Pefloxacin - Regulatory History

Regulatory History

Pefloxacin has not been approved for use in the United States, hence there is no FDA regulator history to refer to. However pefloxacin is categorized under the following by the FDA: Anti-Infectives; ATC:J01MA03. In 2008 the FDA mandated a Black Box Warning be added to all fluoroquinolone drugs in reference to the potential for severe adverse reactions resulting in spontaneous tendon ruptures.

In 2008 the National Pharmaceutical Control Bureau, Ministry of Health Malaysia required the addition of stronger warnings concerning the tendon issues. The DCA had decided that all drugs found within the fluoroquinolone class must have the following statement in the section “Special Warnings and Precautions for Use” of the package inserts:

Musculo-skeletal system: “The risk of developing fluoroquinolone-associated tendonitis and tendon rupture is further increased in people older than 60, in those taking corticosteroid drugs, and in kidney, heart, and lung transplant recipients. Patients experiencing pain, swelling, inflammation of a tendon or tendon rupture should be advised to stop taking their fluoroquinolone medication (to specify the active ingredient) and to contact their healthcare professional promptly about changing their antimicrobial therapy. Patients should also avoid exercise and using the affected area at the first sign of tendon pain, swelling, or inflammation”