Tequin Petition - Petition Letter to the FDA to Ban Tequin

Tequin is currently being considered to be taken off the market. Below you can read an excerpt from the petition letter to the FDA demanding that Tequin (Gatifloxacin) be taken off the market place due to the dangerous side effects it imposes on its users.

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Petition to the FDA to Immeidately Ban the Antibiotic Gatifloxacin (Tequin)

May 1, 2006

Andrew von Eschenbach, MD, Acting Commissioner
US Food and Drug Administration
5600 Fishers Lane
Rockville, MD 20857

Dear Dr. von Eschenbach:

Public Citizen, representing more than 100,000 consumers nationwide, hereby petitions the Food and Drug Administration (FDA), pursuant to the Federal Food, Drug, and Cosmetic Act 21 U.S.C. Section 355(e)(3) and 21 C.F.R. 10.30, to immediately ban the widely prescribed fluoroquinolone antibiotic gatifloxacin (Tequin, Bristol-Myers-Squibb—1.2 million prescriptions filled in 2005) because of the increased risk of dysglycemia (hypoglycemia [low blood sugar] and hyperglycemia [high blood sugar]) in humans. Gatifloxacin was approved for use in the United States in December of 1999. According to our analysis, there have been 388 patients with gatifloxacin-associated dysglycemia, including 20 deaths and 159 hospitalizations, reported to the FDA from January 1, 2000, through June 30, 2005. The fourth label change of February 15, 2006 was an insufficient remedial action for a drug that we will show carries unique risk without unique clinical benefit compared to the 7 other fluoroquinolones currently approved by the FDA and other drugs approved for similar indications. Bristol-Myers-Squibb’s quiet announcement last Friday that it would no longer manufacture Tequin for economic reasons is similarly inadequate to protect the public’s health since they apparently have no intention, absent FDA action to ban the drug, to stop selling the large amount of Tequin already in the channels of commerce. Thus, without an FDA ban, thousands of additional patients will be prescribed this unacceptably dangerous drug.

Gatifloxacin is indicated for the treatment of acute exacerbations of chronic bronchitis, acute sinusitis, community-acquired pneumonia, uncomplicated urinary tract infection, complicated urinary tract infection, pyelonephritis, and uncomplicated urethral and cervical gonorrhea. Other drugs to treat these conditions do not have the risks of gatifloxacin. When this drug is banned, it will be the fifth drug out of 13 approved in this to be taken off the market because of serious safety problems. The banned quinolone antibiotics are temafloxacin (because of hypoglycemia, renal failure, and hemolytic anemia) grepafloxacin and sparfloxacin (because of QT-interval prolongation and increased risk of heart arrhythmias), and trovafloxacin (because of liver toxicity).

Public Citizen’s concern is based on the following information: 1) the relatively high numbers and rates (compared to other fluoroquinolones and/or antibiotics with similar indications) of gatifloxacin-associated dysglycemia Adverse Event Reports (AERs) calculated from data collected by the US FDA’s Adverse Event Reporting System (AERS) and Health Canada's Adverse Drug Reaction Monitoring Program (CADRMP); 2) a study by Park-Wyllie, et al published on March 1, 2006, in the New England Journal of Medicine (NEJM) that showed that all patients (diabetic and non-diabetic, combined) receiving gatifloxacin had approximately 17 times the odds of having a hyperglycemic episode and 4 times the odds of having a hypoglycemic episode compared to those taking macrolide antibiotics (e.g. erythromycin); and 3) the relatively high numbers and rates (compared to other fluoroquinolones and/or antibiotics with similar indications) of gatifloxacin-associated dysglycemic events in the manufacturer’s safety studies in uninfected patients and other studies in infected patients including: clinical trials, cohort studies, case-control studies (including the study above), post-marketing surveillance studies, and case reports.

Weitz & Luxenberg is no longer accepting Tequin cases.

see also:

FDA Label Changes Tequin Breaking News - FDA Labeling Changes due to Dangerous Side Effects
FDA requiring Tequin to change label for Warnings about Hypoglycemia

Tequin Recall Tequin - Is Tequin being recalled? Are you being hurt by Tequin?
Tequin Recall - Discover the dangers of Tequin - FREE Tequin Advice

News & Warnings Tequin Breaking News & Warnings
Breaking News Stories about the dangerous antibotic drug Tequin