Public  Citizen, representing more than 100,000 consumers nationwide, hereby petitions the Food and Drug
                                                   Administration  (FDA),  pursuant to the  Federal Food,  Drug and Cosmetic Act 21 U.S.C. Section 355(e)(3)
                                                   and 21 C.F.R.  10.30,  to  immediately  add  a  black  box  warning  regarding  the  risk of tendinopathy and
                                                   tendon  rupture  to  the product labels of all fluoroquinolone antibiotics presently on the market in the United
                                                   States  [Ciprofloxacin, (Cipro; Bayer),   Enoxacin (Penetrex; Aventis),   Gatifloxacin (Tequin; Bristol Meyers
                                                   Squibb),  Levofloxacin (Levaquin; Ortho McNeil),   Lomefloxacin  (Maxaquin; Unimed),  Moxifloxacin (Avelox;
                                                   Bayer),    Norfloxacin (Noroxin; Merck),   Ofloxacin (Floxin; Daiichi-Sanyko)].    We  also  urge  the  FDA to
                                                   mandate  a  "Dear Doctor"  letter  to  warn  physicians  of  these  adverse  effects and require distribution of
                                                   an  FDA  approved  Medication  Guide  for  all  patients,  to  be  dispensed  when the prescriptions are filled.
                                                   From  November  1997  through  December  31, 2005,  the FDA had received reports of 262 cases of tendon
                                                   rupture in patients using one of the above fluoroquinolone antibiotics....
                                                          
                                                   Read the Full Petition
   Dr. Sidney Wolfe of Public Citizen
   Jamie Rose The New York Times

              The FDA's response to the Attorney General, State of Illinois's Petition

   I am writing to inform you that the Food and Drug Administration (FDA) has not yet resolved the issues raised
  in your Citizen Petition submitted  on May 24, 2005.   Your petition request that the Agency take the following
  actions  with  respect  to  the  entire  class of fluoroquinolone drug products and the potential adverse event of
  tendonopathy  and  tendon  rupture  to: 1)  revise  the  labeling  to  increase the warnings, 2)  provide "BLACK
  BOX"  warnings,  3)   require  manufacturers  to issue   "DEAR HEALTH CARE PROFESSIONAL"  letter  that
  informs  these  professionals  of  the  potential  health  hazards  associated with the use of this class of drugs
  and  details  your  proposed  labeling  changes,  4)   supplement  information  provided to patients with bolded
  warnings,  and  5)  submit  the  issue  for review  and  analysis  to  FDA's  Drug Safety Oversight Board.  FDA
  has  been  unable  to  reach  a  decision on your petition because it raises complex issues requiring extensive
  review and analysis by Agency officials.  This interim response is provided in accordance with FDA regulations
  on citizen petitions.    This is a PDF File Adobe Reader Required to view Read the Full Response
  Dr. Andrew von Eschenbach
    Acting FDA Commissioner        Read what U.S. Senator Chuck Grassley has to say about Dr. Andrew von Eschenbach (12-7-2006)


              Public Citizen's Petition filed 10 years ago dealing with this same issue:
                   Petition to Require a Warning on All Fluoroquinolone Antibiotics
                                                                HRG Publication #1399) August 1, 1996

Based on more than 130 reports of  tendon inflammation (many involving rupture), most  frequently  involving  the
 Achilles  tendon, in  persons  using  widely  prescribed  class  of antibiotics  known as  fluoroquinolones,  Public
 Citizen, representing   consumers nationwide,  hereby petitions the F.D.A., pursuant to  the  Federal Food, Drug
 and Cosmetic Act 21, U.S.C. Section 355(e)(3), and C.F.R. 10.30, to add a warning  about this  serious problem
 to the label of all fluoroquinolone antibiotics marketed in the  United  States.  These include  ciprofloxacin  (Cipro;
 Bayer), enoxacin (Penetrex; Rhone-Poulenc Rorer), lomefloxacin (Maxaquin, G.D. Searle),   norfloxacin  (Noroxin
 Merck & Company) and ofloxacin (Floxin, McNeil Pharmaceutical).   (In 1995 there were 14.4 million prescriptions
 filled for these antibiotics in the U.S. retail pharmacies according to data from IMS.)  In addition, consumers must
 be  warned  through  F.D.A.  approved   MedGuides  (patient package inserts)  how to recognize and react to this
 potentially  serious  adverse  effect  of the fluoroquinolone  antibiotics.  Only one  fluoroquinolone antibiotic sold in
 the U.S., ofloxacin  (Floxin)  (which  accounts  for less than one-fifth of fluoroquinolone prescriptions), now carries
 any  statement   that   tendinitis  or rupture have been reported with it's use, but even this statement is in a part of
 the  label  which  misleadingly  implies  that  tendon  damage  may  have  no  relationship  to  using the drug.   (1)
 Doctors  and  the  public  must  be  warned  to  immediately  discontinue  use  of fluoroquinolone antibiotics at the
 onset  of  tendon  pain.   The  frequency of  tendon damage from fluoroquinolones is unknown, but Achilles Tendon
 rupture  is   a  serious  condition,  often  requiring  surgical  repair.  Prompt  cessation of use of these antibiotics if
 patients get tendinitis may avoid the progression to frank rupture of the Achilles or other tendons.     
 Sidney Wolfe, M.D. Director of Public  Click Here to Read the Full Petition
    Citizen's Health Research Group


The Fluoroquinolone Toxicity Research Foundation has sent a letter to every Attorney General in the United States on September 27, 2006, regarding the Petitions of Public Citizen and the Attorney General of the State of Illinois, asking for their support of these petitions.

  I am writing you on behalf of those Citizens residing in the State of ****** who have  suffered needlessly due to
  severe and non abating adverse drug reactions to a class of chemotherapeutic agents commonly referred to as
  Fluoroquinolones or Quinolones.  The Fluoroquinolones (i.e. Cipro, Levaquin, Avelox and Tequin amongst other
  drugs in this class), have a horrendous history of severe and non abating adverse reactions that go as far back
  as1962.  More than fifty percent of these  drugs have been  removed from clinical  practice due to such toxicity
  and fatalities.   (i.e. Trovan, Raxar, Lomefloxacin, Sparfloxacin, Temafloxacin, Grepafloxacin,  and others within
  this class, with Tequin being the  most recent, circa 2005.  Yet the treating physicians have no prior knowledge
  concerning these events due to the F.D.A.'s total and complete failure to make such warnings available.  Since
  1982 the  FDA  has  been  made  aware  of the fact that spontaneous tendon rupture may occur anytime during
  therapy  as  well  as  long  after  such therapy has been discontinued.  Yet today, almost twenty five years later
  the  treating  physician  has  NO  knowledge  concerning  such a risk and adamantly denies that such a rupture
  had anything to do with the drug he or she prescribed to the patient.   Read the Full Letter
    Mr. D. T. Fuller / Director
    Fluoroquinolone Toxicity         Read the various Attorney General's response to this letter by clicking here.
     Research Foundation

__________________________________________________________________________________________________________________________


   If you wish to add your comments in support of Public Citizens Petition follow this link and then click on "Submit
   Comment"  at the bottom of the  comment window.  After filing in your name in the registration form you are then
   allowed to add your specific comments.  Simply follow the prompts. FDA Docket Comments

   Please write to your Attorney General.  We are asking all visitors and patients to write to their Attorney General
   and to express  their concern regarding  the total failure of the  FDA to protect them from these horrendous side
   effects. 

   Clicking here for the contact information for every Attorney General in the United States.


__________________________________________________________________________________________________________________________


          Additional Concerns Regarding Peripheral Neuropathy, Toxic Psychosis and Fatalities

                                         Peripheral and Central Nervous System Disorders Associated with the Fluoroquinolones
                                                                     Peripheral Neuropathy Associated with Fluoroquinolones, Dr. Jay S. Cohen

   In contrast to previous reports suggesting that fluoroquinolone-associated PNS events are mild and
   short-term, 36 of the 45 cases reported severe events that typically involved multiple organ systems.
   Although many newer cases are still evolving, symptoms had lasted more than three months in 71%
   of cases and more than one year in 58%.  Onset of adverse events was usually rapid, with 15 (33%)
   events  beginning  within  24  hours  of  initiating  treatment,  26 (58%) within 72 hours and 38 (84%)
   within one week.   Sixty  courses  of  fluoroquinolones  were  prescribed: levofloxacin (n = 33 cases)
   ciprofloxacin  (n = 11),  ofloxacin (n = 6),  lomefloxacin (n = 1),  trovafloxacin  (n = 1), in  eight cases
   was prescribed twice.
   CONCLUSIONS:  These cases suggest a possible association between fluoroquinolone antibiotics
   and  severe,  long  term  adverse  effects  involving  the  PNS as well as other organ systems.  The
   severity  of these cases may reflect a different population that typically reported to drug companies
   or  MedWatch,  which often  originate  from health  care  providers.  In contrast, Internet Web Sites
   may  provide  a forum  for  patients  experiencing  adverse  effects  that  have not resolved promptly.
   Further  study  is warranted.   Meanwhile,  the occurrence of PNS symptoms during fluoroquinolone
   therapy should prompt immediate discontinuation of the agent used.   Read the Full Report
Dr. Jay S. Cohen Associate Clinical
Professor, Departments of Family and
Preventive Medicine, and Psychiatry
University of California, San Diego, CA


Family Says Medication Led to Son's Rampage. Family members say Brewer had been taking Cipro for about two weeks after toe surgery.
   Matthew Brewer is recovering from several stab wounds to his face, hands and chest.  He was in court today
   to support the very man he says is responsible for his injuries.  His younger brother, Jonathan.  "We are all
   behind  him  no matter what." said Matthew.   Jonathan Brewer was arrested last month after police say he
   attacked  his  brother, mother,  father, grandmother and aunt during an argument.  But family members say
   they were all asleep at  the time and blame  Brewer's bizarre behavior on the antibiotic he was taking.  "We
   know no one  knows him  like we know  him  so we know  he's not  capable  of evil". said Matthew.  Family
   members say Brewer had been taking  Cipro for  about two weeks after toe surgery.  The list of side effects
   that  come  with  the drug  include confusion or hallucinations, even depersonalization and manic reactions.
   Brewer's  attorney  is hoping  it's enough  to get  the  charges  of  attempted  murder  and  attempted man-
   slaughter  dropped.   Police  say two  weeks  ago, Jonathan Brewer  stabbed  his brother, his grandmother
   and his great aunt.  He then bashed his parents over the head with a lamp.   His family said the drug Cipro
   caused his violent reaction.  When the Brewers  talked to their son in jail, they say Jonathan said he didn't
   remember hitting anybody but Matthew.  Gilber Brewer also says Jonathan does not know why he did what
   he  did  or  even  why  he  drove  from  Louisiana  to  his parent's house in the middle of the night that night. 
   Gilbert  and  Mattie  think they know why.  They believe the antibiotic, Cipro, that Jonathan was taking for a
   toe  infection  is to blame.   "General delirium type side effects, including hallucinations, have been reported.
   Paranoia has been reported.  Patients can see things, patients can hear things," says Pharmacist Shannon
   Finks.   Read the Full Story of Jonathan Brewer
Jonathan Brewer Accused of
attempted Murder


                                                       Fatalities Associated with the Fluoroquinolones

Gary and Ruth Pettijohn, of Batesville, Ind., hold a photo of their daughter, Kristen, who died after being prescribed a powerful antibiotic called Avelox.
   Gary and Ruth Pettijohn, of Batesville, Ind., hold  a photo  of their daughter, Kristen,   who died after being
   prescribed a powerful antibiotic called Avelox. Early in the morning of May 15, Pettijohn's mother took her 
   to an emergency room. Forty-two minutes later, Pettijohn was on her way to the drugstore. The doctor had
   diagnosed her with acute bronchitis and prescribed Avelox. That was a Thursday. By Sunday, Kristen was
   nauseated and suffering adominal pain.  Her mother packed a plastic bag with the remaining Avelox pills
   and took her to the hospital.  Over the next five days, Kristen was incoherent. She had a burning rash and
   her skin began peeling off.  She lipped into a coma, resting on  an air bed, totally wrapped as though she
   were a severe burn patient.  Kristen's liver was in full  failure, and she was experiencing a form of Stevens-
   Johnson  syndrome, a rare  and extreme drug reaction  mentioned  on the  Avelox  label.  She had a liver
   transplant on Friday.  The doctors reported  that her old liver  had turned to  mush and fallen apart in their
   hands. Soon after the operation, Kristen had a heart attack, then another. Her death certificate cited Avelox
   as the prime contributing factor in her death.        Click here to continue
Gary and Ruth Pettijohn and photo of
their daughter Kristen