Antibiotics and stethoscope

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.

Get The Graedons' Favorite Home Remedies Health Guide for FREE

Join our daily email newsletter with breaking health news, prescription drug information, home remedies AND you'll get a copy of our brand new full-length health guide — for FREE!

  1. Erin
    OH
    Reply

    Recently prescribed Cipro. for a serious UTI. After taking just 1 capsule, awoke to horrible pain behind my eyeballs and blurry vision. Immediately stopped the drug, and called the doctor. I had been on Cipro before, and had experienced some knee pain and muscle weakness. My thigh muscles would literally shake. Because of this website, and reading the medication information insert, I was alerted to potential problems. Luckily my side effects were not permanent. Took about 3 days to return to normal.

  2. Sherrie D.
    TN
    Reply

    The doctor discovered that my husband has a really bad prostate infection. He discussed that he could either give him Bactrim or Levaquin. He discussed that they sometimes affected the tendons and decided to give him Bactrim. Hoping that Bactrim doesn’t have the reputation of having the same side effects as Cipro or Levaquin. He is to take it for a month.

  3. Cindy
    California
    Reply

    FQs brought me from a strong, very strong healthy middle-aged woman to feeling like a weak 80 year-old with tons of problems. I feel I will injure myself at the drop of a hat, when my body before was strong and limber from being a gymnast in my younger days. I have two torn meniscus tendons, torn rotator cuff, weak muscles and tender tendons, joint pain, small fiber neuropathy, blurry vision, brain fog, chronic fatigue, super ventricle tachycardia, gut problems, 4 months of skin rashes all over my whole body, brain confusion, anxiety, depression. All from an antibiotic that was supposed to help, from doctors who are supposed to help, and drug companies that are supposed to help. This drug ruined my life, and makes me unable to work!

  4. Peggy
    Florida
    Reply

    I was treated for a UTI with Cipro, and immediately after taking the prescription I noticed a tingling sensation on my right side. It was as if my right side went to sleep. I also have a problem with the muscles on my right side. They are in a constant state of contraction, mostly in my back, hip and ankle. It has been 13 months and no improvement noticed, so apparently this is permanent damage. I have seen my primary care doctor and a neurologist with no relief. I would never take Cipro again nor would I recommend it to anyone else.

  5. paul
    Texas
    Reply

    Levaquin prescription April 18, 2018. Life-threatening Aortic dissection July 7, 2018. No previous history with this issue.

  6. Claire
    South Carolina
    Reply

    I believe my husband has experienced muscle weakness as a result of Cipro for “suspected” prostatitis. Prostatitis turned out not to be the case! Can’t change that. The question now is: is there anything that can help? Or just keep maintaining exercise as able?

  7. Helen
    Anaheim CA
    Reply

    Why does it take the FDA so long to do anything is the question. I can’t believe we are still discussing Floroquinolones. There were women on the old Oprah show years ago who had had serious problems after taking them, and one had died. Her husband was suing the drugmaker. A co-worker in my office started telling me about some symptoms he had and he did not have to finish the story…..I said “you took Cipro, right ?” He had. I had had the same problem. (Same doctor).

    Here is part of the problem. If you have a simple UTI, which is common, and the doctor does a culture and sensitivity to see what drugs can be used, the report comes back with a Floroquinolone as one of the drugs. Unless you stand your ground, after learning the hard way, the doctor will write for Levaquin or Cipro. It is routinely given because it’s on the list from the lab test.

    Hospitals will ask you for allergies anytime you go in for any procedure. I always mention I do not want Levaquin or Cipro and then have to explain why. It almost takes an argument to refuse it. I now make them include it on my wristband, along with my penicillin allergy. I am now going to print your articles and take them to my doctor and to the hospital if I need to go in for any treatment.

  8. Mary Ellen
    NC
    Reply

    I am currently dealing with a stubborn case of Tibial Tendonitis. Makes me wonder about the Cipro and Levaquin I have taken in the past. I think I will list them as allergic reaction drugs, or at least refuse them when suggested.

    • Mark
      Ontario
      Reply

      Hi Mary Ellen. If you join Fluoroquinolone toxicity group on Facebook, I’m willing to bet that you are amazed at the number of people who have the same health issues as you. If you took FQs and you have persistent tendon issues, then you are floxed. You need to look into it further. Magnesium is agreed to be one of, if not the single most important part of healing from this, other than time. I wish you the best!

  9. Mona
    Florida
    Reply

    Over the last 10 to 15 years I have suffered ruptured tendon, swollen eyelids and made a note that I felt like I was in twilight zone while on levaquin. I try to refuse all meds in this family of medications.

    • Sherry
      Waxhaw, NC
      Reply

      Yes. It is probably from the FQs you took, although your Dr might say no. Sorry this happened to you.

  10. Cynthia Z.
    Bellevue, WA
    Reply

    I was taking Cipro for a bladder infection. I broke out in hives. I called my doctor. Now it is noted with every medical professional I see, I am allergic to Cipro.

  11. Tammy B
    IA - Iowa
    Reply

    I was taking Levofloxacin for two ton muscles in my lower legs and I was on bed rest for almost 4 years on my right foot cause it’s was so bad and now I have severe nerve damage and ALOT of pains in my right foot.

  12. Annie
    Lake Forest, CA
    Reply

    My life has changed since I was given Levaquin for a tooth infection several years ago. Besides poor memory, I developed photosensitivity on the right side of my face. SPF’s of 90 are barely sufficient to prevent burns to that side of my face. But far worse than that, my hair fell out and permanent tiny pockmarks began appearing on my face. I have spent $1000’s at the health foods store buying anti-oxidants, collagen supplements, and other supplements. That these drugs are still being prescribed is OUTRAGEOUS. I tell doctors what’s happened to me as a result of Levaquin, as well as warning all my friends. These are very harmful drugs!!!

  13. Terri
    Florida
    Reply

    Good to know. I took Cipro for a UTI and it worked quite well with no side effects. I was also prescribed Cipro for an eye infection with no problems; however if I am ever prescribed it again I will ask questions.

  14. Wanda
    Washington
    Reply

    While taking Cipro I experienced peripheral neuropathy for the first time. When I went to urgent care I was told that this was not a typical side effect, but they switched me to another antibiotic and the neuropathy gradually went away. It comes back with anxiety. I don’t know if the anxiety I experience is worse because of it or just a coincidence. I wish I’d known about the possibility of these side effects.

What Do You Think?

We invite you to share your thoughts with others, but remember that our comment section is a public forum. Please do not use your full first and last name if you want to keep details of your medical history anonymous. A first name and last initial or a pseudonym is acceptable. Advice from other commenters on this website is not a substitute for medical attention. Do not stop any medicine without checking with the prescriber. Stopping medication suddenly could result in serious harm. We expect comments to be civil in tone and language. By commenting, you agree to abide by our commenting policy and website terms & conditions. Comments that do not follow these policies will not be posted. Learn how your comment data is processed.

Your cart

Total
USD
Shipping and discount codes are added at checkout.