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.
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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:
P.O. Box 305
Glenview, IL 60025