FDA Gives Manufacturer(s) of 'Cipro' 30 Days to Comply with Stricter Labeling

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Early this year, the Public Citizen, a US-based consumer advocacy / watch-dog sued the US Food and Drug Administration (FDA) in an effort to have more stringent and precise labels on the fluoroquinolone family (Cipro, Levaquin, Avelox, Noroxin and Floxin) of antibiotics—commonly used to combat urinary tract infections and other similar conditions.

As reported by CNN (Health), reports of severe complications extend as far back as 2001. Specifically, there had been a number of reports of damaged and / or ruptured tendons after receiving this drug. According to Dr. Edward Cox, director of the FDA's Office of Antimicrobial Products,

The FDA ... [had] received "hundreds" of reports of tendon problems linked to fluoroquinolones, without being more specific, citing the ongoing lawsuit. But Cox said "the FDA continues to receive a considerable number of reports on tendon adverse effects."

Although complications with tendons are relatively rare in this larger family of drugs (1 in 100,000 uses), the fluoroquinolone variants have an increased incidence factor of 3 to 4 times.

Cipro had also been linked to a series of severe digestive tract infections – with a number of fatalities – at a number of long-term care facilities in Canada (see updated info on Clostridium difficile). As this family of antibiotic agents indiscriminately attacks the DNA of bacteria, thereby killing both damaging and beneficial types that are common (and often necessary) in the digestive tract, it leaves immune-suppressed patients prone to more severe infections.

The new labeling will highlight these dangerous complications and provide additional warnings to patients (and doctors) regarding the reporting of them.