GATIFLOXACIN Do Not Use Do Not Use

Generic drug name: Gatifloxacin Brand name(s): TEQUIN (Bristol-Myers Squibb Company)

All brand names are trademarks of their respected manufacturers.  The information being provided below is to be considered a quick reference guide. 

For complete information please view the complete package insert at www.rxlist.com or by entering the drug name at Drugs@FDA 

A PDF version of the package insert can be found at the FDA website following this link. Remember Adobe Reader is required to view this. hhttp://www.fda.gov/cder/foi/label/2004

Removed from use by the manufacturer, Bristol-Meyers Squibb, May 2006 due to severe adverse reactions.
Public Citizen has Petitioned the FDA to Immediately Ban the Antibiotic Gatifloxacin (Tequin) (HRG Publication #1768)

Click here to read Additional Articles concerning Tequin's removal

Click here to read about Gatifloxacin-Associated Acute Hepatitis

In October of 2004 new warning labels added to the fluoroquinolones regarding Peripheral Neuropathy (irreversible nerve damage), Tendon Damage (spontaneous tendon ruptures), Heart Problems (prolonged QT Interval / Torsades de pointes), Pseudomembranous colitis, Rhabdomyolysis (muscle wasting), Steven Johnson Syndrome, as well as concurrent usage of NSAIDs.

Read the FDA Mandated Label Changes, October 2004,for Tequin

Listed in Public Citizen as a Do Not Use DO NOT USE drug
Numerous other, safer antibiotics are approved to treat the same infections as this drug

Peripheral Neuropathy
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.

GATIFLOXACIN MAY HAVE THE POTENTIAL TO PROLONG THE QTc INTERVAL OF THE ELECTROCARDIOGRAM IN SOME PATIENTS. DUE TO THE LACK OF CLINICAL EXPERIENCE, GATIFLOXACIN SHOULD BE AVOIDED IN PATIENTS WITH KNOWN PROLONGATION OF THE QTc INTERVAL, PATIENTS WITH UNCORRECTED HYPOKALEMIA, AND PATIENTS RECEIVING CLASS IA (E.G. QUINIDINE, PROCAINAMIDE) OR CLASS III (E.G. AMIODARONE, SOTALOL) ANTIARRHYTHMIC AGENTS.

Ruptures of the shoulder, hand, and Achilles tendons that required surgical repair or resulted in prolonged disability have been reported in patients receiving quinolones. Tendon rupture can occur during or after therapy with quinolones.

Quinolones may cause central nervous system (CNS) events including nervousness, agitation, insomnia, anxiety, nightmares, or paranoia.

As with other quinolones, disturbances of blood glucose, including symptomatic hyper- and hypoglycemia, have been reported, usually in diabetic patients receiving concomitant treatment with an oral hypoglycemic (e. g., glyburide) or with insulin. In these patients, the monitoring of blood glucose is recommended.

As with other members of the quinolone class, gatifloxacin has caused arthropathy and/or chondrodysplasia in immature dogs.

Convulsions, increased intracranial pressure, and psychosis have been reported in patients receiving quinolones. Quinolones may also cause central nervous system (CNS) stimulation, which may lead to tremors, restlessness, lightheadedness, confusion, hallucinations, paranoia, depression, nightmares, and insomnia. These reactions may occur following the first dose. If these reactions occur in patients receiving gatifloxacin, the drug should be discontinued and appropriate measures instituted.

Serious and occasionally fatal hypersensitivity and/or anaphylactic reactions have been reported in patients receiving therapy with quinolones. These reactions may occur following the first dose. Some reactions have been 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, itching, and other serious skin reactions.

TEQUIN should be discontinued 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, have been reported in patients receiving antibacterial therapy. 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 or failure; hepatitis, jaundice, acute hepatic necrosis or failure; anemia, including hemolytic and aplastic; thrombocytopenia, including thrombotic thrombocytopenic purpura; leukopenia; agranulocytosis; pancytopenia; and/or other hematologic abnormalities.

Pseudomembranous colitis has been reported with nearly all antibacterial agents, including TEQUIN, and may range in severity from mild to life- threatening. Treatment with antibacterial agents alters the flora of the colon and may permit overgrowth of clostridia. Studies indicate that a toxin produced by Clostridium difficile is the primary cause of "antibiotic-associated colitis."

When rats were given oral doses of 200 mg/kg of gatifloxacin beginning in late pregnancy and continuing throughout lactation, late postimplantation loss increased, as did neonatal and perinatal mortalities. These observations also suggest fetotoxicity. Similar findings have been seen with other quinolones.

Gatifloxacin is excreted in the breast milk of rats.

Quinolones, including gatifloxacin, cause arthropathy and osteochondrotoxicity in juvenile animals (rats and dogs).

ADVERSE REACTIONS

Body as a Whole: allergic reaction, chills, fever, back pain, chest pain

Cardiovascular System: palpitation

Digestive System: abdominal pain, constipation, dyspepsia, glossitis, oral moniliasis,stomatitis, mouth ulcer, vomiting

Metabolic/Nutritional System: peripheral edema

Nervous System: abnormal dream, insomnia, paresthesia, tremor, vasodilatation, vertigo

Respiratory System: dyspnea, pharyngitis

Skin/Appendages: rash, sweating

Special Senses: abnormal vision, taste perversion, tinnitus

Urogenital System: dysuria, hematuria

Additional drug-related adverse events:

Abnormal thinking, agitation, alcohol intolerance, anorexia, anxiety, arthalgia, arthritis, asthenia, asthma (bronchospasm), ataxia, bone pain, bradycardia, breast pain, cheilitis, colitis, confusion, convulsion, cyanosis, depersonalization, depression, diabetes mellitus, dry skin, dysphagia, ear pain, ecchymosis, edema, epistaxis, euphoria, eye pain, face edema, flatulence, gastritis, gastrointestional hemorrhage, gingivitis, halitosis, hallucination, hematemesis, hostility, hyperesthesia, hyperglycemia, hypertension, hypertonia, hyperventilation, hypoglycemia, leg cramp, lymphadenopathy, maculopapular rash, metrorrhagia, migraine, mouth edema, myalgia, myasthenia, neck pain, nervousness, panic attack, paranoia, parosmia, pruritus, pseudomembranous colitis, psychosis, ptosis, rectal hemorrhage, somnolence, stress, substernal chest pain, tachycardia, taste loss, thirst, tongue edema, vesiculobullous rash.

Laboratory Changes

These included the following: neutropenia, increased ALT or AST levels, alkaline phosphatase, bilirubin, serum amylase, and electrolytes abnormalities.

Nonsteroidal anti-inflammatory drugs (NSAIDS): The concomitant administration of nonsteroidal anti-inflammatory drugs with a quinolone may increase the risks of CNS stimulation and convulsions

TEQUIN may produce changes in the electrocardiogram (QTc interval prolongation); TEQUIN should be avoided in patients receiving Class IA (e.g., quinidine, procainamide) or Class III (e. g. amiodarone, sotalol) antiarrhythmic agents; TEQUIN should be used with caution in patients receiving drugs that may effect the QTc interval such as cisapride, erythromycin, antipsychotics, and tricyclic antidepressants

TEQUIN may be associated with hypersensitivity reactions, even following the first dose, and to discontinue the drug at the first sign of a skin rash, hives or other skin reactions, difficulty in swallowing or breathing, any swelling suggesting angioedema (e.g., swelling of the lips, tongue, face, tightness of the throat, hoarseness), or other symptoms of an allergic reaction

The complete package insert can be viewed at www.rxlist.com