Fluoroquinolones Get New Safety Labeling, But Not A REMS
This article was originally published in The Pink Sheet Daily
Risk of disabling, potentially permanent serious side effects that can occur together will be added to Cipro, Levaquin labels along with limitation against use for some self-limiting conditions unless there are no alternative treatments.
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Lefamulin was approved in the US to treat community-acquired bacterial pneumonia, providing a needed IV and oral drug initially in the hospital setting, but new antibiotics have been a tough sell.
The European Medicines Agency wants to hear testimonies from the public about serious side effects that have been observed in patients treated with quinolone- and fluoroquinolone-containing medicinal products.
FDA advisory committee's preferred approaches – linking mandatory training to DEA registration or state medical board licensing – are outside agency's existing regulatory authority.