Floxin is manufactured by Ortho-McNeil Corporation. Floxin is an antibiotic in the class of drugs known as fluoroquinolones which are synthetic antimicrobial agents that were modeled after nalidixic acid, a non-flourinated quinolone antibiotic. Nalidixic acid was approved by the FDA in 1963 for the treatment of urinary tract infections. It is rapidly absorbed after oral administration and is excreted into the urine in bactericidal concentrations. Nalidixic acid had several limitations in that it has a narrow spectrum of activity and microorganisms easily developed a resistance to it.
During the 1980's, modifications to this drug were made. New fluoroquinolone antimicrobials were developed and put on the fast track for FDA approval without the benefit of adequate premarket testing to accurately determine the probability of certain side effects within the general population. After gaining FDA approval, the new fluoroquinolones were aggressively marketed by the manufacturers. In doing so, the manufacturers failed to provide adequate warnings to the prescribing physicians of the dangers, risks and adverse side effects associated with fluoroquinolones.
Severe adverse reactions associated with fluoroquinolones, including Floxin are:
- Central nervous system (CNS) adverse reactions including convulsions, seizures, visual disturbances, sleep disorders, agitation, insomnia, headaches and dizziness
- Cardiovascular adverse reactions including prolongation of the Qtc interval which can potentially lead to ventricular arrhythmias and sudden cardiac death
- Hematologic adverse reactions including anemia, leukopenia, increased and decreased prothrombin time and increased and decreased platelet counts
- Immunologic adverse reactions including skin manifestations, allergic reaction, fatal hypersensitivity vasculitis and hypatotaxoicity
- Liver disease and elevated liver enzymes
Gastrointestinal adverse reactions including colitis, abdominal pain, nausea and vomiting
Compounding the problem is that there are numerous drugs which should not be taken in combination with fluoroquinolones. There are increased risks of injury when fluoroquinolones are taken in combination with corticosteriods (e.g.: Prednisone, Flovent, Nasarel, Azmacort, Advair Disku, Methylprednisolone Dospak, Elocon Cream, Desoximetasone Cream, and Sterapred) and when taken in combinations with non-steroidal anti-inflamatory drugs (NSAIDs) (e.g.: Motrin, Pamprin, Aleve, Advil, and Ibuprofen, among others). Physicians are frequently not aware of these contraindications and prescribe dangerous combinations of drugs which cause severe injuries to their patients. Physicians may also not be able to identify that their patient is suffering an adverse reaction and instruct them to continue to take more fluoroquinolones resulting in very serious and perhaps preventable injuries.