Cipro has been Black Boxed!

Cipro was issued a Black Box warning by the FDA on July 8th, 2008 due to concerns of tendonitis and tendon ruptures. Cipro is manufactured by Bayer HealthCare and is an antibiotic and used in adults as a lung, sinus, skin and urinary tract infection treatment. Cipro (ciprofloxacin) is in a class of antibiotics called fluroquinolone, which are drugs approved for the treatment or prevention of certain bacterial infections. Like other antibacterial drugs, fluoroquinolones do not treat viral infections such as colds or flu.

The FDA has recently conducted a new analysis of the available literature and post-marketing adverse event reports for Cipro and found that its use is associated with an increased risk of tendon rupture and, despite the current warning of tendon rupturing in the labeling large numbers of adverse events continue to be reported. It has been discovered that the risk of tendonitis or tendon rupture is higher in patients over the age of 60, in those taking corticosteroid drugs, and in kidney, heart, and lung transplant recipients.

The FDA states that pain, swelling, inflammation, and tears of tendons including the Achilles, shoulder, hand, or other tendons can happen in patients taking fluoroquinolone antibiotics such as Cipro. Pain, swelling or inflammation in a tendon area could be symptoms of tendonitis or tendon rupture, as well as, a snap or pop in a tendon area, bruising right after an injury in a tendon area and inability to move the affected area or bare weight.