Washington D.C. Personal Injury Lawyer – The Abelson Law Firm: Washington, D.C. Medical Malpractice Attorney, Baltimore Car Accident Lawyer, Maryland Truck Accident Attorneys.

Washington Injury by Brett & Coats, PLLC, Bellingham WA Personal Injury lawyers, Wrongful Death, Medical Malpractice, Accidents, Product Liability, Cross Border Claims  Lawyers - Bellingham, WA - (360) 733-0212

Washington Injury - Accidents & Collisions, Personal Injury, Wrongful Death, Insurance Law, Sexual Harassment, Bellingham, WA - (800) 925-1875

West Virginia Social Security LawyerJan Dils Attorneys at Law: Social Security Disability, SSI and SSDI Claims, Veteran's Benefits, and VA Benefits.

White & Allen, P.A., Commercial Law, Employment Law, Estate Planning, Health Care, Personal Injury, Real Estate, Criminal Law, Kinston and Snow Hill, NC - (252) 527-8000

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

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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

 

 

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