PharmTech Followup: Fluoroquinolone Antibiotics

October 15, 2008

Angie Drakulich was editorial director of Pharmaceutical Technology.

ePT--the Electronic Newsletter of Pharmaceutical Technology

FDA has completed its labeling updates to fluoroquinolone antimicrobial drugs.

Rockville, MD (Oct. 16)-In July 2008, Pharmaceutical Technology reported that the US Food and Drug Adminstration had asked manufacturers of fluoroquinolone antimicrobial drugs to add a black-box warning label on their products noting the increased risk of tendonitis and tendon rupture with the drug’s use. Also in July, the European Medicines Agency (EMEA) had recommended strengthening the warnings for oral moxifloxacin medicines and concluded that these drugs should only be prescribed to treat acute bacterial sinusitis, acute exacerbation of chronic bronchitis, and community-acquired pneumonia when other antibiotics cannot be used or have failed.

Now, three months later, FDA has completed its labeling updates. The agency posted the new labels on its website last week.

Affected drugs include: “Cipro” and generic ciprofloxacin, “Cipro XR” and “Proquin XR” (ciprofloxacin extended release), “Factive” (gemifloxacin), “Levaquin” (levofloxacin), “Avelox” (moxifloxacin), “Noroxin” (norfloxacin), and “Floxin” and generic ofloxacin.