inappropriate antibiotics

We can hardly believe that once again the Food and Drug Administration is warning about fearsome complications from antibiotics like Cipro and Levaquin. Serious fluoroquinolone side effects have been a worry for decades. Despite that, we calculate that over 10 million prescriptions are dispensed annually for drugs like ciprofloxacin and levofloxacin. They were originally perceived as highly effective and quite safe for a range of infections including sinusitis, cystitis, prostatitis, bronchitis and skin infections.

The FDA’s OLD Caution about Serious Fluoroquinolone Side Effects:

Two years ago the FDA changed its official labeling information for drugs like:

  • Ciprofloxacin (Cipro)
  • Delafloxacin (Baxdela)
  • Gemifloxacin (Factive)
  • Levofloxacin (Levaquin)
  • Moxifloxacin (Avelox)
  • Ofloxacin

The FDA warned that fluoroquinolone antibiotics:

“…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.

“We have determined that fluoroquinolones 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.”

“Patients must contact your health care professional immediately if you experience any serious side effects while taking your fluoroquinolone medicine. 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. Talk with your health care professional if you have any questions or concerns (see List of Serious Side Effects from Fluoroquinolones).”

The FDA’s NEW Caution about Serious Fluoroquinolone Side Effects:

On top of all the old serious fluoroquinolone side effect notifications the Food and Drug Administration has issued new safety warnings (July 10, 2018).

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.

A Short History of FDA’s Announcements About Serious Fluoroquinolone Side Effects:

Fluoroquinolone antibiotics have been around for decades. Cipro has been on the market for over 30 years. It took the FDA a long time to recognize and warn physicians, pharmacists and patients about serious fluoroquinolone side effects.

This from the FDA. Please note the dates:

“Today, the FDA also published a drug safety communication about safety information regarding hypoglycemic coma and mental health side effects with fluoroquinolones.

“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 (serious nerve damage).

“In 2016, the FDA enhanced warnings about the association of fluoroquinolones with disabling and potentially permanent side effects involving tendons, muscles, joints, nerves and the central nervous system. Because the risk of these serious side effects generally outweighs the benefits for patients with acute bacterial sinusitis, acute bacterial exacerbation of chronic bronchitis and uncomplicated urinary tract infections, the FDA determined that fluoroquinolones should be reserved for use in patients with these conditions who have no alternative treatment options.”

What About Aortic Aneurysm?

As far as we can tell, the FDA has not issued a warning about fluoroquinolones and aortic aneurysms. We have asked executives at the FDA to consider this as one of the most serious fluoroquinolone side effects. So far we have seen no response.

This is the last communication we could find on this very serious matter (May 10, 2017):

“As part of our ongoing review of fluoroquinolone antibiotics, FDA is informing the public that patient cases identified by the FDA and findings from published studies currently do not support reports that these medicines may result in detachment of the retina in the eyes, or bulges or tears in the aorta blood vessel called aortic aneurysm and aortic dissection.”

Here is a recent article we have written on fluoroquinolones and aortic aneurysms. There is new research. Why, we wonder, does it take the FDA so long to issue new warnings.

Fluoroquinolone Antibiotics and Life-Threatening Aortic Aneurysm

Share your own story about serious fluoroquinolone side effects below in the comment section.

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  1. Mae
    SC
    Reply

    I am allergic to Levaquin, two week after I finished I was breaking out in hives on my back end. It spread and itched a lot, very bright read hives.

  2. Helen
    NC
    Reply

    I took cipro years ago and will never take it again.. I april,2018 I took levaquin for h-pylori for 7 days and had to be the worst drug I have ever taken., took 500 mg for 7 days once a day and I can tell you I haven’t felt good since, I feel it has effected my nervous system, I cry a lot,feel irritated and agitated every day, I didn’t feel this way before those terrible pills.

    They should be banned from giving them to people, pretty disgusting that Dr’s don’t think nor do they tell you what the side effects are, shame on them. Now I have to have TMS treatment because I have such terrible issues with the above mentioned side effects. I am so upset don’t want to on.

  3. Douglas R
    Plano, TX
    Reply

    I took Cipro 4 1/2 years ago – what a nightmare. As a guy who played basketball 3 times and tennis 2 times a week, I went to hardly being able to get up the stairs to my apartment. Last summer I was able to get back to playing full court BB, but not with the same mobility. On April 14, 2018 I took Keflex(anti biotic) for an infected finger damaged on the BB court.

    Six days later I played full court BB, 2 days after that(8th day on antibiotic) I was volunteering for a charity event at a hotel, my legs were in such pain that I told them I had to leave and thought I might need a wheel chair to get to my car in the parking garage. I have been drinking 1/4 teaspoon of Borax in a liter of water everyday.

    I haven’t been able to play BB yet but the debilitating pain in the lower legs and tendons has subsided to the point that I am about 80% back to where I was. I tell everyone I can about these drugs – but the Doctors I talk to are CLUELESS!

  4. Ginny
    Hobe Sound, FL
    Reply

    I was prescribed Cipro for an UTI. After reading the insert, I did not want to take it because it stated that it could cause an irregular heartbeat! This concerned me since I have a-fib! After talking to the pharmacist and nurse at my cardiologist, I was assured that it was OK to take the drug. A day and a half after taking Cirpo I wound up in the ER with PAC’s!! I was told to stop taking it and to never use it again.

  5. TJ
    PA
    Reply

    Cipro got me. No one believes it will happen to them until it does. My adverse effects were musculoskeletal and the spinal damage is permanent. There is no way to know ahead of ingestion if you will react adversely. It’s quite risky.

  6. Susan J
    San Antonio, TX
    Reply

    Last year Ciprofloxacin was prescribed by my physician resulting in a terrible bout of tendonitis in my wrist and thumb. I went to see an orthopedist who gave me a steroid shot. Unfortunately the condition retuned! I had never had anything like tendonitis before taking the Cipro.

  7. Jean
    WA
    Reply

    A young friend of mine was given Cipro for intestinal problems when she was in Morocco. It completely destroyed her gut for two years, resulting in constant pain, diarrhea and vomiting. She was diagnosed with a C-dif infection which occurred opportunistically due to the Cipro. Five years later she is still not fully recovered. Why this drug is still on the market is mind boggling.

  8. Jane
    Raleigh, NC
    Reply

    In 1999 I took my mother to an integrative medicine doc who gave her Cipro as part of a treatment protocol. She was 76 at the time and suffering from fibromyalgia. She actually had bleeding from the small blood vessels of her legs which the doc dismissed. She, on her own, decided to stop the cipro. Thank goodness, she could have suffered even more damage I now discover from your report.

  9. Joan
    FL
    Reply

    About 2 months ago, I got a UTI. It was on a Saturday but I had felt something coming on a few days before. When I stopped urinating I did some research. Of course things like this seem to come when your regular MD is not in so I went to the local walk in clinic run buy a local hospital.

    By the time I got there I couldn’t even walk. My son got a wheelchair and had to lift me out of the car and put me in the wheelchair. I was really weak. The Dr in charge wanted a urine sample but no matter how long I sat I could not urinate. He wanted me to go to the ER and have them catherize me so I could get a suitable antibiotic.

    I’ve had UTIs before and I knew there were antibiotics that would help without testing my urine. I talked him into giving me a broad spectrum antibiotic. He chose Cipro. By this time I was nearly unconscious. I took what he gave me without even looking at the papers that came with it.

    Fortunately, I had some acidophilus and took that with it. The next day I was hallucinating and had no clue that it could be from the cipro. I took it for 3 days and then only because my daughter came to see how I was and realized that the cipro was making me sicker than the UTI. I was urinating by that b time and I stopped taking the cipro. I went to my regular MD and he gave me a different antibiotic.

    In a few days I was ok but then I developed tendoneitis in my heel and both elbows. I still have it and it’s been 2 months. I did have my Dr put a note in my records that I was allergic to cipro. Why is that drug still on the market?

  10. Mark
    Ottawa
    Reply

    THANK YOU FOR THIS EXCELLENT ARTICLE!

    The fluoroquinolones, or FQs, are unbelievably toxic drugs that wreak havoc on everyone’s bodies on a sub-cellular level, from head to toe, body and mind, as FDA is slowly admitting. the reason it takes FDA so long to issue new warnings because FDA works for BIG PHARMA, not for the people. The truth is that FQs are so incredibly toxic and dangerous that even an agency as corrupted as FDA cannot go on pretending they are safe.

    Plus, the EMA just held a hearing in London where they pointed out that the FDA warnings have had minimal effect so far. Doctors are still handing the stuff out like candy. I am cautiously optimistic that we are on the cusp of a bit of a battle between FDA and EMA to appear as the most responsive to this crisis, a crisis which is much much larger than either of them realize at this point.

    There are HUGE numbers of people who have been harmed but due to the delayed responses the vast majority of us have not connected our overwhelming health problems to antibiotics we took several seasons before they all set in. We are routinely misdiagnosed with any of hundreds of WRONG conditions and then prescribed more toxic and often addictive medications.

    It’s almost impossible to convince a doctor that he or she has wrecked your life, even if the evidence is overwhelming. This announcement is one more piece of solid info that we can share with our clueless medical teams to help them become less harmful as they do what they do.

  11. Sandy
    Irvine, CA
    Reply

    When I told the doctor I did not want to take Cipro because of the possibility of tendon rupture, he looked at me and said ‘are you a nurse?’ I told him no, just an informed patient because I read the People’s Pharmacy!

  12. Sharon
    Reply

    12 years ago I was given IV Levaquin prophylactically for minor surgery.
    I HAD NO INFECTION! My life changed forever. My adverse reaction seem to be permanent!

  13. Kelly
    Springfield, MA
    Reply

    Most doctors and pharmacists don’t read the updated safety warnings. I confronted my Dr. with the blackbox warning concerns and told her about the horror stories from people online. She assured me it was rare and nothing would happen to me because I was young and that it only happened to the elderly and not to believe what I read on the internet. After 2 days, these antibiotics ruined my life!!

    It’s been 5-1/2 years and I still struggle daily with pain due to nerve damage. Every single doctor I went to afterwards tried to blame it on something else. You don’t go from being healthy to crippled OVERNIGHT after taking a drug that is known to cause debilitating side effects.

    I wish I listened to my instinct and asked for a safer alternative. As much as I’ve tried to warn others about taking it, people still do because they have the mentality that “this won’t happen to me” – unfortunately, a few people I know since this happened to me have also been affected. I wish I could have saved them. Thank you for posting this important update from the FDA!!

  14. Nancy
    Reply

    Some years ago I was prescribed Levaquin, I developed severe insomnia. At the time I was working and also watching my young grandson. It was hard to get through the day, sometimes with only an hour or two of sleep. I asked my husband to ask the pharmacist about the side effects of this medicine and the pharmacist said he never heard of Levaquin causing this problem. I thought I was having a nervous breakdown (and was probably getting ready to have one from so little sleep). I then asked my husband to ask for a printout about Levaquin and the insomnia was listed #2 for side effects. I never dealt with that pharmacy again.

  15. Carol
    Baltimore, MD
    Reply

    I would like to see an evaluation of the value in giving these antibiotics for a course prior to and for several days following, oral surgery. I am in the process of getting implants, which involved bone graft and sinus lift. Still have more procedures to go. I took the antibiotics and had no side effects (I eat at least a cup of plain yogurt daily) — but I still feel uncomfortable about this seemingly unquestioned routine.

  16. mary
    IN
    Reply

    I know cipro has some bad side effects. I have experienced this. For me, it is the only med that has helped with bladder infection without fail. Only time I use it.

  17. Karen
    Arizona
    Reply

    It is really interesting that the FDA is finally stating what thousands of us have been saying all along! the FQs have destroyed our bodies and we are sick of their coverups. I was treated as if I was a hypochondriac, crazy, needing attention and all sorts of other painful labels when in reality the FQs nearly killed me.

    Six years after getting an IV of Levaquin and a 5 day supply of levofloxacin, i am still dealing with the repercussions and yes, parathesia, tendon and joint issues are but a small part of the the horrific effects.I wrote to the FDA, wrote to congressmen, senators, President Obama and no one cared to do a thing about it. It was so much easier to discount the crazy lady and pretend that she overreacted than to face the truth of the matter.

  18. SuziQ76
    WI
    Reply

    I have a nephew that has been permanently rendered a cripple from Levaquin. His life is ruined. And a grandson with a ruptured Achilles tendon. They tried to give it to my husband for a root canal & I said NO! They argued but I held my ground. No quinolones for us .

  19. Lida
    Ohio
    Reply

    What are comparable but safer choices?

  20. Lida
    Ohio
    Reply

    What are comparable but safer antibiotics to use?

  21. Margy H F
    Baltimore
    Reply

    My elderly mothe rhasbeen on Levaquin for 14 days after a life threatening UTI. Although her white count did go down, she is having such serious side effects. Those effects are depression, refusing food because the taste is off, hallucinations, more confusion than usual, electric like pops and feeling like her eyeball jumped out of its socket, and generally feeling horrible.

    The problem is her allergies to penicillin like drugs. So there was no other choice. I am hoping that the medication will leave her system quickly

    • Nancy
      North Ft Myers FL
      Reply

      I was floxed by IV push in fall of 2008. Once it is done the damage never goes away. I have just learned recently that neuropathy is one of the side effects. I have it big time in my feet and legs. The effects of this stuff once poisoned is something you just learn to live with. My mom’s kidneys shut down with in 45 days of being given levaquin. We lost her with in days. She just gave up.

  22. Sherry
    Waxhaw NC
    Reply

    As you know I have been writing about the perils of fluoroquinolones for several years now. The FDA is just very slow in getting the word out while we the patients are getting poisoned by them, many of us never connecting the dots.

    I will applaud the FDA ONLY when they add the ear and eye drops to their list. These forms of FQs are just as dangerous. I know. I am what you call “living” proof.

    Thank you once again for bringing this to the attention of your subscribers, now we have to work on the doctors who still and always will prescribe them like candy and use them prophylacticlly.

    IMO, only if you have a Rabbi or Priest by your bedside should they be used.

  23. Sherry R
    Waxhaw, NC
    Reply

    Hi,

    You can repeat all my stories for the last several years that I have written about these horrible drugs!

    The FDA is just VERY slow in putting new findings out while we suffer.

  24. Carol
    Chesterfield, Mi
    Reply

    After taking Cipro I felt nauseated and lightheaded. So bad that I refuse to take this antibiotic anymore. I always thought I was allergic to the ingredients.

  25. Bonnie W
    NC
    Reply

    These drugs should be taken off the market! I had a horrible reaction in the hospital ER and had severe hallucinations from it there. They rushed me into acute trauma unit. Then after 2 weeks, I began to develop strange blisters on my skin. I was miserable one particular night and stayed up searching the Internet until I found pics to match mine.

    It turns out that I had Stevens Johnson syndrome and confirmed the following day with my dermatologist. I had to be put on a regimen of 11 prednisone per day to start. This is a serious condition which leads some to have to go to burn centers. I’m glad you put out this article for others to know about these terrible side effects!

  26. Erin J
    FL
    Reply

    Several years ago I was prescribed Levaquin to treat an upper respiratory infection. I managed the first round of it with just mild stomach discomfort, but the infection didn’t clear up. My doctor prescribed another round of the drug and that is when the problem started.

    Within just a few minutes of taking the first dose of the second batch I began to notice a severe pain in each foot, and up my legs. We were out to dinner so on the way home I stopped and asked my pharmacist what the pain could be. He looked up a few things and directed me to go to the emergency room. He advised me that Levaquin could rupture tendons. I had a lot of pain in my feet, hands, and legs for months afterward.

    I spent 5 days in the hospital. You can be sure that I’ve never taken a drug from the Quinalone family again.

  27. Donna
    Maryland
    Reply

    I have taken Cipro many times without side effects. Took levoquin and do well on it and felt joint pain , which could be arthritis?? But had. Mouth ulcers from avelox.

  28. Ricardo B
    Chesterfield va
    Reply

    Almost 5 years later, I still suffering with the side effects of that poison no other name for that. Pain all over my body joints fatigue. Vision and GI problems. Anxiety 24/7. If you want to read about horror stories look for floxies on facebook.

  29. Bill
    Reply

    Twenty-four years ago, the official prescribing information for Cipro (1994 Physicians’ Desk Reference) includes:

    In the WARNINGS section:

    “The oral administration of ciprofloxacin caused lameness in immature dogs. Histopathological examination of the weight-bearing joints of these dogs revealed permanent lesions of the cartilage. Related quinolone-class drugs also produce erosions of cartilage of weight-bearing joints and other signs of arthropathy in immature animals of various species.” (1994 PDR, page 1571)

    “…toxic psychosis [has] been reported in patients receiving drugs in this class.” (1994 PDR, p. 1571)

    The ADVERSE REACTIONS section includes the following behavioral effects:

    manic reaction, depersonalization, depression (1994 PDR, page 1572)

  30. Joyce
    Kansas
    Reply

    I was sure I was dying within 5 minutes of taking Avelox. Water ran.off of me extremely.hot couldnt hardly walk. Was told it was just a reaction. I REFUSE ANY DRUG W FLUORQUINOLONE IN IT.

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