In 1992 the fluoroquinolone antibiotic Omniflox/temifloxacin was removed from the US market after causing three deaths.
To note the removal from the market, the FDA released the following statement:
“The Food and Drug Administration today announced that Abbott Laboratories of Abbott Park, Ill., is voluntarily recalling the broad-spectrum anti-infective drug Omniflox (temafloxacin) tablets, and will halt all further distribution of the drug.
This action is being taken because of severe adverse events associated with the use of the drug that have been reported to the company and to FDA in the first three months of marketing.
Temafloxacin was approved in late January 1992 and marketed in mid-February. Since that time there have been approximately 50 reports of serious adverse reactions, including three deaths. There were several cases of severe low blood sugar, especially in very elderly patients with decreased kidney function. Among the severe reactions there were a number of cases of an unusual complex of adverse reactions consisting of hemolitic anemia (destruction of red blood cells) and other blood cell abnormalities.”
I’m glad that Omniflox/temafloxacin was removed from the market. I’m glad that, in 1992, the FDA was able to move quickly to do the right thing and take a dangerous drug off the market.
It begs the question though – Why is Levaquin/levofloxacin still on the market?
Levaquin/levofloxacin has caused far more than three deaths. According to an FDA review with the subject, “Pediatric Exclusivity Postmarketing Adverse Event Review,” between 12/20/1996 and 08/27/2008, 924 people were killed by Levaquin/levofloxacin, including three children.
It should be noted that, “Many studies have documented that only 10%-15% of serious adverse reactions are reported” to the FDA. Seeing as adverse reactions to Levaquin/levofloxacin, and other fluoroquinolone antibiotics, are often delayed and bizarre in their nature (who would think that multi-symptom, chronic illness could result from taking an antibiotic?), it is reasonable to think that only 10% of the reactions to Levaquin/levofloxacin are reported to the FDA.
Assuming that only 10% of the harm was reported, 9,240 people (including 30 children) were killed by Levaquin/levofloxacin in the 12 years measured.
Additionally, there were 10,166 reports of harm done by Levaquin/levofloxacin in that time period. If that’s 10% of the actual harm done, 101,660 people were harmed by Levaquin/levofloxacin in that 12 year period.
Again, THREE people died from Omniflox/temafloxacin before it was promptly pulled from the market in 1992. Johnson & Johnson is apparently on friendlier terms with the FDA than Abbott Labs.
Rest in Peace Chris Dannelly
Since 2008, Levaquin/levofloxacin has claimed many more victims. Chris Dannelly is one of the people who tragically died after taking levofloxacin in January, 2013. Chris was a 41 year old husband and father of two young kids. He was an athlete at the prime of his life.
Chris was killed by two pills of levofloxacin. You can read Chris’s story HERE. From Chris’s Story, “After reviewing the autopsy report, doctors stated that ‘all signs point to Levaquin’ as being the cause of death.” And, “Chris was a healthy, active man in the prime of his life. He worked out five days per week, and enjoyed playing both indoor and outdoor soccer regularly. Within a matter of less than a week’s time he went from being perfectly healthy, to losing his life…all because he took two little pills of Levaquin.”
Chris’s tragic story, highlighted by WSB-TV 2 out of Atlanta, Georgia, and told by Chris’s brave wife Kathy, can be viewed here –
Kathy states in the interview, “If I can get involved in this drug somehow coming off the market one day – then that’s the least I can do.”
Because Chris was given levofloxacin, the generic form of the drug, and the Supreme Court decided that drug manufacturers couldn’t be held responsible for harm caused by generic drugs, neither Kathy nor her children have the opportunity to pursue legal recourse for Chris’s tragic death. Taking this horrible drug that killed her husband off the market is the least the FDA can do to right this tragic situation of a husband, father and athlete being killed by a dangerous drug like Levaquin/levofloxacin.
Rest in Peace Richard Davis
Also on WSB-TV 2 Atlanta, Sandy Davis tells the story of how her husband Richard was killed by Levquin/levofloxacin:
Sandy Davis states, “I don’t think it should even be on the market. If it’s killing people – No.” Indeed. Richard was 60 years old when he passed.
But, but, but…
People will argue that we need Levaquin/levofloxacin because bacterial resistance to antibiotics is making more powerful antibiotics necessary. There may be some truth to that argument. But rather than seeing dangerous, complex drugs like Levaquin/levofloxacin in simplistic black and white terms, perhaps some thoughtful consideration of the grey area is in order.
IF it is deemed impossible for the FDA to remove Levaquin/levofloxacin from the market (and I do believe that it should be taken off the market – it is, after all, KILLING PEOPLE), it should be severely restricted. Levaquin/levofloxacin should ONLY be used in life or death situations. It should ONLY be used when all other non-fluoroquinolone antibiotic options have been exhausted. It should ONLY be used in patients who haven’t previously been exposed to fluoroquinolones. It should ONLY be used in people who are not genetically predisposed toward an adverse reaction to fluoroquinolones. (Who is genetically predisposed toward an adverse reaction to Levaquin/levofloxacin? Good question. Figure it out, FDA.) It should NEVER be given to children, athletes, the elderly, those with an autoimmune disease, those with autonomic nervous system dysfunction, those with a history of psychiatric illness, or anyone who needs to use contraindicated drugs, like steroids and NSAIDs, to survive.
IF Levaquin/levofloxacin must stay on the market, everyone who takes it should be provided with information that ensures that they know that Levaquin/levofloxacin can cripple or kill them.
Before anyone insists that Levaquin/levofloxacin must stay on the market, perhaps we (collectively) should do some due diligence to make sure that it, and other fluoroquinolone antibiotics, don’t have intergenerational adverse effects. After all, their mechanism of action is interruption of topoisomerase enzymes, enzymes that are necessary for DNA and RNA replication. In case it needs to be said, disrupting the DNA and RNA replication process of cells may have some deleterious effects on future generations. Don’t assume for a second that this concern has been examined. Warnings about the DNA toxicity of fluoroquinolone antibiotics have been ignored.
Though I understand that antibiotic resistance and loss of antibiotic efficacy is a problem, I can’t say that I entirely buy arguments that Levaquin/levofloxacin must stay on the market. No one claims that we are worse off because Omniflox/temafloxacin was removed from the market. Infections were also being adequately treated by non-fluoroquinolone antibiotics prior to 1987, when Levaquin/levofloxacin was approved by the FDA.
Kathy Dannelly and her children, Sandy Davis and her loved ones, and all other loved ones of victims of Levaquin/levofloxacin deserve justice. Many of them aren’t getting justice. The least that the FDA can do is keep others from dying in pain from fluoroquinolone toxicity caused by Levaquin/levofloxacin.
Good job, Lisa!
Add ‘the elderly’ (>60?) to those who should NOT be given these antibiotics. Any issue they get is dismissed as “old age problems”. These are often the ‘formulary go-to drugs’ in nursing homes, also in hospitals. This whole host of ignored problems with these drugs is a disgrace! The FDA gets 2/3 of their funding from these drug companies; and uses the same drug companies to test the drugs they are selling, at billions per year profits. Talk about tiers of conflicts of interest…it’s all about MONEY and NOT about DO NO HARM!.
AMEN. We’d be better off without an FDA at this point…at least that way people would KNOW there’s nobody protecting them. As it stands we have an FDA that is completely corrupt and only serves to create the false illusion of consumer protection.
For anyone reading this, do yourselves a huge favor and stay the hell away from fluoroquinolone antibiotics (Levaquin, Cipro, Avelox & a few others). It’s not worth it!!
I so agree with you all is there any real truth in this crazy world. The FDA, The Medical Profession all around the world seem to be in cahoots with Big Pharma. Thank you Lisa for all your great work. I wish you lived in IRELAND.
One very disturbing thing is that just because you take a generic to this, like Chris did, you have no recourse, he died and his family gets nothing from any drug companies, that should be illegal!!! Generic co. should be held accountable too!!! So they can give out medications that kill people and not have any responsibility!!!! Wrong!!!
Lisa, you have done a fantastic job! I admit that recently I’ve become very frustrated going on the fq Facebook group because some people there, even some admins, make an argument for keeping the drug on the market. But obviously, they can’t see the bigger picture. They can’t see that as long as the drug stays on the market and it’s so cheap, and so cheap because it is synthetic, almost no other antibiotics are being developed except fluoroquinolone antibiotics. Having it removed would force the drug companies to come up with more safer antibiotic’s. Especially if they were forced to take responsibility for the many deaths and people hurt from their poison. I was floxed in May 2013 and I hold the doctor and the drug company responsible, and frankly, also people who were formally floxeds that are going around saying there is a reason that we must not take this poison off the market. It baffles me to know that they actually believeThe effectiveness data on the drug provided by the drug company. Having worked for a long office that the mass tort litigation against drug companies and was one of the biggest in Southern California I can tell you with a great deal of certainty… These companies lie nearly anytime it is necessary to protect profits or to win a litigation. The drug will never be restricted in use in the way that these people want, there is no precedent for that. It’s unreal to me to hear the various arguments including… I’m seriously hurt but this drug saved my life. Without really knowing whether or not another drug or combination of drugs could’ve save their life or considering that a better drug a safer drug, could’ve save their life and they could still walk now! I often say to some of these people if you still want the drug on the market after being hurt, you weren’t hurt bad enough. Take another pill! It must come off the market and it must come off the market now.unfortunately, there will always be those who lack the sophistication to understand this very complex issue. And sadly they are among the group that we must continue to battle against.
I took Levaquin for an extended period of time in 2004 and I truly believe that my daughter who was conceived 4 years after my treatments is experiencing side effects directly related to my floxin usage. She’s has joints that click and pop, photo sensativity and extremity weakness. These drugs are dangerous.
Virtually no new class of antibiotics to treat the most serious infections I feel will be developed until they are forced to, & have no choice left but to take them off the market only then will they develop a replacement for FQs.
The warnings do not yet include the topicals, in fact they are hardly if at all seriously even on the radar yet & imo THAT fight is going to be a whole different ballgame. How many kids are going to be crippled in the meantime ? .
The future use of FQs believe me is not going to stop at antibiotic, they are looking at far wider usage of that quinoline nucleus, some things are better not even thought about, & so I tend not to do that often, as that realisation gives me nightmares upon nightmares with bells on. Meanwhile we have even more potent FQs in the pipeline heading our way.right now not long until that Delafloxacin crap hits the fan if all goes to plan thought to be around 32 times more potent than those we have now, & in regards to another FQ in the pipeline one potential use for that one is for irritable bowel syndrome, I mean how many more victims are their going to be if that comes to pass.
Bottom line whilst the FQs are on the market ( & they are VERY useful drugs indeed to big Pharma, allowing Drs free reign to prescribe other drugs for the symptoms of FQ poisoning that mimic so very accurately so many other things) I feel virtually no alternative antibiotic development for the most serious infections will ever be done.
I have personally had it up to here with FQing black box warnings. Drs & pharmacists, especially in the UK where I reside do not even realise they exist, & as for the Federal death agency, it’s way beyond time for the FDA to start protecting their patients, NOT drug companies The FDA as it stands is a client of Big Pharma & therefore they need to be disbanded, along with the UK drug regulatory agency, MHRA corrupt ( as hell, ) aka little FDA
Psychopaths have NO conscience … PERIOD
It all about money FDA is a joke the big pharmaceuticals company’s pay FDA off to approve their dangerous medications hide the side effects now your damaged they want give you another medicine they say FDA Approved will help rid the the side effects if the first med then you got group of the FDA people that are investing in the.big pharmaceuticals company’s in the stock market making billions while we suffer in pain they don’t care about our health they have no heart or compassion for women,men,children not even our pets as long as they get rich
JULY 10 2017 I AM A 79 YEAR OLD WOMEN I WAS GIVEN LEVOLOXAN 500 MG. FOR A COUGH THAT I THOUGHT WAS A ALLERGY MY VITALS WERE ALL FINE NO FEAVER AALMOST IMMITALY I STARTED HAVINGS SYMTOMS I COULDNT SLEEP FOR 3 NIGHTS I DEVELOPED A RACING HEART A CHRONIC COUGH VERY HIGH BLOOD PRESSURE I COULDNT TASTE ANY THING IHAD SORS IN MY MOUTH AND THROAT PAINS IN MY KNEES AND LEGS FATIGUE I ONLY TOOK THEM FOR 3DAYS I WAS COUGHING SO HARD IWAS VOMITING MY ESOFICUS FELT LIKE IT WAS ON FIRE ISTILL HAVE PAIN AND HAVE TROUBLE SWALLOWING ANDSTILL HAVE THIS COUGH IALSO COULD NOT CONTROL MY URINE WHEN I COUGHED I WOULD WET MY PANTS HAD CHEST PAINS MY HUSBAND TOOK 2 ROUNDS OF THIS DRUG NOW HIS KNEES HURT SO BAD HE CAN HARDLEY WALK HE IS 79 THIS DRUG SHOULD NOT BE GIVEN TO OLDER PEOPLE WE WERE HEALTHY BOTH WORKED PART TIME JOBS
I don’t understand the whole issue and why there are not answers! I was given Cipro and Levequin back to back in 2015. No problems. I was given Cipro in October of 2016 (after the stronger warning label in July) and had the pain of tendinitis while taking it. It then disappeared. Three months later in January of 2017 I started developing tendinitis first on my sides from sleeping at night. Slowly it developed in my ankles, wrists, left shoulder and neck. It affected my mouth also. ( red gum line and weird feeling in teeth). I have brain fog also. They sent me to a rheumatologist and she sent me back to my general practitioner after she exhausted every effort to test and diagnose me. I was healthy and a full time Music teacher. Now I get exhausted so easily???????? I am on short term disability. Where is the hope??? Are there any doctors who can diagnose this toxicity?? I feel hopeless. Help???!
I was given the generic for Levoquin March, 2017 by an oncologist for an intestinal infection. I stopped after 2 days because I was so ill and shaky. At my next appt. I informed the oncologist (so called research expert) and his nurse. They acted like I was the only one who had a problem and informed they use the drug all the time. I thought to myself, in that case, the chemo patients wouldnt know if new symptoms of the drug were chemo or their cancer. I was not in treatment. He refused to give me a safer antibiotic and referred me to a gastrointestinal doctor. I went to my pcp instead. She gave me bactrim (spelling?) and it got rid of the infection. For starters; these days I definitely dont trust the generic drugs companys. They buy the drugs cheap from drug manufactures in other countries. In many cases, they come from India. The Drug Companys pay astronomical regulatory fees to the FDA. From what ive researched, the problem is; the manufacturers (ex. India) cant afford the regulatory FDA fees. The quality control of these manufacturers by the FDA, is lacks to say the least; other than a warning here there. I wouldnt know. The Drug Companys, the FDA, the Drug Chains, the Doctors, the Insurance Companys are all making huge profits on cheap drugs, and we have no idea what we are ingesting. This has not been my first miserable experience with generic drugs. We have been told that generics are the same as name brand and their purpose was to lower cost of name brand. IMO, that is a lie. Generics have less active ingredients and differrent formulas of fillers. None of that is disclosed when you pick up the drug. What someone might be allergic to is of no concern to the powers that be. Recently, I had generic percocet switched after a year. The quality of my life got worse overnight. The generic percocet, 5mg 90 tablets is around $40.00 and the name brand is now $1,300. Also another bad experience with generic thyroid medicine. I have lost all faith and trust in the whole system.
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I have been on 8 rounds of Levaquin, since Jan. of 2017. This was for colon issues. The last round was 750.mg, I am a nurse, and my husband a Orthodontist. I had a colon resection in late April. OMG 2 weeks before, I woke up one morning and could not move from joint pain. I saw my Internal med. Dr., he tested for Lupus, Arthritis, MS, and other blood tests. It is now July, same year, and now have 3 orthopedic surgeons. I have both achilles tendons, on the verge of rupture, 1 knee with ACL torn, and Mediscus torn. I had another MRI yesterday and will know that outcome tomorrow of the other knee. I go to PT 4 times a week. I have contacted 5 attorneys, no-one will take a case, unless you have an aortic aneurism. I forgot, saw a wrist and shoulder Dr. today. Will anyone take this case? Most graciously, A. Labart
I take Levaquin for sinus infections. Never a problem. Hard to believe Chris died after two doses of Levaquin. It should only be subscribed for serious infections, not a cold etc. No details mentioned about Chris makes me very skeptical. Some of these people can’t even spell that posted negative comments. Makes me think they were trying to sue to get money, just my opinion. Levaquin is to be used for approximately seven days, unless a patient’s condition warrants longer use.
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