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Fluoroquinolones are the most used type of antibiotics in the United States. Over 26 million people received prescriptions each year. But recent studies link these drugs to aortic dissection and aneurysm. Both conditions weaken the walls of the aorta, the largest blood vessel in the body, and may lead to a rupture or leak which can be life-threatening.
People depend on antibiotics to fight serious infections and stay healthy, and fluoroquinolones are popular because they treat a wide variety of infections. Their effectiveness hinges on them targeting a bacterium’s DNA and preventing it from replicating. This gives the body a chance to fight infection.
Some of the illnesses fluoroquinolones treat include:
Some researchers say fluoroquinolones are over-prescribed for minor issues like earaches and sinusitis. Dr. Mahyar Etminan, an epidemiologist at the University of British Columbia, told The New York Times that overusing these drugs is like “trying to kill a fly with an automatic weapon.”
In 2013, the FDA released a Safety Communication warning about over-prescribing and said current warnings were not clear enough. Specifically, the agency said “the potential rapid onset and risk of permanence were not adequately described,” and the “permanent damage among patients exposed to these medications cannot be calculated.” Then in July 2016, the FDA added that serious, long-term side effects of fluoroquinolones such as Cipro, Levaquin and Avelox affect the "tendons, muscles, joints, nerves, and central nervous system that can occur together in the same patient."
Dr. Jay S. Cohen was an author and professor of psychiatry who discussed preventing medication side effects. Cohen spent years detailing the dangers of fluoroquinolones — which he called the "worst medication disaster in U.S. history." He gathered patient reports of adverse events in his book, How We Can Halt the Cipro and Levaquin Catastrophe.
Reported side effects include:
Pregnant women, children and adults older than 60 are at increased risk of bad reactions from fluoroquinolones. Some studies found the drugs were toxic to a developing fetus. Because these drugs may affect muscles and, doctors do not recommend their use in children. The risk of adverse events is also greater for people with liver disease or those taking NSAIDs like Advil or aspirin.
Some patients who took these drugs say they were left in the dark about risks and filed lawsuits against drug makers because of antibiotic nerve damage. Some may soon do the same for aortic dissection and aneurysms.
The aorta is responsible for carrying blood from the heart to all the organs in the body, except the lungs. Damage to this blood vessel can cause a number of other problems including strokes, heart attacks, organ failure and even death.
Two types of damage linked to fluoroquinolone use are: aortic dissection (tears) and aortic aneurysm (rupture). These conditions are on the rise in the U.S., and about 15,000 Americans die each year from aneurysms alone.
Scientists suspect that fluoroquinolones break down collagen in the body. Collagen is found in the tendons and also makes up the lining of the aorta. Two 2015 studies published in JAMA and BMJ medical journals revealed a connection between these powerful antibiotics and collagen damage that may lead to aortic dissections and aneurysms.
According to the JAMA study, fluoroquinolones were associated with a two-fold increase in risk of dissection and aneurysm within 60 days of using the drug. Authors said, "clinicians should continue to be vigilant for the appearance of aortic aneurysm and dissection in high-risk patients treated with fluoroquinolones."
The BMJ study found nearly a three-fold increase in the risk of aneurysm. Authors of this study followed about 1.7 million patients and found one third of them received a prescription for a fluoroquinolone. "Reducing unnecessary fluoroquinolone treatments or prolonged treatment courses might have possibly prevented more than 200 aortic aneurysms in this population," study authors said.
Tears can form in the aorta, allowing blood to leak in between the layers of tissue in the vessel wall, separating them. This is called aortic dissection.
Dissection interrupts the blood flow to other organs by blocking other blood vessels that feed them. This can lead to stroke, paralysis, kidney failure and other problems. The aorta may even burst or leak, leading to life-threatening complications. All dissections can lead to death, and it is extremely important to catch them early. Doctors typically use CT scans to diagnose them. Treatment may or may not require surgery to replace the dissected portion of the aorta.
There are a few conditions other than fluoroquinolone use that may lead to dissection, such as:
While aortic dissection involves a tear in the layers of the aorta, an aortic aneurysm occurs when part of the wall bulges or enlarges. These bulges weaken the aortic wall and are more likely to burst. These bulges can occur in the abdomen (abdominal aortic aneurysm) or in the chest (thoracic aortic aneurysm). These weak spots are extremely dangerous and once they burst, a patient has a 50 percent chance of survival.
Conditions that put people at risk for aneurysms include:
Unlike dissection, aneurysms often have no symptoms. These bulges may be found while testing for other conditions on a CT scan or ultrasound of the heart. When the thoracic aneurysm ruptures, people have difficulty breathing, severe chest pain, severe back pain or may lose consciousness.
A ruptured aneurysm is an emergency situation and must be treated immediately. Doctors may prescribe surgery or an aortic stent.
This family of antibiotics was first discovered in the 1960s. It wasn't until the late 1980s that Cipro and other modern fluoroquinolones first hit the market. At the time, doctors primarily prescribed them to treat urinary tract infections. Since then, they have become the go-to antibiotic for many infections.
Six fluoroquinolones are currently available in the United States. They can be administered in pills, injections and topical creams.
Generally, they are broken down into two categories: the older group (ciprofloxacin, norfloxacin, ofloxacin) and the newer group (gemifloxacin, levofloxacin, and moxifloxacin). The most popular drugs in the class are Cipro (ciprofloxacin), Levaquin (levofloxacin) and Avelox (moxifloxacin).
Cipro is the most widely used of all the fluoroquinolones, making up 80 percent of all prescriptions, and some 20 million Americans take it each year. It was originally approved in 1990 and is a second-generation fluoroquinolone. Doctors often prescribe it to treat mild-to-moderate respiratory and urinary tract infections, but it also treats other conditions, including: gonorrhea, infectious diarrhea and anthrax.
Cipro comes in the following formulas and doses:
Levaquin is the second-most popular drug in the class, with 28 percent of all prescriptions. It is a third generation fluoroquinilone originally approved in 1996. In 2010, it was the best-selling antibiotic in the U.S. Like Cipro, it treats respiratory and urinary tract infections. It also treats other conditions, including: plague, anthrax, bronchitis and pneumonia.
Levaquin comes in the following formulas and doses:
The third-most popular fluoroquinolone in the United States is Avelox, a fourth-generation medication that makes up about 9 percent of prescriptions. The FDA approved it in 1999 to treat multi drug-resistant types of Streptococcus pneumoniae – bacteria that cause pneumonia, ear infections and meningitis, among other conditions. It also treats skin infections, cellulitis and intra-abdominal infections.
Avelox comes in the following formulas and doses:
|Factive (gemifloxacin), Floxin (ofloxacin) and Noroxin (norfloxacin) each account for about 1 percent of the total number of prescriptions for the class. Maxaquin (lomefloxacin), Raxar (Grepafloxacin hydrochloride) and Zagam (sparfloxacin) are no longer available in the U.S.|
|Factive||Available in 320mg tablets and treats chronic bronchitis and pneumonia.|
|Floxin||Available in 200, 300 and 400mg tablets. This drug is more toxic than others in its class and often causes adverse events in patients.|
|Noroxin||Available in 400mg tablets and treats sexually transmitted diseases and urinary tract infections.|
|Maxaquin||No longer available in the U.S. Though, it may still be used in generic versions.|
|Raxar||Withdrawn from the market in 1999 because it was shown to cause adverse cardiac events.|
|Zagam||Withdrawn from the market in 2001 because of phototoxicity and cardiac events.|
In 2008, the FDA required makers of Cipro, Levaquin, Avelox and other fluoroquinolone drugs to add a warning for tendon rupture to medication labels. The Black Box warning is the FDA’s strongest warning. The agency also asked pharmaceutical companies to develop a medication guide. The FDA’s Adverse Events Reporting System confirmed that tendon ruptures in patients taking fluoroquinolones continue to increase.
Reports of ruptures and tears of tendons exist for the following body parts:
Peripheral neuropathy affects about 20 million Americans, according to the National Institutes of Health (NIH). It occurs when the peripheral nervous system is damaged by injury, illness or exposure to toxic drugs, like fluoroquinolones. Doctors can perform a number of tests to determine the extent of nerve damage, and the type of neuropathy is classified according to the nerves that are damaged.
Damage to the nerves interferes with the messages coming from the brain to the rest of the body. These confused messages can wreak havoc on the types of sensations someone feels. For example, a person may feel severe pain in response to sensations that should not cause pain, like feeling pain from bed sheets or numbness in fingers and toes. The nerves in the hands and feet are the first to be affected.
Depending on the person, symptoms may present in a few days, weeks or years. Some forms are chronic and worsen over time. Neuropathy is typically not fatal, but it can cause a lifetime of suffering.
Some severe symptoms include:
There are over 100 different kinds of neuropathy. Each type has its own symptoms, prognosis and treatment. After doctors diagnose a specific type of nerve damage, they discuss treatment options. In the beginning, they will address the cause, whether hormones, vitamins deficiencies or exposure to toxic medications. Sometimes, removing issues that caused the damage allows nerves to regenerate. Adopting a healthy diet and exercise can also help manage symptoms.
In many cases, doctors may have to prescribe strong drugs including pain killers and antidepressants which have their own laundry list of side effects. Opioid pain killers can also leave some people addicted. Surgery to kill problematic nerves and stop pain is only considered after all other courses of action are exhausted and only work when a single nerve is affected.
The FDA issued a warning in 2013 about the dangers of peripheral neuropathy and fluoroquinolones. Previous warnings were not strong enough or clear enough, it said. In particular, it said older labels failed to explain fully that neuropathy damage can happen immediately after taking the drugs and can be permanent. The FDA told doctors and consumers to discontinue the medication immediately if symptoms of nerve damage surface.
A 2014 study published in Neurology showed long-time users of fluoroquinolones had twice the risk of developing peripheral neuropathy, while new users had a slightly greater risk. Researchers said “clinicians should weigh the benefits against the risk of adverse events when prescribing these drugs to their patients.” Researchers studied more than 30,000 men in the United States from 2001 to 2011.
Warning symptoms could include: