The FDA is continually strengthening the warnings on a popular class of antibiotics, called fluoroquinolones, that are FDA approved to treat certain serious bacterial infections for more than 30 years. They work by killing or stopping the growth of bacteria that can cause illness. These medicines include Cipro (ciprofloxacin), and Levaquin (levofloxacin).
However, fluoroquinolones carry the risk of serious side effects that have caused the FDA to require the manufacturers to include the strongest warning possible for a prescription drug, a Black Box warning, and is designed to call attention to serious or life-threatening risks. The FDA requires Black Box warnings when it determines that medical studies indicate that the drug carries a significant risk of serious or even life-threatening adverse effects.
On multiple prior occasions the FDA has issued important communications (“Drug Safety Communications”) to help health care providers in prescribing and monitoring the safety of fluoroquinolones:
07/10/2018 FDA is strengthening the current warnings in the prescribing information that fluoroquinolone antibiotics may cause significant decreases in blood sugar and certain mental health side effects.
05/12/2016 The U.S. Food and Drug Administration is advising that the serious side effects associated with fluoroquinolone antibacterial drugs generally outweigh the benefits for patients with acute sinusitis, acute 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.
07/26/2016 he U.S. Food and Drug Administration (FDA) approved changes to the labels of fluoroquinolone antibacterial drugs for systemic use (i.e., taken by mouth or by injection). These medicines are associated with disabling and potentially permanent side effects of the tendons, muscles, joints, nerves, and central nervous system that can occur together in the same patient. As a result, we revised the Boxed Warning, FDA’s strongest warning, to address these serious safety issues. We also added a new warning and updated other parts of the drug label, including the patient Medication Guide.
08/15/2013 The U.S. Food and Drug Administration (FDA) has required the drug labels and Medication Guides for all fluoroquinolone antibacterial drugs be updated to better describe the serious side effect of peripheral neuropathy. This serious nerve damage potentially caused by fluoroquinolones (see Table for a list) may occur soon after these drugs are taken and may be permanent.
07/8/2008 FDA is notifying the makers of fluoroquinolone antimicrobial drugs for systemic use of the need to add a boxed warning to the prescribing information about the increased risk of developing tendinitis and tendon rupture in patients taking fluoroquinolones and to develop a Medication Guide for patients. The addition of a boxed warning and a Medication Guide would strengthen the existing warning information already included in the prescribing information for fluoroquinolone drugs.
There are alternatives to fluoroquinolones. It is the patient’s decision to take a drug, and to make that decision the patient has to have a discussion with the doctor about the drug’s risks and benefits.
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