There are side effects and then there are SIDE EFFECTS! A drug that causes headaches or heartburn can be annoying, but such symptoms are tolerable if the medicine is doing great good. Side effects that are potentially life-threatening are a whole different matter. On May 26, 2014 we warned readers of a really serious complication: fluoroquinolone antibiotics and aortic aneurysm. On October 26, 2015 we asked: “Did Levaquin Antibiotic (Levofloxacin) Cause Lethal Aortic Rupture?” A woman shared a tragic story about her father’s aneurysm after a fluoroquinolone antibiotic.

Fluoroquinolone Antibiotics and Aortic Aneurysm?

We discovered an article in JAMA Internal Medicine (online, Oct. 5, 2015) that established a connection between fluoroquinolone (FQ) antibiotics like ciprofloxacin (Cipro), levofloxacin (Levaquin) and moxifloxacin (Avelox) and aortic aneurysm.

What is aortic aneurysm?

This is a life-threatening complication. When the main artery in the body, the aorta, ruptures or tears it is disastrous. Bleeding can be massive and lead to death. To say this is a crisis is an understatement.

Where was the FDA?

We were shocked to read on May 10, 2017 this statement from the FDA:

“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.”

In other words, the FDA determined that fluoroquinolone antibiotics and aortic aneurysm were not a thing. Don’t worry, be happy.

More Evidence of Fluoroquinolone Antibiotics and Aortic Aneurysm!

An article published in BMJ (March 8, 2018) reestablished a connection between FQ antibiotics and aortic aneurysm. We wrote an article about this serious complication on June 18, 2018. We shared another tragic story about a man who died after receiving levofloxacin. The diagnosis: ruptured aortic aneurysm.

Fluoroquinolone Antibiotics and Life-Threatening Aortic Aneurysm

We Contacted the FDA:

On June 5, 2018 we contacted the person at the FDA who is responsible for monitoring adverse drug reactions. We alerted him to the article in the BMJ and a meta-analysis in the American Journal of Medicine (Dec. 2017) that concluded:

 “Evidence from a small number of studies suggests that exposure to fluoroquinolones is consistently associated with a small but significantly increased risk of aortic dissection and aortic aneurysm.

We concluded our message to Dr. Gerald Dal Pan with a request to reconsider the FDA’s stance on fluoroquinolone antibiotics and aortic aneurysm:

“Perhaps now would be a good opportunity to update the public about aortic aneurysm and aortic dissection associated with fluoroquinolones.

“Thank you for your consideration.
Joe (and Terry) Graedon
The People’s Pharmacy

On October 8, 2018 we reported yet another case of fluoroquinolone antibiotics and aortic aneurysm.

The FDA’s New Warning About FQ antibiotics and Aortic Aneurysm

At last, the FDA has issued a new warning about fluoroquinolone antibiotics and aortic aneurysm. On Thursday, December 20, 2018 the FDA announced:

“A U.S. Food and Drug Administration (FDA) review found that fluoroquinolone antibiotics can increase the occurrence of rare but serious events of ruptures or tears in the main artery of the body, called the aorta. These tears, called aortic dissections, or ruptures of an aortic aneurysm can lead to dangerous bleeding or even death. They can occur with fluoroquinolones for systemic use given by mouth or through an injection.”

“Patients should seek medical attention immediately by going to an emergency room or calling 911 if you experience sudden, severe, and constant pain in the stomach, chest or back.  Be aware that symptoms of an aortic aneurysm often do not show up until the aneurysm becomes large or bursts, so report any unusual side effects from taking fluoroquinolones to your health care professional immediately.”

We are glad that the FDA has finally acknowledged that FQ antibiotics can cause this potentially life-threatening reaction. In our opinion it took far too long. That said, we are glad that the FDA Commissioner, Dr. Scott Gottlieb, has been very candid about this problem:

“Today we’re warning patients and healthcare providers that fluoroquinolones can increase the occurrence of rare but serious ruptures or tears in the main artery of the body, called the aorta, which can lead to dangerous bleeding or even death,” said FDA Commissioner Scott Gottlieb, M.D. “Certain patients are at increased risk for aortic aneurysm, including elderly patients and those with a history of blockages of the aorta or other blood vessels, high blood pressure or certain genetic conditions that involve blood vessel changes. Although the risk of aortic aneurysm or dissection is low, we’ve observed that patients are twice as likely to experience an aortic aneurysm or dissection when prescribed a fluoroquinolone drug. For patients who have an aortic aneurysm or are known to be at risk of an aortic aneurysm, we do not believe the benefits outweigh this risk, and alternative treatment should be considered.”

What Do You Think?

Do you agree with us that it took too long for the FDA to take action? FQ antibiotics have been on the market since the late 1980s. It took decades for the agency to discover that these drugs could cause irreversible nerve damage, tendon rupture, retinal detachment and aortic aneurysm. We would like to get your thoughts on this serious situation in the comment section below.

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  1. Elsa
    Boynton
    Reply

    After taking erithromiacin, 3 pills, Zpack in a factory sealed carton, not pharmacist counted and bottled generics as in the US, I am
    taking daily 30 billion probiotics and still feel side effects. Big knots
    on bottom of feet along tendons and some inside hands.
    Podiatrist was useless, said to ignore it, hinting I would not be
    around long enough for it to matter. I am a young, active 79 on
    no meds which most docs find unbelievable. I will no longer be
    his patient… not that he cares!

  2. Nadine McC.
    Indiana
    Reply

    Another drug that can cause all kinds of problems, even death!! My mother had a aortic dissection, (no known cause), Jan. 1995. She was not given much time as she was taken from one hospital to a trauma center hospital that could deal with this kind of surgery. As she was wheeled into the hospital, she was taken straight to the OR bypassing the ER. As she was handed the consent to sign, she was told if she did not have the surgery, she would die within 24 hours, and if surgery was performed, she would have a 90% chance of paralysis if she survived the surgery.

    A graft, from the aortic arch down to the abdominal aorta, replaced the damaged part of the dissecting aorta. She did survive the surgery! She was paralyzed from T7 downward. She did live as good as life as possible for 10 years after the surgery with me as her primary caregiver.

    My mother did have allergies to several medications, and for years prior to the Aortic Dissection, she had been prescribed the Fluoroquinolone antibiotics for UTI’s, URI’s and other ailments. The antibiotics that she took most often were Levofloxacin and Ciprofloxacin. After her paralysis, she was still prescribed these antibiotics, including Moxifloxacin, for different illnesses.

    During the 10 years after her surgery, she developed other problems, such as, Macular Degeneration, Gallbladder disease, High Blood Pressure, Crohn’s disease, and anxiety problems. My mother passed away in Nov. 2005.

    Now, in 2018, the FDA states these drugs, the Fluoroquinolone antibiotics, can cause Aortic Dissection among other medical problems. I believe that it was these drugs that either caused or contributed to the Aortic Dissection and some of her other illnesses.

  3. HK
    Delray Beach, FL
    Reply

    Since reading your articles on FQ (Cipro, etc.) I have refused to take Cipro when the MD’s wanted to give it to me. I keep a FQ ‘list’ in my wallet to make sure I refuse any of those meds. I have a friend whose MD prescribes Cipro for her too often urinary tract infections. I have warned her but am told her MD says that for a short period Cipro won’t hurt but will help the infection. Of course my friend won’t listen to me, as I am not an MD so how does one get through to these people???? Shouldn’t the FDA put these meds on a restrictive list

  4. Cathi
    Bham, AL
    Reply

    I took Cipro in 2003 and have needed 8 joint surgeries since. This antibiotic did permanent damage to my tendons, ligaments, muscles and joints – just 2 of the many FDA black box and strong warnings these antibiotics carry. An antibiotic that can do this and cause aorta aneurysms ???

    What is wrong with the FDA that these antibiotics are still on the market? And, these adverse reactions are not rare everyone. People don’t link their torn tendon, nerve damage, heart problems… to the antibiotic they took days, weeks or months earlier. Read all of the warnings please before taking a fluoroquinoline antibiotic. Know the huge risk you are taking. Evaluate if the risk is worth it and if not, demand a different antibiotic because these antibiotics can ruin your life.

  5. Debra R.
    North Carolina
    Reply

    I’ll be contacting the FDA to report the side effects of Cipro that I experienced. In 2014 I was hospitalized for diverticulitis. I received Cipro antibiotic intravenously while there and a course of Cipro pills after I got home. A few days later I noted that my vision was getting worse & switched from my contacts to my glasses. I made an eye appointment for three days later. During the following days I started seeing a proliferation of small black floaters in my right eye. During my eye appointment my opthalmologist called a retina surgeon located around the corner from his office. I didn’t know what was happening. By the time I got to the retina specialist’s office, the vision in the lower half of my right eye had gone dark. I immediately went into surgery for a detached retina in my right eye.

    In 2015 I had a second painful attack of diverticulitis. The ER put me on 7 days of Cipro, and I went home. The hospital advised me to visit my internist for follow up. She saw me right away, and I reported pain in my right shoulder. She decided that a 7 day course of Cipro wasn’t long enough and insisted that I pick up a prescription for 3 more days of Cipro. By the time I finished the extra 3 days, my left shoulder began to hurt.

    Within days I was in so much pain in both shoulders that my internist had to help me get my shirt off to examine me. I couldn’t raise my arms past chest- height. The doctor referred me to a sports orthopedist right away.

    The orthopedist conducted a sort of doppler ultrasound on both shoulders and diagnosed severe tendonitis in both shoulders. He told me that he had seen many patients with tendonitis after taking Cipro, including a 24 year old tennis player whose tendonitis was so advanced that she could no longer walk. She had taken Cipro like me.

    After months of physical therapy, nitroglycerin patches on each shoulder to speed blood flow, and careful monitoring by this doctor I was lucky enough to finally get back to normal.

    At that point I had researched Cipro and all of the dangers of the related class of fluoroquinolone antibiotics. I learned that doctors could prescribe any number of antibiotics that would have helped with diverticulitis outside of the class of fluoroquinolones, and that detached retina and tendonitis are two of the many devastating possible side effects of that class of drugs.

    I immediately informed all of my doctors to list fluoroquinolones as an allergy for me. I posted what I knew on Facebook and discovered a Facebook support group for people injured by this class of drugs. It’s time for the general public as well as physicians to recognize the dangerous side effects of these drugs since they can cause lifelong disabilities. I was just lucky to recover from the devastation that these drugs cause.

    Thank you for staying vigilant and helping to inform the public when the FDA falls behind on their job.

  6. Robert C.
    Warwick NY
    Reply

    Perhaps the FDA could consider devoting more resources to the examination of problems with so called ” legitimate” medical products and less prosecuting purveyors of ” alternative ” health products. While clearly there are risks associated with Herbs and the like, the larger dangers continue to lie with those drugs and devices already approved and in wide distribution….

  7. jane
    Phoenix NY
    Reply

    In 2007 I was prescribed Avalox for an upper respiratory infection. Almost immediately I was vomiting blood and had bloody diarrhea. We had to call an ambulance it was so bad. Since then it is in my medical record that I am allergic to this medication. Recently had a triple bypass and that info was on my hospital bracelet. Have never been allergic to anything in my life. Thank you for this life saving information!

  8. Janet B.
    Florida
    Reply

    Thanks for your perseverance! I shared the warning with my family and friends. What antibiotics should be prescribed instead of ones in this class?

  9. Dotty
    Houston,Texas
    Reply

    As patient who was diagnosed with Giant Cell Arteritis three years ago, I am grateful to know about the FQ antibiotics. I also have a Factor 11 deficiency (13%). With the GCA having a good chance of affecting my aorta and the blood disorder keeping me from clotting well: I really have to be vigilant!

  10. Mark
    Ottawa, Ontario
    Reply

    Thank you so much for your ongoing coverage of the fluoroquinolone disaster. In 2007 I had a HORRIFIC adverse reaction to Levaquin and I have been disabled ever since. I had all sorts of horrible vascular problems including bloated failing veins carved from 13 entry points so far with more surgeries coming. I also had blood clots, broken blood vessels, deep purple and yellow bruises for no reason and so on.

    I had all sorts of other terrible things happen including spontaneous tendon ruptures, a cartilage transplant from a dead child, a hernia, torn lumbar muscle, collapsed lung, pulmonary edema, pleurisy, COPD, brain damage of some sort, anxiety attacks, balance problems, auditory distortions and tinnitus, hair loss, nails fell off, teeth crumbled away, visual problems of many kinds, insomnia, joint pain, muscle weakness, gastrointestinal distress, loss of bladder control, blisters, calluses, photosensitivity, dry mouth, racing heart, low blood pressure, palpitations, kidney lesions, non-alcohol fatty liver, hemochromatosis, seizures, spasms and twitches, wounds wouldn’t heal, neuropathy, and some serious depression.

    That is the short list. There is probably nothing out there that can do more damage to our bodies than FQs. I urge everyone to read the other great articles in the collection and to follow up in google. Go where it leads. You need to know more about this. Doctors hand this stuff out like candy and then misdiagnose the damage they’ve done as a hundred or more wrong conditions. This is actually happening to people all over the place all the time. Please, protect yourselves with more information!

    Thanks again!

  11. Jjanis
    Matthews, NC
    Reply

    Thank you to the Graedons for sounding the warning about Levaquin and related drugs. Where HAS the FDA been? I do applaud the current FDA head for finally declaring the risks of Levaquin to the public.

  12. c
    usa
    Reply

    If this was a vitamin or herbal supplement causing these problems, would it still be allowed on the market?

    I think not.

  13. sylvia r
    VA
    Reply

    Levaquin is very dangerous. It caused great trouble with tendons in shoulders and especially legs, took many months to recover and still one leg not exactly right. Beware of this drug. Dr. told me it would not hurt me. Basically crippled for quite some time.

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