Fluoroquinolones "should be used with special caution in the elderly, patients with kidney disease and those who have had an organ transplantation because these patients are at a higher risk of tendon injury. Since the use of a corticosteroid with a fluoroquinolone also increases this risk, combined use of these medicines should be avoided," the EMA advised.
On the basis of available evidence, the EMA concluded that fluoroquinolones are associated with prolonged (up to months or years), serious, disabling, and potentially irreversible drug reactions affecting more than one and sometimes multiple systems, organ classes, and senses.
The adverse effects include tendonitis, tendon rupture, arthralgia, pain in the extremities, gait disturbance, neuropathies associated with paraesthesia, depression, fatigue, memory impairment, sleep disorders, and impaired hearing, vision, taste, and smell.
Tendon damage (especially to the Achilles tendon but also other tendons) can occur within 48 hours of starting a fluoroquinolone, but the damage may be delayed several months after stopping treatment, the EMA said.