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FDA Approves Label Changes for Fluoroquinolones


July 26, 2016

The US Food and Drug Administration (FDA) approved label changes for fluoroquinolone antibiotics due to side effects that can be disabling.

What do the potentially permanent side effects include? The FDA noted that muscles, tendons, joints, nerves, and the central nervous system can be impacted.

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The Boxed Warning has been revised to reflect this.

“We have determined that fluoroquinolones should be reserved for use in patients who have no other treatment options for acute bacterial sinusitis, (ABS), acute bacterial exacerbation of chronic bronchitis (ABECB), and uncomplicated urinary tract infections (UTI) because the risk of these serious side effects generally outweighs the benefits in these patients,” the agency noted.

Patients experiencing any side effects should immediately contact their health care professional, the agency added.

In May, the FDA announced that it was requiring label changes for this type of medication.

Click here to read the announcement.

 

--Stephanie Vaccaro

 

Reference:

US Food and Drug Administration. FDA updates warnings for oral and injectable fluoroquinolone antibiotics due to disabling side effects. FDA Drug Safety Communication. www.fda.gov. July 26,2016.

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