Joint pain and swelling occurs in approximately 1% of people taking fluoroquinolones and usually remits within days of stopping treatment. A rare but serious adverse reaction with fluoroquinolones involves spontaneous tendon ruptures. Such injury to the patient include ruptures of various tendons (other than just the Achilles) and muscles, as well as damage to the cartilage and ligaments. Fluoroquinolones also have adverse effects on cartilage. The risk of tendon disorders with fluoroquinolone use is 0.1% to 0.4% or 3 cases per 1000 patient-years of exposure. These problems usually start 13 days after treatment was started and may possibly persist for a month. Risk of tendon rupture is even less with only 38 of 46,000 people treated with fluoroquinolone suffering a rupture of the achilles. This is 1.9 times the rate seen in the general population. The achilles is the most common tendon affected. This risk is greatest in those older than 60, in those taking corticosteroid drugs, and in kidney, heart, and lung transplant recipients. Because of their possible negative effect on cartilage, they are not recommended for use in pregnant women or children. The FDA recommends stopping treatment, contacting a physician and resting affected limbs if these adverse events occur.
As with any number of other drugs, drug induced fibromyalgia like symptoms are found with the fluoroquinolones. The multiskeletal adverse reactions of the fluoroquinolones may resemble rheumatological disease states, in particular, fibromyalgia, hypothyroidism, or rheumatoid arthritis. There have been numerous reports of fluoroquinolone-induced fibromyalgia. Fluoroquinolone-induced fibromyalgia may be conceptualized as impaired sensory information processing in a neural network, resulting in dysfunctional responses resulting from the CNS and PNS damage outlined above.
One of the most disabling adverse reactions is spontaneous rupture of multiple tendons, which may occur during therapy, as well as up to 6 months after therapy has been discontinued. Although the onset of symptoms typically occurs within 12 weeks, injury was also described within hours to as long as months after the initiation of treatment, and even after discontinuation. Tendon injury was reported to occur as early as two hours after receipt of the first dose of a fluoroquinolone (ciprofloxacin) to as late as 6 months after treatment had been terminated. Tendinitis, arthralgia, myalgia, as well as severe joint, muscle, and tendon pain, are found to be the top-three adverse reactions reported to the FDA via the Adverse Event Reporting System (AERS) for all the drugs within this class. For example:
November 1997 – November 2001—Ciprofloxacin 1,558 events
Bone, Tendon, Muscle and Ligament Damage
- Pain in the Extremity (153)
- Myalgia (148)
- Tendonitis (122)
November 1997 – November 2001—Levofloxacin 2,898 events
Bone, Tendon, Muscle and Ligament Damage
- Arthralgia (368)
- Tendon Disorders (318)
- Tendonitis (232)
The odds ratios (ORs) of suffering a spontaneous rupture of the achilles tendon are 4.3, for current exposure 2.4, recent exposure and 1.4 for past exposure to a fluoroquinolone drug, respectively, compared with non-exposure. Within the Netherlands, a large simultaneous increase in non-traumatic tendon ruptures and fluoroquinolone use was observed in the period between 1991 to 1996 following the introduction of the fluoroquinolones. The incidence of spontaneous tendon rupture within the kidney recipient population is even more common. In the renal transplant population, an incidence of 12.2%–15.6% is reported, compared with 0.6%–3.6% for transplant recipients not receiving fluoroquinolones. In one study of 149 heart transplant patients, fourteen (9.5%) patients developed Achilles tendinopathy, which in three patients (2.25%) progressed to tendon rupture.
It is rare that rhabdomyolysis (muscle death) occurs, sometimes with fatal outcomes. In Japan, the Pharmaceutical Affairs Bureau gave notice to practicing physicians that it had amended the product information to state that rhabdomyolysis may occur with the use of enoxacin, fleroxacin, norfloxacin, sparfloxacin, and tosufloxacin tosilate.
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