The federal agency said that the warning on the drug is necessary to ensure that the drugs' benefits outweigh the risks. It is also requiring the manufacturers to provide a medication guide to patients about the potential side effects of tendon rupture.
Fluoroquinolones are effective in treating certain bacterial infections but people older than 60 are at a greater risk of developing fluoroquinolone-associated tendinitis and tendon rupture. Also at risk are those who have undergone kidney, heart and lung transplants and are taking corticosteroid drugs.
The FDA said that tendon rupture pain, swelling, inflammation, and tears of tendons-including the Achilles, shoulder, hand, or other tendons-can happen in patients taking fluoroquinolone antibiotics, which include Cipro. Tendons connect muscles to joints.
The federal agency is also asking doctors to advise their patients that if they have any sign of tendon pain and swelling or inflammation, they should stop taking the drugs immediately. Patients also should avoid exercising the affected area and contact their doctor immediately.
The medications which will be affected by the new label warnings include Cipro and generic ciprofloxacin, Cipro XR and Proquin XR, Factive (gemifloxacin), Levaquin (levofloxacin), Avelox (moxifloxacin), Noroxin (norfloxacin) and Floxin and generic ofloxacin.
A black box warning, also sometimes called a black label warning or boxed warning, is a type of warning that appears on the package insert for prescription drugs that may have serious adverse effects. It is so named for the black border that usually surrounds the text of the warning.
