- 1 Fluoroquinolones are the most used type of antibiotics in the United States. Over 26 million people received prescriptions each year. What most people don’t know is that these drugs are marketed as safe but can cause permanent nerve damage, leaving being disabled for the rest of their lives.
- 2 What Is Peripheral Neuropathy?
- 3 Problematic Antibiotics
- 4 Cipro (ciprofloxacin)
- 5 Levaquin (levofloxacin)
- 6 Avelox (moxifloxacin)
- 7 Other Fluoroquinolones
- 8 Black Box Warning for Tendon Rupture
- 9 FDA Peripheral Neuropathy Warning and Studies
Fluoroquinolones are the most used type of antibiotics in the United States. Over 26 million people received prescriptions each year. What most people don’t know is that these drugs are marketed as safe but can cause permanent nerve damage, leaving being disabled for the rest of their lives.
There are six FDA-approved fluoroquinolones, and this drug class makes up about 16.6 percent of the world market for antibiotics. Medical experts expect the demand for antibacterial drugs to grow, and they estimate by 2019 the class will generate more than $7 billion in revenue for drug manufacturers.
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:
- Urinary tract infections
- Skin infections
- Joint and bone infections
- Pelvic inflammatory disease
- Typhoid fever
In some cases, these medications drugs are life-saving, but they do harbor some serious side effects. Two of the most serious are permanent, painful nerve damage called peripheral neuropathy and tendon ruptures that can leave people disabled.
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.”
However, patients who took these drugs prior to the more detailed warnings were left in the dark about risks. Some patients filed lawsuits against drug makers because of antibiotic nerve damage.
FREE ANTIBIOTIC CASE REVIEW
If you developed Peripheral Neuropathy after taking Cipro, Levaquin or Avelox, you may have legal options.
What Is Peripheral Neuropathy?
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 touching them at night or fingers and toes may go numb. The nerves in the hands and feet are the first to be affected.
Some severe symptoms include:
- Burning pain at night
- Muscle wasting
- Organ or gland dysfunction
- Sweating/ lack of sweating
- Digestive issues
- Poor sexual function
- Poor bowel control
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.
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.
Six fluoroquinolones are available in the United States. They can be administered in pills, injections and topical creams. Oral and injectable forms are ones linked to peripheral neuropathy.
In addition to nerve damage, side effects include:
- Stomach problems
- Skin rash
- Tendon rupture
- Abnormal heart rhythm
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 fluoroquinilone. 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:
- Oral: 100, 250, 500 and 750mg tablets and 500 and 1,000mg extended release tablets
- Intravenous: 200 to 400mg
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:
- Oral: 250, 500 and 750mg tablets
- Intravenous: 500mg
The third-most popular fluoroquinolonei n 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:
- Oral: 400mg tablets
- Intravenous: 400mg
Factive (gemifloxacin),Floxin (ofloxacin) and Noroxin (norfloxacin) each account for about 1 percent of the total number of prescriptions for the class.
- Factive is available in 320mg tablets and treats chronic bronchitis and pneumonia.
- Floxin is 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 is available in 400mg tablets and treats sexually transmitted diseases and urinary tract infections.
Black Box Warning for Tendon Rupture
In 2008, the FDA required makers of these 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:
- Achilles tendon (most prevalent)
- Rotator cuff (shoulder)
FDA Peripheral Neuropathy Warning and Studies
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.
Warning symptoms could include:
- Change in sensation of pain or temperature
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 weight he 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.