On Thursday, May 12, 2016, the U.S. Food and Drug Administration (FDA) issued an advisory to prescribers regarding the use of a common class of antibiotics, fluoroquinolones. The agency’s concern is the potential side effects of Cipro and other drugs in this class.
Unlike previous advisories issued by the FDA on this drug class, this information advises physicians and other prescribers to avoid using these antibacterial medications as a first line of defense against routine infections such as sinusitis, bronchitis and uncomplicated urinary tract infections. The federal agency cites the risk of serious side effects from the use of Cipro, Levaquin, Floxin and other fluoroquinolones outweighs the potential benefits of using these medications unless the medical condition warrants it.
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Potential side effects associated with fluoroquinolones include disabling damage to the central nervous system, nerves, joints, tendons and muscles that can become permanent. Such damage may manifest as tingling sensations, confusion or hallucinations.
The side effects may occur without regard to the form of the medication, whether it be taken orally or parenterally. Topical forms of the medications are not known to produce these side effects. Warning labels will now be required for drugs in this class of drugs, warning users of the potential risks.
Thursday’s advisory follows a safety review conducted by the FDA, a probe that is ongoing and may issue more safety warnings related to these medications in the future. Thursday’s advisory is the implementation of the agency’s advisory committee who made the recommendation in November 2015.
Health care providers and patients are being advised to report these side effects and others experienced with any of these medications to the FDA MedWatch program, an ongoing program where adverse affects to these or any prescription medication may be reported.
Medications in the fluoroquinolone class have been available for two decades, with an average of 23 million prescriptions written annually between 2010 and 2014, according to U.S. News and World Report.
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