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[e-drug] Moxifloxacin - safety concerns and restrictions in use

E-DRUG: Moxifloxacin - safety concerns and restrictions in use 
In October 2005 E-drug posted a press release from the TB alliance on
moxifloxacin, a fluoroquinolone, to enter clinical trials  as a
candidate for use in tuberculosis. The trials were to start after an
agreement between the manufacturer, Bayer Healthcare, and the TB
Leo Offerhaus questioned the anticipated efficacy of moxifloxacin:
In November 2007 TB alliance isssued a press release on new trials for
TB in which they hailed moxifloxacin. I posted a message questioning the
very positive press release issued by the TB alliance:
as it said nothing about safety concerns with moxifloxacin and other
This week the Committee for Medicinal Products for Human Use (CHMP) of
the European regulatory authority, EMEA,  issued a press release
recommending restrictions in the use of oral moxifloxacin
due to safety concerns, mainly an increased risk of liver toxicity. CHMP
therefore recommends restricting use. For acute bacterial sinusitis and
acute exacerbations of chronic bronchitis it should only be used if no
other antibiotic can be used or has failed. For community acquired
pneumonia it should only be given when treatment with other antibiotics
cannot be used. Other warnings they recommend strengthening are risk of
diarrhoea, risk of heart failure in women and older patients, severe
skin reactions and fatal liver injury.
Still they regard benefits to outweigh the risk (!). May well be that
the best candidate was not chosen for clinical trials in TB.

Ms Kirsten Myhr, MScPharm, MPH
RELIS Drug Info and Pharmacovigilance Centre
Ulleval University Hospital
0407 OSLO, Norway

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