FDA Updates Antibiotic Safety Warning to Limit Use

The U.S. Food and Drug Administration (FDA) recently made a significant change to the content of the safety warning on fluoroquinolone antibiotics in an attempt to restrict their use to more serious infections. Fluoroquinolones are the most commonly prescribed antibiotics, and include some big names like as ciprofloxacin (Cipro) or levofloxacin (Levaquin). The FDA is warning prescribers to be more cautious about the use of these medications, because of several very serious side effects that can cause irreversible harm to patients.

In a small percentage of patients, fluoroquinolones can have a devastating effect on the integrity of the body’s connective tissue. More specifically, it can cause an inflammation of the tendons which can be so severe as to cause tears in the tissue that lead to rupture. It is most common in the achilles tendon, and while surgical repair is possible, some patients are permanently disabled after even one dose of the medication. Rupture of the achilles tendon is an extremely rare side-effect – only 17 cases per 100,000 courses of treatment – but it occurs in fluoroquinolone-taking patients at three times the rate we’d expect to see in the random population.

The risk of permanent damage from these drugs was of enough concern to the FDA that they put a “boxed warning” on the medications in 2008 to warn patients and physicians of the possible danger. Soon afterwards, other boxed warnings were added as evidence began to show that use of fluoroquinolone antibiotics could also worsen the symptoms of patients who had the muscle disorder myasthenia gravis. Still another warning followed in 2015 when it became apparent that irreversible fluoroquinolone-induced nerve damage could even happen in healthy people without any underlying muscle or nervous system conditions.

In Steps the FDA

The FDA’s latest warning about fluoroquinolones is the most serious one to date. It clearly states that the “serious side effects associated with fluoroquinolone antibacterial drugs generally outweigh the benefits for patients with acute sinusitis, acute bronchitis, and uncomplicated urinary tract infections who have other treatment options. For patients with these conditions, fluoroquinolones should be reserved for those who do not have alternative treatment options.”

Why are we still using this class of medications, if they’re so dangerous that the side effects outweigh the benefits? Should you fight back against your doctor if you’re prescribed one of them for an infection? Yes and no. The majority of patients won’t ever see such severe side effects. Patients who take fluoroquinolones most commonly report run-of-the-mill gastrointestinal upset – nausea, diarrhea, vomiting – and headache. No worse than any other antibiotic. A fluoroquinolone probably won’t hurt you, statistically speaking. But it isn’t just about the side effects.

They’re very effective drugs, especially in some very serious infections requiring hospitalization. But even so, it’s probably not a great idea to jump immediately to ciprofloxacin or levofloxacin, or any of their cousins, if you still have “alternative treatment options” available. The unfortunate truth is that overuse of fluoroquinolones hurts everyone, even those who never experience the severe side effects. That’s because overuse of any antibiotics leads to antibiotic resistance.

Avoiding Antibiotic Overprescription

Up to 42% of fluoroquinolone prescriptions between 1995 and 2002 were written for “unapproved diagnoses” like ear infections, sinus infections, and acute bronchitis, all of which are often caused by viruses and not bacteria. But because this class of antibiotic is often effective as a second- or third-line attack when other treatments fail, it’s easy for doctors and patients alike to see them as magic bullets. Why wait until other treatments fail, if this one will work? Why have the patient come back in a week after the penicillin fails, only to jump up to ciprofloxacin anyway?

The decision about which medication to use should always be a carefully considered one. The best rule to follow when it comes to bacterial infections and antibiotic resistance is to be as targeted as possible and to save the big guns for when you really need them. Because using them first means that more bacteria are exposed to them, giving them a chance to develop strategies to resist.

Because fluoroquinolones are broad-spectrum antibiotics, they can kill both Gram-negative bacteria and Gram-positive bacteria. A broad-spectrum drug is often used when treating the infection quickly is more important than taking a culture and growing the organism in the lab to see what it is and what drug would be best to kill it. That’s a good thing, sometimes, when the hurry is a hospitalized patient with a severe infection. But when the rush is a physician trying to get a patient out the door, fully satisfied with a prescription in hand for “the good stuff,” we’re taking shortcuts s can lead to much more serious problems down the road when even the good stuff stops being effective.

As with all medications, have a chat with your doctor to understand why it’s being prescribed. Ask whether there are other options. Be sure that you understand the risks and the benefits.