The broad-spectrum fluoroquinolone antibiotics are used to treat common infections such as respiratory tract infections, urinary tract infections. However, their use is associated with serious adverse events regarding which the US FDA has issued safety communications.

In July 2008, the FDA mandated the first black box warning for fluoroquinolone antibiotics for increased risk of tendinitis and tendon rupture. Since then, other black box warnings have been issued: August 2013 (peripheral neuropathy), May 2016 (restricting use for certain uncomplicated infections), July 2016 (disabling side effects) and the most recent being in July 2018 (hypoglycemia and mental health side effects including disturbances in attention, disorientation, agitation, nervousness, memory impairment and delirium).

A study conducted in 2012 showed the strong association of fluoroquinolones with increased risk of Achilles tendonitis and tendon rupture, especially in those who also used oral glucocorticoids at the same time (Am J Med. 2012;125(12):1228.e23-1228.e28). In a study from Italy, concomitant use of corticosteroids and fluoroquinolones was associated with a threefold increased risk for tendon rupture and a 43-fold greater risk of rupture of Achilles tendon (Drug Saf. 2006;29(10):889-96).

Patient safety is a very important aspect of delivery of health care. Hence, the use of fluoroquinolones with corticosteroid must be avoided as much as possible, especially in the elderly patients with renal insufficiency or other risk factors, due to increased risk of potentially disabling fluoroquinolone-associated tendinitis (Pharmacy Times. April 11, 2016). Patients receiving this combination should be carefully monitored for any sign of tendon injury. Discontinue the drugs as soon as signs are detected and minimize activity until the symptoms resolve.

Dr KK Aggarwal

Padma Shri Awardee

Vice President CMAAO

Group Editor-in-Chief IJCP Publications

President Heart Care Foundation of India

Immediate Past National President IMA