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Demand FDA require BLACK BOX WARNINGS on ALL FLUOROQUINOLONE DRUGS for Risk of Permanent Central Nervous System & Peripheral Nervous System Damage

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I am one of the tens of thousands who have been severely disabled by Fluoroquinolone Drugs. This stuff is handed out like Coco Cola but I was never warned that ingesting ONE tablet of CIPRO, I was risking serious permanent damage to my Central Nervous System & Peripheral Nervous System, causing extreme pain and dysfunction through out my body. I took 3 in total, out of 14 tablets...when everything began to change. I  was never warned that I was at risk for losing the ability to stand or walk, (need a wheelchair) , see, hear, digest & swallow, use my arms & hands, or fall to sleep. Join me with countless others that are determined to stop this savagery of the public. I have personally met 48 people who have been severely harmed by these drugs. Some have lost organs, hearing, ability to walk, or stand and have been hospitalized several times from complications. This Class of Drugs has severely injured the very young and athletic men and women, young moms, career men and women in their prime, seniors & doctors!

"ALL" of the risks are not disclosed to the Doctors who prescribe them or to the Pharmacist who dispense them, for Sinus infections, Prostate infections, Urinary & Respiratory infections! 

I was never warned that Fluoroquinolone drugs are unlike any other antibiotic in that they are "Chemo Therapeutic" antibiotics. They DO NOT distinguish between "our" DNA and the bacteria's DNA. These injuries are profound, and do not subside from stopping usage of the drug. 

Tragically for many, even though the "first prescription" all appears fine, but for aches in their joints, the "next"  time they are prescribed the exact same drug or another drug from the  Fluoroquinolone Class, they are suddenly, rapidly spiraling  through a horror of symptoms and disability that alters their lives forever.  How can this be?  The first bottle seemed OK?  The saturation point for destruction could be 3 tablets as it was for me and others or the 2nd or 3rd bottle with a year inbetween.  Unknown, unpredictable and demonstrates that the threshold differs in individuals but is extremely dangerous for all of us.  

The need for this Black BOX WARNING is specifically to warn & protect the public, & our families, from the reckless and negligent abuses of the FDA and the following Pharmaceutical Companies: Bayer, Johnson & Johnson, 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, Tro, 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.

 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.

 These adverse events were not made known to physicians, pharmacists and patients. In fact they are prescribed in such a casual manner, 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 immoral consequences. These severe adverse effects are often delayed by weeks and months.....leaving patients and the medical community unaware of what the cause is for these systemic injuries. This is a horror perpetrated on the public and the medical doctors who prescribe them.

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.

And Now again, 

We the people, By the people, For the People are demanding that the Public, Pharmacists, and Medical community is fully and effectively informed of ALL the  risks and dangers of Fluoroquinolone Drugs. 



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