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Avelox, Similar Antibiotics Face European Restrictions Due to Liver Damage

Jul 31, 2008 | Parker Waichman Alonso LLP

Moxifloxicin, a fluoroquinolone antibiotic sold as Avelox by Bayer, is being subjected to new warnings and restrictions by the European Medicines Agency (EMA) because of its association with adverse liver reactions.  

Moxifloxacin is used to treat respiratory infections, including acute sinusitis, acute exacerbations of chronic bronchitis, and community-acquired pneumonia, as well as skin and skin structure infections. Moxifloxacin is also used for the treatment of complicated intra-abdominal infections, such as those seen in hospitals.  It has also been used as a second line treatment for tuberculosis.

In February 2008, Bayer issued a "Dear Healthcare Provider" letter to doctors in Europe warning that Avelox (moxifloxacin) had caused incidents of severe liver and skin side effects in patients.  Bayer has included the additional warnings in the packaging of Avelox products since the previous autumn, after some incidents of severe side effects were monitored.

Today, the European Medicines Agency (EMEA) announced it had completed a review of new data on the safety of oral formulations  of Avalox and other moxifloxacin-containing medicines. The Agency’s Committee for Medicinal Products for Human Use (CHMP) concluded that the benefits of these medicines for the treatment of acute bacterial sinusitis, acute exacerbation of chronic bronchitis and community-acquired pneumonia continue to outweigh their risks. However, due to safety concerns, mainly related to an increased risk of adverse hepatic reactions, CHMP recommended restricting their use to the treatment of these conditions when other antibiotics cannot be used or have failed. 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 CHMP opinion will now be forwarded to the European Commission to apply to all oral moxifloxacin-containing medicines authorized in the European Union.