FDA issues new label changes for common antibiotics

RICHMOND, Va. (WRIC) — On Thursday, the FDA announced that it is now requiring label changes for antibacterial drugs called fluoroquinolones, including an updated boxed warning and Medication Guide, and advising that the serious side effects associated with fluoroquinolones generally outweigh the benefits for patients with sinusitis, bronchitis and uncomplicated urinary tract infections who have other treatment options.

For patients with these conditions, fluoroquinolones should be reserved for those who do not have alternative treatment options.

Examples of fluoroquinolones include Avelox, Cipro, and Levaquin.

Patients share horror stories from commonly used antibiotics

According to the FDA, a safety review has shown that fluoroquinolones are associated with disabling and potentially permanent, serious side effects that can occur together. These side effects can involve the tendons, muscles, joints, nerves, and central nervous system.  As a result, the FDA is requiring label changes for all systemic fluoroquinolone antibacterial drugs to reflect this new safety information.

The FDA released the following statement:

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 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.

Janssen Pharmaceuticals, the manufacturer of Levaquin, also released a statement:

At Janssen, our first priority is the well-being of the people who use our medicines. We are reviewing the Drug Safety Communication and will continue our ongoing collaboration with the FDA to support the safe and appropriate use of fluoroquinolone antibiotics. LEVAQUIN® (levofloxacin) has been used for nearly 20 years to treat bacterial infections, including those that may be serious or life-threatening. LEVAQUIN® is part of the important fluoroquinolone class of anti-infective prescription medications, and its safety profile remains well-known and established.

Bayer the makers of Cipro and Avelox also released a statement:

“Bayer is aware of the FDA’s May 12, 2016 Drug Safety Communication in regard to the fluorouquinolone class of antibiotics. Cipro® (ciprofloxacin) and Avelox® (moxifloxacin) are both part of this important class of antibiotics, which has been used to treat a range of infections for many years. Bayer’s highest priority is patient safety, and we will carefully review the information that FDA posted today and will continue to work closely with the agency on this topic.”

The Quinolone Vigilance Foundation which has been fighting for patient safety issued this statement.

“QVF applauds the Food and Drug Administration for implementing these vital changes to the boxed warnings and medication guide. Fluoroquinolone antibiotics are too risky for routine infections such as sinus infections, urinary tract infections, and bronchitis, and should only be used to treat life threatening infections. When the risks of a treatment for infection outweighs the benefits, changes need to be made at the highest levels to protect the health, safety, and lives of patients. We are pleased that the FDA listened to the testimonies from the QVF and other victims who selflessly shared their stories so that others do not suffer the devastating and life-altering adverse reactions that we have.”

For more information, please see the FDA’s limited Drug Safety Communication.

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