I did contact you and was told you weren't interested despite my several tendon operations. I have contacted another attorney, one who'd like to work, I suppose.

Jeff,
You are correct. Doctors rely on information from the FDA and product literature from big pharma, as well as research (also mostly subsidized by big pharma). They only worry about information they know about. Doctors have a few minutes to see a patient, make a diagnosis and suggest a procedure or write a prescription. They don't have the time to do Medline searches or review the Medwatch data from the FDA. And we know most of the material that gets into medical journals is subsidized by big pharma. I saw a psychiatrist for some of my injuries from Cipro, and she wouldn't even pull out the PDA to see if the adverse reactions matched up, nor would she spend a few minutes on fqresearch.org or even review other anecdotal reports because if the occurrence is rare, it must not be real. If a tree falls in a forest and there is no one there to hear it fall, does it make a sound? Physicists would say yes. But would the FDA? I doubt it. You are an attorney - please tell me in 2001 when so many people reported adverse reactions from Cipro during the anthrax scare, why didn't the class action suit started by Sheller P.C. ever make it to court?

Here's the link to the a story written about Cipro that talks about Bob Grozier and Sheller P.C. back in 2001. Even back then, people knew these drugs were dangerous. Only because Bayer is so big and has clout over the FDA can they get away with this. They didn't even admit they were wrong when the Baycol suits were settled.

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'Children do not get prescribed these medications.' This statement simply is not true. The use of the fluoroquinolones within the pediatric population continues to climb and has been ongoing for over twenty years now. Even though this is NOT an approved use, physicians prescribe it to kids for the frivolous of reasons without a second thought what so ever; as if they were handing out Halloween candy.

Rather than retype the following comment over and over, as so many sites are running with this story, I would beg pardon from the host of this site to allow me to paste the following comment, which has been spell and grammar checked for errors as well as submitted to those other sites.

I believe it captures the concerns of those who have been injured by this class, as well as cites to two examples of pediatric use that resulted in disasters for the patients. Hence I believe it to be a relevant comment to this story, as well as adding the facts that have been deliberately excluded by the FDA within their press release:

Tendon rupture is the least of the patient's concerns. This class is associated with irreversible peripheral neuropathy, fatal liver and kidney damage, fatal hypo and hyperglycemia, SJS and TEN, toxic psychosis, spontaneous ruptures not only of the tendons but also muscles, ligaments and cartilage, the list of serious adrs is boundless. More than half of the drugs found in this class have been removed from clinical practice due to severe and even fatal adverse reactions.

I just received a report of a 14year old male who tore the cartilage in both knees requiring extensive surgical intervention as a result of being on levaquin to treat a nail infection. Not to mention they young lady who has been in a wheelchair for the past decade due to the damage done to her tendons which rendered them beyond surgical repair. She was given cipro for an earache.

Within the NDA (new drug application) for levofloxacin we find clinical studies that revealed an adr rate in excess of 40% (one or more reactions) and a number of listed fatalities. We find these same numbers with all the NDAs for this class. This tendon issue we are now discussing was first revealed to the FDA back in 1982 (bailey et al). The FDA did NOTHING until Public Citizen filed a petition in 1996 seeking both black box warnings and dear doctor letters. The FDA did neither. Another petition was filed by the Attorney General of the State of Illinois in 2005 seeking these same actions. In 2006 Public Citizen once again petitioned the FDA. Rather than respond to these petitions as required by law, the FDA stonewalled the petitioners for more than three years. It was not until suit was filed in Federal Court by Public Citizen to compel the FDA to respond to these petitions did the FDA do anything.

And what they did was nothing more than a 'slap to the face' to those of us who have had our lives destroyed by these drugs. It is far too little, far too late. And we would not even be tossed this 'bone' if this lawsuit were not pending. This is nothing more than a blatant attempt by the FDA to avoid full disclosure of the true safety profile of this class which will be required when they lose in Federal Court.

Bayer issued a European "Dear Doctor Letter" in February of 2008 in regards to fatal liver injury as a result of being on Avelox. Yet we see no such letter being issued here in the States, nor do we see the FDA requesting one either. This class has been crippling and killing patients since the mid sixties. For more than forty years now the FDA has hidden the true safety profile from both the patient as well as the treating physician.

Those who have an interest in reading this forty years worth of medical journal entries, case reports, newspaper articles, clinical studies, etc., that documents all that I state here are invited to log unto More ... " rel="nofollow">More ... The FDA is also grossly misleading when they state that the risk factor is one in one hundred thousand. The actual risk is .5% to 16% depending upon which citation you prefer to reference as well as the year in which it was published.

I find the manufacturers to be grossly misleading the patient and physician alike when they state that this class is a safe and effective antibiotic with minimum side effects. I have forty years worth of medical documentation that proves that they are anything but for those who care to read it, rather than this line of misleading and false information being provided by the FDA.

Mr. David T. Fuller
Director
Fluoroquinolone Toxicity Research Foundation
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fqresearch@aol.com
davidtfull@aol.com

Though I had posted this on other sites dealing with this issue, it is still relevant to the discussion at hand and I would hope the host of this site would not take offense at me repeating it here:

In addition to the recent "Black Box Warnings" as well as the European "Dear Doctor" issued by Bayer overseas back in February 2008 concerning Avelox, the European Medicines Agency has moved to severely restrict the use of Avelox (moxifloxacin), to wit:

FRANKFURT, July 24 (Reuters) - The European Medicines Agency has recommended limiting the use of oral moxifloxacin-containing medicines after finalizing a review of the safety of the antibiotics, the agency said on Thursday.

The European body (EMEA) said it had concluded that these drugs should only be prescribed for acute bacterial sinusitis, acute exacerbation of chronic bronchitis and community-acquired pneumonia when other antibiotics cannot be used or have failed.

"The agency also recommended strengthening the warnings for oral moxifloxacin medicines," it said in a statement.

Moxifloxacin, a fluoroquinolone antibiotic, is marketed by Bayer (BAYG.DE: Quote, Profile, Research) under its brand Avelox.

At its July 2008 meeting, the agency's Committee for Medicinal Products for Human Use (CHMP) concluded that the benefits of oral moxifloxacin medicines continued to outweigh its risks.

However, due to safety concerns, mainly related to an increased risk of adverse hepatic reactions, it recommended restricting their use in these indications.

The CHMP opinion will now be forwarded to the European Commission to apply to all oral moxifloxacin-containing medicines authorized in the European Union.

Responding to the recommendation, Bayer said the review confirmed the positive benefit-risk profile of the drug.

"We would welcome an EMEA assessment of other antibiotics used for treatment of these infections in a similar fashion in the interest of patient care," said Kemal Malik, a member of Bayer HealthCare executive committee and chief medical officer.

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Black Box Warnings, Dear Doctor Letters, restrictions place on the use of Avelox, thousands of patients responding to these articles claiming severe injuries from this class, hundreds if not thousands of adverse drug reaction forums with tens of thousands of members world wide, as well as more than fifty percent of these drugs removed from clinical practice, and last but not least the fact that Nalidixic Acid, upon which all these drugs are based is a listed cancer causing agent, I dare to ask: are we still to believe the following comment which can be found at the end of just about any article written about this class?

'The fluoroquinolones as a class are generally well tolerated; most adverse effects are mild in severity, self-limited, and rarely result in treatment discontinuation...'

Or are we to continue wonder if we are the only ones who have bothered to do any research on this class in the past twenty six years. For surely who ever would make such a claim has not.

“Repeat a lie a thousand times and it becomes the truth ...” - usually credited to Dr Joseph Goebbels, Propaganda Minister of the Third Reich. I now credit it to those medical researchers who continue to state how safe and effective this class of chemotherapuetic agents are. For they have repeated this lie a thousand times a thousand times. Rather odd coincident that they are both (Goebbels, and these medical researchers who state such blatant lies) members of the medical community.

HOW MUCH DID YOU GER PAID FOR WRITING THIS????? WE ALL KNOW THE DRUG COMPANIES PAYS FDA THEIR SALARIES AND PEOPLE LIKE YOU.... KNOW ALL THE FACTS BEFORE YOU MAKE SUCH STATEMENTS!!!!

SORRY FOR MY POST.... I MEANT IT FOR THE 2 DOCTORS WHO KEPT TELLING PEOPLE TO KEEP TAKING THE DRUG..(QUINOLONES)... I APOLOGIZE.....

Really great info from Mr. David T. Fuller. His site contains a wealth of solid facts and figures.

Everyone is at risk who take these medicines. If doctors knew the true facts of how many people have been injured and what all adverse reactions they have suffered, then maybe they wouldn't be so willing to prescribe these medicines. If they wish to play Russian roulette with their patients after seeing a Black Box on these medicines, then they should be prepared to pay the consequences. I didn't blame the doctors for their lack of knowledge when they failed to connect my husband's injuries to Cipro. I blamed the warnings because they were insufficient. Even though the warnings will still be insufficient, the Black Box should inform physicians that this medicine can cause serious problems. If physicians choose to ignore this Black Box, then I believe they should be held accountable for any and all damages their patients will suffer if there were other medicines safer to use for the conditions their patients have. They would certainly be worried then and I doubt they would be so eager to prescribe these medicines.