Fluoroquinolones pdf

As a result, the Blood Glucose Disturbances subsection of the labeling for all systemic fluoroquinolones will now be required to explicitly reflect the potential risk of coma with hypoglycemia.

Today, the FDA also published a drug safety communication about safety information regarding hypoglycemic coma and mental health side effects with fluoroquinolones. The FDA first added a Boxed Warning to fluoroquinolones in July for the increased risk of tendinitis and tendon rupture. In February , the risk of worsening symptoms for those with myasthenia gravis was added to the Boxed Warning.

In August , the agency required updates to the labeling to describe the potential for irreversible peripheral neuropathy serious nerve damage. In , the FDA enhanced warnings about the association of fluoroquinolones with disabling and potentially permanent side effects involving tendons, muscles, joints, nerves and the central nervous system.

Because the risk of these serious side effects generally outweighs the benefits for patients with acute bacterial sinusitis, acute bacterial exacerbation of chronic bronchitis and uncomplicated urinary tract infections, the FDA determined that fluoroquinolones should be reserved for use in patients with these conditions who have no alternative treatment options. The patient Medication Guide that is required to be given to the patient with each fluoroquinolone prescription describes the safety issues associated with these medicines.

The FDA, an agency within the U. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices.

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