Archive for the ‘Doctors that have been poisoned by a Quinolone’ Category

Dear Doctor letter

Wednesday, February 4th, 2009

Here is a Dear Doctor letter from a doctor who has been poisoned from Levaquin for several years. Noted in the letter is that the incidence of these reactions is much higher than previously reported. Does anybody honestly believe that quinolone manufacturers are stating the truth about the incidence of side effects? I posted about a week ago a story from Readers Digest about how Sanofi actually made up the safety data concerning Ketek antibiotic. Yes, that’s right, the data was forged. The story was in Readers Digest. It is reposted in my blog. And what did the FDA do regarding this? They helped conceal the data. Our government agency, the FDA is helping to protect the financial interests of the pharma companies at the expense of the individual.  Please read the letter from Dr. Plumb below.

http://www.fqhelp.com/sites/default/files/Todd%20Plumb%20Dear%20Doctor.pdf

Antibiotics side effects

Friday, January 9th, 2009

Some antibiotics overprescribed, effects not widely known

When Dr. J.T. Cooper hobbles around his Marietta medical office, the boot brace on his right foot is a reminder of a danger posed by some of the most popular — and misprescribed — antibiotics on the market.

Like thousands of others who have taken Levaquin, Cipro and other fluoroquinolone antibiotics, Cooper suffered a near-rupture of his Achilles tendon. Tendon side effects have been reported for at least 20 years, but drug makers only began sending letters to doctors warning them of the problem in recent months.

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Sara Hopkins/Special

Dr. J.T. Cooper says he and his physicians didn’t know about tendon risks associated with Levaquin.

SPOTLIGHT: ALISON YOUNG
Alison Young
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KNOW THE SIDE EFFECTS
All medications have potential side effects. The key, experts say, is balancing risk with potential benefit.
Antibiotics called fluoroquinolones, sometimes referred to as quinolone antibiotics, include the brand names Avelox, Cipro, Factive and Levaquin. Generic drug names often include “floxacin” as part of their name, such as ciprofloxacin.
While the U.S. Food and Drug Administration says serious side effects are rare, here are some to watch for and let your doctor know about immediately:
Tendon disorders: Beware of any pain, swelling or inflammation of your tendons. The problems, tendinitis and tendon rupture, most frequently involve the Achilles’ tendon, which runs along the back of the heel, but also have been reported in the shoulder, hand and other tendons. The side effect can happen while the patient is taking the antibiotic — or even several months after completing treatment, the FDA said. The risk is further increased in patients older than 60, in those also taking corticosteroids, and in recipients of kidney, heart and lung transplants.
Heart problems: Serious heart rhythm problems, called a prolonged QT interval, can be caused by drugs in this class. Elderly patients and those who take certain drugs to control heart rhythm are among those at special risk.
Dangerous diarrhea: These antibiotics can cause a serious intestine infection characterized by persistent or watery diarrhea. It can occur two months or more after patients finish taking the pills. While the side effect can occur with most types of antibiotics, some studies indicate fluoroquinolones may pose a higher risk.
Nerve problems: Damage to nerves in the arms, hands, legs or feet can be caused by these drugs, causing numbness, weakness, burning and tingling.
Others: Seizures, hallucinations, depression, light sensitivity, as well as damage to the liver, kidneys or bone marrow, and changes in blood sugar.
Source: FDA-approved drug labels and medication guides, AJC research

Related links:
Citizen’s guide to public records

 

WHAT YOU CAN DO
Research your drugs: Learn about side effects and potential drug interactions. Be aware that the drug information stapled to your prescription bag in most cases hasn’t been reviewed by the FDA and may be incomplete or downplay risks. Besides asking your doctor and pharmacist, check out the Public Citizen Health Research Group’s site, www.worstpills.org, for detailed reviews on hundreds of drugs, including more than 200 they say should never be used. Some information requires a $15 annual subscription.
Report reactions: Both health care professionals and patients can help alert federal regulators to potential side effects by reporting them to the U.S. Food and Drug Administration: www.fda.gov /medwatch/how.htm.
Sign up for alerts: To subscribe to e-mail alerts from the FDA about medical products, go to www.fda.gov /medwatch/elist.htm.

Tell us what you want investigated. Call us at 404-526-5041 or e-mail spotlight@ajc.com.

Cooper said he’d never heard about the risk until his foot swelled up painfully in September while he was taking Levaquin for pneumonia. Neither had his doctors, Cooper said, and he worries that many still don’t know about it.

“The best defense is for the patient to know,” he said.

In 2007, U.S. patients received more than 40 million prescriptions for fluoroquinolone antibiotics, according to IMS Health, a health care information company. Some studies have found these drugs are often misprescribed, chosen first by doctors when other antibiotics are more appropriate — or when none are needed.

“At one hospital the nurses told me they call Levaquin ‘Vitamin L’ because everybody is on it,” Cooper said.

While rare, the tendinitis and tendon rupture side effects can be disabling, making it difficult or impossible to use the affected limb. In some cases surgery is required to repair the tendon. Cooper said he was hospitalized for six days and lost two weeks of work. After weeks in the boot brace, he is only now being allowed brief periods out of it, in a special shoe. It will be the end of the month before he can start driving again.

The experience, he said, is prompting him to limit prescribing fluoroquinolones for his patients when other antibiotics will work, and to try to get the word out to other doctors and patients.

“I don’t want other people to experience the same thing,” said Cooper, 73.

Last summer, the U.S. Food and Drug Administration told the makers of pill and injectable fluoroquinolone antibiotics to add to the drugs’ prescribing information a black-box warning — the most serious type — about the increased risk of tendinitis and tendon rupture. The agency stopped short of requiring that drug companies send letters to doctors alerting them of the change, though a few have done so voluntarily in recent months.

“We wanted to make sure they had all the information they needed in treating their patients,” said Amy Firsching, a spokeswoman for Ortho-McNeil, which sells Levaquin.

Bayer HealthCare Pharmaceuticals sent letters in October to doctors about Cipro and Avelox. Oscient Pharmaceuticals, which sells Factive, said its letters were to go out by this weekend.

To make sure consumers are better informed, the FDA is requiring that pharmacists begin providing an agency-approved medication guide to patients picking up prescriptions for this class of antibiotics.

The guide, a somewhat rare action for the FDA, details tendon and other serious side effects such as heart rhythm disorders and nerve problems.

One reason for the new warnings was a lawsuit by Public Citizen’s Health Research Group against the FDA last January. The suit alleged the FDA was dragging its feet taking action on the group’s August 2006 petition for stronger warnings about the tendon dangers.

The FDA has received nearly 2,250 reports of tendon disorders and 775 reports of tendon ruptures among patients taking fluoroquinolones, though the actual numbers are likely much greater since most side effects are never reported.

“The tendon ruptures are entirely preventable if at the time they start getting pain they call their doctor and get switched to another drug,” said Dr. Sidney Wolfe, director of the Health Research Group at Public Citizen, a Washington-based watchdog group.

The FDA-approved label, or prescribing information, for this class of antibiotics has included information about tendon side effects for several years, representatives for the drug makers note. But these labels are often 20 or more pages long and packed with details about the medication’s chemistry, absorption, approved uses as well as various precautions, warnings and contraindications.

Until now, the tendon warnings weren’t prominent enough, Wolfe said, adding that sending warning letters directly to doctors is critical. “If doctors knew about this, we wouldn’t continue to see this continuing onslaught of tendon ruptures,” he said.

“The focus of the marketing of drugs is mainly on the benefit side,” Wolfe said. “Doctors are historically underinformed about the risks of drugs.”

Not only should patients be on the lookout for any sign of tendon pain, they should question their doctors about whether they should be taking a fluoroquinolone antibiotic at all, Wolfe said. His group considers it one of the most overprescribed classes of drugs in the nation.

“They are just not the first-choice drugs for many diseases,” Wolfe said.

Researchers at the University of Pennsylvania found that inappropriate use of fluoroquinolones was “extremely common.” Of 100 consecutive patients prescribed the class of drugs at two medical center emergency departments, 81 received it for inappropriate conditions.

Why have fluoroquinolones become so popular with doctors? “It’s an antibiotic that in many ways requires you not to have to do a lot of thinking,” said Dr. Ebbing Lautenbach, a co-author of the 2003 study. Because the drugs kill a broad spectrum of bacteria, he said, a doctor has a good shot at covering whatever is causing the infection.

While other, older or more targeted antibiotics might be considered the first-line therapy, he said, doctors may prescribe a fluoroquinolone first in case the infection is resistant to the older antibiotic.

“It’s a shortsighted way of approaching uncertainty,” said Lautenbach, who is co-principal investigator at the federally supported Center for Education and Research on Therapeutics at the University of Pennsylvania.

Lautenbach advises patients to ask their doctors several questions: Do I have an infection? What kind of infection do you think I have? Do I really need an antibiotic?

“Most physicians assume the patient wants an antibiotic,” said Lautenbach, but they may not need it.

Please educate others on the severe and often permanent side effects of quinolone antibiotics.

Dr. Todd Plumb’s Levaquin poisoning

Thursday, December 11th, 2008

In late August of 2006 I took a one week course of Levaquin for a gastrointestinal infection I believe I contracted from eating at a fast food establishment.  The reason I chose Levaquin was because I knew that it had a broad spectrum of bactericidal activity against enteric pathogens, and because after talking to one of my Doctor friends, he had some samples of Levaquin  which would save me a costly pharmacy charge.  My gastrointestinal infection was accompanied by fever, chills, nausea, weakness and diarrhea.  I did not want to wait a week to see a doctor and it is difficult for me to find someone to fill in at the operating room where I work as an anesthesiologist. 

 

Soon after taking the Levaquin I immediately seemed to worsen.   In the first days of starting the medication I began to experience feeling of burning heat in my skin and profound insomnia.  I developed the burning skin in all parts of my body an it became painful.  I developed  progressive anxiety, insomnia, a wierd buzzing sensation upon sleeping and waking, deep muscle pain, muscle fasciculations, mild diffuse tendon pain, cold extremities, tremor, muscle weakness tinnitus, mild jaundice, white stools, ongoing diarrhea, esophageal reflux and GI distress and weight loss, and eventually numb skin everywhere (particularly feet and hands).

 

The last 22 months have been the hardest experience of my life and I have suffered tremendously from taking Levaquin and have met hundreds of others who have also suffered.  My life was altered in many ways and I have difficulty enjoying life due to the physical limitations caused by the drug.  I developed the following problems directly attributed to the drug.

 

Central Nervous System:   I developed many CNS symptoms and abnormalities including elevated Intracranial Pressure measured on spinal tap.  Profound persistent insomnia and sleep transition disturbance, with attacks similar to hypnogogia (despite the fact that my sleep study showed no sleep apnea).   For many months I was unable to transition past stage 2 sleep.  I developed severe and persistent anxiety with panic attacks.  I had never experienced this until after age 43.  I have been in many stressful situations throughout my life and have been able to remain calm and focused.  I was an emergency room doctor for 9 years and have worked in the operating room since then.  I have been through two medical residencies receiving the highest honors in both.  I have been involved in countless life or death patient situations and have been known for my cool head and decisiveness.  I didn’t know what anxiety and panic where until after Levaquin. 

 

I developed tinnitus in both ears that progressively worsened for months and with loss of hearing.   I have visual photosensitivity and vitreous floaters.  I have numbness and paresthesias in the distribution of all the sensory cranial nerves (my whole head and face feels numb).  I have fasciculations and weakness in motor cranial nerves.   I have pressure associated palsies in nerves of the face and head.  The spinal tap that I had resulted in a post- dural puncture headache which necessitated that I undergo an epidural blood patch for resolution of the headache.  

 

 During the first months of the medical evaluation of my condition, I underwent the following tests:  Brain MRI, PET scan, EEG, sleep study, spinal fluid analysis.  The only abnormality on these tests was the finding of mildly elevated spinal fluid opening pressure which is a known adverse reaction to fluoroquinolones.   I was evaluated by a local neurologist and again by neurologists at the Mayo Clinic in Scottsdale, Arizona.   No firm diagnosis was made.  No one considered the possibility of a neurotoxic reaction to fluoroquinolones.

 

Peripheral Nervous System:  This has been my biggest struggle.  I have chronic painful peripheral neuropathy.  I have toxic small fiber neuropathy of all of the skin of my body, but my feet and hands and genitals have suffered the most.  I have continual loss of sensation in feet hands and skin everywhere with associated paresthesias of pain and burning.  I have had pain in many areas of sensory nerve distribution in particular in my back.  My feet are continually painful and this makes it difficult to walk any distance. Before taking the medication I enjoyed hiking, weight lifting, biking, canyoneering and running.  I am a father of young children and am no longer able to participate in activities with them which involve any prolonged standing or walking, let alone running or hiking.   I was active and physically fit before Levaquin.  The constant pain in my feet has made me sedentary.  I also have motor nerve involvement with body wide muscle fasciculations, weakness in many muscles and mild spasticity in my lower legs with activity.   During the first months of my illness from Levaquin I had 2 EMGs and nerve conduction tests which showed slowing of peripheral nerve conduction velocities.  My initial EMGS were before the continued and worsening progression of my nerve injuries.   I was also noted to have decreased sensation in my extremities on neurologic examination.

 

Autonomic Nervous System:  I developed postural hypotension that took over a year to improve.  I had abnormal sudomotor (sweat response) and Sinus tachycardia for many months.  I had temporary incomplete bladder emptying and temporary erectile dysfunction for months.   I had autonomic testing which showed abnormal sweat response.  I continued after the autonomic testing to have postural hypotension, erectile dysfunction and bladder dysfunction.  Fortunately these problems have somewhat resolved.

 

Cardiovascular System:  In the first several months after taking the Levaquin I developed persistant sinus tachycardia which gradually resolved.   I have suffered from Raynauds phenomenon with very uncomfortable almost painful cold feet and hands.  I believe this is probably secondary to the autonomic dysregulation of vascular tone in my extremities from nerve damage.  I am sure that the sedentary lifestyle imposed by my painful feet is not helping my cardiovascular risk profile.  In the first months of my drug reaction I which showed good cardiovascular fitness.  This was before the progressive neuropathy reached its peak and before the 2 years of sedentary lifestyle.

 

Musculoskeletal System:  I developed wide spread tendon, joint and muscle pain which has persisted for nearly two years.  I have painful ankle, knee, hip, hand and wrist, and shoulder joints and tendons.  The joint and tendon pain was not apparent immediately but came on gradually within a week of stopping the medication.  I had an avulsion injury of my ulnar styloid with just minimal lifting and chronic pain associated with it.  Many of my ligaments and tendons have a “loose” feeling and I am careful about undue stress on them.   I know that tendon and joint injury are the more well known adverse reactions to fluoroquinolones but they have been secondary compared to my nerve injuries and pain.

 

Endocrine Sytem:  Soon after taking the Levaquin I had a thorough endocrine workup.  I was found to have a very low testosterone.  I was also found to have anti-thyroid antibodies and Hashimoto’s thyroiditis, but my thyroid function was still normal. 

 

Gastrointestinal System:  Initially for many months after taking levaquin I had severe ongoing abdominal discomfort, bloating, diarrhea, and heartburn, and I lost 31 pounds.  In the first days after taking the Levaquin I developed white stools, and dark urine.  I was found to have elevated liver enzymes.  I had 2 CT scans, of my abdomen, 1 CT of my pelvis, 1 CT of my chest, and an upper GI with small bowel follow through. 

 

I was evaluated by many doctors during my initial workup.  None of them were able to link my condition to my Levaquin use.  I was prescribed antidepressants and sleep aids and much head scratching and poor follow up was done.   In the first 3 months I saw 1 ER doctor, 3 internists, 2 Endocrinologists, 2 Neurologists, 1 gastroenterologist, 1 psychiatrist, and 1 pulmonary and critical care specialist.  I had thousands of dollars of blood tests, urine tests, radiological tests etc.   I became frustrated with my colleagues in their inability to find the problem and began researching my condition on my own.  I corresponded with many other doctors and finally was able to recognize fluoroquinolone toxicity after talking to Dr. David Flockhart of Indiana University.

 

As you can probably tell this has made a negative impact in many areas of my life.  Just after becoming ill I was nominated to be the chairmen of my local anesthesia group and had to turn this down because of the health issues.  I have greatly cut back on my work and have had to take many days off and try to work as little as possible.  This has reduced my income.   My duties to my family have been difficult since I have barely been able to provide for them.

 

I have also found many other patients who have suffered the same symptoms from Levaquin and other fluoroquinolones.  A few months ago I began to keep a tally of patients who I know in my local community.  The list is growing and includes 3 other members of my local medical staff, two of whom had serious tendon rupture.  This is obviously much more common than the public and doctors are led to believe and the cellular damage done by the fluoroquinolones is not limited to tendon disruption in select population.  The true damage to patients involves multiple body systems in patients of all ages.


Dr. Edward Cooper’s Avelox poisoning.

Thursday, December 11th, 2008

Edward’s Story

I am a 54 y/o urgent care physician who was 8 months into rehabbing after ACL reconstructive knee surgery, progressing to the point that I was running regularly.I have recurrent sinus infections and had been advised by my ENT to have sinus surgery. I had been taking Augmentin for about a week but the infection was not improving. According to the Sanford Guide to Antimicrobial Therapy (the gold standard for physicians treating infections), for severe sinus infections lasting over 3 days without improvement, quinolones are the only meds. listed for treatment. The Sanford guide was given to me by the Avelox representative, by the way.

On 5-28-04 I took one 400mg. tab of Avelox. The next A.M. I woke up with severe pain from my left hip through to my left foot. My left leg from the mid-calf to the entire foot was reddened and swollen with all tendons in severe, burning pain and all muscles were in painful spasm. I could only crawl to the restroom for my activity that day. There were also elements of depersonalization, anxiety and panic during this time. It is now eleven days since I took a single Avelox pill and I continue to have great difficulty walking with constant pain in my left leg, and increasing instability in my surgically reconstructed right knee along burning pain in both Achilles tendons.

It is all I can do to go to work and feed myself, finding it very difficult to tolerate much time standing and may have to cut back on my work schedule as I fear the rupture of my Achilles tendons or the AC ligament. I know from reading other postings that this process can take an indefinite period of time to resolve, if ever. I have never missed a day of work in almost 30 years of practice except for the knee surgery, but that may change soon if the pain, weakness, and instability of my joints continue to worsen.

The Avelox rep. did not even offer to report this as an adverse drug reaction and suggested that I was probably working out too much! I guarantee that I will actively pursue this progressive poisoning of our people with further research and political actions. They have been making “new, safe” quinolones for many years but the facts show that most of these are soon withdrawn from the market once they are taken by the general public and the adverse reactions occur. Is there any other product in the U.S.A. that can get away with stating that “if your tendons rupture, then stop taking our product”?

Story updated – 09/01/04:

This a 90 day update. There has been improvement my leg strength to the extent that I can use a recumbent bike and have progressed to an elliptical machine as of 8-04, but any attempt at prolonged walking leaves me with severe muscle spasm, Achilles tendon pain, and a rather alarming instability of my surgically reconstructed right knee. The right leg became symptomatic about a week after the ADR, with searing pain in the ligament and all tendons. Recently, I have had increasingly severe CNS symptoms with floaters in my eyes which are very dense and almost curtain-like along with anxiety and insomnia which requires three 3 mg. melatonin at bedtime. I have developed severe photophobia which primarily occurs after exercise. I have a cyst on my kidney and on tendons of my left hip, these enlarge after activity. It’s hard to believe that less than a year ago, I could do any level of step aerobics and could dance as well as most of the 20 somethings in the classes; an activity that I had been doing for about 12 years. I live a very withdrawn life now, the depersonalization symptoms became so bad, that at one point I actually had to sit down and make an outline of my life as I remembered it. Memories of the first two months of the ADR are of coming to the clinic where I work an hour early to put hot packs on my hips and legs and still feeling that my torso would actually fall down through between my legs if I continued to stand for periods of time, trying to do an upward facing dog yoga pose and feeling tendons pulling away from their bony attachments to my frontal pelvic area almost like tissue paper, or having to get my food at a drive-up restaurant because I could not stand long enough to make my own meals, then realizing that the ADR would relapse severely from eating meat, especially poultry. Of course these problems are really quite minor compared to the other stories on this site and are almost amusing to me now, until I think about the plans to get these poisons authorized for young children. I continue  to only be able to work 3 days per week but I will continue to actively pursue my attempts to return to full function and campaign to have these drugs only available through infectious disease specialists and hospitals. Please, if you are an FQ victim, make reports to med watch on a periodic basis to indicate that these ADRs are not short term and can affect our lives severely for long periods of time.

Story updated – 07/30/05:

I meant to provide a one year follow-up but am only now recording my experiences after over one year from the ADR.

I continue to have periodic episodes of tendinopathy with instability of ankles, knees, hips and even low back with ongoing pain and increasing weakness of lower extremities. My left Achilles and plantar fascia are becoming more loose with each cycle with increasing nodularity at the tendon attachment at the heel.

It’s been 4 months since I have eaten away from home, the last time was when I could not stand it anymore and had BarBQ in Oakland and was unable to ambulate for 2 weeks due to pain in hips. I was unable to work for 6 months since last fall after being able to work 5-6 twelve hour shifts in urgent care as well as work out with wts, and aerobics on days off.

My ACL repair has been affected: one evening I felt intense pain in my posterior rt knee, which subsequently became unstable. An MRI revealed that the replacement ACL had become “thin, and functionally incompetent”, my ortho could understand this and prescribed further PT which really did not prove to have any lasting improvement.

I finally realized that the replacement ACL is from a cadaver Achilles tendon and it was also ultimately affected by the ongoing allergic/inflammatory or whatever reaction.

If I take aspirin, corticosteroid nasal spray, or NSAID I am unable to sleep due to the subsequent stimulant reaction which can resemble a severe panic attack. Even taking a soy protein powder supplement which was once a regular part of my diet will cause severe muscle and tendon pain and further looseness of Achilles tendon.

So I must be very careful about diet and discover cross-reactions as I go. At least, I did not use the vioxx samples that were given to me. Finally, as an MD for almost 30 years, I have become completely disenchanted with medicine as I increasingly view the continued “takeover” of medical education by the pharm cos., having recently read about a dorm residency that will actually be funded by them.

Doctors poisoned by quinolones

Thursday, December 11th, 2008

Fo anyone reading this blog that has not been damaged by a quinolone I thought I would post some stories of doctors that have been poisoned. I know it must be hard to conceptualize that  people have been crippled for decades from just a handful of antibiotics. It’s all true though. Please don’t take a chance on these antibiotics. It’s like playing russian roulette. You may take it once and not have a problem but the second or third time you take it could end up being the nail in the coffin. I think one day it will be revealed that one of the contributing causes for fibromyalgia, auto-immune diseases, and many other chronic conditions is due to quinolone antibiotics. Showing some examples of doctors that have been poisoned adds some credibility to this unrelenting toxicity.