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
 

PDF version of the package insert can be found at the FDA website following this link.  Remember Adobe Reader is required to view this.

http://www.fda.gov/cder/foi/label/2004

The CD containing a copy of the ANTI-INFECTIVE DRUGS ADVISORY COMMITTEE 67TH MEETING (THURSDAY, OCTOBER 21, 1999) in which the adverse reactions to moxifloxacin were discussed is available at no charge upon request.  Send the address to which the CD is to be sent to: fqresearch@aol.com and indicate that you wish to receive a copy of this CD.

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

Do Not Use
Generic drug name: moxifloxacin (mox ee FLOKS a sin)
Brand name(s): AVELOX (Bayer Pharmaceuticals Corp.)
FAMILY: Fluoroquinolones

Changes made to the package insert for Avelox, July 2004:

WARNINGS
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. {notice the lack of warning regarding the fact that this is irreversible}

Tendon Effects: Ruptures of the shoulder, hand, Achilles tendon or other tendons that required surgical repair or resulted in prolonged disability have been reported in patients receiving quinolones, including Moxifloxacin. {notice the lack of warning regarding the fact that tendon rupture can occur during or after therapy with quinolones}

 

FDA SAFETY LABEL UPDATES: AVELOX (moxifloxacin) Tablets & Injection
[May 16, 2002: Bayer]
WARNINGS
Last paragraph revised to read:
Although not observed in moxifloxacin clinical trials, Achilles and other tendon ruptures that required surgical repair or resulted in prolonged disability have been reported with quinolones. Post-marketing surveillance reports indicate that the risk may be increased in patients receiving concomitant corticosteroids, especially in the elderly. Moxifloxacin should be discontinued if the patient experiences pain, inflammation, or rupture of a tendon.
 

Moxifloxacin

ADVERSE REACTIONS

Moxifloxacin was discontinued due to adverse reactions thought to be drug-related in 3.8% of patients.

Adverse reactions: nausea, diarrhea, dizziness, headache, abdominal pain, vomiting, taste perversion, abnormal liver function tes), and dyspepsia

Additional events::

Body as a Whole: asthenia, moniliasis, pain, malaise, lab test abnormal (not specified), allergic reaction, leg pain, pelvic pain, abdominal pain, back pain, chills, infection, pain, chest pain, hand pain

Cardiovascular: palpitation, vasodilatation, tachycardia, hypertension, peripheral edema, hypotension

Central Nervous System: insomnia, nervousness, anxiety, confusion, hallucinations, depersonalization, hypertonia, incoordination, somnolence, tremor, vertigo, paresthesia

Digestive: dry mouth, constipation, oral moniliasis, anorexia, stomatitis, gastritis, glossitis, gastrointestinal disorder, cholestatic jaundice, GGTP increased

Hemic And Lymphatic: prothrombin time decrease, prothrombin time increase, thrombocythemia, thrombocytopenia, eosinophilia, leukopenia

Metabolic And Nutritional: amylase increased, hyperglycemia, hyperlipidemia, lactic dehydrogenase increased

Musculoskeletal: arthralgia, myalgia

Respiratory: asthma, dyspnea, cough increased, pneumonia, pharyngitis, rhinitis, sinusitis

Skin/Appendages: rash, pruritus, sweating, urticaria, dry skin,

Special Senses: tinnitus, amblyopia

Urogenital: vaginal moniliasis, vaginitis, cystitis, kidney function abnormal

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

MOXIFLOXACIN HAS BEEN SHOWN TO PROLONG THE QT INTERVAL OF THE ELECTROCARDIOGRAM IN SOME PATIENTS. THE DRUG SHOULD BE AVOIDED IN PATIENTS WITH KNOWN PROLONGATION OF THE QT INTERVAL, PATIENTS WITH UNCORRECTED HYPOKALEMIA AND PATIENTS RECEIVING CLASS IA (E.G. QUINIDINE, PROCAINAMIDE) OR CLASS III (E.G. AMIODARONE, SOTALOL) ANTIARRHYTHMIC AGENTS, DUE TO THE LACK OF CLINICAL EXPERIENCE WITH THE DRUG IN THESE PATIENT POPULATIONS.

Pharmacokinetic studies between moxifloxacin and other drugs that prolong the QT interval such as cisapride, erythromycin, antipsychotics, and tricyclic antidepressants have not been performed. An additive effect of moxifloxacin and these drugs cannot be excluded, therefore moxifloxacin should be used with caution when given concurrently with these drugs.

The effect of moxifloxacin on patients with congenital prolongation of the QT interval has not been studied, however, it is expected that these individuals may be more susceptible to drug-induced QT prolongation. Because of limited clinical experience, moxifloxacin should be used with caution in patients with ongoing proarrhythmic conditions, such as clinically significant bradycardia, acute myocardial ischemia.

The magnitude of QT prolongation may increase with increasing concentrations of the drug, therefore the recommended dose should not be exceeded. QT prolongation may lead to an increased risk for ventricular arrhythmias including torsade de pointes.

Convulsions have been reported in patients receiving quinolones. Quinolones may also cause central nervous system (CNS) events including: dizziness, confusion, tremors, hallucinations, depression, and, rarely, suicidal thoughts or acts. These reactions may occur following the first dose. If these reactions occur in patients receiving moxifloxacin, the drug should be discontinued and appropriate measures instituted. As with all quinolones, moxifloxacin should be used with caution in patients with known or suspected CNS disorders (e.g. severe cerebral arteriosclerosis, epilepsy) or in the presence of other risk factors that may predispose to seizures or lower the seizure threshold.

Serious and occasionally fatal hypersensitivity (anaphylactic) reactions, some following the first dose, have been reported in patients receiving quinolone therapy. Some reactions were accompanied by cardiovascular collapse, loss of consciousness, tingling, pharyngeal or facial edema, dyspnea, urticaria, and itching. Serious anaphylactic reactions require immediate emergency treatment with epinephrine. Moxifloxacin should be discontinued at the first appearance of a skin rash or any other sign of hypersensitivity. Oxygen, intravenous steroids, and airway management, including intubation, may be administered as indicated.

Severe and sometimes fatal events, some due to hypersensitivity, and some of uncertain etiology, have been reported in patients receiving therapy with all antibiotics. These events may be severe and generally occur following the administration of multiple doses. Clinical manifestations may include one or more of the following: rash, fever, eosinophilia, jaundice, and hepatic necrosis.

Pseudomembranous colitis has been reported with nearly all antibacterial agents and may range in severity from mild to life-threatening.

Although not observed in moxifloxacin clinical trials, Achilles and other tendon ruptures that required surgical repair or resulted in prolonged disability have been reported with quinolones. Moxifloxacin should be discontinued if the patient experiences pain, inflammation, or rupture of a tendon.

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

Moxifloxacin is excreted in the breast milk of rats. Moxifloxacin may also be excreted in human milk. Because of the potential for serious adverse reactions in infants nursing from mothers taking moxifloxacin, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Moxifloxacin may produce changes in the electrocardiogram (QTc interval prolongation).

Moxifloxacin should be avoided in patients receiving Class IA (e.g. quinidine, procainamide) or Class III (e.g. amiodarone, sotalol) antiarrhythmic agents.

Moxifloxacin may add to the QTc prolonging effects of other drugs such as cisapride, erythromycin, antipsychotics, and tricyclic antidepressants.

Moxifloxacin may be associated with hypersensitivity reactions, even following a single dose, and to discontinue the drug at the first sign of a skin rash or other signs of an allergic reaction.

LABORATORY CHANGES

Changes in laboratory parameters, without regard to drug relationship, which are not listed above included:
Increases in MCH, neutrophils, WBCs, PT ratio, ionized calcium, chloride, albumin, globulin, bilirubin; decreases in hemoglobin, RBCs, neutrophils, eosinophils, basophils, PT ratio, glucose, pO₂, bilirubin and amylase. 

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