Date: ________________
A petition To the United States Congress
I , _________________________________________am signing this petition to request
the United States Congress to immediately take action to protect consumers from
the reckless and negligent abuses of the FDA and the following Pharmaceutical
Companies: Bayer, Ortho-McNeill, Pfizer, Merck, Bristol-Myers Squibb, Sanofi
Winthrop, Bertek Pharmaceuticals – Rhone-Poulenc Rorer and Barr. These companies
manufacture and distribute fluoroquinolone antibiotics in the United States in a
manner that fails to warn of serious adverse event risks, and downplays and
fails to warn physicians of the serious risks associated with fluoroquinolone
therapy. As a result, physicians and patients cannot adequately assess the
Risk/Benefit ratio of medical therapy using these drugs, leaving patients
permanently crippled, paralyzed, in chronic pain with a host of other
long-term/permanent, multi-systemic adverse drug reactions. The fluoroquinolone
antibiotics manufactured and distributed are: Cipro, Levaquin, Floxin, Avelox,
Tequin, Noroxin, Maxaquin, Trovan, Raxar, Zagam, Ciloxin, Quixin, Ocuflox,
Penetrex, Chibroxin, Cinoxin, Vigamox, and Factive, to name a few.
Fluoroquinolone adverse events which were known by the drug companies and the
FDA, have been occurring for over twenty years. These adverse events were not
made known to physicians, pharmacists and patients. In essence, the drug
companies marketed their drugs in a reckless manner, recommending these powerful
“last-line of defense” antibiotics be prescribed as a “first-line of defense”
drug in order to capitalize on expanding markets and maximize profits. These
companies pushed and pressured physicians to prescribe these drugs for
“off-label” uses and failed to disclose and make known to doctors the serious
adverse reactions that are causing long-term and sometimes permanent crippling
damage. Physicians have been left with the illusion that fluoroquinolone
antibiotics are safer and superior to other competitive drugs on the market
although they are not.
The adverse drug reactions listed below are some of the long lasting and/or
permanent reactions caused by these antibiotics: cardiovascular damage;
peripheral and central nervous system damage; tendon and muscle damage including
tenosynovitis, tendonitis, atrophy, joint and bone damage; vision
problems; hearing loss; liver damage; kidney damage; cancer; brain toxicity and
death, just to name a few.
Two decades after introducing these drugs, the FDA finally mandated the drug
companies to make warning label changes to their package inserts providing
almost anecdotal warnings of some of these reactions. Unfortunately those
warnings do not adequately describe the serious potential long term effects of
the medications. Physicians, pharmacists and patients remain unaware of the
potentially lethal effects of these drugs.
Because the drug companies failed to warn of these serious adverse reactions
when they first learned of them years and years ago, as required by law, these
companies have evaded litigation by dodging under the statute of limitations.
With these actions, the companies have committed fraud, depraved indifference,
false advertising, and a number of other violations of the law. This behavior
must be addressed and justice served.
In August, 1996, Public Citizen petitioned the FDA to:1) Immediately require a
warning in bold type in the official product labeling (package insert) for all
fluoroquinolone antibiotics sold in the U.S.; 2) Immediately require that a
MedGuide (patient package insert) be distributed with all new and refill
fluoroquinolone prescriptions warning the public of possible tendon damage and
informing the public to stop using the drug and contact their physicians if
tendon pain develops; 3) Immediately inform all U.S. physicians through a "Dear
Doctor Letter" by registered mail about the risk of tendon rupture with
fluoroquinolone antibiotics; 4) Immediately inform all other U.S. health
professionals through the F.D.A. Medical Bulletin about the new warning.
The FDA and drug companies DID NOT FOLLOW THROUGH to warn anyone and in the
meantime, thousands more people have had their lives destroyed by these
antibiotics.
The FDA and pharmaceutical companies should be held liable for the disabilities,
loss of income and medical bills attributed to the dangerous adverse drug
reactions of this class of antibiotic drugs. The FDA and pharmaceutical
companies have long been aware of these issues and continually do nothing about
it. By law, if the pharmaceutical companies know their products have a safety
issue, they are required to notify the medical community and general public
through amended product labeling, Dear Doctor Letters and advertisements in
clinical and research health journals, publications and other media sources.
I respectfully request that that the United States Congress immediately and
fully investigate the misconduct of the
pharmaceutical companies and the FDA and implement a procedure for the victims
of this misconduct to be compensated for the damages they have
suffered—notwithstanding existing statutes of limitations.
Name:__________________________________ (Required)
Congressional District__________________________________ (Required)
If you don’t know your Congressional District, please visit
http://www.house.gov/writerep/
You simply need to type in your zip code.
Address:____________________________________ (optional)
City:_______________ (optional) State: _____ (optional)
Zip Code: _________ (optional)
Telephone: ( )________________
(optional)
Fax: ( )_________________
(optional)
Email: _______________________________ (optional)
I, _______________________________took the Fluoroquinolone aka Quinolone Drug(s)__________________________
to treat the medical condition of ______________________________on Date: ______________________
The Adverse Drug Reactions that happened to me is/are and started on date:
_____________
______________________________________________________________________________________
Sex: Male_____ Female_____ Age _______
As of today’s date,__________________ , I am suffering from the following:
________________________________________________________________________________________
________________________________________________________________________________________
________________________________________________________________________________________
________________________________________________________________________________________
________________________________________________________________________________________
________________________________________________________________________________________
Signed: _________________________________ Date: _______________________
Please mail to:
Quinolones
P.O. Box 305
Glenview, IL 60025