Alert / FDA MedWatch - Fluoroquinolone Antibacterial Drugs: Drug Safety Communication - FDA Advises Restricting Use for Certain Uncomplicated Infections

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Division of Quality Assurance: Notifications & Updates

Attention: Health Care Providers

Alert / FDA MedWatch - Fluoroquinolone Antibacterial Drugs: Drug Safety Communication - FDA Advises Restricting Use for Certain Uncomplicated Infections

The FDA is advising that the serious side effects associated with fluoroquinolone antibacterial drugs generally outweigh the benefits for patients with sinusitis, bronchitis and uncomplicated urinary tract infections which have other treatment options. For patients with these conditions, fluoroquinolones should be reserved for those who do not have alternative treatment options. Fluoroquinolone drugs include; levofloxacin (Levaquin); ciprofloxacin (Cipro); moxifloxacin (Avelox); norfloxacin (Noroxin); ofloxacin (Floxin); and gemifloxacin (Factive).

An FDA safety review has shown that fluoroquinolones, when used systemically (i.e. tablets, capsules, and injectable), are associated with disabiling and potentially permanent serious side effects that can occur together. These side effects can involve the tendons, muscles, joints, nerves, and central nervous system.

For details about this FDA Drug Safety Communication, please see the webpage located at FDA. GOV

Please share this information with your prescribers and pharmacists within your organization.