RxISK Stories: The Myth of the Magic Bullet – Flox Tox

In July this year, Antimicrobrial Agents & Chemotherapy had an article – Fluoxetine is a Potent Inhibitor of Coxsackievirus Replication by Zuo J, Quinn KK and colleagues. “No antiviral drugs currently exist for the treatment of enterovirus infections, which are often severe and potentially life-threatening. Molecular screening of small molecule libraries identified fluoxetine, a selective serotonin reuptake inhibitor, as a potent inhibitor of coxsackievirus replication. Fluoxetine and its metabolite norfluoxetine markedly reduced the synthesis of viral RNA and protein”.

Another blog on the latest developments recently billed both Prozac and Zoloft as anti-microbials.

These come over as good news stories. That wonderful little Prozac, see what else it can do, isn’t it smart? Except the definition of a smart drug – a Magic Bullet – is that it should only do what it is told to do. Evidence that Prozac or Zoloft do more indicates they may be poisonous rather than medicinal. If we turn the story on its head, the problem may be a little clearer. If an antidepressant can be an antibiotic, what might an antibiotic do, and would we like it? If smart drugs do just what they are supposed to do, the fluoroquinolone antibiotics are in the running to be the dumbest drugs ever.

The Myth of Floxing by Billiam James, 2012

 

Joanne’s Story

In April 2011, I was prescribed Cipro for an uncomplicated, routine Urinary Tract Infection. After only 6 days of 250mg twice daily, I was suddenly hit with a host of symptoms. Within two hours I went from being a healthy, 49 year-old to someone mutilated from head to toe, fighting for my life. My life has changed irreversibly. I have medical documentation of partial paralysis, head to toe tendon damage, hearing loss, heart murmur, kidney and liver damage, erythema multiforme, extreme food allergies.

I was initially told that these symptoms, especially appearing collectively, was “rare”. While this did little to help me, at least I thought I was just unlucky. Imagine my horror when I found that, even using conservative numbers, hundreds of people are poisoned from fluoroquinolones each year with the same devastating result I endure. Not only are there countless scores of FaceBook, YouTube, and blogs on the internet from people with crippling stories almost exactly like mine, there are many people I have met within just my local area that are suffering in this same way.

There is ample documentation to show that the FDA knows that these effects appear syndromically. The FDA knows the devastation caused by fluoroquinolones. Yet, the FDA allows these “medications” to be used in a flippantly casual manner by unknowing doctors with only a black box warning of possible tendon damage. Possible tendon damage implies a bad case of tennis elbow or, at worst, a rupture of the Achilles tendon. Nothing can explain my terror at suddenly having every tendon in my body as fragile as wet tissue paper. Nothing can explain the heartache of having to be fed like a baby by my eight year-old child or being unable to use the bathroom without the assistance of others. Although I have made improvements in the last seven months my chance of complete recovery, based upon expert information, is almost non-existent.

MedWatch, as it currently stands, does not work as an accurate reporting system. It requires doctors to report on their own errors. If physicians recognized the error, it is doubtful they would have made it in the first place. My PCP is a conscientious physician but just did not have enough information on the effects of fluoroquinolones. He reported to MedWatch that I was “recovered” only about 10 weeks out from the onset of my initial symptoms because I was no longer using a wheelchair full-time. He simply could not believe that the plethora of symptoms I suddenly had could be caused by a drug. I have to agree that it is completely unbelievable that anything so dangerous would be out on the market.

The subsequent specialists I now see: cardiologist, nephrologist, endocrinologist, immunologist, orthopedist, GI specialist, neurologist, physical therapist, etc., feel they cannot report my symptoms to MedWatch because I was not under their care at the time of the poisoning and, so, cannot confirm the cause and effect.

There is no established first-aid protocol for those poisoned by fluoroquinolones. We called the Poison Control Center. They confirmed that the effects I was experiencing were caused by Cipro but when we asked what to do they said, “Well, if you rupture, go to the emergency room.” This was not helpful. My doctor also prescribed NSAIDS. Not only should physicians be informed that NSAIDS and steroids are contraindicated, there should be an intervention that includes the immediate administration of antacids or something to bind the remaining fluoroquinolone in an attempt to reduce damage.

The Myth of Floxing by Billiam James, 2012

 

Erin’s Story

May 5, 2004. I was having dinner at Le Cirque at the Belaggio Hotel in Las Vegas. I paid the price for 6 years. Eight hours later I was rushed by the hotel security to a cab because they didn’t think an ambulance would get there in time to save me. The description of what Ecoli is like is too gruesome to share. I was taken to the ER and shot up with Levaquin. The E-coli nightmare stopped. I was to take 500 mg twice a day for 7 days.

OK, I can do that, not a problem. I slept for 4 days straight in a hotel room and boarded a plane and went home where I was kept on Levaquin for a total of 14 days. I could not get out of bed for 2 months. No one recognized me because I looked so deathly. I was sure it was the E-Coli. I struggled with the diarrhea and cramping, the rashes, the memory loss, sore body and broken mind. Then the eight month came. It began with itching and my lips and eyes swelling shut. Well, I do have allergies so maybe that’s it. I began to have severe reactions to every food I ate so I became very selective. As my food choices narrowed my diet adjusted and I eliminated almost everything.

Doctors had no idea what this was and kept giving me cortisone shots and telling me to take Advil for pain. They knew as much about Levaquin as I did. I had developed full blown angioedema, a life threatening condition that makes everything from the neck up swell so badly that the windpipe can swell shut. I couldn’t go anywhere. I needed to be within 15 minutes of a hospital at all times. I was down to being able to eat rice, milk products, apples and green vegatables. I did this for 6 years. No meat, a very hard task for a carnivore like me. I was lucky enough to have a good marriage. My husband watched me go through all of this in disbelief but gave me complete support.

Then after 6 years without any sign it was going to happen, it did pass. The constant burning of my neck and face and the looming threat of the angioedema quietly came to an end.

Three months later I ended up in the ER with a nasty case of cellulitis. I have run out of standard antibiotics due to severe allergic reactions and so Levaquin, once again was the drug of last resort. After my very verbal protest as to how horrible my last round of Levaquin was the ER doctor actually told me that it was this or nothing at all. It was actually the only drug that could get me out of there with a pill rather than an IV administered drug that had to be done once a day for 4 days as an out patient. Cost is everything here. With the thought of losing my leg, I said OK, maybe this time it will be better.

I could not have been more wrong. I took one pill and immediately checked out mentally. I have very few recollections of the 7 days of 500 mg once a day. All I knew was that I was determined to finish this pill and go on with my life. My symptoms on the medication ranged from extreme nightmares, depersonalization, inability to sleep, anxiety attacks, missing time, delirium, fever for 2 hours after I took the pill, then dropped to 96.2 degrees and I was unable to get my body temp up, frozen to the core, inability to empty my bladder, itching, tinnitus, hair falling out, burning skin, broken teeth both times, irregular heartbeats, shaking so bad that I could barely feed myself, semi-hysteria, depression, suicidal thoughts, my skin literally hung from my bones due to collagen degeneration. I lost 15 pounds.

I now have to wear glasses because my vision was damaged. My bones hurt. My tendons snapped. My body ached. My joints swelled. A week after I stopped the meds, I suffered a severe tendon pull from opening a bottle of water. The same arm had tendonnitis of the shoulder and felt like it would fall out of the socket. I could not extend my arm for 3 months. It burned like fire from the pull and my elbow filled with blood. My thyroid seemed to stop working as all of my hypothyroid symptoms returned on top of the Levaquin induced symptoms. The first two month after the discontinuation of the drug was hell, really hell. My blood pressure was so high it terrified my doctor. I was a stroke just waiting to happen.

It took me four months to regain my memory. I still remember very little of the floxing week. I do remember freaking out over the periods of missing time. I did tell everyone around me that I was having dark thoughts and voices telling me to kill myself. Fortunately, no matter how out of my mind I am, I know in my soul that God determines my check out time, not me. I now know that I probably had a small stroke as I could barely talk for almost a month.

It has been  almost 2 years. Here’s the good news. The first time I was poisoned I knew nothing. I did everything wrong and allowed doctors to do everything wrong to me. The first time I was given 3 cortisone shots for the rashes and told to take Advil for the pain. A more appropriate recommendation would have been to dowse myself in gasoline and have a cigarette.

References:

1. Fluoroquinolone-induced suicidal ideation
https://www.deepdyve.com/lp/elsevier/fluoroquinolone-induced-suicidal-ideation-LfMBv3r2mB
A case study about man who became suicidal after being given fluoroquinolone. The introduction notes that adverse CNS reactions to FQs affect up to 1in 25 patients, with severe problems affecting 1 in 200.

2. Fluoroquinolone therapy and idiosyncratic acute liver injury: a population-based study
http://www.cmaj.ca/content/early/2012/08/13/cmaj.111823, published Aug 13, 2012: “Fluoroquinolones are among the most widely prescribed antibiotic agents in North America, and the use of broad spectrum fluoroquinolones such as levofloxacin and moxifloxacin is increasing. Despite their popularity, safety concerns have led to the restriction and, in some cases, withdrawal of several members of this class of drugs… The varied and unpredictable nature of these adverse reactions has led to the ongoing scrutiny of the entire class of drugs.”

3. Based on number direct reports to FDA in 2011, Levaquin is FDA’s 3rd most dangerous drug.
QuarterWatch: http://www.ismp.org/quarterwatch/pdfs/2011Q4.pdf

Illustrations: The Myth of Flox and The Truth of Flox,  2012 © Billiam James

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