Ofloxacin - Adverse Effects

Adverse Effects

See also: Adverse effects of fluoroquinolones and Levofloxacin#Adverse effects

Serious adverse events occur more commonly with fluoroquinolones than with any other antibiotic drug classes. There has been a number of regulatory actions taken as a result of such adverse reactions associated with ofloxacin therapy, which included published warnings, additional warnings and safety information added to the package inserts which includes a black box warning concerning spontaneous tendon ruptures and the resultant permanent disability. In 2008 the FDA had also requested that the manufacturers of Floxin (as well as generic ofloxacin) issue a "Dear Doctor Letter" to inform physicians of this black box warning.

In 2004 the FDA requested new warning labels to be added to all of the fluoroquinolones, including ofloxacin, regarding peripheral neuropathy (irreversible nerve damage), tendon damage, heart problems (prolonged QT interval / torsades de pointes), pseudomembranous colitis, rhabdomyolysis (muscle wasting), Stevens–Johnson syndrome, as well as concurrent usage of NSAIDs contributing to the severity of these reactions. Subsequently changes were made to the package insert for Floxin to state that Floxin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria, and additional warnings concerning irreversible peripheral neuropathy and Torsades de pointes being associated with floxin therapy were added. In 2007 warnings regarding fatal Clostridium difficile associated diarrhea (CDAD: reported to occur over two months after the administration), severe photosensitivity/phototoxicity reactions and hepatic failure (including fatal cases) and Toxic Epidermal Necrolysis (TEN) were added to the package inserts.

The psychiatric adverse events, as well as central nervous system and peripheral nervous system associated with ofloxacin has been well documented within the literature.

Adverse reactions may manifest during, as well as after fluoroquinolone therapy.

Liver damage and dysglycemia has been associated with ofloxacin. Additionally in 2005 acute rhabdomyolysis had been associated with ofloxacin/levofloxacin therapy.

Some groups refer to the presentation of these multiple adverse events as "fluoroquinolone toxicity". These groups of patients claim to have suffered serious long term harm to their health from using fluoroquinolones. This has led to a class action lawsuit being filed by these groups as well as action by the consumer advocate group Public Citizen. Partly as a result of the efforts of Public Citizen the FDA requested a Black Box Warnings on all fluoroquinolones advising consumers of the possible toxic effects of fluoroquinolones on tendons.

Severe hepatotoxicity has been reported as noted above. Reports of hepatic or hypersensitivity vasculitis occurring as a result of ofloxacin therapy have also been reported. Older patients may have an increased risk of tendinopathy (including rupture), especially with concomitant corticosteroid use and such patients may also be more susceptible to prolongation of the QT interval. Patients with known prolongation, those with hypokalemia, or being treated with other drugs that prolong the QT interval should avoid the use of ofloxacin. Hematologic reactions (including agranulocytosis, thrombocytopenia), and renal toxicities may occur after multiple doses.