What does it mean to be “Floxed”? Antibiotic risk linked to Bobby Caldwell’s death

R&B singer Bobby Caldwell died this week Reportedly after many years of health problems related to taking a fluoroquinolone antibiotic, something referred to as “floxed”.

The legendary musician, who sang “What you won’t do for love“, died at the age of 71.

His was not an isolated case. The FDA has even named the constellation of rare symptoms that some people experience as fluoroquinolone-related disability or FQAD; and published boxed warnings on the label. Some newer fluoroquinolones have been withdrawn from the market due to toxic effects.

Although all drugs have potential side effects, they seem to vary in their vast variety and severity. Since fluoroquinolones were first introduced in the 1970s, problems have included cases of tendinitis, a swelling of tendons that can lead to tears. headaches and rashes; aortic aneurysms, which can be life-threatening. neuropathy, a type of nerve damage. High blood sugar; and stress.

Caldwell’s symptoms were reportedly nerve-related and began with a Achilles tendon rupture after prescribing drugs in 2017.

What are fluoroquinolones?

Fluoroquinolones refer to a class of antibiotic drugs that includes ciprofloxacin (Cipro), levofloxacin (Levaquin), and moxifloxacin (Avelox). It is one of the most widely prescribed antibiotic drugs in the US. They are often used to treat sinusitis, bronchitis, urinary tract infections and pneumonia along with gastrointestinal infections such as gastritis and diverticulitis, according to William L. Musick, a pharmacist and clinical infectious disease specialist at Houston Methodist Hospital.

The drugs save lives in many cases and, unlike many other antibiotics, can be easily used both in and out of hospitals.

“Very sick patients inside a hospital can use IVs as well as orals outside,” Musick said. “That made it very easy to aggressively walk someone into the hospital and give them a pill to take home to finish the course. Unfortunately, we don’t have many antibiotics that meet these criteria.”

They are also effective. “They are wonderful antibiotics. They can eliminate many infections, even anthrax, and they’re also very cheap to make,” said Cecilia Bove, an assistant professor of biology at York College in Pennsylvania. Bove has also researched published on the subject.

What does it mean to be “ruined”?

Once the drugs hit the market and were used by millions and millions of people as opposed to the hundreds or so in clinical trials, some of the rare side effects inevitably occurred. But it took a while, with the first label change (related to the risk of Achilles tendon rupture) not happening until 2004, nearly 30 years after the drugs went on sale, Bove said.

Most drugs go through a similar cycle (Vioxx and Celebrex, painkillers, are prime examples), but fluoroquinolones seem to differ in the variety of rare problems associated with them.

There are musculoskeletal problems like tendon ruptures as well as psychiatric effects, aortic aneurysms, nerve problems, blood sugar problems and digestive problems, which collectively look more like a syndrome than individual side effects, Bove said.

The other difference is that many of the side effects last a long time. Some have even remained permanent. “The researchers observed a group of patients who would suffer for up to two or three months, if not longer, from a constellation of side effects that persisted long after the drugs were stopped,” Bove said.

“Unless it’s an event like a heart attack that can have permanent consequences, doctors often ignore that side effects can not only last longer than the medication period, but new problems can appear and develop after discontinuation. of a drug,” said Dr. Beatrice Golomb, professor of medicine at the University of California, San Diego, School of Medicine. “For example, someone might start out with a tendon rupture and then develop fatigue and then neuropsychiatric symptoms after FQ use.”

Why are the symptoms?

There is still much we don’t know about why fluoroquinolones have these effects in some people.

At a basic level, it seems clear that in addition to killing bacteria, antibiotics also attack the human body, Bove said. For example, they may damage collagen and prevent repair, which would explain the effects on tendons, he added.

Her research team and others are still trying to find a common denominator that would explain the effects on different physiological systems.

“It’s been an underserved area in research because not many people have it,” Bove said. “It is a rare disease, although it may be underreported due to a lack of diagnostic criteria.”

Disability associated with fluoroquinolone

In trying to qualify as FQAD, the FDA has stated that the effects must interfere with a person’s ability to perform the tasks of daily living and must last at least 30 days after stopping the drug. There must also be symptoms in at least two of these body systems:

  • Musculoskeletal
  • Neuropsychiatry
  • Peripheral nervous system
  • Senses (sight, hearing, etc.)
  • Skin
  • Cardiovascular

Who is at risk?

It is not entirely clear who is at risk of having these symptoms. The FDA’s adverse event reporting system for cases between 1997 and 2015 indicates that about three-quarters of cases occurred in people ages 30 to 59, with most occurring in women.

A study of nearly 50 million antibiotic prescriptions in US adults found an alarming increase in aortic aneurysms within 90 days of using a fluoroquinolone (as opposed to another antibiotic), but there did not appear to be patterns in age, sex, and underlying health, except that those affected were 35 years and older. (The study found an association, but could not prove that fluoroquinolones were the direct cause.)

Aortic aneurysms occur when the inner lining of the body’s largest blood vessel separates from the outer lining, fills with blood, and balloons out in a way that increases the risk of a dramatic and life-threatening rupture.

Overuse of fluoroquinolones

Like many antibiotics, fluoroquinolones appear to be overprescribed.

A study conducted by the CDC and published in 2018 found that 5.1% of topical fluoroquinolone prescriptions for adults were for conditions that did not require antibiotics at all, while nearly 20% were for conditions that should have been treated with another antibiotic.

“They are so easy and convenient to use both in the hospital and in the outpatient setting,” Musick said. “I feel strongly that this is one of the things that led to their abuse on the outpatient side. Other options have been set aside.”

“Most people who go on to develop these serious problems had at least minor side effects during or soon after FQ use. However, most with minor side effects do not develop chronic problems,” added Golomb, who was the lead author of a report on four previously healthy adults who had experienced these adverse events. “Often, they are young, active people with no chronic health problems. And often they were people who should never have received an antibiotic in the first place.”

What to do

Future efforts to reduce the incidence of these effects will probably have more to do with prevention than treatment. But fluoroquinolones may be more useful for very sick patients in hospitals than for people who can stay at home, Musick said.

“The labels clearly state that these drugs should not be given for simple infections that could be treated with other antibiotics,” Bove said. “Doctors still prescribe them for something as simple as a UTI.”

“There are many options for treating many infections, and the first thing in the world of antimicrobial stewardship is, ‘Does the patient really need antibiotics for what they have?’ said Music.

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