Fluoroquinolones are a class of antibiotics approved to treat or prevent certain bacterial infections. The fluoroquinolone antibiotics include ciprofloxacin (Cipro), gemifloxacin (Factive), levofloxacin (Levaquin), moxifloxacin (Avelox), and ofloxacin (Floxin).
However, some people who take these medicines may develop disabling and potentially permanent side effects of the tendons, muscles, joints, nerves, and central nervous system. These can occur in someone all at the same time.
The U.S. Food and Drug Administration (FDA) advises against using fluoroquinolone antibiotics for the treatment of three common infections: acute sinusitis, acute bronchitis, and urinary tract infections (UTI) without complications. The agency made this decision because the chances of serious side effects outweigh the benefits for most people.
The FDA says it’s OK use fluoroquinolones for other serious infections or for patients who have no other choice of treatment. This might include patients with allergies to other antibiotics or infections caused by hard-to treat, resistant bacteria.
The FDA approved changes to the labels and medication guides of fluoroquinolones taken by mouth or by injection based on patient reports of side effects. The FDA revised the boxed warning, the agency’s strongest, to address these serious safety issues, and updated the patient medication guide. The medication guide is a paper handout that comes with many prescription medicines.
Serious side effects reported to the FDA included ruptured tendons, pain, “pins and needles” sensations, as well as depression, anxiety, and thoughts of suicide. About half of the patients who had serious side effects from fluoroquinolones said the side effects began after the first or second dose.
Most patients reported:
- Long-term pain
- Pain, burning, tingling, numbness, weakness
- Symptoms affecting tendons, muscles, and joints, including swelling, pain, and tendon rupture
- Symptoms that lasted longer than a year
- Depression or anxiety
- Sensation changes or nerve damage in hands, feet, arms, or legs
- Dramatic impact on quality of life such as job loss, financial problems, and increased family tension
Since most patients reported symptoms lasting longer than a year, it is possible that some of these effects will be permanent.
If you have side effects while on a medication, you can file a report with the FDA's MedWatch program.