EU Drug Watchdog Wants Avelox Use Limited Mainly Due To Liver Toxicity Concerns

Risk Of Adverse Hepatic Reactions, Including Fatal Liver Injury, Is Cited by European Regulators At July 2008 Meeting

(Posted by Tom Lamb at DrugInjuryWatch.com)

The Committee for Medicinal Products for Human Use (CHMP), a division of the European Medicines Agency (EMEA), concluded at its July 2008 meeting that the benefits of oral moxifloxacin medicines continued to outweigh the risks, but went on to state that these antibiotics should be prescribed on a limited basis, only, going forward.

Moxifloxacin, a fluoroquinolone antibiotic, is marketed by Bayer under the brand name Avalox in Europe and Avelox in the U.S.  According to a July 24, 2008 Reuters article, "EU agency recommends restricting moxifloxacin use": 

Avelox had sales of 445 million euros ($697.3 million) worldwide last year. ($1=.6382 Euro)....

The CHMP opinion will now be forwarded to the European Commission to apply to all oral moxifloxacin-containing medicines authorized in the European Union.

What the limited prescribing of Avelox, as recommended by the CHMP, would do to sales revenues for this Bayer antibiotic remains to be seen.

Details of the CHMP recommendation to restrict Avelox use make clear that the primary reason for their action is the increased risk of liver toxicity associated with Avalox / Avelox.  From the EMEA's July 24, 2008 press release, "European Medicines Agency recommends restricting the use of oral moxifloxacin-containing medicines":

At its July 2008 meeting, the CHMP concluded that the benefits of oral moxifloxacin medicines continue to outweigh its risks. However, due to safety concerns, mainly related to an increased risk of adverse hepatic reactions, the CHMP recommended restricting their use in these indications. For acute bacterial sinusitis and acute exacerbations of chronic bronchitis, they should only be prescribed when other antibiotics cannot be used or have failed. For community acquired pneumonia, they should only be given when treatment with other antibiotics cannot be used.

The CHMP also recommended that the warnings of oral moxifloxacin-containing medicines should be strengthened concerning the risk of diarrhoea, heart failure in women and older patients, severe skin reactions and fatal liver injury.

The July 24 Reuters article includes an apparent "so-what" response from Bayer about this EMEA-CHMP action regarding Avelox:

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.

Together with its July 24 press release, the EMEA made available an explanatory document, "Questions and answers on the recommendation to restrict the use of oral formulations of moxifloxacin-containing medicines".

In an article posted here earlier this month, "Will There Be An Avelox - Liver Toxicity Warning Letter From Bayer Coming Soon In The U.S., Or Not?", I referred back to the February 2008 "Dear Doctor" letter about Avelox / Avalox that Bayer sent out in Europe, only, and then inquired about any corresponding letter to health care providers in the U.S.

We will continue to wait and see what, if anything, Bayer or the FDA tells American doctors about Avelox and its association with liver toxicity.