In late 1998, prompted by many drugs with clear evidence of dangers not being adequately regulated, Public Citizen surveyed FDA medical officers who were the primary reviewers in the Center for Drug Evaluation and Research (CDER) for new drug applications. The responses, from 53 FDA physicians, included 27 instances cited in which the FDA medical officer thought a drug too dangerous to be approved but approval occurred over their objection.   Seventeen medical officers described the current standards of FDA review for safety and efficacy as "lower" or "much lower" compared to those in existence prior to 1995. And several medical officers said they had been instructed by their superiors to censor their reports or presentations.

A study in 2001 by the FDA itself, precipitated by high turnover rates among scientists and physicians in the agency, showed that about one-third of medical officers did not feel comfortable expressing differing scientific opinions, and a similar number felt that decisions adverse to a drug were stigmatized within the agency. A number of reviewers said that decisions should be based more on science and less on corporate wishes.

A subsequent study by the HHS Inspector General in 2003 confirmed that decisions concerning drug safety and effectiveness were being overturned. Eighteen percent of surveyed FDA physicians and scientists felt pressure to recommend that drugs be approved for sale despite their reservations about the drug’s safety, efficacy or quality. The report concluded: "Overall, these findings present a significant warning signal."

The FDA's action concerning Trovan is a prime example of such ongoing malfeasance by the FDA. Trovan (trovafloxacin-antibiotic) like two other drugs also approved in 1997, the painkiller Duract (bromfenac) and the diabetes drug Rezulin (troglitazone), (now both off the market) there was also clear evidence of liver damage caused by Trovan (in animals and in humans) before the drug was approved in December 1997. In one study prior to approval in which the drug was used to treat prostatitis, almost 10% of the men (14 out of 140) given the drug developed evidence of liver toxicity. With eight other drugs in the fluoroquinolone antibiotic family available in the U.S, as well as dozens of other safer and equally or more effective drugs for infections, the removal of Trovan from the market would not have deprived doctors or patients of a drug that could possibly be considered indispensable. Instead of banning Trovan as was done everywhere else in the world, the FDA chose to “limit” its use in the United States to patients who were either hospitalized or in nursing homes. At the time of our petition in 1999 to ban the drug, there were eight cases of liver failure, including five deaths and three liver transplants. There are now a total of 56 cases of liver failure, including 29 deaths and nine people requiring liver transplants, (circa 2005).  

Head of FDA continues to frustrate Congressional Investigations

Dear Doctor Letters
Although the FDA has NOT issued any Dear Doctor Letters, Bristol-Myers Squib has recently issued one regarding Tequin. However, several other Countries have issued Dear Doctor letters years ago regarding the adverse drug reactions associated with fluoroquinolone therapy. 

Drug Alerts / Medical Bulletins

View All the Fluoroquinolone  approval letters, labels, package inserts and review packages here

Minutes from the various FDA advisory committee meetings regarding the
fluoroquinolones

The FDA's AERS

The New Drug Approval Process

FDA's Expedited Drug Approvals Cost Lives

The Adverse Drug Experience Regulation

FDA advisers tied to Industry

Drug After Drug, Warnings Ignored - Raxar

FDA Briefing Package
(Gemifloxacin) Anti-Infective Drugs Advisory Committee (March 4, 2003) New Drug Application (NDA) 21-158 Factive (gemifloxacin mesylate) PDF File

Excerpts from the Anti-Infective Drugs Advisory Committee 67th Meeting (Thursday, October 21, 1999); in regards to Moxifloxacin and heart problems

Full Text of the Anti-Infective Drugs Advisory Committee 67th Meeting
Thursday, October 21, 1999 PDF File

Excerpts from the Food And Drug Administration Anti-Infective Drugs 
 Advisory Committee 62nd Meeting (Wednesday, November 19, 1997);
in regards to severe and crippling adverse reactions
in the pediatric population

Full text of the Food And Drug Administration Anti-Infective Drugs  Advisory Committee 62nd Meeting Wednesday, November 19, 1997 PDF File

Full Text of the Department Of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research Pediatric Advisory Subcommittee of the Anti-Infective Drugs Advisory Committee
Wednesday, June 9, 2004 PDF file 

The FDA history of levaquin approvals

FDA's finest moments

FDA automates event database

Phase three clinical trials Ofloxin

Phase 3 clinical trials Levaquin

March 2003 issue of Signal - Analyses of adverse reaction reports in the WHO database. Moxifloxacin and respiratory insufficiency / Gatifloxacin and rhabdomyolysis

The FDA's history regarding it's response to the tendon issues
This is the original article that appeared in the New England Journal of
Medicine, September of 1994:
"Achilles Tendinitis and Tendon Rupture Due to Fluoroquinolone Antibiotics"

Pediatric Adverse Drug Reactions associated with Levofloxacin and Ciprofloxacin therapy as reported to the FDA (1997/2001)

DEPARTMENT OF HEALTH AND HUMAN SERVICES FOOD AND DRUG ADMINISTRATION CENTER FOR DRUG EVALUATION AND RESEARCH PEDIATRIC ADVISORY SUBCOMMITTEE OF THE ANTI-INFECTIVE DRUGS ADVISORY COMMITTEE
Wednesday, June 9, 2004 PDF FILE

Ciprofloxacin Anthrax Approval; FDA Medical Review PDF FILE

FDA Warning Letter Pfizer RE: Trovan Failure to disclose PDF FILE

FDA Warning Letter Bayer RE: Cipro Violative 
promotional activities PDF FILE

FDA Warning Letter Bayer RE: Avelox false
and misleading press release PDF FILE

Division of Special Pathogen and Immunologic Drug Products
Summary of Clinical Review of Studies Submitted in Response to a Pediatric Written Request Applications:
19-537/S-049, ciprofloxacin tablets
20-780/S-013, ciprofloxacin oral suspension
19-847/S-027, ciprofloxacin IV 10 mg/mL
19-857/S-031, ciprofloxacin IV 5% dextrose
Applicant: Bayer Corporation, Pharmaceutical Division
Established: Ciprofloxacin PDF FILE

Sitafloxacin ®, drug information March 2000 PDF FILE

Dr. Andrew von Eschenbach to be Commissioner of the Food and Drug Administration, in spite of his continuing contempt shown for Congressional oversight concerning the FDA's activities.

Public Citizen Petitions the FDA to Include a Black Box Warning on Fluoroquinolone Antibiotics (HRG Publication #1781) August 29, 2006

The Office of Attorney General, State of Illinois's petition to the FDA filed May 18, 2005, seeking the same "Black Box" warnings as Public Citizen  PDF File (Adobe Reader Required)

When compared with other antibiotics used to treat minor infections, the incident of serious rashes has Food and Drug Administration officials concerned about the safety of the drug, Factive or gemifloxacin.

FDA concerned about new use of Gemifloxacin (Factive)9/2006.

Petition to the FDA to Immediately Ban the Antibiotic Gatifloxacin (Tequin) (HRG Publication #1768)

On February 16, 2006, the manufacturer of gatifloxacin announced that the drug’s label would change. According to a Food and Drug Administration (FDA) press release, “Since the approval of gatifloxacin in 1999, there have been rare cases of life-threatening events reported globally in patients treated with the drug."  David Jurrlink, M.D., one of the original authors of "Outpatient Gatifloxacin Therapy and Dysglycemia in Older Adults" stated "Speaking as a clinician, I would NEVER prescribe this drug."   Sidney Wolfe of Public Citizen stated "This represents a unique danger in the absence of a unique benefit...This is more than enough reason to think about petitioning the Food and Drug Administration to BAN this drug, and we probably will." 
click here to read more

Additional articles regarding Tequin's new warnings

Quotes from a recent FDA hearing regarding approval of Moxifloxacin (Avelox) a fluoroquinolone

Plan to end pediatric drug trials draws fire

FDA SAFETY LABEL UPDATES: AVELOX (moxifloxacin) Tablets & Injection

PDUFA Reauthorization The Need for Congressional Oversight And Legislative Changes to Improve Drug Safety

Drug-Development and Drug-Approval Process

FDA's Expedited Drug Approvals Cost Live

FDA to Issue Rule Beefing Up Drug Reporting Standards 8 Jan 2001

FDA proposes new labels for antibiotics

FDA Medical Bulletin * October 1996 * Volume 26 Number 3 REPORTS OF ADVERSE EVENTS WITH FLUOROQUINOLONES

Petition to the Food and Drug Administration to immediately stop the distribution of dangerous, misleading prescription drug information to the public. (HRG Publication #1442)
June 9, 1998

Petition to Require a Warning on All Fluoroquinolone Antibiotics (HRG Publication #1399)
August 1, 1996

News Reports Containing Inaccuracies About New Drugs Have Potential to Harm

Black Box Warnings we have requested that the FDA add to the  package inserts:

To date the FDA has not added ANY black box warnings to the drugs found within this class.

Click here for a Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- June 2005 for Avelox (Moxifloxacin):

Letter to the Food and Drug Administration to immediately ban the antibiotic Trovafloxacin (Trovan). (HRG Publication #1485)
Date: June 3, 1999
Author: Sidney M. Wolfe, M.D., Director Public Citizen's Health Research Group

Petition to the Food and Drug Administration to immediately stop the distribution of dangerous, misleading prescription drug information to the public.
HRG Publication #1442
Date: June 9, 1998
Author: Sidney M. Wolfe, M.D., Director Public Citizen's Health Research Group

Petition to Require a Warning on All Fluoroquinolone Antibiotics
HRG Publication #1399
Date: August 1, 1996
Author: Sidney M. Wolfe, M.D., Director Public Citizen's Health Research Group

NDA (New Drug Approval) Package for Levaquin

FDA Medical Bulletin * October 1996 * Volume 26 Number 3
REPORTS OF ADVERSE EVENTS
WITH FLUOROQUINOLONES
FDA is asking prescribers and pharmacists to alert patients and other caregivers to the potential for tendinitis and tendon rupture while taking or after taking antimicrobial fluoroquinolones. The Agency has taken steps to have the package insert revised for the following antimicrobial agents: ciprofloxacin, enoxacin, lomefloxacin, norfloxacin, and ofloxacin. Letters have been issued to the manufacturers requesting that they revise their package inserts to include the following information: The WARNINGS section will have a new paragraph that should read: "Ruptures of the shoulder, hand, and Achilles tendons that required surgical repair or resulted in prolonged disability have been reported with [the specific drug name]. [The specific drug name] 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 tendinitis or tendon rupture has been confidently excluded. Tendon rupture can occur at any time during or after therapy with [the specific drug name]."
As an added precaution, the following statement will be added to the Information for Patients subsection of the PRECAUTIONS section: "Patients should be advised to discontinue treatment and inform their physician if they experience pain, inflammation, or rupture of a tendon, and to rest and refrain from exercise."

The revisions have been made to the ciprofloxacin, enoxacin, and norfloxacin package inserts. The lomefloxacin and ofloxacin revisions should be completed shortly.
 
1997 Burn v. Johnson & Johnson Antibiotic Floxin caused ruptured Achilles tendons in elderly man.

EIGHT YEARS LATER THE FDA FINALLY ADDED NEW WARNINGS REGARDING SPONTANEOUS TENDON RUPTURES AS FOLLOWS. FOR ALMOST TEN YEARS NOW SUCH WARNINGS WERE SEVERELY LACKING !!!!!!

Tendon Effects
Ruptures of the shoulder, hand, Achilles tendon or other tendons that require surgical repair or resulted in prolonged disability have been reported in patients receiving quinolones. Post-marketing surveillance reports indicate that this risk may be increased in patients receiving concomitant corticosteroids, especially the elderly. Fluoroquinolone therapy should be discontinued if the patient experiences pain, inflammation, or rupture of a tendon. Patients should rest and refrain from exercise until diagnosis of tendonitis or tendon rupture had been excluded. Tendon rupture can occur during or after therapy with quinolones.