The European Medicines Agency recommends restricting the use of antibiotics based on moxifloxacin because of the potential risk of liver damage, and also wants strengthened warnings. (EMEA statement).

The EMEA’s Committee for Medicinal Products for Human Use concluded at a meeting this month that the benefits continue to outweigh its risks, but due to safety concerns, the CHMP says oral antibiotics containing moxifloxacin should only be prescribed for acute bacterial sinusitis, acute exacerbation of chronic bronchitis and community-acquired pneumonia when other antibiotics cannot be used or have failed. The CHMP opinion will now be forwarded to the European Commission to apply to all oral moxifloxacin-containing medicines authorized in the European Union.

The move comes shortly after the FDA suggested adding Black Box warnings to several fluoroquinolone antimicrobial drugs used to treat bacterial infections, including Bayer’s Cipro and Avelox, and Johnson & Johnson’s Levaquin, over concerns the meds cause tendonitis and tendon rupture. (Back story).

Bayer maintained the review confirmed the positive benefit-risk profile of the drug. “We would welcome an EMEA assessment of other antibiotics used for treatment of these infections in a similar fashion in the interest of patient care,” Kemal Malik, a member of Bayer HealthCare executive committee and chief medical officer, tells Reuters. Avelox had sales of $697.3 million worldwide last year.