Post Marketing Reports June 2004

James H. Beale - Fri, 18 Jun 2004 14:01:46 -0400 - #2270

Re: director: flouroquinolone toxicity research foundation
I am a pharmacist/store owner injured by Levaquin. I have many patients that have also suffered from the toxicity of these drugs. Our physicians are not being informed about the dangers of these drugs. I have just written a letter to my congessman about the lack of FDA action. Lets all write our congessmen and keep the problem in the limelight. Has anyone contacted the major news organizations? Thats the only way we will get anything done. Bad Publicity will work wonders !

James H. Beale, RPh
 

Mon, 28 Jun 2004 19:19:36 -0400 by cathyl1971, #6316
Re: 1 dose of levaquin
Posted By: cathy m <CATHYL1971@aol.com>
Date: Monday, 28 June 2004, at 3:20 p.m.

In Response To: Re: 1 dose of levaquini (cathy m)

A doctor prescribed Levaquin, several times, to my sister for sinus infections. She then began developing lupus like symptoms. So she went to the ER at the hospital. She was refered to a doctor who diagnosed her with lupus. The treatments she was given has killed her red blood cells, she has been admitted to ICU after suffering a seizure. She is not breathing on her own and her condition is worsening. We are afraid the Levaquin is responsible for her condition and now the treatments will end up killing her. Anyone with any information, anything at all, please reply to CATHYL1971@aol.com Thanking you in advance, Cathylm



Fri, 25 Jun 2004 03:30:23 -0400 by Guest, #6266
I took Floxin for about a week FIVE YEARS ago. I still feel like my knees are going to fall off and the pain in my neck and shoulders is horrible. It does not get better!!! Im only 31 but my body hurts like im 91. Even my 60 year old neighbor doesnt hurt like I do. HOW can they STILL be perscribing this stuff???????????????

Sun, 13 Jun 2004 18:20:58 -0400 by Guest, #6107
I did more research, my husband is starting to say .. step away from the
computer.

However, I do not believe it's fair that we are out here in all corners of
the earth trying to find answers when Johnson & Johnson and Orth Mcneil
probably have the answers we need.

Ortho Mcniel is owned by Johnson & Johnson. They are located in Brunswick,
NJ. About 1/2 way between Philly and New York City.

Now I know you may think I'm crazy... but I would be more than willing to
buy a plane ticket to NJ/NY/Philly if I could convince enough of you to join
me there to protest Johnson & Johnson's headquarters.

They have the resources to find out exactly what is going on with us, and
probably already know. I think that they are a darling company in the
American eyes and would not want the bad press that a protest would bring.

So if anyone is interested, let me know and I'll leave my sunny home in
naples for a few days in NJ.
I would think we would need at least 15-20 members of the group to attend.

And I guess I will say that it would be a most interesting protest... I know
I can't walk for very long so we'll have to bring lawn chairs :)

Taunda


Mon, 31 May 2004 23:46:12 -0400 by Guest, #5897
June 2004
.
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 tendonosis, tynsynovitis, 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)
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City: (optional) State: _____ (optional)

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I, took 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
PO Box 305
Glenview, IL 60025