Torn Knee Cartilage requiring surgical repair in a Pediatric Patient, secondary to levaquin.

Dear Doctor Letters sent by Bayer regarding SEVERE adrs to Avelox, February 14, 2008

Pacific Beach BioSciences, a San Diego start-up, and Dong Wha Pharmaceutical have signed a development and commercialization deal for zabofloxacin, a novel fluoroquinolone antibiotic discovered by the Korean pharma, the companies announced Aug. 10, 2007

Non-Fatal Acute Liver Injury Possibly Related to High-Dose Ciprofloxacin

The use of initial empiric antimicrobial therapy with a β-lactam and a fluoroquinolone was associated with increased short-term mortality for patients with severe pneumonia in comparison with other guideline-concordant antimicrobial regimes.

Fluoroquinolones were the most commonly prescribed class of antibiotics for adults in 2002

Substituting or adding fluoroquinolones to established first-line antituberculous drug regimens gives no additional benefit

Adverse events associated with levofloxacin   "We studied a case series of 17 individuals...Adverse events including those that affect the central nervous system, skin and musculoskeletal systems, as well as elevated liver enzymes, all occurred in less that 2% of patients prescribed levofloxacin during clinical trials. The incidence of adverse effects observed in our patients (100%) greatly exceeded that expected." (PDF File) Adobe Reader Required

Gatifloxacin-Induced Hallucinations in a 19-Year-Old Man

Ciprofloxacin interacts with thyroid replacement therapy

Concomitant Use of NSAIDs With Norfloxacin (Noroxin) May Increase Seizure Risk

Fatal hypoglycemia induced by levofloxacin

Antimicrobial Drug Prescribing for Pneumonia in Ambulatory Care
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

ODS POSTMARKETING SAFETY REVIEW
Consult: One-Year Post Pediatric Exclusivity Postmarketing
Adverse Events Review  Ciprofloxacin
NDA: 19-537, 19-847 PDF File
(In summary, in the 13-month period of review the 17 unique pediatric cases showed mostly labeled hematological, musculoskeletal, allergic/hypersensitivity, and CNS events...  because one report was concerning due to the patient requiring a wheelchair after developing drug associated symptoms...)

Stingray bite and bilateral Achilles tendonitis due to LEVOFLOXACIN use  Lini S. Bhatia, M.D., PGY2, Department of Internal Medicine, James H. Quillen College of Medicine, ETSU, Johnson City, TN

Public Citizen Calls on FDA to Ban Antibiotic Tequin
Antibiotic Is Linked to Increased Risk of Blood Sugar Abnormalities, Responsible for 20 Deaths and 159 Hospitalizations

US group seeks ban on discontinued Bristol drug

Antibiotic pulled from Canadian and U.S. markets

Tequin's Serious Injuries - Bristol-Myers Feigns

Antibiotic Tequin taken off market

Troublesome Tequin coming off market

FDA Asked to Ban Antibiotic Tequin

ANTIBIOTIC TEQUIN TO DISAPPEAR SOON

Company Pulls Antibiotic Tequin Off the Market

Bristol-Myers to stop sale, manufacture of antibiotic Tequin

PUBLIC COMMUNICATION Health Canada Endorsed Important Safety Information on Tequin* (gatifloxacin) December 19, 2005

FDA, Bristol-Myers warn on antibiotic Tequin By Jennifer Corbett Dooren Last Update: 1:06 PM ET Feb 16, 2006

Diabetics warned against using antibiotic drug Tequin Pharmaceutical News Published: Thursday, 16-Feb-2006

Stronger warnings for antibiotic Tequin ROCKVILLE, Md., Feb. 16 (UPI) -- The Food and Drug Administration said Monday Bristol-Myers Squibb has bolstered its warnings for Tequin(gatifloxacin).

Canadian Adverse Reaction Newsletter Volume 13, Number 3, July 2003 Gatifloxacin (Tequin™): hypoglycemia and hyperglycemia

UPDATE 2-Bristol-Myers warns diabetics about Tequin-FDA
Thu Feb 16, 2006 2:16 PM ET WASHINGTON, Feb 16 (Reuters)

Stronger Warnings for Tequin

The U.S. Food and Drug Administration (FDA) has accepted for filing Oscient Pharmaceuticals' (Nasdaq: OSCI) supplemental New Drug Application (sNDA) seeking marketing approval for the use of FACTIVE(R) (gemifloxacin mesylate) tablets (320 mg once-daily) for the five-day treatment of mild to moderate community-acquired pneumonia (CAP). The FDA has refused to accept the sNDA filing for the five-day treatment of acute bacterial sinusitis (ABS).

Health Canada warned yesterday that an Gatifloxacin, sold under the brand name Tequin, has been associated with cases of both hypoglycemia (low blood sugar) and hyperglycemia (high blood sugar) that can be serious and life-threatening.
The Canadian Press TORONTO (Dec 21, 2005)

Switching Fluoroquinolones in Patients with Neutropenia May Increase Infection Risks

The use of Factive (Gemifloxacin) in elderly persons is not strongly recommended in light of the associated risks and the fact that it does not offer any benefit over other fluoroquinolones.

Yet another pediatric trial: Quinolones no better than standard antibiotics when treating treating typhoid and paratyphoid fever with Norfloxacin having more clinical failures than other fluoroquinolones. 

South African Treatment Guidelines allow the use of fluoroquinolones in the pediatric population:  "The BCG vaccine is given routinely to infants in settings where TB is endemic and is recommended for HIV-positive children in South African treatment guidelines....In HIV-positive children local or systemic disease should be treated with a four drug TB regimen of isoniazid, rifampicin, ethambutol, pyrazinamide, and ciprofloxacin or ofloxacin."

The following is a list of the drugs found within this class that have been reported to authorities in the United Kingdom via the "Yellow Card" system which is the equivalent to the MedWatch program used in the United States.  Click on the drug name to view the reports.  Abode Reader is required to view these files:

Ciprofloxacin: 5,643 ADRS / 70 Fatalities

Nalidixic Acid: 1,980 ADRS / 5 Fatalities

Ofloxacin: 1,580 ADRS / 10 Fatalities

Levaquin: 580 ADRS / 6 Fatalities

Norfloxacin: 438 ADRS / 2 Fatalities

Cinoxacin: 98 ADRS / 0 Fatalities

Temafloxacin: 68 ADRS / 0 Fatalities

Avelox: 61 ADRS / 0 Fatalities

Enoxacin: 41 ADRS / 0 Fatalities

Grepafloxacin

Am J Rhinol. 2005 Jul-Aug;19(4):395-9. Related Articles, Links
Fluoroquinolone-induced arthralgia and myalgia in the treatment of sinusitis. O-Lee T, Stewart CE 4th, Seery L, Church CA.

Wife of deceased inmate sues county jail, Newton Hospital The wife of a former county jail inmate who died from uncontrolled bleeding {allegedly as a result of taking Cipro and Coumadin} has filed a civil action against the Sussex County jail and Newton Memorial Hospital. Cipro is known to cause uncontrolled bleeding when given in conjunction with Coumadin,

Link Between Tequin (gatifloxacin) and Hypoglycemia Strengthened

Avoiding Achilles tendon ruptures in the elderly - Literature Monitor Clinician Reviews, Oct, 2003
It has now been confirmed that quinolones, the most frequently prescribed antibacterial agents, increase the risk of Achilles tendon rupture in elderly patients, according to van der Linden et al

Antimicrobial therapy with fluoroquinolones can be associated with tendinitis and other tendon disorders as an adverse reaction associated with this class of antimicrobials.

Levofloxacin-induced acute fulminant hepatic failure in a patient with chronic hepatitis B infection.

 Fluoroquinolone antibiotics may cause tendon pain and rupture.

Fluoroquinolone-induced arthralgia and myalgia in the treatment of sinusitis.

Fixed intravenous doses of levofloxacin will lead to greater drug exposure in women. Thus, women may have more of an increased risk of fluoroquinolone toxicity than men

Fatal hypoglycemia associated with levofloxacin.

Fungal Infections Associated with Ofloxacin.  "An increase in incidence of fungal infections of the ear were found in the period after widespread use of ofloxacin began."

Antibiotic Treatment Does Not Reduce Risk of Secondary Cardiac Events

Arthralgia associated with the pediatric use of Gatifloxacin. "Six patients (2.2%) in the gatifloxacin group...developed transient symptoms of ...arthralgia."

An unusual form of crystal-forming chronic interstitial nephritis following long-term exposure to tosufloxacin tosilate.

Orofacial dyskinesia after ofloxacin treatment.

Fluoroquinolone prescribing in the United States: 1995 to 2002.

Thrombocytopenia associated with intravenous ciprofloxacin.
Starr JA, Ragucci KR.
College of Pharmacy, Medical University of South Carolina, Charleston, South Carolina.

Research to Study Effects of Antibiotics on Intestinal Microbes - "David Relman, MD, associate professor of medicine (infectious diseases and geographic medicine) and of microbiology and immunology emphasized that Cipro poses minimal risk to study participants." Apr 10, 2005, 09:25

TaiGen Biotechnology Co. Ltd. announced today that it has initiated dosing in a Phase 1B trial for TG-873870, a novel quinolone antibiotic...

Family Says Medication Led to Son's Rampage.  Family members say Brewer had been taking Cipro for about two weeks after toe surgery.

Posted: 6/14/2005 8:02:30 PM  Today Eyewitness News talked to a man who says "Cipro" caused him to go crazy. Vince Mule´ says his doctors have even confirmed that it was "Cipro" that caused his irrational behavior. "

NEW WARNINGS FOR CIPRO, LEVAQUIN, AND OTHER QUINOLONE ANTIBIOTICS. NEW WARNINGS FOR CIPRO, LEVAQUIN, AND OTHER QUINOLONE ANTIBIOTICS. Serious Reactions Continue to Be Reported. A message from Dr. Jay S. Cohen

Four cases of spontaneous tendon rupture associated with Levofloxacin.  The four patients described were originally enrolled into a study of levofloxacin treatment of lower respiratory tract infection. This study included 489 patients treated with levofloxacin, a total of 3217 treatment days. Tendinopathy was not measured as an outcome in the study.

Spontaneous Achilles tendon rupture in patients treated with levofloxacin  (PDF File, Adobe Reader required to view)

Levaquin reported as having Numerous muscle and skeletal adverse reactions at a rate far exceeding other drugs found within this class.  (Article in German, Circa 2001, PDF File, Adobe Reader required to view)

Families Sue Pfizer on Test of Antibiotic
Tamar Lewin / NY Times 30aug01

Irish Medicines Board Drug Safety Newsletter - Drug Safety – January 2002 - Issue No.14 The Pharmacovigilance Unit, Irish Medicines Board,Earlsford Centre, Earlsford Terrace, Dublin2.
Tel: 676 4971-7 Fax: 676 7836

Washington Post, April 30, 2005 
FDA Calls Efforts For Bayer Illegal
Lawmakers' Help for Drug Firm Tests Limits

FDA officials called on Alcon to "cease the dissemination" of misleading information regarding their antibiotic ear drops, called Cipro HC Otic., and told company officials to respond to the
warning by May 11, 2005

GLUNT v. COLUMBUS CTY. SCHOOLS, 039675 (2-16-2005)
JOYCE GLUNT, Employee, Plaintiff v. COLUMBUS COUNTY SCHOOLS, Employer, SELF-INSURED (KEY RISK MANAGEMENT SERVICES, Administrator), Defendant. I.C. NO. 039675.
NORTH CAROLINA INDUSTRIAL COMMISSION. Filed 16 February 2005. (Physicians fail to even consider an adverse reaction to Cipro in this case even though the plaintiff had 37 known drug allergies)

A former West Orange police officer claims in a new lawsuit that medicine prescribed to him at Newton Memorial Hospital two years ago drove him to madness,

August 2004, Moxifloxacin (Avelox) when prescribed for Community Acquired Pneumonia, Chronic Bronchitis, Acute Bacterial Sinusitis offers no compelling advantages over established treatment.  Claims that oral moxifloxacin provides "rapid relief from chest infections" are unsubstantiated.

FDA Grants Approval for New Oral Solution of LEVAQUIN(R)Thursday October 28 2004

The recent changes (July 2004) regarding the warnings included in the following fluoroquinolone package inserts appear to indicate that: Peripheral Neuropathy, Pseudomembranous Colitis, Spontaneous Tendon Rupture are all CLASS EFFECTS regarding this class of chemotherapeutic agents

Child disfigured for life after antibiotic treatment for a cold and ear ache.

Of 100 total patients, 81 received an FQ for an inappropriate
indication. Of the 19 patients who received an FQ for an appropriate indication, only 1 received both the correct dose and duration of therapy. ( 1% received the appropriate drug at the appropriate dose, hence 99% of the prescriptions were in error)

Individuals with a history of hypersensitivity to quinolones {fluoroquinolones} should avoid exposure to this product {poultry and meat treated with fluoroquinolones}."

August 2004 Dr. Sidney Wolfe Director Public Citizen’s Health Research Group

August 2004 Ten Year Old Child’s Death Associated with Antibiotic Therapy Plant City Florida

July 2004 The Honorable Michael Bilirakis, Bill Nelson, Robert Graham  United States House of Representatives

CAIRO, Jul 24 (IPS) Antibiotics Can Be the Problem, Not the Remedy
Cam McGrath

June 2004 A petition To the United States Congress

Addressed to the Honorable Rush Holt, United States House of Representatives on February 12, 2004, on behalf Kristen Pettijohn (deceased) by Mr. and Mrs. Pettijohn

Antibiotics do not improve sinusitis symptoms, study shows.  Lancet March 8, 1997 / World Health Report, 1996 World Health Organization Geneva Switzerland May 1996

Antibiotic use in treating bronchitis is unnecessary and risky  The Journal of Family Practice 1997;44(3):261-265

Antibiotics useless on cold viruses, the uncontrolled and inappropriate use of antibiotics. 

The overuse of antibiotic such as happened with children suffering from otitis media has given rise to a breed of super bacteria which are resistant to antibiotics entirely.
Source: "Antimicrobials for acute otistis media; A review from the International Primary Care Network". British Medical Journal July 5, 1997.  "Penicillin resistant streptococcus pneumoniae found in chronic otitis media with effusion." American Academy of Otolaryngology Sept. 2, 1997
(Seven years later the FDA has approved Clinical Trials for the Pediatric use of fluoroquinolones to treat Otitis Media in children as young as six months old)

Antibiotics' Futility Against Bronchitis Confirmed

Deaf and blind due to the ingestion of a fluoroquinolone 2002

Levaquin Approved as Cancer Treatment Levaquin Publish Date: 10/13/99

Combining the Gonzales and Evans study we find about 24 million prescriptions for an antibiotic in which 90% (21.6 million patients) would receive no greater benefit than if they had taken vitamin C.

A total of three hundred (300) ADRs were reported at the Jamaica Hospital Medical Center; Antibiotics accounted for 51 such events (17.0%)
Cipro, Related Antibiotics Over-Prescribed...A new study heightens concerns that Cipro and related broad-spectrum antibiotics known as fluoroquinolones are being over-prescribed...

Gatifloxacin and moxifloxacin have no proven clinical advantages over other fluoroquinolones, macrolides, or amoxicillin