Fluoroquinolone REMS Will Survey Patients, Doctors on Understanding of Risk
FDA's risk evaluation and mitigation strategy for fluoroquinolone antibiotics requires manufacturers to survey patients and prescribers to make sure they understand the risks of tendon injury associated with the products
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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.
Advisory committee unsure how to describe fluoroquinolone-associated disability in labeling.
Overwhelming votes against existing labels for the antibiotics likely means sponsors and FDA have some safety planning to do.