If you are taking Cipro - Levaquin or any other Fluoroquinolone you need to
view the following.

http://www.fqresearch.org/the_quinolones.htm

 For more than forty years (since the introduction of the first quinolone,
Nalidixic Acid) the FDA has allowed the manufacturers of the class of
chemotherapeutic agents, commonly referred to as fluoroquinolones to be
aggressively marketed as a " safe and effective antibiotic with an excellent
safety profiles… and to be remarkably free of clinically significant adverse
effects." This has been done in spite of compelling evidence to the contrary.
Evidence that the FDA has ignored since 1939. For almost forty years the FDA
has turned a blind eye to the severe, crippling and at times fatal adverse drug
reactions associated with this chemotherapeutic agent. Even going so far as to
allow these drugs to be marketed to physicians as a safe antibiotic with
minimum side effects. First and foremost one must understand that
fluoroquinolones are NOT an antibiotic but a man made chemotherapeutic agent,
concocted in a laboratory, genetically engineered to destroy the DNA of the
bacterial agent. They are not and cannot be put in the same class as
antibiotics, which are substances produced as metabolic products of one
microorganism, which inhibit or kill other microorganisms. Antibiotics may
exhibit adverse drug reactions but such reactions resolve upon cessation of
therapy or modification of the therapeutic dose. The toxic adverse drug
reactions associated with fluoroquinolones do not appear to be not dose
dependant and do NOT resolve upon cessation of therapy in some cases. In most
cases such adverse drug reactions do not even manifest until weeks, months and
even years after such therapy has been terminated. These latent reactions also
do NOT appear to resolve and become chronic conditions to which there is no
known treatment protocol. Tens of thousands (literally) of patients may have
died as a result of such therapy and hundreds of thousands more have had their
lives destroyed by these drugs. Yet the FDA does nothing to prevent this
ongoing carnage and continues to approve additional agents within this class
without a moment’s hesitation. In fact, Nalidixic Acid (the "father: of
fluoroquinolones), was added to the OEHHA Prop 65 list as a carcinogen May 15,
1998. [Nalidixic Acid, case number 389-08-02, listing mechanism AB, NTP (1989b]

 A review of the med watch database (November 1997- November 2001) indicates
that the FDA has received no less than 32,000 adverse drug reaction reports
with 774 associated fatalities involving Cipro, Floxin and Levaquin. It has
been over two years since I had requested the data associated with the other
fluoroquinolones under the Freedom of Information Act, and I have yet to
receive this information. One must keep in mind that the date found within the
med watch data base consist of LESS than 4% of such events. 96% of the adverse
events are NEVER reported to the FDA. A majority of the physicians are not even
aware such a program even exists. Less than 5% even bother to make such reports
to the FDA. Often times citing that they find it to be a nuisance and an
inconvenience. Physicians routinely fail to recognize, treat and report such
events. The threat of litigation, should they document an adverse drug
reaction, appears to be the primary motivator for failure to take such action.
Reviewing the data that was received from the FDA we find the following:
Table 1

Adverse drug reactions, MedWatch November 1997 – November 2001 (four years)

Drug ADR rate Fatality

Cipro 12,444 328

Floxin 7,255 173

Levaquin 11,656 273

The other fluoroquinolones are not included, as the FDA as of has not provided
such information to me yet, despite the fact that it was requested over two
years ago.

A total of 31,355 adverse drug reactions and 774 associated fatalities. Bayer,
the manufacturer of Cipro states that "…30% of the patients treated with
Cipro will experience an adverse drug reaction". With over fourteen million
prescriptions filled for Cipro alone we would expect a reported adr rate of at
least four million. We find a little over twelve thousand within the med watch
database. These numbers found within the med watch database do NOT indicate a "
safe and effective antibiotic with an excellent safety profiles… and to be
remarkably free of clinically significant adverse effects", as claimed by the
manufacturers, but the gross and complete failure of the med watch system. Such
data accumulates year, after year, ignored by the FDA and never made available
to the prescribing physician. In fact, such data is not even allowed to be
presented in civil suits for malpractice or product liability. The only one who
reads this data are researchers such as myself and even then it is easier to
get a camel through the eye of a needle than it has been to gain such access.

In 1982 spontaneous tendon ruptures were reported to have occurred long after
such therapy had been terminated. In some cases well over a year later. Year
after year numerous case studies, clinical trials and medical journal entries
have documented this severe and crippling adverse drug reaction, often times
citing the co-administration of steroids to be a contributory factor. The FDA
has ignored this research and continued to approve additional agents and
monographs devoid of this caveat for over twenty years. Only recently has the
following warning been added to the monographs, twenty years later.

"Achilles and other tendon ruptures that required surgical repair or resulted
in prolonged disability have been reported with Ciprofloxacin and other
quinolones. Ciprofloxacin should be discontinued if the patient experiences
pain, inflammation, or rupture of a tendon."

The patient being advised to:

"To discontinue treatment; rest and refrain from exercise; and inform their
physician if they experience pain, inflammation or rupture of a tendon "

Yet when the patient presents with tendon pain and/or rupture he or she is told
it cannot possibly be the drug by the attending physician. For more than
fourteen years the FDA turned a blind eye to this until Public Citizen filed a
petition demanding that they take action. They failed to do so. Despite the
overwhelming evidence presented by Public Citizen, who demanded that at the
very least a black box warning be added to the monographs and a "Dear Doctor"
letter be sent, the FDA did nothing. No black box warning and no information
provided to the prescribing physician, who to this day does not associate such
spontaneous rupture to fluoroquinolone therapy. The clueless physician also
prescribes STEROIDS to treat such events once they manifest in his or her
patient. Which results in severe injury to the patient with the resulting
tendon ruptures. . In fact the FDA has recently approved yet another
fluoroquinolone with severe rash being a known adverse drug reaction together
with the approval of the use of STEROIDS to treat such an event once it
manifest in the patient.

The warnings within the monographs for this class of chemotherapeutic agents
minimizes, trivializes, and distorts the potential risk involved in such
therapy and claim that such events resolve upon cessation of therapy. The FDA
knows full well that they do not but allows such bold face lies to be printed
on a daily basis and does nothing. Refusing to educate the physician and his or
her patients. The following is a partial list of the adverse drug reactions,
known, published and listed within the monographs for fluoroquinolones. You
would need a Greek translator to readily identify these disease states within
the monographs for in a blatant effort to confuse the physician and the patient
common verbiage is substituted with arcane medical terms and descriptions.