FDA Issues Updated Safety Warnings for Fluoroquinolones

The FDA recently approved a new change to the safety label for fluoroquinolones, a class of antibiotics that kill bacteria growth.

These changes emphasize warnings about disabling and potentially permanent side effects, according to the FDA. They also said these medications should not be used in patients with a less serious and uncomplicated bacterial infection.

When they conducted a safety review, the FDA discovered they are associated with disabling adverse effects relating to the tendons, muscles, joints, nerves, and the central nervous system. These adverse effects can occur as soon as hours after the treatment is administered, and could be permanent, the FDA reported.

It is suggested that patients with acute bacterial sinusitis, acute exacerbation of chronic bronchitis, and uncomplicated urinary tract infections not take this type of antibiotic. But, for other more serious infections, such as anthrax, plague, and bacterial pneumonia, the benefits of these antibiotics outweigh the risks that it poses, according to the FDA.

These changes will be in the form of an updated Boxed Warning and updated Warnings and Precautions section of the label.

The FDA will also add new limitation-of-use statements that advise patients to take the medication only if they have a complicated infection, or do not have an alternative treatment for acute bacterial sinusitis, acute bacterial exacerbation of chronic bronchitis, and uncomplicated urinary tract infections.

“Fluoroquinolones have risks and benefits that should be considered very carefully,” said Edward Cox, MD, director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research. “It’s important that both health care providers and patients are aware of both the risks and benefits of fluoroquinolones and make an informed decision about their use.”