“Death by Levaquin” Brain/Body Toxic Drug

Here is another very tragic story sent to this blog.  

I’ve had chronic recurring epididymitis ever since I was young which was usually treated with anti-inflamatories just to come back later. I was prescribed 500mg of Cipro for 3 weeks in fall 2005 even though I didn’t have any signs of infection. As soon as I had finished the course my foot swelled up with gout and I was unable to walk. I went to urgent care and asked if it couldve been caused by the medicine they said no. A week later I went to urology because I was still having pain. Again I asked about the connection between gout and the medicine. I was told no again and prescribed Levaquin for a month which didn’t work either. Later I was told by another urologist that the swelling could indeed have been caused by the medicine

The pain resolved on its own after several months in spring 2006 and I was ready to get back to life. I had gone back to school because I wanted to get a degree, join the military as an officer and then come back and teach PE. That summer I started getting earaches. I had no infection and was diagnosed with a Eustachian tube disorder. 1 week later the headaches started. It was so bad I thought I had meningitis and was going to die. I wanted to cry so much from the pain. My neck hurt and was stiff. I couldn’t keep my head up straight nor keep my eyes open. My head pounded and burned. I had increased pressure and the outside of my head hurt to touch and my sinuses burned. At one point I even passed out and was taken to the hospital. I had a CT scan done and was told I had a sinus infection. I was given antibiotics but this time a different kind (Probably amoxicillin.) That didn’t work as well. So then they changed their diagnosis to allergic rhinitis. Went to a neurologist
 who ordered an MRI which came back negative as well. Gradually this pain went away as well. The headaches still return a couple times a month although not as severe.

Then In Fall 2006 the joint pain started. At first, It was just my shoulders and my back which I thought were related to weight lifting. So I stopped for awhile but the pain didn’t go away. Next, the knee pain started. They were stiff, popped a lot, and when I would take a step I would get a sharp pain which made it feel like my knee had locked up. X-rays were performed which showed know damage. I was sent to physical therapy for six months which only aggravated the symptoms. Later pain showed up in other areas such as my Achilles, feet, elbows, hips and wrists. I have seen two orthopedists and a rheumatologist. One orthopedist didn’t believe me. MRIs were done of both knees know damage shown. The other has heard about the damage but says its just case reports and that what’s done is done. He tried to reassure me by saying if anything is ever damaged he can fix it. Rheumatologist said that antibiotics can cause autoimmune disorders and performed a lot of blood tests all
  of which were negative or within range. He then sent me to genetics thinking I might have Marfan’s which I don’t have either. I contacted him following my genetics appointment and was told he didn’t have anymore tests to perform so not to come back.

I have all the typical symptoms of the reactions to the medication. Joint pain, joint popping, numbness, tingling, spasms/twitches, headaches, eye pain, eyes burn, always tired, always cold. I’m sure some things have even slipped my mind. I can’t get anyone to look at even part of the Flox report. Most recently I’ve been diagnosed with Seborrheic Dermatits and I get coldsore outbreaks around my mouth every two weeks when I used to get them about twice a year.

I have no idea what I am supposed to do. My whole life is on hold. I can’t work. We pay more than $500 a month for health insurance because of all the appointments due to medicine I was prescribed. I’m 26 years old I haven’t been able to workout or play sports in years. My girlfriend left me, she didn’t feel like I could protect her anymore, and said I wasn’t man enough and wanted some one she could kiss. My mom wants me out. My “friends” just say I’m getting old or need to workout and eat more. I am completely out of time and out of options. How can I get a job like this? How can I get MY job like this? I shouldn’t have to compromise. I just pray that one day soon I’ll be strong enough to end my suffering and that people will regret not taking me seriously.

….When will this insanity end ?  Another severely poisoned quinolone victim.  

in sept of ‘98 my sister was floxxed subsequent to a hospital admission for asthma.  she died on the table, but was ‘brought back’ by medical workers.  unfortunately, the effects have been both devastating and permanent.  similar to the effects of a severe stroke, my sister still is 100% disabled, cannot drive, write, and falls often.  she also has trouble concentrating, or remembering short and long term.  i see many notices of legal actions for other symtoms of levaquin poisoning, but apparently her reaction was more rare than the norm.  i just last week filed an adverse event report with the fda.

With the possible pandemic of swine flu there may be a temporary jump in the number of antibiotic prescriptions. Antibiotics are generally not really useful against a virus. They are meant to be used for bacterial infections. Those with weaken immune systems would be most susceptible to the flu. The elderly would be at greatest risk. I read that the biggest danger from this flu and other flus is not the actual flu itself but the secondary infections such as upper respiratory infection or pneumonia that come as a result of the flu. If this is actually the case that would mean more antibiotic prescriptions. Levaquin and Cipro are two of the most commonly prescribed antibiotics for difficult to treat bacterial infections. If the number of Levaquin and Cipro prescriptions spike because of swine flu you can probably expect a similar increase in the number of people that will be suffering from fluoroquinolone toxicity. As fluoroquinolone prescriptions grow so do the number of fluoroquinolone poisoned people.

 If swine flu becomes a more serious problem there will be many more seriously damaged fluoroquinolone victims. The older you are the harder it is to recover from this poisoning from what I have read.  ”Night of the Living quinolone dead” could be a new horror movie if the situation got out of control. A horror movie that would actually be factual instead of fiction.     

Hear is a terrible story I received on my blog today. Aminoglycoside antibiotics are ototoxic to some people. This person now has permanent hearing loss. Ototoxic antibiotics have ruined his life.

 Hello -
Our son was prescribed numerous ototoxic ear drops for ear infections.  The medical community has known since the 1940’s that the family of aminoglycosides (gentamycin, garamycin, neomycin, tobramycin, streptomycin and the ear drops pediotic) cause permanent hearing loss and vestibular damage.  As you may guess, he lost his hearing.   Ototoxic medicine has ruined his life.  How can we stop this madness, educate the public and protect our children?

Here is one of the best Youtube videos I have ever seen. Definitely better and more impactful than the Levaquin videos I made. This is presented by Bob who has done a great job in helping to spread the message of the dangers of this class of antibiotics. I talked to Bob on the phone a little over a week ago and he is doing a great job in helping to inform the public on fluoroquinolone toxicity. I hope he keeps up the outstanding work he does. This video needs to be shared and forwarded to as many people as possible.  

http://www.youtube.com/watch?v=UjpNGWgIylc&eurl=http%3A%2F%2Fnoquinolones%2Eproboards%2Ecom%2Findex%2Ecgi%3Fboard%3Dactivism%26action%3Ddisplay%26thread%3D1277%26page%3D1&feature=player_embedded

Comment:
I have the story of quinolone toxicity that could probably put the hurt on the companies that make all of these medications more so than anyone could imagine.  I do not want to take up too much space here but another day I will list every horrible thing that has happened to myself and my family members trying to help me.   I am 37 today but it all started at 18.  I took cipro for prostatitis and noticed after a couple of doses my left wrist started popping and it still pops today.  I never had any joint problem before then actually really healthy playing baseball, basketball, raquetball and many other sports.  My physician again prescribed the ciprofloxacin at about age 20 or 21 and I remember after taking a few doses having horrible panic attacks and wanting to die.  I felt extremely depressed and anxious and could not sleep.  I felt as if everything was not real a sort of depersonalization or disconnect from reality.  My parents and physician and friends did not know what w
 as wrong with me and I wasn’t exactly sure either.  I had never felt like that before.  Then my physician gave me alprazolam with the cipro and I felt even worse after that.  I will never forget I never really prayed to god but did then please make me feel normal or end it.  Then I layed in bed tossing and turning never able to fall asleep really and the next thing I know off to the right side of me came a golden white light and I cursed, ” holy f___s___.  I never cussed before that.  I was sucked out of my body and started to go down this tunnel to this pinpoint of golden white light.  At first I was scared but then a telepathic voice said, ” Do you want to stay or go back?”  The amazing thing about this whole experience was that I was no longer in any pain and wasn’t depressed, I felt very peaceful.  I telepathically said, ” No not now.”  Then I was slammed into my body feet first and felt like crap again.   I know I digressed here but this wasn’t by far the worst experien
 ce I have had with fluoroquinolones.
      At 23 I was preparing for pharmacy school and the physician prescribed floxin for prostatitis again.  I don’t know why I kept getting prostatitis.  This was the worst experience I have every had.  I had extreme panic attacks and insomnia beyond belief.  I really didn’t sleep hardly at all for close to two weeks.  Then in the dorm room I passed out and was on the floor.  I woke up with a heavy head feeling and dizziness and felt like the life had been sucked out of me.  Then later I went to the bathroom and was found on the floor by the urinal with a bloody face.  I did not want to go to the hospital so I went back to the dorm room and passed out again on the floor and hit my head again.  Finally my roommate called and ambulance for me.  The physicians in the ER kept asking me if I was taking elicit drugs.  I have never and would never do that.  They did not find much except that my blood sugar was really low.  I told the doctors about the Floxin and they said those side
  effects couldn’t happen and continue taking it.  
     Actually you would think all of this was enough, but it was just the beginning.  I had to later be admitted to the hospital and go in a psych hospital for panic attacks.  I will continue with the second part of the story in a few days.  I’m getting a little emotional now because I remember laying in the hospital not being able to sleep and the doctors wouldn’t give me anything.  So I layed and prayed and pleaded with god to either help me get well please or help me die at 23 years old.  Sorry to have to continue but this is tough.

Kristine’s Story

There is no way to describe how this has changed my life.  What these drugs did to my body is just horrific.I went from a being a woman with a  urinary tract infection to a woman with upwards of 65 different symtomologies, unable to take care of my family, myself.   I truly feel that I am here because I somehow in the middle of complete horror found the courage to totally take my health into my own hands.  What this has cost my family.. I could even begin to place a dollar amount on that…this shook us to the core…my children watching me cry uncontrollably, watching me crawl up our front walkway determined to get one bag of groceries into the house when the pain was too much to bare, not being able to carry around my youngest child who was just a nine month old baby when I was given the 1st Quinolone, watching the tears stream down my husbands face as we drove around Boston trying to find a doctor to help us…him begging me to hold on and me begging him to never let our children forget me……….the tens of thousands of dollars that this cost us are nothing compared to what we have been through because of these drugs and the cover up of their toxicity. I have had to work 24/7 for every bit of health that I have gotten back.  My recovery has been a long hard journey but I am eternally grateful for every bit of it.  Every day is about health in my family now and every moment is fully lived.  I have spoken at alternative health conferences about the my story…my journey to wellness and my husband and I continue to speak to any group or individual that expresses interest.  Every day we will work to help as many people as possible so that no one else will suffer that great horror of the quinolones.The horror of quinolone antibiotics *severe gastrointestinal symptoms   extreme diarrhea   nausea   sudden weight loss  121 lbs to 103 lbs in 4 weeks   leaky gut   loss of most of good flora in gut   inability to break down food   abdominal pain *all over joint pain *severe burning sensation in arms *insomnia *chills (in middle of summer) *drenching night sweats *extreme anxiety attacks *night terrors *hallucinations * skin burned instantly in the sun for 4 days after Cipro *extreme pain and tendon damage over my entire body *extreme fatigue *muscle twitches( worst between my ribs, calves and face *tingling in hand and forehead *tremors in hands and toes *intracranial pressure *seizures *loss of menstrual period for 5 months Systemic candida   Thrush    yeast infection * burning pain in lungs *eye pain, floaters ,blurry vision, light sensitivity * swollen lymph nodes *hair loss *swollen liver *Brain fog *ear pain, occasional ringing *jaw pain *circulation problems very weird things like   huge yawns that would come on uncontrollably   severe burning around outline of my mouth   feeling like little flickers of water were being thrown on legs Please educate others on the severe and often permanent damage caused by Quinolone antibiotics.

http://www.askapatient.com/viewrating.asp?drug=20635&name=LEVAQUIN

Hundreds of crippling injuries documented in this database. Average rating: An abysmal 1.9

Phil’s horror story from just a few pills of Floxin.

I fell asleep that night, just like any other. Little did I know that it would not turn out like any other. I was about to embark upon the most frightening, life-altering nightmare I’d ever experienced. And it did not end when I awakened.

After one or two hours of sleeping, I awakened with a start, and without any voluntary effort on my part, I was standing on my feet beside the bed. It was as if someone had jerked me from my sleep. I was so cold, I shivered. Yet, I was sweating profusely. I felt a strangeness that I could not identify, and an underlying anxiety. “Maybe I have a fever I thought…go back to bed, I’ll feel better in the morning”. But it was not to be. It took some time to fall back asleep. I felt a buzzing sensation as if someone were running electricity through my head. My body would involuntarily jerk on occasion, and the aroma of smoke filled my nose, but something inside told me it wasn’t there. I was hallucinating. I felt as if I was somehow drifiting away from my body…losing touch with it. I would only later be able to articulate that I felt as though I was on another level of consciousness. Not awake, not asleep, but instead in some unrecognizable state between the two. When I finally drifted off amidst all of this and my now growing anxiety, I would awaken in the same startled manner within an hour or two convinced morning was here. Each time to be informed otherwise by the darkness outside and the clock by the bedside. Time had suddenly taken on an unreal quality, and had none of the consistency as in the past. The anxiety grew with each awakening, until finally, it became outright fear. “God, what’s happening to me? I feel like I’m losing my mind”. And there was no peace in sleep.

Morning finally came, and I knew I was changed. Somehow different. What the next few months held for me would be a journey of sheer terror. Far exceeding any nightmare or the most terrifying thought I could have conjured. I experienced a full break with reality, held together only by God and by the thought (but not feeling), that somewhere deep inside I was still me, and that this world was still real. I would learn later that my feelings had names. Depersonalization (the sensation of not recognizing one’s self) and derealization (the feeling that the world is not real). In short, my world took on a strange and unrecognizable quality. I could not think or concentrate, my nights would bring the same horror, I experienced panic attacks and sheer terror but for no identifiable reason. What was I afraid of? Myself? Existing? I would hear chatter in my head (no discernable voices, but the sound of background noise in a crowded room). My limbs would jerk involuntarily, instead of seeing black when I closed my eyes in a darkened room, I saw blue flashing lights and swirling patterns. I was so fatigued, I didn’t want to get out of bed, yet because of the buzzing activity in my head, I had a strange insomnia which kept me awake for 2 days straight, before I finally took a prescription to put me to sleep. I was hungry, but one bite of food nauseated and repulsed me to the point where I could not eat. Spicy food was the worst offender. My vision was constantly blurred, and fluorescent lights seem to flicker relentlessly. My balance was off, and public places with fluorescent lighting and much activity (like grocery stores) disoriented me severely. I also suffered from tinnitus (ringing in the ears), and hissing in the ears that in the quiet became almost unbearable. Finally, and perhaps most frightening, I had trouble controlling my thoughts. It was as if the line between conscious and subconscious was blurred and thoughts would emerge from my subconscious mind to pervade my conscious. This seemed especially troublesome as I began to drift to sleep, as if when my subconscious began to really take over, I would jerk awake. My days became constant panic, fear and emotional pain.

 

Pfizer’s Nigerian Nightmare
Nicole Perlroth 12.08.08, 12:00 AM ET

  What if a drug company experimenting on critically ill children doesn’t get the proper parental consent, 11 of those children die and a whistleblower is fired?

Those are the charges leveled against Pfizer in a legal battle that has dragged on for the past seven years in Manhattan federal court and in Nigeria, where the government is seeking $8.5 billion in restitution and damages–and jail terms for various Pfizer officials, including former chief executive William Steere.

Things may come to a head soon. A federal appeals court is expected to rule on whether the children’s parents can go after Pfizer in New York. Meanwhile, to avoid what’s shaping up to be an ugly court battle, Pfizer is said to have offered to settle with the Nigerian government for $150 million, plus money to modernize and equip a Nigerian infectious disease hospital.

Pfizer says the children died from the disease, not from the drug trial, won’t confirm a possible settlement, and says it’s “proud” of its role during the 1996 epidemic, an ugly trifecta of meningitis, cholera and measles. Twelve thousand Nigerians died from meningitis alone, many of them children.

What really happened at a remote sub-Saharan hospital in Kano, Nigeria may never be known. But interviews with Pfizer employees, parents of some of the victims, Food & Drug Administration officials, court filings and other legal documents provide an unsettling look at the pitfalls of doing hurried drug trials in Third World countries.

That’s happening more often these days. Under pressure to reduce research costs and win fast-track approvals, drug companies do 43% of their clinical trials abroad, up from 14% ten years ago. The Tufts Center for the Study of Drug Development says that number will rise to 65% within three years.

Roll the tape back to the spring of 1996. Outside the cluster of cinder block structures that make up Kano’s Infectious Diseases Hospital, hundreds of sick children are lined up, awaiting treatment from Doctors Without Borders, the nonprofit group, which has set up a tent on hospital grounds.

The doctors are injecting the children with oily chloramphenicol, endorsed by the World Health Organization as the recommended treatment for bacterial meningitis epidemics. The half-century-old drug is rarely used in developed countries because of a sometimes fatal side effect (blood disorders). But it’s readily available in Third World countries because it is economical and effective.

Five thousand miles away in a Pfizer research lab in Groton, Conn., infectious disease specialist Scott Hopkins is surfing the Internet when he spots a story on the epidemic–and sees opportunity. Pfizer was waist-deep in an ambitious test of Trovan, an antibiotic showing promise against a wide variety of infections, from bronchitis to pneumonia. It had potential to be Pfizer’s answer to Bayer’s Cipro, then the leader in the $11 billion anti-infection market.

Pfizer had already enrolled thousands of adults in Trovan clinical trials but had not tested it yet on children, which posed a problem. Trovan belongs to a category of powerful antibiotics called quinolones, which have the ability to penetrate tissues to kill bacteria.

But there can be serious side effects, including liver problems and cartilage and tendon abnormalities. In early stage testing quinolones had caused liver and joint damage in young rats and dogs. In order to gain maximum market share, Pfizer would have to develop an oral form of Trovan that proved safe for pediatric use.

Hopkins put together a group of five researchers and within six weeks had chartered a DC-9 to Kano, Nigeria. Normally, it takes nine months to design a late-stage drug trial. Pfizer says the trip could never have been made so quickly if a global pediatric trial hadn’t already been in the works.

One physician stayed behind. Pfizer had hired Juan Walterspiel, a pediatric infectious disease specialist at Yale Medical School, in 1994 for Trovan’s pediatric clinical development. Pfizer says it doesn’t know why Dr. Walterspiel wasn’t selected to go to Nigeria. But Dr. Walterspiel, who declined to speak with FORBES, would later write to chief executive Steere that the Nigerian study was “in violation of ethical rules for the conduct of medical experiments in humans.”

Once in Nigeria, Dr. Hopkins and his team set up shop near the Doctors Without Borders tent. Over the course of two weeks they picked 200 out of the thousands of children awaiting treatment, between 3 months and 18 years old. Half got a full daily dose of Trovan, orally or by injection, depending on age and/or ability to swallow, for five days. The control group got an injectable dose of Rocephin, a Hoffmann-La Roche drug widely used against meningitis. Those kids got 100mg of Rocephin on the first day but only one-third of that dose each of the next four days.

Why? Pfizer argues that Rocephin injections can be painful. The full dosage takes several seconds to inject. “Kids don’t like needles,” says a spokesman.

Plus, Pfizer says one of its on-site doctors had helped develop Rocephin at Roche and believed the lower dose “more than enough.” But that wasn’t proved until seven years later, when a Doctors Without Borders study showed the lower dose to be effective.

A month later five children in the Trovan group and six in the Rocephin group were dead. Pfizer says those results were “remarkable,” given that the epidemic killed 10% of those infected.

But parents of the dead children in the Trovan group claim they were never shown–or were read–a consent form and weren’t told about Trovan’s risks or that a proved treatment from Doctors Without Borders was just steps away.

Parents of the dead children in the Rocephin group argue their children would have lived had Pfizer given them the full dose. Dozens of others allege that the trial left their children paralyzed, deaf, mute or blind.

Pfizer says it had bilingual nurses on-site who obtained oral consent from all the parents. The company also says it has all the patient charts with “yes” and “oral” boxes checked as to whether and how their consent was obtained. But Pfizer declined to show these consent forms to a reporter.

Are all the plaintiffs in fact the parents of the dead and injured children? Pfizer says that not all the names on the complaint match up with initials of patients listed on the medical charts. (Pfizer says it’s common to record only initials to protect confidentiality.)

The drug trial ended in May 1996. Dr. Walterspiel’s letter to Steere, dated Dec. 18, 1997, was not well received. Among the points he made: “Some of the children were in critical condition and most of them malnourished, which made oral absorption even more unpredictable. At least one died after a single oral dose; such a patient … should never have received an experimental antibiotic orally.”

---

Responding in a Feb. 26, 1998 letter, a Pfizer lawyer refuted everything in Dr. Walterspiel’s letter: “The company acted appropriately and with complete regard for all legal, ethical, and humanitarian concerns.”

The next day Dr. Walterspiel was fired. Pfizer confirms that, but says it was “completely unrelated” to his complaints. Really? A wrongful termination suit subsequently filed in a Connecticut federal court was later settled. Neither Pfizer nor Dr. Walterspiel would comment on the settlement.

During a 1997 FDA audit Pfizer produced a letter dated a week before the trial began from a Nigerian hospital granting it ethical clearance. But the letter doesn’t really help Pfizer’s case: It was backdated.

Pfizer concedes the backdating is “unfortunate” but now argues there’s no Nigerian law or regulation requiring ethical committee approval before conducting a clinical trial. “Therefore,” Pfizer argues, “there was no need to obtain what the law did not require.”

However the lawsuits turn out, no more patients will be exposed to Trovan. Having initially applied to use it for pediatric meningitis, Pfizer withdrew that use from its application after the FDA audit found dozens of discrepancies in Pfizer’s records. The company says it intended to renew its application following a global pediatric trial already under way.

But it never had the chance. After approving Trovan for 14 other uses in 1997, the FDA advised Pfizer to pull the drug–two years and more than 2.5 million prescriptions later–citing “safety concerns.” The problem: deaths from Trovan-linked liver injuries.