EMEA Raises Warnings for Moxifloxacin Drugs

July 31, 2008
Angie Drakulich
ePT--the Electronic Newsletter of Pharmaceutical Technology

The European Medicines Agency 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.

London (July 24)-The European Medicines Agency (EMEA) 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.

Moxifloxacin is a fluoroquinolone antibiotic. Earlier this month, EMEA’s US counterpart, the US Food and Drug Administration, asked manufacturers of fluoroquinolone antimicrobial drugs to add black box warnings to their these products due to increased risk of tendonitis and tendon rupture (see related story).

EMEA’s Committee for Medicinal Products for Human Use (CHMP) reviewed information on the safety of moxifloxacin-containing medicines for oral use, following concerns over their liver safety, according to an EMEA press release.

CHMP concluded that “the benefits of oral moxifloxacin medicines continue to outweigh its risks.” However, due to safety concerns, mainly related to an increased risk of adverse hepatic reactions, CHMP recommended restricting their use in these indications. CHMP also recommended that the warnings of oral moxifloxacin-containing medicines be strengthened concerning the risk of diarrhea, heart failure in women and older patients, severe skin reactions and fatal liver injury.

The European Commission will now consider the committee’s recommendation and decide whether to apply it to all authorized oral moxifloxacin-containing medicines in the European Union.