Who Reads the Drug Warning Labels?

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drug side effect labels
I have a confession – I didn’t even glance at the warning insert that came with my Cipro prescription. I didn’t even think about reading it. I didn’t think for a second that I needed to be worried about the side-effects of an antibiotic. I assumed that all antibiotics were safe, thoroughly tested, had few side-effects and that any side-effects that they had wouldn’t hurt ME. After all, I was a fit, strong 32 year old with zero health issues other than the urinary tract infection that I was trying to treat. I thought that I had nothing to worry about and that medicine generally and antibiotics specifically fell into the category of things that do good, not harm. So when I developed severe Central, Peripheral and Autonomic Nervous System malfunctions and inflamed tendons after taking Cipro, I was shocked and shaken that an ANTIBIOTIC that is prescribed every day to treat simple urinary tract and other infections, could cause me, a healthy and fit woman, to be suddenly systemically sickened.

I suppose that, since I didn’t read the warning label, I have to take a certain amount of personal responsibility for what happened to me. Officially, I was warned. I should have known that Cipro, one of the most popularly prescribed broad-spectrum antibiotics on the market, could cause tendonopathy, renal failure, rash, anemia, hepatic failure, hallucinations, seizures, permanent peripheral neuropathy, etc. I should have read the warning label so, at the very least, I would have known that when I experienced inflammation and weakening of every tendon in my body (lightly referred to as tendonopathy – as if that even comes close), hives all over my body, loss of memory and reading comprehension, inability to concentrate, peripheral neuropathy, anemia, etc., that I was experiencing an adverse reaction to the drug that I had taken. Should’ve, would’ve, could’ve. I lived and learned and will certainly read warning labels in the future. However, I don’t think that I am unusual in not bothering to read the warning label that accompanied my prescription for antibiotics. Do other people read drug warning labels?

Doctors certainly don’t seem to read drug warning labels. Every single doctor who I asked whether or not Cipro could have caused my symptoms said that it couldn’t have, despite the fact that the majority of my symptoms are listed on the warning label.

And even if I had read the warning label, would I have been sufficiently warned? I assumed, as I think most people do, that drug side-effects are transient, that they are stopped as soon as administration of the drug is stopped, or at least as soon as the drug is fully metabolized. I had no idea that a drug could cause a syndrome that would take me years to recover from. Nowhere on the warning label does it say that side-effects can be long-lasting and, when I took Cipro in 2011, nowhere on the label was the word “permanent.” It was only added to the warning label in 2013 in reference to permanent peripheral neuropathy.

Who would think that a drug, an antibiotic no less, could cause a chronic syndrome that includes pain and nerve destruction? Again, doctors certainly don’t because not a single one acknowledged that my cascade of physical and mental issues that cumulatively was a toxicity syndrome, was caused by Cipro. This was despite not only the warning label but also thousands of patient reports, lawsuits, media reports and studies that show that I was not crazy or suffering from sudden onset of an autoimmune disease; I was poisoned by a prescription antibiotic.

Even if I had read the warning label, I likely would have assumed that side-effects were rare. The people who acknowledged that Cipro caused the damage that it caused in me dismissed the possibility that what happened to me could happen to them by saying that adverse effects of fluoroquinolone antibiotics (Cipro, Levaquin and Avelox) are rare. How, I wonder, would anyone have a clue whether or not Fluoroquinolone Toxicity Syndrome is rare? Given that the onset of symptoms is often delayed by days, weeks or even months after administration of the drugs has stopped; that doctors and patients alike are looking for allergic reactions when they are looking for adverse drug reactions, not systemic breakdown in the form of a syndrome; that the doctors who prescribe fluoroquinolones (general practitioners and emergency care doctors) are typically not the same doctors who treat the symptoms (rheumatologists, neurologists, psychologists, etc.); that there appears to be a tolerance threshold for fluoroquinolones (meaning that you can take it up to your threshold point without incident but once you cross your threshold point you suffer from a severe onslaught of symptoms), a concept that those who are doing drug studies don’t even seem to consider; and that almost everyone in the medical field is in complete denial about the dangers of these drugs, how in the world would anyone, including the FDA, have a clue what the frequency of adverse reactions to these drugs is???

Risk is not properly communicated via drug warning labels. Risk is a function of severity and frequency. Individual adverse symptoms are listed on drug warning labels, but nowhere does it state how severe each symptom can be, or whether multiple symptoms can occur simultaneously, or if the drug can trigger a long-lasting syndrome that itself is a chronic disease. How can people possibly assess the risk of experiencing severe, life-altering, long-term side-effects if it’s nowhere on the warning label that those things can happen? And if frequency of adverse reactions is systematically under-acknowledged for the reasons listed above, how can people possibly assess the likelihood that an adverse reaction will happen to them?

Perhaps doctors and patients alike are doing the sensible thing in not bothering to read drug warning labels. If the information that they give is arbitrary and they don’t help people to assess the actual risk associated with a drug properly, they should be ignored.

The only party that the warning labels are truly serving is the drug companies, because if they can say that they warned you through the paperwork that accompanies dangerous drugs, you can’t sue them.

So who is appropriately communicating the real risk of adverse drug reactions to patients? Who is communicating the risk to doctors? How is anyone supposed to know the real severity and frequency of adverse drug reactions? We’re not getting that information – from anyone. The FDA is failing to provide that information. Neither doctors nor patients are demanding that information. Everyone is assuming that adverse drug reactions are rare, while the number of deaths from prescription drugs climbs and the number of chronic diseases that people suffer from, many of which are caused by adverse drug reactions, skyrockets.

Perhaps it is time that we start demanding that drug warning labels mean something. They should accurately and completely reflect the real dangers associated with each and every drug. Frequency of adverse events should be noted on the warning labels. This is not too much to ask for. Patients, doctors and everyone else involved should insist on it. We deserve to know.

For a list of warnings that should be on the label for fluoroquinolone antibiotics, please visit www.ciproispoison.com.

For more information about Fluoroquinolone Toxicity and the author’s experience, please visit www.floxiehope.com.

This article was published previously in October 2013.  

 

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9 Comments

  1. Even when you read the label, they make it sound as if it won’t happen to you. They use the word rare and list small percentages of risks and people will automatically think, it won’t happen to me. The doctors don’t warn you and when you bring it up, they automatically take Big Pharma’s side leaving us to wonder if they’ve been bought by these corporations.
    This is why I question everything now, even procedures get questioned. I get calls from my PCP regularly wanting me to come in because it’s time for a check up. Tell me that isn’t about money. Greed has destroyed the nobility of the medical profession.
    The one side effect you won’t find on the label (and maybe is should be) “Adverse events caused by this drug will destroy your trust in the medical industry.” Which is a real side effect the medical industry fails to recognize.
    Another side effect are the psychological side effects of paranoia and I have even seen people develop hypochondria. Many are left wondering if a drug caused a problem when it didn’t. There is no safety in solving problems with pills to include vitamins and other supplements. We have become a pill society dependent upon convenience and the false promise you will get better.
    I hate having to question my doctors, but now I can no longer trust their judgement. I’d trust a shady used car salesman before I ever trusted my doctors. The medical industry becomes offended when you question their judgement. Quite frankly, I have every right to question them. It’s right up there when you trust that stranger that offers you $5 and a ride…think about it, isn’t that what we are doing when we don’t question things?
    Ultimately it is up to us to protect ourselves from the listed and unlisted adverse events of our pill society. So if your medical providers get offended when you ask questions, find someone else, obviously they are not interested in making a living.

  2. Hi Antonia,

    Thank you so much for your kind words, for taking the survey, and, most importantly, for heeding the warning of others who have gone through fluoroquinolone toxicity. I hope that you don’t develop further symptoms and that you heal quickly from both the pneumonia and any effects of the levaquin.

    Your doctor probably simply doesn’t know about the adverse effects of fluoroquinolones. If he is interested in learning about fluoroquinolones, or if you need something more than my article to back you up on your decision to stop taking the medication (which you always have every right to do), peer reviewed articles about the dangers of these drugs can be found here – http://floxiehope.com/fluoroquinolones-links-resources/ One of the articles that I think is good to show doctors is this one – http://www.levaquinadversesideeffect.com/wp-content/uploads/Documents/Hall-2011.pdf – because it notes that young, healthy people can be hurt by fluoroquinolones. Another interesting article is this one – http://www.bu.edu/abl/files/stm_kalghatgi.pdf It should be noted (by both you and your doctor) that oxidative stress and mitochondrial damage don’t go away as soon as administration of the drug stops. I hope that your doctor is receptive! If you have any questions or if you need any more information, please let me know.

    I’m not sure if you saw these, but both Debra’s and Patti’s stories illustrate why fluoroquinolones and corticosteroids shouldn’t be administered together. They’re here – http://www.hormonesmatter.com/glabrata-deadly-post-fluoroquinolone-infection-youve-never-heard/ and http://www.hormonesmatter.com/doctor-said-worry-levaquin-warnings/

    Please don’t be too scared – anxiety isn’t good for anyone. Most people have reactions that are much more mild than Debra’s, Patti’s or mine.

    Regards,
    Lisa

  3. I want to thank you for sharing your story and for your activism on this medication. I was prescribed, 2 days ago, Levaquin, in combination with Dulera, an inhaler containing a corticosteroid! These were both prescribed to me for walking pneumonia.

    I am stopping both medications (am 2 days into it), and will consult again with my physician to ask him to please change the medication.

    Thanks for your light shared! I took the survey. My side-effects, as of now, are not bad, but I’ve just become aware that they may arise in a delayed fashion, even after stopping the medication. I did already take a full course of Levaquin just a few months ago for a UTI. Shameful!

  4. Actually I did read the indications, and was aware, but for some reason, I figured the “less than 1 percent” was good enough for me. To make matters worse, Even after reading the warnings, when I did get the first side effect (Dequervains) in my left hand, I did not associate it with the cipro since it was not my achillies tendon…. Now 4 months later, I am all screwed up since I did not make the connection, and kept taking the cipro for 5 weeks…….

  5. Jeannie, first off, I am so sorry for the pain caused by your tendon tear (which was, of course, caused by Cipro)! I suggest that you go over the warning label for Cipro with your physician. Here it is – http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019537s082,020780s040lbl.pdf There is a big black-box warning for tendon ruptures, so I don’t know why they’re denying that your tendon issues are from the Cipro. there are probably hundreds of reasons why Physicians are remaining willfully ignorant about the dangers of these drugs. They prescribe them all the time and they certainly don’t want to think of themselves as people who do harm to their patients. They probably truly want to help and heal their patients. Most people don’t have a severe adverse reaction to fluoroquinolones the first time they take them (their livers are able to metabolize the toxins until they aren’t able to do so any longer) and therefore Physicians think that these drugs are safe. Adverse reactions are often delayed and so the prescribing physician doesn’t see the damage that the drug has caused. The adverse effects of fluoroquinolones are ABSURD. I could go on and on with reasons. Here is a list of reasons why these reactions are seen as rare, even though the probably aren’t – http://floxiehope.com/2013/08/09/is-fluoroquinolone-toxicity-rare/ Good luck in gaining recognition! More importantly, good luck in healing! I hope that you find some healing and that your tendons generally are not effected too badly.

  6. I rarely take meds and thought just an antibiotic for UTI not to worry – I only took one dose and sustained an extremely painful tendon tear. I’ve had Cipro before and have had other symptoms. One doc says no tear,Cipro not bad, another doc diagnose tear but also say not Cipro. Attorney you posted say need diagnosis. Why do all these pgysicians deny this?

  7. Thanks for your comment, Kat!

    I assumed that an adverse drug reaction could be stopped too. I figured that if I started to feel bad, I could stop taking the drug and that I would feel better as soon as I stopped taking it, and that my bad reaction would stop as soon as the drug was metabolized. None of those assumptions are true for fluoroquinolones. My entire reaction started 2 full weeks after I had finished taking Cipro. I lost my memory about 3 months after I had finished taking it. There is nothing that doctors could do to stop the destruction that the Cipro had done in my body.

    I love “magic always comes with a price” and the analogy of taking the red pill. We both see the world differently after taking fluoroquinolones. Too bad everyone is stuck in the matrix and they can’t see what we see. I wouldn’t wish my reaction on anyone, but I do wish that others could see things how I do. So I will continue to write. Hopefully with enough people screaming about the dangers of FQs, the notion that they are dangerous and ludicrous drugs will enter the common consciousness.

  8. When i used to take drugs (Rx), i would make the pharmacy give me the PDR info attached to the bottles they get. But i would not read the info right away. I would take the drug for a few days, note my reactions, and then go to the PDR info to “verify” that i was right. You see, i was afraid that i would “psych myself” into the adverse reactions if i read them in advance. I had been taught -bludgeoned over and over by mainstream med – that i couldn’t trust my own body and what it was telling me. So, no, i did not read the Cipro info. I’ve said it before, but the “Once Upon a Time” TV show’s mantra, “Magic always comes with a price” is the perfect mantra for drugs, “Medicine always comes with a price.” I have chosen to live without the benefit of modern drugs. I use supplements, but no thank you to the poisons sold a drugs. I could go on and on – i’ve seen first hand how they do the drug studies in hospitals, and it is not to be trusted. We who have to live with this have taken the red pill (the Matrix) and can’t see it any other way. But it is sad to see how many people, doctors and pharmacists included, who still believe that what they have been told is reality.

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