RUTHFULLY YOURS

Urinary tract infections affect millions of women, and often they are prescribed Ciprofloxacin (Cipro), Gemifoxacin (Factive), Levofloxacin (Levaquin), Moxifloxacin (Avelox), Norfloxacin (Noroxin), or Ofloxacin (Floxin).  These are fluoroquinolones, antibiotics, and have been on the market for more than 30 years.  They are also routinely prescribed for a range of infections – sinusitis, cystitis, prostatitis, bronchitis, and skin infections.

For some people, what is supposed to be a helpful medicine has turned into a medical nightmare, and many are still unaware of the dangers posed by these antibiotics.

Fluroquinolones, when used as tablets, capsules, or injectables, are associated with disabling and potentially permanent serious side-effects that can occur together.

The concerns about the antibiotic fluoroquinolone drugs are not new.  In fact:

The FDA first added a Boxed Warning to fluoroquinolones in July 2008 for the increased risk of tendinitis and tendon rupture.  In February 2011, the risk of worsening symptoms for those with myasthenia gravis was added to the Boxed Warning.  In August 2013, the agency required updates to the labeling to describe the potential for irreversible peripheral neuropathy or serious nerve damage.

Then, on May 12, 2016, the FDA warned that fluoroquinolone antibiotics (emphasis added):

… are associated with disabling and potentially permanent side effects of the tendons, muscles, joints, nerves, and central nervous system that can occur together in the same patient. …

[F]luoroquinolones should be reserved for use in patients who have no other treatment options for acute bacterial sinusitis, (ABS), acute bacterial exacerbation of chronic bronchitis (ABECB), and uncomplicated urinary tract infections (UTI) because the risk of these serious side effects generally outweighs the benefits in these patients.  For some serious bacterial infections the benefits of fluoroquinolones outweigh the risks, and it is appropriate for them to remain available as a therapeutic option.

Some signs and symptoms of serious side effects include unusual joint or tendon pain, muscle weakness, a ‘pins and needles’ tingling or pricking sensation, numbness in the arms or legs, confusion, and hallucinations. (see List of Serious Side Effects from Fluoroquinolones).

On July 10, 2018, another FDA caution about serious fluoroquinolone side-effects was issued.  It stated:

The labels will be amended to caution about disturbances in attention, disorientation, agitation, nervousness, memory impairment and delirium.  In addition, the FDA is concerned about the potential for hypoglycemic coma.  This occurs when blood sugar levels drop precipitously.  Hypoglycemic coma is a potentially life-threatening complication.

Joe Graedon and Teresa Graedon have long written about dangerous medical interactions.  Their article “Fluoroquinolone Antibiotics and Life-Threatening Aortic Aneurysm” poses concerns about this possible connection.

In the March 21, 2018 Nature article “When antibiotics turn toxic,” author Jo Marchant describes how:

… [i]n 2014, Miriam van Staveren went on holiday to the Canary Islands and caught an infection.  Her ear and sinuses throbbed, so she went to see the resort doctor, who prescribed a six-day course of the popular antibiotic levofloxacin.  Three weeks later, after she had returned home to Amsterdam, her Achilles tendons started to hurt, then her knees and shoulders.  She developed shooting pains in her legs and feet, as well as fatigue and depression.  ‘I got sicker and sicker,’ she says.  ‘I was in pain all day.’  Previously an active tennis player and hiker, the 61-year-old physician could barely walk, and had to climb the stairs on all fours.

She’s not alone.  Levofloxacin is one of a class of drugs called fluoroquinolones, some of the world’s most commonly prescribed antibiotics.  In the United States in 2015, doctors doled out 32 million prescriptions for the drugs, making them the country’s fourth-most popular class of antibiotic.  But for a small percentage of people, fluoroquinolones have developed a bad reputation. … [T]housands of people who have fallen ill after fluoroquinolone treatment gather to share experiences.  Many of them describe a devastating and progressive condition, encompassing symptoms ranging from psychiatric and sensory disturbances to problems with muscles, tendons and nerves that continue after people have stopped taking the drugs.  They call it being ‘floxed’.

It was only after persistent campaigning by patient groups that the U.S. Food and Drug Administration (FDA) announced the first of what would finally be a series of strong alerts about the side-effects of fluoroquinolone drugs.

From the 1980s to the end of 2015, the FDA received reports from more than 60,000 patients detailing hundreds of thousands of ‘serious adverse events’ associated with the five fluoroquinolones still on the market (most commonly tendon rupture, as well as neurological and psychiatric symptoms), including 6,575 reports of deaths.  The FDA says that the reports of adverse events it receives – sent in by drug manufacturers, by doctors and directly by consumers – cannot be used to reach conclusions about the severity of problems associated with drugs.  Still, the fluoroquinolones have attracted more complaints than other more widely used antibiotics.

Furthermore, most reactions occur quickly, sometimes with just a few doses of the fluoroquinolone antibiotic.

There is a distinct disconnect among FDA warnings, patient awareness, and a reduction in prescribing these medications.  The FDA’s warnings on drug labels have been slow to produce results.  Prescriptions for the drugs did not fall between 2011 and 2015, according to the CDC.  Thus, the alerts were not having the desired effect.  Finally, in 2016 and 2017, prescriptions for these antibiotics did drop.

Pharmacologist David Kroll has long been studying the effects of fluoroquinolone antibiotics.  In 2016, he wrote in Forbes that he first learned of the unexpected side-effects of fluoroquinolones when he read Stephen Fried’s book, Bitter Pills: Inside the Hazardous World of Legal Drugs.  Fried’s wife, Diane, suffered an infrequent side-effect of mental confusion and delirium from ofloxacin (Floxin), samples of which were given to her by a gynecologist for a urinary tract infection.

In fact, this book “helped to trigger a wave of reports on websites such as the Quinolone Antibiotics Adverse Reaction Forum.”

Afflicted people report anxiety, nervousness, horrible nightmares, and hallucinations, as well as nausea and vomiting.  Others maintain that “[f]luoroquinolone toxicity has been like an atomic bomb exploding in their bodies damaging their muscles and scrambling their DNA to the point many are too sick to work, too weak to walk.”

Kroll also cites a 2012 piece with almost 150,000 reviews where Melanie Haiken writes about the deadly side-effects of Cipro.  Accumulating evidence suggests that fluoroquinolones are damaging mitochondria, which can affect every cell in the body.  In a 2013 study, researchers reported that such damage to the mitochondria “inhibits their function across a range of mammalian cells with the largest effects seen in the quinolones.”

While life-saving in many instances, quinolone antibiotics have a dark side, which must become more highly publicized.

Eileen can be reached at middlemarch