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Levaquin Mitochondrial Toxicity Warning Urged in FDA Petition

  • Written by: Irvin Jackson
  • 3 Comments

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A drug watchdog group is asking federal regulators to put a new black box label warning on Levaquin, which would alert doctors and patients about the potential risk of mitochondrial toxicity from the antibiotic, which may be causing users to suffer a number of serious disorders. 

The citizen’s petition was filed with the FDA late last week, according to a report by Law360.com, urging the drug regulatory agency to take immediate action strengthen the warnings provided with the Johnson & Johnson drug.

The petition indicates that information about the Levaquin mitochondrial toxicity risk should be placed prominently in a bold, black box on the label, which is the strongest form of warning the FDA can require a drug to carry. The group also indicates that the label should include information about the risk that mitochondrial toxicity from Levaquin may increase the risk of Alzheimer’s disease, Lou Gehrig’s disease, liver damage, and Parkinson’s disease.

The request comes from the Southern Network on Adverse Reactions (SONAR), from the University of South Carolina. It describes itself as a multidisciplinary pharmacovigilance initiative, whose goal is to reduce the time between the detection of adverse drug reactions and the medical community and FDA’s response  to those reactions. The group conducts studies of adverse events reported to the FDA and other databases.

According to the petition, research by the FDA and others have linked all antibiotics belonging to the class known as fluoroquinolones, which includes Levaquin and Cipro, to potential mitochondrial damage. However, SONAR found that FDA’s adverse event database recorded a significantly higher number of complaints from doctors and patients involving Levaquin than with other drugs of the same class.

SONAR notes in its petition that mitochondrial toxicity manifests in a number of ways, and has likely been reported to the FDA as other potential Levaquin side effects, such as liver damage. The group estimates that mitochondrial toxicity could be the cause of as many as 31% of the nearly 80,000 Levaquin adverse events reported between November 1, 1997 and February 3, 2011. The group also notes that only between 1% and 10% of adverse events are estimated to actually be reported, suggesting the true extent of the problems may be substantially greater.

Stronger warnings about the risk of mitochondrial toxicity from Levaquin could lead doctors to consider using alternative antibiotics, according to the group. This could prevent consumers from suffering serious and potentially life-long complications, as well as reduce costs on the health care industry, Medicare and Medicaid.

According to the FDA, there are about 23.1 million patients who received a prescription for an oral fluoroquinolone in 2011. Cipro dominated the market, comprising 70% of those prescriptions, followed by Levaquin or a generic equivalent, which was used by 28%. Another 3.8 million patients received injections in 2011, with Levaquin or a generic equivalent making up 63% of those, followed by Cipro at 28%.

In July 2008, the FDA required that a “black box” warning be added about the tendon rupture risk with Levaquin and other fluoroquinolone antibiotics. However, the label update came at least two years after consumer advocates called for stronger tendon rupture warnings. The prominent consumer advocacy group Public Citizen filed a petition with the FDA in 2006, insisting that consumers and the medical community be provided with clearer warnings about the risk of tendon damage.

Several thousand people throughout the United States who suffered a tendon rupture or other tendon damage after taking the drug subsequently pursued a Levaquin lawsuit against Johnson & Johnson, alleging that the drug maker withheld critical safety information about the drug by failing to update the warning label earlier.

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3 comments

  1. Lisa Reply

    Thank you so much for this article! People need to know that when they take a fluoroquinolone antibiotic, they are damaging their mitochondria. Mitochondria are the engines of our cells. They’re quite important. Here’s a post about how fluoroquinolones damage mitochondria – http://www.hormonesmatter.com/fluoroquinolone-antibiotics-damage-mitochondria-fda-adds-warning/ and here is a post about how mitochondria are tricky organelles that need to reach a threshold of damage before disease results – http://www.hormonesmatter.com/fluoroquinolone-time-bomb-mitochondria-damage/ People should know that mitochondrial damage (fluoroquinolones cause mito damage) is linked to almost every chronic disease there is – Alzheimer’s, Parkinson’s, autoimmune diseases, diabetes, autism, even cancer.

  2. Charles Reply

    To Whom It May Concern,

    Currently I am in pretty bad shape. My story is unfortunately similar to many that have taken Cipro, Levaquin, Avelox, and many other Fluoroquinolone antibiotics. All started in June of this year with a kidney stone. Previous to this, I have been an active, healthy individual with virtually no health issues other than a couple bad stomach bugs, over the years. I have not had a flu shot in 20 years. Have not had any major illness ever. I worked 14 hour days in the southern New Mexico oil fields for Halliburton as a Tech. Keep an entire production and stimulation crew running. After that I was managing 40 oil wells for Concho, the largest oil producer in the state. Great job, great friends, had a good life. Little did I know………

    From June to September of 2013 I had 4 kidney stone attacks. The 4th one ended with me getting lithotripsy to remove the stone. Levaquin IV was given preoperative and week followup of cipro 500 mg 2x day. All was fine then had the stent removed during outpatient procedure. Single 500 mg cipro dose given then. After this all was good for about a week. Then started having groin pain for about 3 weeks. Dr did another outpatient cytoscopy and said all was fine. Another single 500 mg dose of cipro. Still had pain. So doc did prostate exam and found elevated white blood cells. No culture was done. Script was 500 mg 2x day of cipro for 6 weeks. No help with pain. Dr added sulindac NSAID to help. 12/7 had another surgery performed to make sure no small stones or strictures were present. None found. More preoperative Levaquin given via IV. About a week later started feeling better. I knew of risk factors with cipro and was paying attention to them. On 12/28. Noticed tight muscles in my calves and by next morning the burning in my legs began. Stopped taking cipro that day. Dr said that cipro could cause the muscle issues but did not know of issues with neuropathy. So now 8 months out I have insomnia, peripheral neuropathy, tinnitus, cognitive dysfunction, suicidal thoughts, depression, some anxiety, and mild depersonalization, chronic fatigue, dye eyes and ears, dry mouth, intolerance to heat and cold. Cold hands and feet, improper sweating. Gi motility dysfunction, lost 30 lbs so far.

    Cannot work, cannot sleep, cannot walk correctly somedays, cannot care for myself. My spouse now does 90 percent of the work for both of us. I spend most of days in bed. This issue has created a lot of stress and depression not only for me, but for my entire family, which now has to help me with many aspects of my life. The uncertainty of recovery also plays a large role in my overall stress/anxiety level.

    Now it’s August of 2014. Been to Mayo, University of Washington, The Peripheral Nerve Clinic, and Anderson Specialty Medical Clinic, and Progressive Medical Center in Atlanta so far. Tried IV Therapy, supplements, vitamins, Physical Therapy, Analgesic Nerve Therapy, etc. Had almost every test imaginable. MRI, CT Scans, Blood tests, autonomic tests. Have more tests coming. So far, not much of any improvement. Some better with sleep, but still have to take all kinds of drugs to get sleep. Anxiety is not bad, tendinopathy is better, and some slow improvements in GI function, but have bad relapses every couple weeks. Have spend 10’s of thousands of dollars, not including insurance paid costs, for treatments, supplements, travel, etc.

    There are reports that many of the symptoms are tied to mitochondrial dysfunction and autonomic system dysfunction. I have added a file outlining the new request to the FDA about the dangers of Mitochondrial toxicity caused by fluoroquinolones. Mito dysfunction causes an entire cascade effect and creates a vicious circle of ROS and cell apoptosis. I could kill you with the technical details regarding NO/OONO cycles, Electron Transport Chain, oxidative phosphorylation, anerobic cell respiration, etc, but I have posted some references at this end of this email.

    I just want people to know what many practitioners, do not tell you when they give you drugs. There is no INFORMED CONSENT, no consultation, no nothing, they usually just give you a pill and send you home. They leave it up to you to find out what the pill may do to you. For me, I have never had issues with any drugs, especially an antibiotic, so I trusted the Dr to know what he was doing. Now I am screwed up permanently. Please just do your homework and make sound decisions before you trust your health to someone else.

    I totally understand that not all doctors are idiots. Actually, I have met quite a few that are very good, and informed, so I don’t fault the entire medical profession. I do however blame the “system” we have, that promotes 15 minute DR visits, insurance companies that deny claims based on cost/benefit analysis, regardless of what the best interests of the patient, or if the doctor deems a procedure necessary. There is too much emphasis on costs, not the care of the patient. Both insurance and the medical profession are to blame. Case in point when I had my tests done at Progressive Med Center in Atlanta, the cost to the insurance company was 13K. My costs for the same tests if I was paying for them was 3K……

    I also see that responsibility lies in the realm of the patient, and society to a certain degree. Many people in our time, either are not patient enough to allow an illness to take it’s time pass, or just (due to the demands that society puts on us), don’t have the time to wait for an illness to pass. So they come in to doctors office and demand a quick fix. “Don’t you have a pill for that” is a common phrase that comes to mind. So doctors are trained to make sure a person is not dying, run some labs and based on lab results, prescribe a bill recommended by the companies that make the pill. Look at how many pharmaceutical commercials you see now.

    Not that long ago, in many cases, doctors would prescribe things less noxious, and or would recommend diet and lifestyle changes to help with issues we had. Now it’s 10 minutes in the office, a few cursory glances, and a script. Some of this is simply dictated by the insurance company and what they will pay for office visits.

    Case in point, my urologist did not even culture my EPS, just looked under a scope and said “WBC count high, consistent with infection” and loaded me up with cipro, no consult, no warning, no nothing. I am not a doctor and I know that high WBC can also be due to inflammation, not related to infection. I was in pain, and suffering after the surgery for months, and I attributed it to the surgery, and maybe infection, so I keep taking the crap, not realizing that it was in fact most likely the cause for my symptoms. By the time my legs went out on me, it was too late. So now I am a prisoner in my own house, bound to the recliner. I am lucky as my spouse takes good care of me, but she is very stressed trying to keep it all together.

    Don’t get me wrong, I do think these kinds of antibiotics are useful, and in some cases are the the only option, but doctors really need to be more informed of the dangers. I cannot tell you how many doctors have no idea of the adverse affects this class of antibiotics can cause. Secondly they need to make sure the patient is fully aware of the possible issues they could have with these drugs and that all other options have been tried before hand.

    If I was a practitioner, I would be damn certain a person needed a fluoroquinolone, and I have exhausted all other options before prescribing it. Then if needed, informed consent to the patient would be mandatory, and I would have weekly follow up and labs done to ensure they were responding well to the drugs. Of course the minimum dosage and duration would be paramount.

    Here are some links that further describe what has happened to me, and thousands of others.

    http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3760005/
    http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2094848/
    https://www.facebook.com/FluoroquinoloneToxicity
    http://en.wikipedia.org/wiki/Adverse_effects_of_fluoroquinolones
    http://well.blogs.nytimes.com/2012/09/10/popular-antibiotics-may-carry-serious-side-effects/?_php=true&_type=blogs&_r=0
    http://www.fda.gov/Drugs/DrugSafety/ucm365050.htm
    http://www.survivingcipro.com/
    http://floxiehope.com/
    https://www.facebook.com/pages/The-Fluoroquinolone-Wall-of-Pain/209182505773463

    All the Best,

    Charles

  3. james Reply

    I am also a victim of flouroquinolone antiobiotics. Cipro, Levaquin and all flouroquinolones should be destroyed and never given to anyone unless in life or death situation and the person is told the real side effects of these drugs. My life is now I only exist and have no life. I have begged to GOD to be allowed to die. The pain is so terrible as it never stops and move all around body. The drug companies know how toxic these drugs are but they do not care. I have read thousands of posts from people that are in misery everyday, but BIG PHARMA blocks this from being put on the news. I hope all BIG PHARMA burns in hell forever.

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