Although you have read on the FLOX-REPORT that we do not believe that fluoroquinolones
should be taken off the market, because they are needed to fight bacteria in
many cases, there is an exception: floxin.
Floxin is so toxic, that very few doses and short treatments cause very
frequently extraordinary severe adverse effects.
Floxin has also a distinctive profile: many times floxin causes
extremely delayed reactions at around the 18 months mark. Many persons take
floxin without clear side effects, but after one and a half years, a full
adverse reaction develops with plenty of floxing symptoms, in many cases of
similar intensity to an intermediate reaction.
Unfortunately, no study has been undertaken in the world to study the
health of all the persons that took more than 1 week of ofloxacin (floxin), 18
months after completing the treatment, so floxin will continue impairing
people, many for life, without ever knowing the real reason of their ailments.
Here you have the side effects list of floxin, obtained from www.rxlist.com
ACKNOWLEDGED SIDE
EFFECTS OF FLOXIN (OFLOXACIN)
The following is a
compilation of the data for ofloxacin based on clinical experience with both the
oral and intravenous formulations. The incidence of drug-related adverse reactions in patients
during Phase 2 and 3 clinical trials was 11%. Among patients
receiving multiple-dose therapy, 4%
discontinued ofloxacin due to adverse experiences.
In clinical trials, the
following events were considered likely to be drug-related in patients
receiving multiple doses of ofloxacin:
nausea 3%, insomnia 3%, headache 1%, dizziness 1%, diarrhea 1%, vomiting 1%, rash 1%, pruritus 1%, external genital pruritus in women 1%, vaginitis 1%, dysgeusia 1%.
In clinical trials, the
most frequently reported adverse events, regardless of relationship to drug,
were:
nausea 10%, headache 9%, insomnia 7%,
external genital pruritus in women 6%, dizziness 5%, vaginitis 5%, diarrhea 4%,
vomiting 4%.
In clinical trials, the
following events, regardless of relationship to drug, occurred in 1 to 3% of
patients:
Abdominal pain and cramps, chest pain, decreased appetite, dry mouth, dysgeusia, fatigue, flatulence, gastrointestinal distress, nervousness, pharyngitis, pruritus, fever, rash, sleep disorders, somnolence, trunk pain, vaginal discharge, visual disturbances, and constipation.
Additional events,
occurring in clinical trials at a rate of less than 1%, regardless of
relationship to drug, were:
|
Body as a whole: |
|
|
cardiac
arrest, edema,
hypertension,
hypotension,
palpitations,
vasodilation |
|
|
Gastrointestinal System: |
|
|
Genital/Reproductive System: |
burning,
irritation, pain and rash of the female
genitalia; dysmenorrhea; menorrhagia;
metrorrhagia |
|
Musculoskeletal System: |
|
|
Nervous System: |
seizures, anxiety,
cognitive
change, depression,
dream abnormality, euphoria,
hallucinations, paresthesia,
syncope,
vertigo,
tremor,
confusion |
|
Nutritional/Metabolic: |
thirst, weight loss |
|
respiratory arrest, cough, rhinorrhea |
|
|
Skin/Hypersensitivity: |
angioedema, diaphoresis, urticaria, vasculitis |
|
Special Senses: |
decreased
hearing acuity, tinnitus,
photophobia |
|
Urinary System: |
dysuria,
urinary frequency, urinary retention |
The following laboratory abnormalities appeared in ≥1.0% of
patients receiving multiple doses of ofloxacin. It is not known whether these
abnormalities were caused by the drug or the underlying conditions being
treated.
|
anemia,
leukopenia,
leukocytosis,
neutropenia,
neutrophilia,
increasedband forms, lymphocytopenia, eosinophilia,
lymphocytosis,thrombocytopenia,
thrombocytosis, elevated ESR |
|
|
elevated: alkaline
phosphatase, AST
(SGOT),
ALT
(SGPT) |
|
|
Serum chemistry: |
hyperglycemia,
hypoglycemia,
elevated creatinine,
elevated BUN |
|
Urinary: |
glucosuria, proteinuria, alkalinuria, hyposthenuria, hematuria, pyuria |
Post-Marketing Adverse
Events:
Additional adverse events,
regardless of relationship to drug, reported from worldwide marketing
experience with quinolones, including ofloxacin:
Clinical:
|
Cardiovascular System: |
cerebral thrombosis,
pulmonary
edema, tachycardia,
hypotension/shock, syncope |
|
Endocrine/Metabolic: |
hyper-
or hypoglycemia, especially in diabetic patients
on insulin
or oral hypoglycemic
agents. |
|
Gastrointestinal System: |
hepatic dysfunction
including: hepatic necrosis,
jaundice
(cholestatic or hepatocellular), hepatitis;
intestinal perforation; pseudomembranous
colitis (the onset
of pseudomembranous colitis
symptoms may occur during or after antimicrobial
treatment), GI hemorrhage;
hiccough,
painful oral mucosa,
pyrosis. |
|
Genital/Reproductive System: |
vaginal candidiasis |
|
Hematopoietic: |
anemia,
including hemolytic
and aplastic; hemorrhage, pancytopenia,
agranulocytosis,
leukopenia, reversible bone marrow
depression, thrombocytopenia, thrombotic
thrombocytopenic purpura, petechiae,
ecchymosis/bruising |
|
Musculoskeletal: |
tendinitis/rupture;
weakness; rhabdomyolysis |
|
Nervous System: |
nightmares;
suicidal
thoughts or acts, disorientation, psychotic reactions, paranoia; phobia,
agitation, restlessness, aggressiveness/hostility, manic
reaction, emotional lability;
peripheral
neuropathy, ataxia,
incoordination; possible exacerbation
of: myasthenia
gravis and extrapyramidal disorders; dysphasia,
lightheadedness . |
|
Respiratory System: |
dyspnea,
bronchospasm, allergic pneumonitis, stridor |
|
Skin/Hypersensitivity: |
anaphylactic
(-toid) reactions/shock; purpura,
serum sickness, erythema
multiforme/Stevens-Johnson Syndrome,
erythema
nodosum, exfoliative dermatitis,
hyperpigmentation,
toxic epidermal
necrolysis, conjunctivitis,
photosensitivity,
vesiculobullous eruption |
|
Special Senses: |
diplopia,
nystagmus,
blurred
vision, disturbances of: taste,
smell, hearing and equilibrium, usually reversible following discontinuation |
|
Urinary System: |
anuria, polyuria,
renal
calculi, renal
failure, interstitial nephritis,
hematuria |
|
Laboratory: |
|
|
Hematopoietic: |
prolongation of prothrombin time |
|
Serum chemistry: |
acidosis,
elevation of: serum triglycerides,
serum cholesterol,
serum potassium,
liver
function tests including: GGTP, LDH,
bilirubin
|
|
Urinary: |
albuminuria, candiduria |
In clinical trials using
multiple-dose therapy, ophthalmologic abnormalities, including cataracts and multiple punctate lenticular opacities,
have been noted in patients undergoing treatment with other quinolones. The
relationship of the drugs to these events is not presently established [IT IS
VERY CLEARLY STABLISHED, BUT THE MANUFACTURERS ARE DELAYING AS MUCH AS POSSIBLE
ANY ACKNOWLEDGE OF THE REAL FACTS].
CRYSTALLURIA and
CYLINDRURIA HAVE BEEN REPORTED with other quinolones.
DRUG INTERACTIONS
Antacids, Sucralfate, Metal
Cations, Multivitamins:
Quinolones form chelates
with alkaline earth and transition metal cations. Administration of quinolones
with antacids containing calcium, magnesium, or aluminum, with sucralfate, with divalent or trivalent
cations such as iron, or with multivitamins containing zinc or with Videx® (didanosine) may
substantially interfere with the absorption of quinolones resulting in systemic levels considerably lower than desired. These
agents should not be taken within the two-hour period before or within the
two-hour period after ofloxacin administration.
Interactions between
ofloxacin and caffeine have not been detected
Drugs metabolized by
Cytochrome P450 enzymes:
Most quinolone antimicrobial drugs inhibit cytochrome P450 enzyme activity.
This may result in a prolonged half-life for some drugs that are also
metabolized by this system (e.g., cyclosporine, theophylline/methylxanthines, warfarin) when co-administered with quinolones. The extent
of this inhibition varies among different quinolones.
Non-steroidal anti-inflammatory
drugs:
The concomitant
administration of a non-steroidal
anti-inflammatory drug with a quinolone, including ofloxacin, may increase the
risk of CNS stimulation and convulsive seizures.
THE SAFETY AND
EFFICACY OF OFLOXACIN IN PEDIATRIC PATIENTS AND ADOLESCENTS (UNDER THE AGE OF 18
YEARS), PREGNANT WOMEN, AND LACTATING WOMEN HAVE NOT BEEN
ESTABLISHED. (See PRECAUTIONS:
Pediatric Use, Pregnancy, and Nursing Mothers Subsections.)
In the immature rat, the
oral administration of ofloxacin at 5 to 16 times the recommended maximum human
dose based on mg/kg or 1-3 times based on mg/m2 increased the incidence and severity of osteochondrosis. The lesions did not regress after 13 weeks of drug withdrawal.
Other quinolones also produce similar erosions in the weight-bearing joints and
other signs of arthropathy in immature animals of various species. [UNFORTUNATELY,
THE HUMAN IS ONE OF THOSE SPECIES, AND FOR DOSES IDENTICAL TO THE RECOMMENDED
FOR STANDARD TREATMENTS]
Convulsions, increased intracranial pressure, and toxic psychosis have been reported in patients receiving
quinolones, including ofloxacin. Quinolones,
including ofloxacin, may also cause central nervous system stimulation which may
lead to: tremors, restlessness/agitation, nervousness/anxiety, lightheadedness, confusion, hallucinations, paranoia and depression, nightmares, insomnia, and rarely suicidal thoughts or acts. These reactions may occur
following the first dose. If these reactions occur in patients receiving
ofloxacin, the drug should be discontinued and appropriate measures instituted. Insomnia may be more common with
ofloxacin than some other products in the quinolone class. As with all
quinolones, ofloxacin should be used with caution in patients with a known or
suspected CNS disorder that may predispose to seizures or lower the seizure threshold (e.g., severe cerebral arteriosclerosis, epilepsy) or in the presence of other risk factors that may
predispose to seizures or lower the seizure threshold (e.g., certain drug therapy, renal dysfunction).
Serious and occasionally
fatal hypersensitivity (anaphylactic/anaphylactoid) reactions have been
reported in patients receiving therapy with quinolones, including ofloxacin.
These reactions often occur following the first dose. Some reactions were
accompanied by cardiovascular collapse, hypotension/shock, seizure, loss
of consciousness, tingling, angioedema (including tongue, laryngeal, throat or facial edema/swelling), airway obstruction (including bronchospasm, shortness of
breath and acute respiratory distress), dyspnea, urticaria/hives, itching, and other serious skin reactions. A few patients had a history of
hypersensitivity reactions. The drug should be discontinued immediately at the
first appearance of a skin rash or any other sign of hypersensitivity. Serious acute hypersensitivity
reactions may require treatment with epinephrine and other resuscitative measures, including oxygen, intravenous fluids, antihistamines, corticosteroids, pressor amines, and airway management, as clinically indicated.
Serious and sometimes fatal events,
some due to hypersensitivity, and some due to uncertain etiology [NOT SO UNCERTAIN, THE QUINOLONE IS THE CAUSE],
have been reported in patients receiving therapy with quinolones, including
ofloxacin. These events may be severe and generally occur following the administration
of multiple doses. Clinical manifestations may include one or more of the
following: fever, rash or severe dermatologic reactions (e.g.,
toxic epidermal necrolysis, Stevens-Johnson Syndrome); vasculitis; arthralgia; myalgia; serum sickness; allergic pneumonitis; interstitial nephritis; acute renal insufficiency/failure; hepatitis; jaundice; acute hepatic necrosis/failure; anemia, including hemolytic and aplastic; thrombocytopenia, including thrombotic thrombocytopenic purpura; leukopenia; agranulocytosis; pancytopenia; and/or other hematologic abnormalities.
The drug should be discontinued immediately at the first appearance of a skin
rash or any other sign of hypersensitivity and supportive measures instituted
[WE ARE STILL LOOKING FOR A HUMAN THAT IS NOT "HYPERSENSITIVE" AFTER
PROLONGED OR REPEATED TREATMENTS].
Rare cases of sensory or sensorimotor axonal polyneuropathy
affecting small and/or large axons resulting in paresthesias, hypoesthesias,
dysesthesias and weakness have been reported in patients receiving quinolones,
including ofloxacin. Ofloxacin should be discontinued if the patient
experiences symptoms of neuropathy including pain, burning, tingling, numbness, and/or weakness
or other alterations of sensation including light touch, pain, temperature,
position sense, and vibratory sensation in order to prevent
the development of an irreversible condition.
Pseudomembranous colitis has been reported with nearly all antibacterial agents, including ofloxacin, and may range in severity from mild to life-threatening. Therefore,
it is important to consider this diagnosis in patients who present with diarrhea subsequent to the administration of any
antibacterial agents.
Treatment with
antibacterial agents alters the normal flora of the colon and may permit overgrowth of clostridia. Studies indicate a toxin produced by Clostridium difficile is one primary cause of "antibiotic-associated colitis".
After the diagnosis of
pseudomembranous colitis has been established, therapeutic measures should be initiated. Mild cases of
pseudomembranous colitis usually respond to drug discontinuation alone. In
moderate to severe cases, consideration should be given to management with
fluids and electrolytes, protein supplementation, and treatment with an
antibacterial drug clinically effective against C. difficile colitis.
Tendon effects:
Ruptures of the shoulder, hand, Achilles tendon or other tendons that required
surgical repair or resulted in prolonged disability have been reported in patients receiving quinolones, including ofloxacin.
Post-marketing surveillance reports indicate that the risk may be increased in
patients receiving corticosteroids, especially the elderly. Ofloxacin should be
discontinued if the patient experiences pain, inflammation, or rupture of a tendon. Patients should rest and refrain from exercise until the diagnosis of
tendonitis or tendon rupture has been confidently excluded. Tendon rupture can
occur during or after therapy with quinolones, including ofloxacin.
General:
Prescribing FLOXIN®
(ofloxacin tablets) Tablets in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient
and increases the risk of the development of drug-resistant bacteria.
Adequate hydration of patients receiving ofloxacin should be maintained to prevent the formation of a highly concentrated urine
.Carcinogenesis, Mutagenesis, Impairment of Fertility:
Long-term studies to determine the carcinogenic potential of ofloxacin have
not been conducted.