Pefloxacin - Adverse Effects

Adverse Effects

See also: Adverse effects of fluoroquinolones

Fluoroquinolones are generally well tolerated with most side effects being mild and serious adverse effects occurring rarely. Some of the serious adverse effects, which occur more commonly with fluoroquinolones than with other antibiotic drug classes, include CNS and tendon toxicity. Unusual adverse reactions include psychosis and chorea (involuntary muscle movements). The currently marketed quinolones have safety profiles similar to that of other antimicrobial classes. Phototoxicity, neurological symptoms, impaired colour vision, exanthema, abdominal pain, malaise, drug fever, peripheral neuropathy, dysaesthesia and eosinophilia have been observed as adverse effects of Pefloxacin.

The serious events may occur with therapeutic or with acute overdose. At therapeutic doses they include central nervous system toxicity, cardiovascular toxicity, tendon/ articular toxicity, and rarely hepatic toxicity. Events that may occur in acute overdose are rare and include renal failure and seizure. Children and the elderly are at greater risk. Adverse reactions may manifest during, as well as after fluoroquinolone therapy.

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 (United States) and Public Citizen the FDA ordered a black box warnings on all fluoroquinolones advising consumers of the possible toxic effects of fluoroquinolones on tendons.

• Irreversible peripheral neuropathy has been associated with Pefloxacin.

• Pefloxacin has associated with the highest reporting rate in regards to adverse reactions.

• Severe phototoxic adverse events are also noted for pefloxacin.

Pefloxacin is also reported to be the most potent inducer of photosensitivity in the ultraviolet A(UVA) range, with a higher incidence of skin rash and photosensitization than other quinolones.

• Pefloxacin has been associated with thrombocytopenia, which appears to be dose related.

• Pefloxacin has also associated with ocular damage when given to animals in high dosages. Manifestations included cataracts, multiple punctate lenticular opacities, retinal morphologic changes, and altered visual acuity.

Tendinitis and rupture, usually of the Achilles tendon, are a class-effects of the fluoroquinolones, most frequently reported with pefloxacin. The estimated risk of tendon damage during pefloxacin therapy has been estimated by the French authorities in 2000 to be 1 case per 23,130 treatment days as compared to ciprofloxacin where it has been estimated to be 1 case per 779,600. As early as 1996 E, Voisin MC et al. report upon the destructive polyarthropathy in a 17-year-old male after administration of Pefloxacin, which resulted in total bilateral knee and right hip replacements.