The European Medicines Agency has recommended restricting the use of antibiotics based on moxifloxacin, marketed by Bayer as Avelox, because of the potential risk of liver damage.

The EMEA says that following a review of the safety of moxifloxacin-containing medicines for oral use, it has concluded that they 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 on Avelox, a fluoroquinolone, and labelling should note the risk of diarrhoea and heart failure in women and older patients, as well as severe skin reactions and fatal liver injury. The EMEA added that it will send its opinion to the European Commission, but is telling doctors to immediately take the new warning into account when prescribing the drug.

The EMEA's Committee for Medicinal Products for Human Use (CHMP) started reviewing the safety of moxifloxacin drugs following concerns over their liver safety but concluded that the benefits continue to outweigh its risks. However, the increased risk of adverse hepatic reactions has led to the CHMP’s recommendation to restrict their use in the aforementioned indications.

Bayer, which had already warned healthcare professionals in February that Avelox may lead to potentially fatal liver damage and skin disease in rare cases, and chief medical officer Kemal Malik said the firm “welcomes the CHMP review which confirms the positive benefit-risk profile of moxifloxacin as we believe this is an important treatment option”.

The Leverkusen-based group quoted Hartmut Lode, a professor at the Research Center for Medical Studies in Berlin, as saying that “due to increasing resistance of Streptococcus pneumoniae in Europe,
commonly-used first line agents may not be appropriate in these countries”. However he noted that oral moxifloxacin “remains an important treatment option in these respiratory tract infections”. Ten days ago, the European Commission granted a further indication for Avelox for the treatment of mild to moderate pelvic inflammatory disease.

In welcoming the review, however, Dr Malik also went on to say that “we would also welcome an EMEA assessment of other antibiotics used for treatment of these infections in a similar fashion in the interest of patient care”.

Meantime, Bayer says it has appointed Andreas Fibig, currently a senior vice president at Pfizer, as the chairman of its Bayer Schering Pharma unit. He will take over from Arthur Higgins who will return to focusing on his primary role as head of Bayer Health Care, now that the integration of Schering has largely been completed.