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FDA Updates Safety Warnings for Class of Antibiotics


Last week, the U.S. Food and Drug Administration announced that it has signed off on safety label changes for a class of antibiotics known as fluoroquinolones to support warnings about potentially permanent side effects.

Fluoroquinolones hinder the growth of bacteria and effectively treat serious infections. However, a recent safety review of the drugs revealed a link with side effects involving the central nervous system, muscles, tendons, and joints.

The FDA noted how these side effects can occur hours to weeks after exposure to the antibiotics and can be irreversible.

An updated box warning and revisions to the precautions section regarding these risks have been added to the label. Patient medication guides will also describe these newly-discovered risks.

The FDA suggested that fluoroquinolones should only be used for patients with acute bacterial exacerbations of chronic bronchitis and uncomplicated urinary tract infections when they do not have any other treatment options.

Fluoroquinolones can remain an option for treatment for patients with other serious bacterial infections, such as pneumonia, plague, or anthrax.

This class of drugs has various brand-names, including Avelox, which is marketed by Merck & Co. Inc., as well as Bayer Corp.'s Cipro and Johnson & Johnson's Levaquin.

The antibiotic class has also been the subject of several lawsuits.

Read the FDA's Drug Safety Communication to learn more.

To contact us about a potential defective drug or medical device claim, please click here to complete an online intake form for a free consultation.

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