History of Ofloxacin

Ofloxacin is an antibiotic that is used to treat bacterial infections. It belongs to the fluoroquinolone class of antibiotics which includes levofloxacin (Levaquin), ciprofloxacin (Cipro), gatifloxacin (Tequin), norfloxacin (Noroxin), moxifloxacin (Avelox), trovafloxacin (Trovan) and others. Ofloxacin stops the multiplication of bacteria by inhibiting the reproduction and repair of their genetic material (DNA). The FDA approved ofloxacin in December 1990.

Ofloxacin(CAS NO:82419-36-1) was developed as a broader-spectrum analog of norfloxacin, the first fluoroquinolone antibiotic, it was first patented in 1982 (European Patent Daiichi) and received U.S. Food and Drug Administration (FDA) approval December 28, 1990. One of the first major adverse reactions noted with Ofloxacin were psychiatric in nature. It can cause serious psychiatric side effects with up to 25% of such patients suffering such reactions. This reaction was detailed within Stephen Fried’s 1999 book: “Bitter Pills”

In the United States name branded ofloxacin is rarely used anymore, having been discontinued by the manufacturer, Ortho-McNeil-Janssen, a subsidiary of Johnson & Johnson Johnson and Johnson's annual sales of Floxin in 2003 was approximately $30 million, whereas their combined sales of Levaquin/Floxin exceeded $ 1.15 billion in the same year. However generic use continues. The FDA website lists Floxin (Ortho McNeil Jannsen) as being discontinued, with just a few generic equivalents still in use. The otic solution continues to be listed as being available both as an original drug as well as a generic equivalent.

Oral and I.V. Floxin is not licensed by the FDA for use in children due to the risk of serious reversible and irreversible injury to the musculoskeletal system. Other fluoroquinolones do have a limited licensed uses in children but are generally not recommended due to safety concerns. Ofloxacin (and its derivatives) has also been associated with a few isolated reports of unexplained pediatric fatalities. Children (those under 18) are also at an increased risk of bone, joint, or tendon toxicities.

Prescribing ofloxacin in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of severe adverse drug reactions.

In the adult population ofloxacin is limited to the treatment of proven serious and life threatening bacterial infections such as:
1.Acute bacterial exacerbations of chronic bronchitis
2.Community-acquired pneumonia
3.Uncomplicated skin and skin structure infections
4.Nongonococcal urethritis and cervicitis
5.Mixed Infections of the urethra and cervix
6.Acute pelvic inflammatory disease
7.Uncomplicated cystitis
8.Complicated urinary tract infections
9.Prostatitis
10.Acute, uncomplicated urethral and cervical gonorrhea.

Ofloxacin has not been shown to be effective in the treatment of syphilis. Floxin is now considered to be contraindicated for the treatment of certain sexually transmitted diseases by some experts due to bacterial resistance.

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