Norfloxacin - Adverse Effects

Adverse Effects

See also: Adverse effects of fluoroquinolones

Serious adverse events occur more commonly with fluoroquinolones than with any other antibiotic drug classes.

Joint and tendon problems, as seen with all drugs within this class, have been associated with norfloxacin since 1983. In 1989 Jeandel et al. comments on arthritis being induced by norfloxacin. And in 1995 Terry el reports upon arthalgia being induced by norfloxacin. Within the cases of tendinopathy reported to the FDA from 1987 to 1997, more reports of ruptures and tendonitis were associated with norfloxacin, than any other fluoroquinolone in use at that time.

Hypersensitivity reactions such as erythema multiforme, TEN (toxic epidermal necrolysis), Sweet syndrome (acute neutrophilic dermatosis), fixed drug eruptions(FDE), systemic contact dermatitis, acantholytic bullous eruptions as well as pustular eruptions have been associated with norfloxacin since its introduction.

On September 23, 2008, the FDA required the manufacturer to add an additional warning to the package inserts that stated that “Serious and occasionally fatal hypersensitivity (anaphylactic) reactions, some following the first dose, have been reported in patients receiving quinolone therapy, including Noroxin.”

As with other drugs in this class norfloxacin is also associated with severe and even fatal liver diseases. Acute liver failure or serious liver injury (Hepatitis), was reported in 1993. Hepatitis, jaundice, including cholestatic jaundice and elevated liver function tests have been reported during norfloxacin therapy. Severe reversible thrombopenia has occurred with norfloxacin. Norfloxacin-induced hepatitis,

Acute pancreatitis has also been linked to norfloxacin. Which is but one of the many serious adverse effects that may occur as a result of norfloxacin therapy. Another such serious reaction is irreversible peripheral neuropathy. In a 1996 study it was noted that paraesthesia of the feet, legs, hands and arms occurred in 81% of the patients while 51% involved reports of hypoaesthesia and numbness. Of the thirty- seven reports found within this study, thirty one involved Norfloxacin. Twenty nine percent of these patients were reported to still be experiencing peripheral sensory disturbances after therapy had been discontinued.

Allergic nephropathy is also associated with norfloxacin as well other serious kidney problems. Renal failure was first report in 1986, and reports of neutropenia, thrombopenia, agranulocytosis, nephrotic syndrome, eosinophilia and acute interstitial nephritis all being associated with norfloxacin therapy. Additional serious adverse reactions include temporary as well as permanent loss of vision, QTc prolongation/torsades de pointes, severe central nervous system disorders (CNS) including seizures, drug induced psychosis and hallucinations, clostridium difficile associated disease (CDAD: Pseudomembranous colitis), as well as photosensitivity/phototoxicity reactions. Pseudotumor cerebri, commonly known as idiopathic intracranial hypertension (IIH), (also referred to as increased intracranial pressure), has been reported to occur as a serious adverse reaction to norfloxacin.

Children and the elderly are at a much greater risk of experiencing such adverse reactions. This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function. Such reactions may manifest during, as well as long after fluoroquinolone therapy had been discontinued. Norfloxacin may also exacerbate the signs of myasthenia gravis and lead to life threatening weakness of the respiratory muscles.

Serious visual complications have also been reported to occur with ophthalmic fluoroquinolone therapy, which may also occur with norfloxacin eye drops, especially corneal perforation, but also evisceration and enucleation. This increased incidents of corneal perforation may be due to fluoroquinolones causing alterations in stromal collagen, leading to a reduction in tectonic strength. There have also been a number of reports over the years of norfloxacin deposits on the corneal causing serious vision problems following the use of eye drops.

Some groups refer to these adverse events as "fluoroquinolone toxicity". These groups of people claim to have suffered serious long term harm to their health from using fluoroquinolones. This has led to a class action lawsuit by people harmed by the use of fluoroquinolones as well as legal action by the consumer advocate group Public Citizen. Partly as a result of the efforts of The State of Illinois and Public Citizen the FDA ordered a black box warnings on all fluoroquinolones advising consumers of the possible toxic effects of fluoroquinolones on tendons.