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Since the early 1980s, the Food and Drug Administration (FDA) has been inundated with consumer complaints emanating from patients treated with a class of popular antibiotics. According to some sources, fluoroquinolones – a broad-spectrum antibiotic including Cipro, Levaquin, Avelox and others – have been associated with a host of devastating side effects, including joint and muscle pain, tendon rupture, aortic aneurysm , nerve damage, delirium and even death.
Finally, in 2008, the FDA began requiring manufacturers to add a "black box label" – the company's strictest warning – to the packaging of the company. 39; fluoroquinolone antibiotics. At that time, the consumer advocacy organization Public Citizen identified more than 400 cases of tendon rupture and more than 300 cases of tendonitis in patients who took this drug.
But more than ten years later, despite additional warnings from the FDA, fluoroquinolone antibiotics remain the third most commonly prescribed outpatient drug in the United States.
The reasons for the popularity of the drugs are complex, says Dr. Valerie Vaughn, assistant professor of medicine at the University of Michigan, who studies the abuse of antibiotics in hospitalized patients.
"In part, I think the information [about fluoroquinolone risks] did not really reach doctors everywhere, "says Vaughn. "I prescribe more than 200 different types of drugs, so it's hard to follow all the warnings."
Another factor is cost, says Vaughn. Fluoroquinolone antibiotics are notoriously inexpensive – a few cents for most doses, unlike newer antibiotic treatments that can cost more than $ 100 per dose. Most importantly, fluoroquinolone antibiotics are effective at killing bacteria and are also effective in the form of tablets or used intravenously, making it a popular choice in hospitals and outpatient clinics. "Doctors have been using fluoroquinolones for decades and have seen them work," says Vaughn. "What worries them is not a side effect, but what would happen if they treated a patient with a narrow-spectrum antibiotic and the patient came back with a resistant infection."
Fluoroquinolones, commercially available since 1978, are broad-spectrum antibiotics, useful for killing a wide variety of bacteria in a short time. "Doctors like to prescribe broad-spectrum antibiotics because we do not always know what we are treating," says Vaughn. "We do not want to miss anything." But now, thanks to their popularity, doctors are fighting against antibiotic resistance and devastating side effects for patients.
To address the problem of fluoroquinolone, hospitals and long-term care facilities are beginning to prevent doctors from prescribing unnecessary antibiotics, as well as choosing more appropriate treatments when antibiotics are indicated. Many of these initiatives, called antibiotic management programs, have made the reduction of fluoroquinolone antibiotics a top priority.
"Fluoroquinolones are a very good example of how the benefits and rationale for antibiotic management are well-illustrated, both from the point of view of reducing resistance and the fact that these drugs have many side effects. undesirable effects, "says Dr. David Hyun. senior officer in the Antibiotic Resistance Project of the Pew Charitable Trusts.
Stewardship programs have been in hospitals for almost two decades, says Hyun, but it is only recently that initiatives have really begun to take off: in 2016, the Joint Commission, an agency in The nonprofit accreditation of hospitals has integrated antibiotic stewardship programs into its accreditation criteria. As a result, management programs have grown tremendously, giving managers hope that the rate of patient complications and the trend of drug resistance will decrease significantly.
"We have seen good data showing that stewardship programs can reduce the inappropriate or broad-spectrum use of antibiotics," Hyun said. "These studies show that when antibiotic management programs target specific antibiotics, it reduces the undesirable effects within the hospital system and modifies the resistance patterns of this institution to the positive."
But while management programs can reduce prescriptions for antibiotics, doctors still have no alternative to fluoroquinolones when antibiotics are needed – and few pharmaceutical companies use them to invest in the development of antibiotics. In 2018 alone, four major pharmaceutical companies announced that they were withdrawing from antibiotic research, leaving only a select few invested in the search for alternative treatments.
The reason, says Vaughn, is a lack of financial incentive. "If a pharmaceutical company creates an antibiotic, the first thing the resistance programs do is not to allow it to be prescribed. They want to keep it for when it's needed, and only for the sickest patients, "she says. "It's a great way to not generate resistance, but it's unfortunately a bad way for pharmaceutical companies to make money."
According to Hyun, the good news is that in 2019, most hospitals have antibiotic management programs, and the data shows that they work. Reducing the use of fluoroquinolone, however, remains a thorny challenge: Pharmaceutical companies must be encouraged to develop alternatives, even though physicians should be discouraged from prescribing them, particularly in ambulatory care centers where Stewardship are rare.
"That's where patients can begin to defend themselves," says Vaughn. "I just know to talk to the doctors myself, many were shocked when I raised [fluoroquinolone risks]- it takes them a long time to become aware of it. It may be easier for patients to check the warnings on the label and inform the doctor. "
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