Quinolone Safety and Efficacy,

Quinolone Safety and Efficacy,

There are 93 comments on the Cdc.gov story from Apr 22, 2005, titled Quinolone Safety and Efficacy,. In it, Cdc.gov reports that:

To the Editor: Richard Frothingham should be commended for providing added perspective on the matter of quinolone selection.

Join the discussion below, or Read more at Cdc.gov.

davidtfull

Plant City, FL

#63 Jul 23, 2008
Deist wrote "I am on Levaquin now and have taken it in the past. I am very pleased with this medication. I believe the ruptured tendon rate is 1 in 400.000? Correct?"
NOPE, wrong as could be. The risk factor is anywhere from .5% to 16% depending upon which citation you care to reference and the year in which it was published.

Rather than retype this comment over and over, as so many sites are running with this story, I would beg pardon from the host of this site to allow me to paste this comment, which has been spell and grammar checked for errors as well as submitted to those other sites.

I believe it captures the concerns of those who have been injured by this class and hence a relevant comment to this story, as well as adds the facts that have been deliberately excluded by the FDA within their press release:

Tendon rupture is the least of the patient's concerns. This class is associated with irreversible peripheral neuropathy, fatal liver and kidney damage, fatal hypo and hyperglycemia, SJS and TEN, toxic psychosis, spontaneous ruptures not only of the tendons but also muscles, ligaments and cartilage, the list of serious adrs is boundless. More than half of the drugs found in this class have been removed from clinical practice due to severe and even fatal adverse reactions.
Within the NDA (new drug application) for levofloxacin we find clinical studies that revealed an adr rate in excess of 40%(one or more reactions) and a number of listed fatalities. We find these same numbers with all the NDAs for this class. This tendon issue we are now discussing was first revealed to the FDA back in 1982 (bailey et al). The FDA did NOTHING until Public Citizen filed a petition in 1996 seeking both black box warnings and dear doctor letters. The FDA did neither. Another petition was filed by the Attorney General of the State of Illinois in 2005 seeking these same actions. In 2006 Public Citizen once again petitioned the FDA. Rather than respond to these petitions as required by law, the FDA stonewalled the petitioners for more than three years. It was not until suit was filed in Federal Court by Public Citizen to compel the FDA to respond to these petitions did the FDA do anything.
And what they did was nothing more than a 'slap to the face' to those of us who have had our lives destroyed by these drugs. It is far too little, far too late. And we would not even be tossed this 'bone' if this lawsuit were not pending. This is nothing more than a blatant attempt by the FDA to avoid full disclosure of the true safety profile of this class which will be required when they lose in Federal Court.
Bayer issued a European "Dear Doctor Letter" in February of 2008 in regards to fatal liver injury as a result of being on Avelox. Yet we see no such letter being issued here in the States, nor do we see the FDA requesting one either. This class has been crippling and killing patients since the mid sixties. For more than forty years now the FDA has hidden the true safety profile from both the patient as well as the treating physician.
Those who have an interest in reading this forty years worth of medical journal entries, case reports, newspaper articles, clinical studies, etc., that documents all that I state here are invited to log unto www.fqresearch.org

I find the manufacturers to be grossly misleading the patient and physician alike when they state that this class is a safe and effective antibiotic with minimum side effects. I have forty years worth of medical documentation that proves that they are anything but for those who care to read it, rather than this line of misleading and false information being provided by the FDA.
Mr. David T. Fuller
Director
Fluoroquinolone Toxicity Research Foundation
www.fqresearch.org
[email protected]
[email protected]
Jlc

South Elgin, IL

#64 Jul 24, 2008
I had never heard of Levaquin causing problems. I have taken antibiotics with no problems in the past.
Last week I went to the Urgent care and was given Levaquin for an infected cyst. On the 5th day I awoke with extreme leg pain from the knee down. I had no idea what it was. I went to the Emergency room and they had no idea. I discontinued the Levaquin at that point as I just had a bad feeling about it. The next day the pain was worse and I had to use crutches to get around. I then googled Levaquin and leg pain and THAT is when I found the association. So as you can see as in ER nurse you may very well have seen someone with the side effect and not recognized it yourself and since I was not aware of the problems or the black box warning before the time I googled there is no way I was self fulling the prophecy. I resent your attitudes as this has been a very painful and upsetting ordeal. If the urgent care doctor had taken my history she would have know I just had Achilles tendon surgery 6 months ago and I should never have had the drug in the first place. My cyst was not life threatening and could have been treated with a much safer antibiotic. I made the mistake of trusting the doctor would take all this into account. I was wrong.
Db Cipro

Bohemia, NY

#65 Jul 24, 2008
The fact that Cipro and quinolones can cause permanent, untreatable tendon damage as highlighted by the need for a black box warning, that leaves patients with crippling untreatable pain, is only the tip of the iceberg when it comes to the other severe and permanently disabling adverse reactions that Cipro and other quinolones can inflict. The product information sheets provided by quinolone manufacturers also fail to indicate that some individuals will suffer from multiple adverse reactions that will become permanent and untreatable. They list a wide variety of adverse reactions that would seriously impair anyone’s quality of life, including psychological, neurological side effects as well as physical, if one had to live with them for life. Some of these reactions can develop days, weeks or months after taking these pills as well, making if more difficult to identify the drugs as the culprit of the disease.
I as well as numerous other individuals, who have tried to report these reactions to their physicians and the FDA, have been ‘ignored’ or ‘rebuffed’ by physicians. I have a ‘constellation’ of symptoms from taking Cipro in 2006 that do not respond to treatment. My permanent adverse reactions in addition to chronic tendinitis include tinnitus, hyperacusis, visual distortions and light sensitivity, smell and taste perversion, insomnia, anhedonia, chronic fatigue, anxiety and severe depression, loss of appetite, peripheral neuropathy, myoclonic muscle jerks, hypertension, hyperlipidemia, hypothyroid, brain fog, memory problems, constipation and 25 pounds of weight loss in addition to the muscular and degenerative bone issues. Tendonitis is a small part of the entire picture. If you find this hard to believe, check the ADR lists for Cipro and Levaquin. They’re all listed, but are considered “rare” reactions. Only tendon damage and peripheral neuropathy are indicated as possible permanent adverse reactions. What I and many others dispute is how “rarely” they occur, and we report that many of these adverse reactions cannot be treated and remain permanent long after taking the drugs. And when people report that they do occur to them after taking Cipro, or Levaquin, doctors are reticent to acknowledge they were caused by the drugs, especially if they develop in these ‘constellation’ of maladies. What's worse is that these symptoms are not treatable in many cases leaving people permanently injured.
Ann

Wilmington, DE

#66 Jul 28, 2008
I took Levaquin in Feb. of 2008 and did not experience anything until April. It comes on quickly - pain in all joints, neuropathy, headaches plus a multitude of other problems. I understand it is a long and arduous road back. As for me - I would NEVER take any fluroquinolone again. The FDA has posted a "black box" warning on these medications. It has ruined my life.
Ann

Wilmington, DE

#67 Jul 28, 2008
Does anyone know of a safe antibiotic to take?

Since: Jan 08

Elk Grove, CA

#68 Jul 28, 2008
Ann wrote:
Does anyone know of a safe antibiotic to take?
Sulfa drugs and I have found that Biaxin XL seems to have very few side effects other that a funky taste in your mouth.
Greg B

Southlake, TX

#69 Jul 28, 2008
I also know that the tendon damage is only the tip of the iceberg. I had a life-altering negative reaction to Cipro three years ago, and was left wondering whether or not I'd ever be the same again. For me the biggest problems were psychological, including paranoia, hallucinations, extreme anxiety and even thoughts of suicide - all things that had never happened in my life prior to taking this horrible drug. In my case, though, I did turn my health around, and did it by taking on a very healthy lifestyle. Basically, I became a vegetarian and started exercising and taking various supplements. I lost all my excess weight and have found that just being as healthy as possible gave my body and mind a chance to heal. As for the supplements, the only thing I found that helped me psychologically was/is GABA, specifically GABA manufactured by SourceNaturals. Doctors have told me that it can't help, that it can't cross the blood-brian barrier. All I know is that when I was at my worst three years ago, I'd take this inexpensive and readily available supplement and feel better within minutes. In any case, I write this as an encouragement to those of you who are suffering because of this terrible drug. In many cases it is possible to get better. It takes time and effort, but it is often possible.
ciprovictimalso

Snyder, TX

#71 Jul 29, 2008
I recently ran across a law firm that would like to hear people's stories about being injured by quinolones like Levaquin, Cipro, Avelox & all the others. They have set up a comment board. Here's the site:
http://tinyurl.com/lawfirm
Rick

Hilton Head Island, SC

#72 Aug 5, 2008
Please excuse my pasting the following comment as there are many websites running this story:

One very negative feature of this class of drugs (fluoroquinolones) is that the damage they cause may very well be permanent. The only reference to permanence I could find on the label is referring to permanent neuropathy. The tendon ruptures, the PN, many of the other debilitating symptoms are also permanent.
"stop taking the drug and call your doctor" the warning says - but that may be too late for alot of people.
Another thing: the ADRs for these drugs may appear months after you take them. This is what happened to me. I took avelox in March 2005 for a sinus infection, and in early June I started feeling the ADRS; fatigue, vision problems, neuropathy, dehydration, tinnitis, insomnia. I had no idea what was causing it, and the med. community was no help. They don't diagnose for ADRs to FQs or any other drug. So patients get mis-diagnosed.

I feel this is nothing short of a health crisis in this country. Between doctors being ignorant and misinformed about these drugs and the FDA doing nothing, we have a problem on our hands!

rick
Bob

Tehran, Iran

#73 Aug 30, 2008
Bob from Lincoln UK

I took 7 days of a 28 day course of Ofloxacin in November 2007
Had to stop the meds due to intense pain in my knees and shoulders.
4 weeks in:-
hardly walk with severe swellings in knees , ankles and hips.
6 weeks in:-
Toxic psychosis, depression, anxiety and suicidal thoughts
9 months in:-
Pain in joints and muscles, tendons popping in every single joint but worse in spine.
Chronic back pain
Worsening of pre existing Tinnitus
Burning sensations on hands and feet.
Flushing sensations
Bee like stings all over
Feeling of being cold even in hot weather.
Urinary problems
New symptoms manifest themselves every week
Symptoms are progressive and not transient as stated in the prescribing literature.
I am 43 but feel like 63.
If you have Prostatitis or any infection that HAS NOT been cultured refuse Fluoroquinolones until they can confirm its life or death, honest it is just not worth the risk.
BE WARNED YOU QUALITY OF LIFE MAY DEPEND UPON IT!!!!!!!!!!
Andrea

Los Angeles, CA

#74 Sep 7, 2008
I was prescribed Ciprofloxacin from an urgent care doctor for a urinary tract infection. My doctor did not mention any kind of side effects. I went home thinking that this was any other antibiotic. I even read the list of side effects before taking the medication. What I read did not prepare me for what I experienced. I later saw the list of side effects as vague and lacking. The problem with ciprofloxacin and probably others is that there is not enough clear, detailed warning added. They are being prescribed too commonly when it is unneccessary. Also, the effects seem to tend to be long lasting. I have never felt this way about a prescription before. This is a real problem. I personally experienced: difficulty breathing, fatigue, severe muscle/body weakness, body pain, carpal tunnel pain, slight vision change, stiffness, mental confusion, difficulty concentrating, heart palpitations, anxiety/nervousness/restlessne ss, malaise etc. So many parts of my body were affected. Many of my symptoms disappeared after discontinuing treatment, while others lingered, coming and going. Some new ones even popped up. For me, the brain fog, memory problems, and weakness have been the worst. It is really too soon to tell though what permanent damage occurred, if any. Hope to recover, and do everything I can to put an end to this problem.
Richelle

North Andover, MA

#75 Oct 21, 2008
Lori wrote:
Anyone with any good results? My Dr just prescribed for acute sinus infection and after reading all this I'm afraid to use. The pharmacist told me it has very little side affects.
This medicine is great!
Quinned out

Tustin, CA

#76 Nov 4, 2008
the labeling says the reactions are not dose dependent. any drug that interferes with dna is dangerous. what if it also interferes with normal cells not only bacterial cells. our science is not advanced enough to be sure it doesn't. what else could explain the multi systemic ADRs many people have. collagen disruption is admitted to by the drug maker. collagen is necessary for healthy tissue in your whole body. i hope doctors think twice, thrice, a hundred times, before ruining someone else's life with quins. anyone who thinks doctor knows best has some growing up to do. educate yourselves, and know that side effects are a lot more common than drug companies with their flawed testing will lead you to believe. the quins gave me permanent damage in much of my body and ruined my life. if i told you the real extent of it no one would believe me. go read the many stories online. it could be you.
Tam

Los Angeles, CA

#77 Nov 6, 2008
Greg B wrote:
I also know that the tendon damage is only the tip of the iceberg. I had a life-altering negative reaction to Cipro three years ago, and was left wondering whether or not I'd ever be the same again. For me the biggest problems were psychological, including paranoia, hallucinations, extreme anxiety and even thoughts of suicide - all things that had never happened in my life prior to taking this horrible drug. In my case, though, I did turn my health around, and did it by taking on a very healthy lifestyle. Basically, I became a vegetarian and started exercising and taking various supplements. I lost all my excess weight and have found that just being as healthy as possible gave my body and mind a chance to heal. As for the supplements, the only thing I found that helped me psychologically was/is GABA, specifically GABA manufactured by SourceNaturals. Doctors have told me that it can't help, that it can't cross the blood-brian barrier. All I know is that when I was at my worst three years ago, I'd take this inexpensive and readily available supplement and feel better within minutes. In any case, I write this as an encouragement to those of you who are suffering because of this terrible drug. In many cases it is possible to get better. It takes time and effort, but it is often possible.
Please tell me that you feel better psychologically and mentally. These areas have been my most worrisome from the drug levaquin. I only took 250mg per day for four days.

Thanks
Russ

Springfield, IL

#78 Nov 24, 2008
Has anyone read anything about a supplement that can relieve some of the side effects of Cipro. I read where Baycol and Cipro were the same type of drug. Both are fluorinated drugs. Baycol killed 40 or so people and was pulled from the market many years ago. I took Baycol for months and the side effects were almost the same as Cipro.
Walter

San Antonio, TX

#83 Jul 17, 2009
Im currently taking Levaquin 500mg 10 days and the first day was a freaking nightmare. I had such severe depression that I even had suicidal thoughts. It got better as the days went by but im never going to forget that night, it was hell. I don't recommend this antibiotic to anybody, it's worse than a bad trip on acid... seriously! And I've also been gettin bad tendon pains.
Stephen

Raleigh, NC

#84 Sep 15, 2009
Tim S wrote:
Took it for a sinus infection and within 2 hours I had a full blown panic attack. I had weird sensory sensations. I am in pain daily and this was back in August. Fill out an ADR!!! I had 3 ER visits and 2 hospitalizations. They wouldn't believe I was having a reaction. MRI, CAT scan, spinal tap, EEG, EKG, blood tests, Urinalysis tests. I was paranoid, didn't sleep for days, didn't sweat when it was in the high 80's and high humidity, heart palpatations, face was burning up, hallucinated..and on and on. Drs. finally said it was the medicine and the drug company is now involved. Finally. We had all our medical bills paid! Nobody else whould ever have to suffer through this.
I took ONE dose (RE: painful urination and fever) and within a few hours I felt like I was "high" on a hard drug-- could not feel my body, could not walk, could not form thoughts at all. A month later I've been diagnosed with Rocky Mountain Spotted Fever. Have taken Doxy for nearly two weeks since the diagnosis to clear that infection... and I'm pretty sure it is gone. However, still cannot think clearly-- it's like the Levaquin reaction I had 6 weeks ago is still manifesting itself, and the drug is stuck in my brain-- I still have panicky feelings on some days. How long did your cognitive dysfunctions last?
kouli

Northampton, PA

#85 Sep 18, 2009
went to the ER 6 months ago with severe abdomen pain and diarrhea, after a CT scan and some blood tests they diagnosed me with intestinal infection and gave me a levaquin pill to take and 9 days worth prescription.I took all of them, during that time I only experienced some dizziness and headace which I attributed to my lack of sleep. But few weeks later I started having all kind of problems, began with shoulder pain, then my knees hurt and finally I am having skin problems (very dry itchy skin)each new day bring new problem. what really pisses me off is that the stool culture results that came a week later revealed NO infection..
cherylkansas130

Mcpherson, KS

#86 Sep 20, 2009
Nick Voulgaris wrote:
Ignorant doctors, mishandled patients. I have given Levaquin and avelox to some of my patients. Then one day i had the bad luck of takin it my self. 2 weeks of cipro were enough to end my medical carreer. I am disabled at the moment. Endless pain for months, loss of vision, adrenal damage, joint aches and burns. The list is endless. Every morning i wake up and consider suicide. Thats the kind of man Cipro has turned me into
Hey Nick you hang in there! I started having the levaquin problems in 1999 when I was 42. I am 52 and have learned to live with the bouts I get as a result of taking that drug multiple times. I went through alot of tests and was still given the drug when I caught a cold to prevent pnemonia. I have pain everyday but I learn to live with it! When I get sick or stressed out I get pain in both legs and hips for the better part of a week and then it calms down. I do take painkillers and hate doing so. I dont know if I could go without them but I do not abuse them. My doctor has suggusted uping the pain meds but I am getting by on what I have. If the bouts become any worse I am sure I will be on a pain patch and do not want to yet. Live life to the fullest and make yourself get up and move!
Ella Belle

New York, NY

#88 Oct 20, 2009
I took this medicine for simple UTI (big mistake, doctor). I was given 500 mg. The day after I took the first pill I had an excruciating headache and eye pain in my left eye. I called the Dr. who told me to halve the dose. By the third day of treatment, my knees started to ache. I knew something was wrong. I took a total of 750 mg. Over the next few days my joints swelled and start cracking with every movement. My muscles started to hurt. I started getting tingling, cold sensations running up and down my legs. For the past week (I'm now on day 12 since I stopped the meds), I have woken up every night with painful dry eyes at 3 a.m. Insomnia is a huge problem. I am hobbling around, hoping nothing will tear.

Two weeks ago, before taking this medicine, I was going to the gym FOUR times a week and dancing socially on weekends. I ran around after my two young kids. I don't know how long this will last and I'm getting scared about it. Finally, even though these are all listed as possible adverse effects, they are indeed somewhat rare. This means that most likely your doctor has never seen them and won't know how to help you, if she even recognizes the source of the pain.

I urge you---UNLESS YOU ARE ON YOUR DEATHBED AND ALL OTHER OPTIONS HAVE BEEN TRIED, DO NOT TAKE THIS DRUG!!!!!!!!!!

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