FDA Imposes "Black Box" Warning on Cipro

The Federal Food and Drug Administration (FDA) announced today that the manufactures of Cipro and similar antibiotics would have to include a “black box” warning on their products. According to the FDA, the drugs, which are known as fluoroquinolone antimicrobial drugs, increase the risk of tendon rupture in some patients. The “black box” is considered the FDA’s most urgent warning.

The boxed warning is meant to highlight the most dangerous risks of a particular drug. The boxed text is more prominent than the text surrounding it and therefore provides a better warning to users. Manufacturers will also have to include a revised medication guide with the antibiotics. It is hoped that these steps will “strengthen warning information already included in product labeling for the fluoroquinolone class of systemic antimicrobial drugs.”

The FDA has taken this urgent step based on an increased risk of tendon rupture with the use of these antibiotics. Tendons are fibrous tissues that connect muscle to bone. They are essential for motion and stability. If one ruptures, it can cause extreme pain and even permanent disability.

Patients are advised to stop taking the medication if they experience tendon pain, swelling or inflammation.