FRANKFURT, July 24 (Reuters) - The European Medicines Agency has recommended limiting the use of oral moxifloxacin-containing medicines after finalizing a review of the safety of the antibiotics, the agency said on Thursday.
The European body (EMEA) said it had concluded that these drugs 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 agency also recommended strengthening the warnings for oral moxifloxacin medicines,” it said in a statement.
Moxifloxacin, a fluoroquinolone antibiotic, is marketed by Bayer BAYG.DE under its brand Avelox.
At its July 2008 meeting, the agency’s Committee for Medicinal Products for Human Use (CHMP) concluded that the benefits of oral moxifloxacin medicines continued to outweigh its risks.
However, due to safety concerns, mainly related to an increased risk of adverse hepatic reactions, it recommended restricting their use in these indications.
The CHMP opinion will now be forwarded to the European Commission to apply to all oral moxifloxacin-containing medicines authorized in the European Union.
Responding to the recommendation, Bayer said 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,” said Kemal Malik, a member of Bayer HealthCare executive committee and chief medical officer.
Avelox had sales of 445 million euros ($697.3 million) worldwide last year. ($1=.6382 Euro) (Reporting by Mantik Kusjanto, editing by Maureen Bavdek)