Quinolone Trivia

More than 300 million patients have been treated with levofloxacin worldwide since 1993. Which exceeds the total population of the United States in 1993 Population U.S. 296,574,045 World 6,452,869,784 As of 21:09 GMT (EST+5) Jul 09, 2005

Total number of ADR Reports in WHO file for Levaquin (circa 2002):

Tendinitis 255

Tendon disorder 268

Tendon rupture 49

Anaphylactic shock 27

Anaphylactic reaction 102

Angioedema 61

Bristol-Myers Squibb Company announced  that TEQUIN, a quinolone antibiotic, reached the  one million new  prescription mark in the United States in its first ten months on the market.  Approved by the U.S. Food and Drug Administration on  December 17,1999,  TEQUIN is the only  quinolone antibiotic to achieve this milestone during the first ten  months on the market, according to audited  data (October, 2000) from IMS Ltd. Previously, the ten-month new prescription record for quinolones was held by Levaquin(R) (levofloxacin,  Ortho-McNeil).

Alcon's Fourth Quarter  Sales Grow 13.7 Percent --Feb. 11, 2004—

The launch of  CiproDex(R) otic  suspension contributed to most of the sales growth in the U.S.

Published: April 18, 2007 at 2:25 AM

STEVE MITCHELL
UPI Senior Medical Correspondent
WASHINGTON, April 18 (UPI) -- Johnson and Johnson's first quarter earnings soundly beat Wall Street's expectations, but analysts expressed concern about the company going forward due to the safety issues revolving around anemia and stent products…Global Levaquin sales rose 18 percent to $475 million, including a 50- percent increase outside of the United States to $15 million.

Avelox was first approved in 1999 in both Europe and the United States. As of March 2003 there have been nearly 17 million prescriptions in more than 80 countries worldwide.

There have been more than 300 million prescriptions worldwide for Ciprofloxacin. Which exceeds the total population of the United States in 2005

Ciprofloxacin and Levofloxacin together command 65% ($3.3 billion) of global sales.

Bayer 1st Quarter 2005 fluoroquinolones sales

Ciprobay®/Cipro® $158 million

Avalox®/Avelox® $103 million

Baytril® $40 million

As compared to aspirin:

Aspirin® $140 million

Schering-Plough's sales of AVELOX and CIPRO totaled $110 million in the quarter of 2005

It has been estimated that more than 10% of the ENTIRE world population has been prescribed a fluoroquinolone and at a bare minimum more than 13 million such patients had experienced an adverse reaction that was not recognized, reported or treated by the physician. However it is strongly suspected that the number of untreated patients to be much greater than this. These numbers continue to increase on a daily basis due to the ignorance and arrogance of the treating physician, as well as rampant scripting abuses.

Despite many published case reports and approximately 3500 cases of tendinopathy that has been reported to the World Health Organization Collaborating Centre for Drug Monitoring, little is known about the mechanisms behind this fluoroquinolone-specific toxicity. Even though such events have been reported for over thirty years the treating physician still to this day, maintains that tendon rupture is not a known adverse drug reaction to the fluoroquinolones.

Between 1995 and 2002, fluoroquinolones became the most commonly prescribed class of antibiotics to adults in the United States. Forty-two percent of fluoroquinolone prescriptions were for non approved diagnoses. Among patients receiving antibiotics, non-approved fluoroquinolone was very common with such prescribing increasing over time. Fluoroquinolone prescribing increased threefold in outpatient clinics and emergency departments in the United States from 1995 to 2002.

Fluoroquinolones became the most commonly prescribed class of antibiotics to adults in 2002.

"… The Nancy (France) pharmacovigilance centre studied the frequency of adverse drug reaction reports per 100,000 patients of rheumatological adverse effects of fluoroquinolone antibiotics such as joint pain and tendon damage using three different methods. Method one was traditional spontaneous reporting. This is the same system used in the U.S. If an adverse reaction is suspected by a health professional the reaction is hopefully reported to the FDA Method two was "encouraged" reporting in which prescribers were asked by Nancy pharmacovigilance centre if they had observed rheumatological side effects with fluoroquinolones. Method three was termed "reinforced" reporting. Prescribers of fluoroquinolones were identified using prescription records and were asked the same questions about fluoroquinolones by social security authorities.  The reporting of adverse rheumatological effects  from fluoroquinolones  varied enormously between the three  methods. The traditional  spontaneous reporting  system produced 1 report per 100,000 patients; "encouraged" reporting  18 per 100,000; and the "reinforced" method 342 reports of adverse rheumatological effects -- including joint pain and tendon damage--per  100,000 patients. Thus,  the rate of reports of these adverse reactions to fluoroquinolones was 342 times higher in the group of doctors identified as having prescribed the  drugs and specifically asked if they had  observed these adverse reactions."

(HRG Publication 1399)

Comparative tolerability of the newer fluoroquinolone antibacterials Ball P, Mandell L, Niki Y, Tillotson G Drug Saf 1999  Nov;21(5):407-21

 "..However, postmarketing surveillance has revealed significant hepatotoxicity  with trovafloxacin…. In  perspective, rare but  serious hepatotoxicity has been reported with other  fluoroquinolones and the  overall incidence of trovafloxacin hepatotoxicity is not dissimilar to that reported with flucloxacillin  and amoxicillin-clavulanic acid… rare but serious hepatotoxicity has been reported with other fluoroquinolones…. Prolongation of the QTc interval is also a class effect,… Tendinitis and rupture, usually of the Achilles tendon, are rare, class-effects of fluoroquinolones,… (Note that this was stated over SIX YEARS AGO by two of the quinolones "head cheerleaders")

 "…the development of  severe neuropsychiatric problems including hallucinations and  psychosis were reported. The reactions occurred predominantly in the  elderly... (Ball, 1989; Jungst &  Mohr, 1988). "

 (Stated SEVENTEEN YEARS AGO)

A systematical and comprehensive evaluation of all reports on adverse drug reactions ascribed to ofloxacin since this antibiotic was launched (1985) until October 1988 shows that severe adverse drug reactions are more often reported spontaneously than in the course of clinical trials. In particular, severe reductions of white blood cell counts, shock and shock fragments, and impairment of sensory organs and renal functions have for the first time been detected by spontaneous case reports. The results demonstrate exemplarily the potency of the spontaneous reporting system as superior to that of clinical trials in providing information on rare adverse drug reactions. Yakugaku Zasshi. 2005 Mar;125(3):255-61.

Within Johnson & Johnson’s UNITED STATES SECURITIES AND EXCHANGE COMMISSION FORM 10-Q (Quarterly Report Pursuant to Section 13 or 15(d) of the Securities Exchange

Act of 1934 for the quarterly period ended March 28, 2004) it is stated:

Item 1 Legal Proceedings

Product Liability Litigation

The Company is involved in numerous product liability cases in the United States, many of which concern adverse reactions to drugs and medical devices."

 10/05 Schering-Plough's  3rd-Qtr Profit More Than Triples Schering-Plough Corp., seeking to add new products since generic  competition began for its  Claritin allergy pills, said  third-quarter profit more than tripled... Avelox and Cipro antibiotics each  added $41 million in sales.

 Result analysis:  JB Chemicals Sales up  25%Source: IRIS (25  October 2005) September  2005, the company had  received final approval from the Office of Generic  Drugs, Food and Drug  Administration (US FDA), to manufacture and  market Fluconazole tablets in the US market. The  company already has US  FDA approval to manufacture and market  ciprofloxacin tablets  250 mg, 500 mg, and 750 mg in the US market.

"Widespread antibiotic use in animals is suspected to have led to the development of resistance in humans and many regulatory authorities, including Australia, are moving to severely restrict or ban their use. From January 1, 2006 Europe will ban the routine prophylactic use of antibiotics in animal feed. The US has already banned fluoroquinolones and while they are moving more slowly than Europe, fast food organizations and other customers in the US are already causing producers to adapt and find alternatives."

Quoting from: "BioDiem wins $2m AusIndustry Grant Award" BioDiem  December 21, 2005

Of note, fluoroquinolone  use in the 18- to 44-year age group more than doubled from 2000 to 2002 (14% to 30%). Among fluoroquinolones prescribed over all years of the study, 74% were for levofloxacin; 51% of levofloxacin prescriptions were considered inappropriate-These findings suggest that those prescribing antimicrobial drugs may be increasingly using fluoroquinolones as a "one-size-fits-all"  regimen without accounting for differences due to age and other risk factors

 Zithromax and Levaquin were the top-selling antibiotics in the United States in 2004 with about

 $1.7 billion in sales. No  other antibiotic exceeded  $800 million.

 Top 10 Drugs Prescribed by Emergency Physicians in 2005 From "Vital Signs" in ACEP News Source:

 Verispan Zithromax Z-Pak:  961 million

 Levaquin: 662 million

 Zithromax suspension: 354  million

 Zithromax: 310 million

 Lipitor: 308 million

 Norvasc: 197 million

 Ambien: 191 million

 Skelaxin: 189 million

 Prevacid: 186 million

This summary is based on the first quarter fiscal 2007 earnings call conducted by Schering-Plough Corp. (SGP: chart) on 19th of April 2007.

- First-quarter profit jumped 55% from a year ago.
- Sales of Avelox climbed 43% to $115 million, primarily as a result of increased market share.
(Approximately 400,000 new scripts in the past year)

The scripting abuse continues unimpeded and the number of clueless victims continues to grow accordingly.

The following is an  alphabetical listing of the  various adverse drug  reactions listed within the  monographs for these drugs:

 A

 Asthenia

 Abnormal Vision

 Anemia

 Angina

 Abnormal Coordination

 Arrhythmia

 Abnormal Dreaming

 Aggressive Reaction

 Agitation

 Anorexia

 Anxiety

 Atrial Fibrillation

 Abnormal Hepatic

Function

 Aggravated Diabetes

 Arthralgia

 Arthritis

 Arthrosis

 Abnormal Platelets

 ARDS

 Asthma

 Abnormal Renal Function

 Acute Renal Failure

 Allergic Pneumonitis

 Anaphylactic Shock

 Anaphylactoid Reaction

 Abnormal EEG

B

 Bradycardia

 C

 Cardiovascular Disorders

 Cardiac Failure

 Circulatory Failure

 Central and Peripheral

 Nervous System

 Disorders

 Coma

 Convulsions

 Cardiac Arrest

 Cholelithiasis

 Coronary Thrombosis

 Carcinoma

 Confusion

 Coughing

 Crystalluria

 Cylindruria

 Cerebrovascular Disorder

 Conjunctivitis

 Cornea Damage

 Cataracts

 D

 Dry Mouth

 Dysphagia

 Decreased Lymphocytes

 Decreased Glucose

 Decreased Magnesium

 Delirium

 Depression

 Dyspnea

 Diplopia

 Dysphonia

 Dehydration

 E

 Edema

 Ear Disorders

 Embolism

 Epistaxis

 Ejaculation Failure

 Encephalopathy

 Eosinophilia

 Erythema Multiforme

 Erythema Nodosum

 Emotional Liability

 F

 Fever

 Facial Edema

 Fungal Infections

 G

 Gastrointestinal System

 Disorders

 Gastroenteritis

 G.I.Hemorrhage

 Genital Moniliasis

 Genital Pruritus Granulocytopenia

 H

 Hypertension

 Hyperkinesia

 Hypertonia

 Hypoaesthesia

 Hearing and Vestibular

 Disorders

 Heart Rate and Rhythm

 Disorders

 Heart Block

 Hepatic Coma

 Hematology

 Hyperglycemia

 Hyperkalemia

 Hypoglycemia

 Hypokalemia

 Hallucination

 Haemoptysis

 Hypoxia

 Hematuria

Hemolytic Anemia

 I

Increased LDH

Impaired Concentration

 Impotence

 Increased International

 Normalized Ratio (INR)

 Prothrombin Time

 Involuntary Muscle

 Contractions

 Increased Calcium

 Increased Sweating

 J

 Jaundice

 K

 L

 Liver and Biliary System

 Disorders

 Leukocytosis

 Leukopenia

 Lymphadenopathy

 M

 Malaise

 Metabolic and Nutritional

 Disorders

 Mellitus

 Musculo-Skeletal System

 Disorders

 Muscle Weakness

 Myalgia

 Myo, Endo, Pericardial

 and Valve Disorders

 Myocardial Infarction

 Manic Reaction

 Mental Deficiency

 Multiple Punctate

 Lenticular Opacities

 Multi System Organ

 Failure (Death)

 N

 Neoplasms

 Nervousness

 O

 Osteromyelitis

 Ophthalmologic

 Abnormalities

 P

 Phlebitis

 Pleural Effusion

 Pectoris

 Parosmia

 Platelet, Bleeding and Clotting Disorders

 Purpura

 Psychiatric Disorders

 Paranoia

 Palpitation

 Paresthesia

 Paralysis

 Pancreatitis

 Pseudomembranous

 Colitis

 Q

 R

 Reproductive Disorders

 Resistance Mechanism

 Disorders

 Respiratory System

 Disorders

 Respiratory Insufficiency

 Respiratory Failure

 Rhabdomyolysis

 Rigors

 Red Blood Cell Disorders

 Retina Damage

 S

 Stevens-Johnson

 Syndrome

 Skin and Appendages

 Disorders

 Skin Exfoliation

 Skin Ulceration

 Suicide

 Sleep Disorders

 Somnolence

 Substernal Chest Pain

 Syncope

 Seizures

 Speech Disorders

 Stupor

 Synovitis

 Supraventricular

 Tachycardia

 T

 Tremor

 Tongue Edema

 Tinnitus

 Tachycardia

 Tendinitis

 Thrombocytopenia

 Tendon Rupture

 Torsades de Pointes

 TENs

 U

 Urticaria

 Urinary System Disorders

 V

 Vertigo

 Ventricular Fibrillation

 Vascular (Extracardiac)

 Disorders

 Vision Disorders

 Vasodilation

 WXYZ

 Weight Loss

 Withdrawal Syndrome

 White Cell and RES

 Disorders

WBC Abnormal Count