Fluoroquinolones Are Too Risky for Common Infections

An FDA panel says popular antibiotics such as Cipro are overprescribed and should have stronger warnings about dangerous side effects

By Teresa Carr / Consumer Reports / Last updated: March 07, 2016

Last November, Rachel Brummert, 45, of Charlotte, North Carolina, stood before a panel of experts and described the ever-worsening series of health problems, including 10 ruptured tendons and progressive nerve damage, she’s suffered as side effects of taking the antibiotic Levaquin, a type of fluoroquinolone, for a suspected sinus infection in 2006.

The Food and Drug Administration convened the panel to consider whether the official drug labels for fluoroquinolones, a group of antibiotics that includes drugs such as Cipro and Levaquin, should be changed to more clearly spell out their risks and discourage overuse. Brummert, the executive director of the Quinolone Vigilance Foundation, was one of more than 30 people who spoke during the open public hearing portion of the meeting about how the drugs had an impact on their lives.

“I am living proof that the risks in using a fluorquinolone to treat a routine infection far outweighs the benefits,” Brummert says.

After reviewing the evidence, the 21-member FDA panel agreed. They voted overwhelmingly that, in most cases, the benefit of fluoroquinolones to treat three common illnesses—bacterial sinus infections, urinary tract infections, and some forms of bronchitis in people with chronic lung disease—was outweighed by the risk of rare, but serious side effects, including irregular heartbeats, depression, nerve damage, ruptured tendons, and seizures.

Currently, those three illnesses account for nearly one-third of all fluoroquinolones prescribed outside of hospitals in the U.S. according to data presented by Janssen Pharmaceuticals, makers of Levaquin, at the FDA meeting.

While the fluroquinolones are essential for treating serious infections such as anthrax, the FDA panel members noted that they are overprescribed for common infections where other treatments would work just as well with less risk. They called on the FDA to strengthen labeled warnings and clarify when the drugs—should—and should not—be used.

Rampant Overprescribing

Over the last 30 years, the FDA has approved five fluroquinolone antibiotics to treat one or more of three illnesses considered by the panel: ciprofloxacin (Cipro), levofloxacin (Levaquin), moxifloxacin (Avelox), ofloxacin (Floxin), and gemifloxacin (Factive). All are also available as generics.

Much of the evidence on the risks of the drugs emerged after the drugs were on the market and used by millions of patients. While medical organizations such as the Infectious Diseases Society of America have updated their guidelines to advise against prescribing fluoroquinolones for milder garden-variety infections—including most cases of bronchitis, sinus infections, and urinary tract infections—many doctors haven’t gotten the message. That's likely because these powerful antibiotics work against a wide variety of bacteria, says Lindsey R. Baden, M.D., an infectious disease physician at Brigham and Women’s Hospital in Boston, Massachusetts, an associate professor at Harvard Medical School, and a member of the FDA panel. That can lead to overprescribing.

“Fluoroquinolones play an important role in treating serious infections such as those caused by bacteria that are resistant to other types of antibiotics,” says Baden. But in the case of less severe illnesses such as a mild bacterial sinus infection or uncomplicated bladder infection, the drugs “should typically be reserved for second-line or even third-line treatment after other antibiotics have failed,” says Baden.

When to Say 'No' to Cipro and Similar Drugs

Below we’ve listed three types of infections where fluoroquinolones are often not the best first choice for treatment along with our medical advisers’ advice about what to do instead.

• Sinus infections. “The vast majority of sinus infections are caused by a virus, not a bacteria and antibiotics don’t work against viruses,” says Baden. Even if bacteria are responsible, the infection will typically clear up on it’s own in a week or so. An antibiotic such as amoxicillin may be warranted if your symptoms last longer than a week, start to improve and then worsen, or are very severe—accompanied by a fever of 101.5 or higher, for example, or extreme pain and tenderness over your sinuses. For more information see Choosing Wisely recommendations from the American Academy of Allergy, Asthma, and Immunology. 
• Urinary tract infections (UTIs). If you have symptoms of a urinary tract infection such as having to urinate frequently, pain or burning when you go, cloudy or bloody urine, and a fever, you may need an antibiotic to treat the infection. Several types of antibiotics are effective against uncomplicated bladder infections; fluoroquinolones are typically only necessary if the infection is resistant to other antibiotics or has spread to the kidneys. Note that people aged 65 and older often have bacteria in their urine, but do not need to be tested or treated for a UTI unless they have symptoms. For more information see Choosing Wisely recommendations from the American Geriatric Society. 
• Bronchitis. As with sinus infections, most cases of bronchitis, or chest colds, are caused by a virus and are not helped by taking an antibiotic. (Read our advice on what to do ease symptoms while your body fights the infection.) One exception: patients with chronic obstructive pulmonary disease (COPD), a condition that causes difficulty breathing, may benefit from antibiotics if they develop symptoms severe enough to require hospitalization. In that case, the best choice of drug depends on the several factors, including which bacteria are prevalent in your area. For more information on using antibiotics to treat respiratory illness in children see Choosing Wisely recommendations from the American Academy of Pediatrics.

All Antibiotics Have Risk

Brummert says she hopes that the FDA will act on the advisory panel’s recommendations. “Curbing unnecessary prescribing of fluoroquinolones could save thousands of Americans from needless suffering,” she says.

Baden points out that all antibiotics—not just fluoroquinolones—should be used more thoughtfully.

“Really, I think the labels for all antibiotics should be strengthened to remind doctors and patients that when the drug is unwarranted, prescribing it has no benefit and exposes patients to needless risk, however small that risk may be,” says Baden. “Antibiotics are overused; as a community we need to be having these conversations about better prescribing based on the balance of benefits to harms.”

Editor's Note: This article and related materials are made possible by a grant from the state Attorney General Consumer and Prescriber Education Grant Program, which is funded by the multistate settlement of consumer-fraud claims regarding the marketing of the prescription drug Neurontin (gabapentin).