Welcome to FDA Drug Safety Podcasts for health care professionals. This is Steve Jackson, a pharmacist from the Division of Drug Information.
On July 26, 2016, FDA approved changes to the labels of fluoroquinolone antibacterial drugs for systemic use (i.e., taken by mouth or by injection). These medicines are associated with disabling and potentially permanent side effects of the tendons, muscles, joints, nerves, and central nervous system that can occur together in the same patient. As a result, we revised the Boxed Warning, FDA’s strongest warning, to address these serious safety issues. We also added a new warning and updated other parts of the drug label, including the patient Medication Guide.
We have determined that fluoroquinolones should be reserved for use in patients with no other treatment options for acute bacterial sinusitis, or ABS, acute bacterial exacerbation of chronic bronchitis (ABECB), and uncomplicated UTI because the risks generally outweighs the benefits. For some serious bacterial infections the benefits of fluoroquinolones outweigh the risks, and it is appropriate for them to remain available as a therapeutic option.
Health care professionals should stop fluoroquinolone treatment immediately if a patient reports serious side effects, and switch to a non-fluoroquinolone antibacterial to complete treatment.
Fluoroquinolone labels already have a Boxed Warning for tendinitis, tendon rupture, and worsening of myasthenia gravis. The labels also include warnings about the risks of peripheral neuropathy and CNS effects. Other serious risks are described in the labels such as cardiac, dermatologic, and hypersensitivity reactions.
FDA evaluated reports of apparently healthy patients who experienced disabling and potentially permanent side effects involving two or more body systems after being treated with a systemic fluoroquinolone. We evaluated only reports submitted to the FDA; there are likely additional cases of which we are unaware. The side effects occurred within hours to weeks after starting the fluoroquinolone. At the time we received the reports the side effects had continued for an average of 14 months, to as long as 9 years, after stopping the medicines. Several cases reported that some side effects stopped or improved after discontinuation of the medicine; others reported that side effects worsened or continued.
Side effects involving fluoroquinolones should be reported to FDA’s MedWatch program at www.fda.gov/medwatch.
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