Avelox belongs to a family of antibiotic drugs known as fluoroquinolones and is used to treat a broad range of bacterial infections, including respiratory infections. It can be taken by mouth in a tablet format, or administered by injection.
This is not the first time warnings have been issued regarding Avelox and liver injuries. In 2008, Bayer issued a "Dear Healthcare Provider" letter in Europe warning that Avelox had caused incidents of severe liver and skin side effects in patients. The letter was meant to emphasize additional warnings Bayer had included the previous autumn in the packaging of Avelox products. Despite this letter, and the recent changes to the Avelox Canadian label, this updated safety information has not yet been provided to patients and doctors in the U.S.
According to a Health Canada press release, a safety review it conducted concluded that Avelox may be associated with the rare but potentially life threatening risk of liver injury, including liver failure. This information has been incorporated into the Warnings and Precautions section, and also in the Consumer Information section of the product monograph for Avelox.
Symptoms of liver problems include abdominal pain, loss of appetite, yellowing of the skin and eyes, severe itching, dark urine, and pale-colored stools. Patients who experience any of these symptoms are advised to stop taking Avelox and contact a health care professional immediately, Health Canada said.
Consumers requiring more information about this information update can contact Health Canada's public enquiries line at (613) 957-2991, or toll free at 1-866-225-0709.
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.