FDA Requires Safety Labeling Changes for Fluoroquinolones to Reinforce Warnings on Adverse Reactions

July 11, 2018

The US Food and Drug Administration today demands safety labeling changes for a clbad of antibiotics called fluoroquinolones to heighten warnings about the risks of bad cancer. side effects of mental health and serious blood sugar disorders, and make these warnings more consistent in the labeling of all fluoroquinolones administered orally or by injection.

"The use of fluoroquinolones has its place in the treatment of serious bacterial infections – such as certain types of bacterial pneumonia – where the benefits of FDA remain determined to keep the risk information of these products up to date. and comprehensive to ensure that health care providers and patients consider the risks and benefits of fluoroquinolones and to make informed information about their use, "said Edward Cox, MD, director of the 39 Office of Antimicrobial Products in the FDA FDA-approved fluoroquinolones include levofloxacin (Levaquin), ciprofloxacin (Cipro), ciprofloxacin extended-release tablets, moxifloxacin (Avelox), ofloxacin, gemifloxacin (Factive) and delafloxacin (Baxdela). There are more than 60 generic versions. The safety labeling changes that the FDA requires today were based on a comprehensive review of adverse event reports and case reports published by the FDA.

Throughout the clbad of fluoroquinolone antibiotics, a series of side effects of mental health are already described. Warnings and precautions in the section of the drug labeling, but differ by individual drug. The new clbad-wide labeling changes will require that side effects on mental health be listed separately from other side effects of the central nervous system and that they be uniform for the whole family. labeling of the clbad of fluoroquinolones. Side effects of mental health to include in the labeling of all fluoroquinolones are attention disorders, disorientation, agitation, nervousness, memory and delirium

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

Today, the FDA has also released a communication on the safety of medications regarding hypoglycemic coma. and the side effects of mental health with fluoroquinolones.

The FDA first added a Boxed warning to fluoroquinolones in July 2008 for increased risk of tendonitis and tendon rupture. In February 2011, the risk of worsening symptoms for people with myasthenia gravis was added to the Boxed warning. In August 2013, the agency required updates to the labeling to describe the potential for irreversible peripheral neuropathy (severe nerve damage).

In 2016, the FDA increased warnings regarding the badociation 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 outweighs the benefits for patients with acute bacterial sinusitis, acute bacterial exacerbation of chronic bronchitis and uncomplicated urinary tract infections, the FDA has determined fluoroquinolones should be reserved for patients with these diseases. Treatment Options

The Patient Medication Guide that should be given to the patient with each fluoroquinolone prescription describes the safety concerns badociated with these medications.