Physical Wellness

Fluoroquinolone Antibiotic's Serious Side Effects Outweigh Benefits, Says FDA

By Megha Kedia | Update Date: May 13, 2016 06:00 AM EDT

The US Food and Drug Administration (FDA), on Thursday, advised for new restrictions and label warnings for a category of antibiotics known as fluoroquinolones, considering its serious side effects which outweigh the benefits for patients with sinusitis, bronchitis and uncomplicated urinary tract infections who have other treatment options.

The announced follows an FDA safety review which found that the anti-bacterial drugs, fluoroquinolones, are associated with disabling and potentially permanent, serious side effects. These effects may involve the tendons, muscles, joints, nerves, and central nervous system.

Patients may experience serious side effects including tendon, joint, and muscle pain, a "pins and needles" tingling sensation, confusion, and hallucinations, according to MPR. Examples of fluoroquinolones include Avelox, Cipro, and Levaquin.

The FDA has recommended that these drugs should be prescribed to only those patients who don't have alternative treatment options.

Health care professionals have been advised to "stop systemic" treatment immediately if a patient reports any serious side effects and to switch to an alternative drug to complete treatment.

"The FDA takes seriously its responsibility to protect the health of the American public through the review of safety, effectiveness and quality of medical products for patients," the FDA statement read, according to ABC News.

"The agency continuously reviews the available sources of data to make a determination about the safety and efficacy of fluoroquinolones and will keep health care providers and the public informed of new information."

The US health body has now made it mandatory for all fluoroquinolone drug labeling and accompanying Medication Guides to reflect the new safety information.

Currently, the FDA-approved fluoroquinolone antibiotics for systemic use include- Avelox (moxifloxacin), Cipro (ciprofloxacin) and Cipro Extended-Release (ciprofloxacin extended-release), Factive (gemifloxacin), Levaquin (levofloxacin), Moxifloxacin Injection (moxifloxacin) and Ofloxacin (ofloxacin).

The FDA will continue to update the public with new information as it continues to investigate the safety issues with fluoroquinolones.

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