Why Hasn’t Levaquin Been Taken Off The Market?

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.

levofloxacin AERS Data

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 FQWall

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.

fluoroquinolone-lawsuit-banner-trulaw

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.

 

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17 thoughts on “Why Hasn’t Levaquin Been Taken Off The Market?

  1. Ms. A February 11, 2015 at 11:25 am Reply

    Good job, Lisa!

  2. Heidi February 11, 2015 at 11:34 am Reply

    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!.

    • Lisa Bloomquist February 11, 2015 at 11:38 am Reply

      I agree, Heidi.

    • Merline Maynard February 27, 2017 at 5:42 am Reply

      My husband is disabled because he was given leviquin. And it has turned our lifes upside down. This needs to be taken off the market.

  3. Jeff (destroyed by Cipro) February 12, 2015 at 2:16 am Reply

    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!!

    • Lisa Bloomquist February 12, 2015 at 8:31 am Reply

      Yup.

      Thanks for putting the WSB videos on youtube, Jeff! Much appreciated!

  4. Mary Patrice Kinnavane February 12, 2015 at 9:46 am Reply

    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.

  5. Cindy Bruckner Baldwin February 15, 2015 at 8:39 pm Reply

    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!!!

  6. Jimmy February 17, 2015 at 11:53 am Reply

    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.

  7. Lyric November 15, 2015 at 8:16 pm Reply

    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.

  8. Debs January 29, 2016 at 4:29 pm Reply

    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

  9. debra May 19, 2017 at 6:45 am Reply

    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

    • debra May 19, 2017 at 6:58 am Reply

      FDA KILLING PEOPLE FOR YEARS FOR THE GREED OF MONEY

  10. Walter Bud Eaton August 9, 2017 at 7:39 pm Reply

    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

    • Lisa August 9, 2017 at 7:46 pm Reply

      I’m so sorry that you were given these horrible drugs! I hope that both you and your husband recover. These drugs should never be given to anyone, but they especially shouldn’t be given to people over the age of 60. You shouldn’t have been prescribed levofloxacin for a cough, and i’m so sorry that you were. Here are some tips for getting through this – https://floxiehope.com/2015/10/12/im-floxed-now-what/. I hope it helps.

      Regards,
      Lisa

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