AVELOX FACES RESTRICTIONS IN EUROPE DUE TO LIVER DAMAGE

 

 

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

 

Avelox (Moxifloxicin) is used to treat respiratory infections, including sinusitis, chronic bronchitis, and community acquired pneumonia, as well as skin infections.   Avelox 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.

 

In July of 2008, the European Medicines Agency (EMA) announced it had completed a review of new data on the safety of oral formulations of Avelox 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.

 

Contact an Avelox attorney today.
Davis & Crump is now handling claims for individuals who have been injured by Avelox.   Davis & Crump is experienced in pharmaceutical product liability cases and settlements.   If you or a loved one has been injured by Avelox, contact us at 1-800-277-0300 or send us an email at info@daviscrump.com.