FDA: Cipro, Levaquin Antibiotics, Too Dangerous For Common Infections


By Theresa Carr

The Food and Drug Administration (FDA) is advising against prescribing fluoroquinolones, a group of antibiotics that includes drugs such as Cipro and Levaquin, to treat three common illnesses —bronchitis, sinus infections, and urinary tract infections. The agency issued the new recommendations after a safety review revealed that fluoroquinolones can cause disabling and potentially permanent side effects that affect the tendons, muscles, joints, nerves, and central nervous system.

“I am living proof that the risks in using a fluorquinolone to treat a routine infection far outweighs the benefits,” says Rachel Brummert, 45, of Charlotte, North Carolina.

Last November, Brummert addressed a panel of experts convened by the FDA 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 Levaquin for a suspected sinus infection in 2006. Brummert,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.

The FDA convened the expert advisory panel to review evidence on the safety of using fluoroquinolones to treat common infections. In the end, the 21-member panel voted overwhelmingly that, in most cases, the benefit of fluoroquinolones to treat bronchitis, sinus infections, and urinary tract infections was outweighed by rare, but serious harms, 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. That overprescribing of the potent antibiotics is exposing patients to needless risk the panel concluded. While fluoroquinolones are essential for treating serious infections such as anthrax, for more common infections, other treatments typically work just as well with less risk.

Rampant Overprescribing

The new FDA ruling calling for restricted use of fluoroquinolones affects five prescription antibiotics: 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 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.

1. 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 its 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.

2. 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.

3. 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. 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.

All Antibiotics Have Risk

Brummert says that she applauds the FDA for "making patient safety a priority" by acting on the advisory panel’s recommendations. “Curbing unnecessary prescribing of fluoroquinolones will 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.”


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