Vibrant, athletic young people who are now bedridden and housebound, formerly high-functioning professionals who have trouble remembering simple words – these individuals all have something in common. A common type of medication called fluoroquinolone antibiotics – often prescribed for such routine ailments as urinary tract infections and prostatitis – have caused devastating health conditions. Fluoroquinolone toxicity, a disorder of the musculoskeletal system that can leave patients paralyzed, has affected tens of thousands of people to date – and experts say the harm may be irreparable.
Fluoroquinolone antibiotics make up over 16 percent of all antibiotics prescribed – worldwide
Fluoroquinolones, a class of synthetic, broad-spectrum antibiotics, include such common drugs as Cipro (ciprofloxacin) and Leviquin (levofloxacin). Cipro is indicated for bacterial infections. In addition to being used to treat typhoid fever, anthrax, sepsis and plague, the medication is also used for more routine ailments – such as diarrhea, sinusitis, bronchitis and urinary tract infections. Leviquin is used to treat many of the same illnesses.
Listed as an “essential medicine” by the World Health Organization, Cipro is active against bacterial pathogens such E. coli, MRSA (methicillin resistant staphylococcus aureus) and Klebsiella pneumoniae. Cipro was administered to American troops during the Gulf War to protect against chemical weapon attacks, and was also given to civilian workers at the Postal Service, the Capitol and the White House during the anthrax scare of 2001. Oral fluoroquinolones continue to be prescribed, with over 22 million Americans receiving prescriptions for the medications in 2014 alone.
Over 180,000 injuries and fatalities may be just the tip of the iceberg
According to RxISK.org, an independent website run by researchers who use data from the U.S. Food and Drug Administration (FDA) Adverse Reporting System, there were 79,000 suspected Cipro-related adverse reactions – including 1,700 fatalities – between the years 2005 and 2015. In addition, 1,000 deaths and 80,000 adverse reactions were associated with Leviquin. Many health professionals say that these numbers grossly underrepresent the scope of the incidence of adverse reactions – with one study estimating that only 1 to 15 percent of adverse effects are ever reported.
Fluoroquinolones can cause a tragic constellation of unwanted health effects
According to a warning issued by Cipro’s manufacturer, Bayer, ciprofloxacin can damage tendons, cartilage, bone and muscle – as well as affecting the heart and central nervous system. The most common adverse effect is tendon ruptures – particularly of the Achilles tendon. In fact, one study reports that the use of fluoroquinolones makes a ruptured Achilles tendon four times more likely to occur. In 2008, the FDA issued a “black box” warning for fluroquinolone antibiotics, advising that the drugs could cause tendonitis and ruptured tendons – as well as a long list of other adverse effects. These included peripheral neuropathy – which features burning, tingling and numbness in the extremities – seizures, difficulty breathing, eye disorders, cognitive issues and psychiatric disorders such as psychosis and panic.
Fluoroquinolones can also worsen myasthenia gravis, a disorder of muscle weakness.
Other dangers of fluoroquinolones include hypersensitivity reactions and liver failure – along with serious, potentially fatal reactions when used with theophylline, a medication used to treat asthma and emphysema. Toxicities can occur within a day of starting fluoroquinolones, and the risk is increased for patients over 60, patients with kidney, heart or lung transplants, and those taking corticosteroids. Shocking statistics: Up to 50 percent of prescriptions for fluoroquinolones may be unnecessary and ineffective Although fluoroquinolone antibiotics can be lifesaving, experts say they should be viewed as a “drug of last resort,” to be used only when no other option exists. However, an eye-opening study published in BMC Infectious Diseases found that almost a third of the fluoroquinolone regimens given to patients at a Cleveland hospital were for syndromes where antibiotics were not warranted at all.
Of the regimens that were appropriate, the authors said that most could have been replaced by a drug with fewer side effects. And a study conducted by the U.S. Centers for Disease Control and Prevention (CDC) reported that fully half of all prescribed fluoroquinolone drugs were unnecessary. And, they rarely issues such statements. As for Bayer, the company maintains that their labeling “accurately reflects the benefit-risk profiles” of its fluoroquinolone drugs – and claims it sent warning letters to healthcare providers in both 2008 and 2011, stressing that some adverse effects could be permanent.
For some, this is not enough.
Rachel Brummert, executive director of the patient advocacy group Quinolone Vigilance Foundation, says that the pharmaceutical industry should do more to warn physicians of the risk of injury. “Doctors are largely in the dark,” she states. “The few patients who are warned are not told that these adverse reactions can be permanent.” Dr. Beatrice Golomb, a professor of medicine at the University of California, San Diego, agrees that the effects of fluoroquinolones can be permanent. She also describes them as “tragic” and “horrifying.” “Fluoroquinolones can … take young lives and really destroy them,” Dr. Golomb declares. Although fluoroquinolones are used by millions without incident, the chance of toxicity does exists – making it a gamble that many do not want to take. It’s best to be vigilant about prescribed medications, and refuse fluoroquinolones unless there is no other option available.
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