Fluoroquinolone Antibiotic Toxicity (Cipro, Levaquin, Avelox, Floxin)
Help Us Make It Stop!! Approved for children!! Costing us Billions!
Fluoroquinolones are currently one of the most commonly prescribed classes of antibiotics being prescribed millions of times each year. They are used to treat many types of infections such as respiratory infections, urinary tract infections, and sinus infections. Like all medications this class of antibiotics has side effects. However, what differentiates this class of antibiotics from others is that fluoroquinolones have the ability to cause severe and permanent disability. Even from as little as a few pills. The insidious part of these chronic adverse reactions is that they can occur many weeks to months after taking the antibiotic. Side effects to fluoroquinolones are often times at their worst long after the antibiotic has been taken. Hence, many people never link their health problems such as nerve and tendon pain, chronic insomnia, and altered mood back to the antibiotic. If you or a family member suffers from unexplained physical and neurological problems please check your medical records to see if you were ever given a fluoroquinolone antibiotic. The most commonly prescribed fluoroquinolones include Levaquin, Cipro, and Avelox. Approximately half of the fluoroquinolone antibiotics that were once on the market have now been removed from clinical practice due to their severe toxicities. Examples include Tequin, Omniflox, Trovan, and Zagam.
Fluoroquinolone antibiotics are extremely powerful medications. They were never meant to be prescribed indiscriminately and without warning to patients. They are meant to be used as a last line of defense against serious and life-threatening infections. Not as a first line agent which is how they are often used today. In addition, the overuse of these potent antibiotics leads to the condition known as bacterial resistance.
In 2008, the FDA mandated that fluoroquinolone antibiotics carry a “black box“ warning for tendon rupture and tendonitis. Public Citizen, a consumer advocacy group, sued the FDA demanding fluoroquinolones carry a black box warning. The FDA gets approximately 50% of their funding for the review of drugs directly from the pharmaceutical companies in what is called prescription drug user fees. This is an absurd conflict of interest that has made the FDA very slow and often reluctant to react to drug toxicities of all kinds. Even the FDA admits that less than 5% of all serious adverse drug reactions ever get reported to their agency.
Unfortunately, the black box warning is far too late for the many victims that are now suffering from devastating physical and neurological disabilities. There is an appalling lack of knowledge within the medical community regarding these chronic reactions including delayed adverse reactions. Since these adverse reactions are far from intuitive, fluoroquinolone victims are often misdiagnosed or even sometimes unfairly labeled as “difficult patients.†Post-marketing studies of several fluoroquinolones have shown an incidence of adverse reactions much higher than were originally reported in pre-clinical studies.
The american public needs to be afforded the right of informed consent with a medication as potent as fluoroquinolones. The manufacturers of fluoroquinolone antibiotics have failed to warn both the public and the medical profession of serious long term physical and neurological injuries. The manufacturers have minimized, distorted, and trivialized these serious adverse reactions. This deception and fraud by the drug manufacturers not only costs the victim and their family but also the taxpayer in terms of increased medical care costs, disability payments, and lost productivity.
We feel there should be congressional hearings on this toxicity. The FDA has long been aware of the crippling and sometimes permanent injuries from this class of antibiotics. They have chosen to turn a blind eye to this toxicity. The mission statement of the FDA is that they are responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs. In regard to fluoroquinolone antibiotics, the FDA has failed to live up to their own mission statement. This Facebook page was created to help raise serious advocacy and activism. We hope to help warn and prevent others from suffering a severe toxic injury. Please forward this site to all of your friends on Facebook and ask them to do the same. Finally, please promote advocacy and activism by contacting congress, the media, and signing the petition on this site. Thank you for your support and activism.
http://www.facebook.com/home.php#!/pages/Fluoroquinolone-Antibiotic-Toxicity-Cipro-Levaquin-Avelox-Floxin/106912045999263?v=app_4949752878&ref=ts
Comment By: T Lucas
Date & Time: May 11, 2010 at 9:04 pm
Whats more dangerous Levaquin vs. Corolla?
LevaquinBlog would like to draw attention to some excellent analysis by the blog http://www.myquinstory.info . We encourage you to read the entire post, but here’s some of the most compelling data:
According to Medwatch, the adverse drug reporting arm of the FDA, the following statistics are available on fluoroquinolone antibiotics, from a period from 1997 to 2007: Levaquin 39,128 adverse drug reactions (ADR’S) and 808 deaths, Floxin 13,495 ADR’s and 311 deaths, Cipro 40,395 ADR’s and 837 deaths, Avelox 30,160 ADR’s and 337 deaths, and Proquin 40,151 ADR’s and 831 deaths. For this list of FQs, and it is not a total inclusive list, the total adverse drugs reactions are 163,329 with deaths totaling 3,124. According to the FDA, reports to Medwatch only represent between 1% and 10% of the actual numbers of occurrence. Why?
The FDA states that most people have never heard of the Medwatch program and a lot of doctors are not inclined to waste their valuable time in reporting adverse drug reactions or telling patients about it. Looking at the facts from the FDA’s own admission, deaths from FQ’s could easily total over 30,000, based on if only 10% of the actual occurrences have been reported.
Now humor me for a minute as my logical mind kicks in. Toyota recalls millions of cars and has to appear before congressional hearings because of the possibility that a defect cause 275 crashes and 18 deaths over 11 years, and the fluoroquinolones antibiotics have caused, at the very least, 163,329 ADR’s and 3,124 deaths, and no hearings, no outcry, no acknowledgement from the medical community? Why?
What do you think? Should Congress, the media and the public spend more time analysing and worrying about Toyota’s car defects or the ongoing danger that is flouroquinolone toxicity (together with the FDA’s malaise when it comes to protecting the public)? Which is really more a danger to the public?
See full post here: http://www.myquinstory.info/?p=202
Comment By: T Lucas
Date & Time: May 14, 2010 at 9:58 pm
Patent extensions
Under the Bush administration (2001–2008), patent extension legislation was signed into law that allowed Johnson and Johnson–Ortho McNeil, as well as other drug companies, a six-month patent extension for testing their products for safety in children. Johnson and Johnson–Ortho McNeil will earn hundreds of millions of dollars due to the FDA's recently granting pediatric exclusivity for Levaquin, as this extends their patent monopoly till the end of 2010. The legislation that was signed by President Bush, granting Johnson and Johnson–Ortho McNeil and other drug manufacturers a six-month extension on their patents (to conduct pediatric testing), was drafted after extensive lobbying of numerous members of Congress by Bayer A.G., Johnson and Johnson–Ortho McNeil, and others. One of the four sponsors of this legislation was Chris Dodd (D-CT), who, at the time, ranked as one of the top three beneficiaries of campaign contributions by drug companies. Sen. Edward Kennedy (D-Mass.), who chaired the committee with jurisdiction over the bill, refused to fight over the language that (if it had been included) would have reduced the drug company's profits due to these patent extensions. The reasons for Sen. Edward Kennedy's decision not to fight for the inclusion of this language were not made known.
The results of these pediatric trials involving levofloxacin included two reported pediatric fatalities that the investigators determined were not related to the drug. Within one study it was stated that the pediatric patient has a 3.8% chance of experiencing a serious musculoskeletal adverse event. However, the two most recent pediatric studies involving the use of levofloxacin, indicates that the pediatric patient has a greater than 50% chance of experiencing one or more adverse reactions, which would be consistent with the studies found within the NDA (new drug application) for levofloxacin,] which showed an ADR rate in excess of 40%, as well as a number of reported fatalities. Within the first study,[56] it is stated that “Of the 712 subjects evaluable for safety, 275 (52%) levofloxacin-treated subjects experienced one or more adverse event…. Serious adverse events were reported in 33 (6%) levofloxacin-treated subjects…. Two serious adverse events in levofloxacin-treated subjects resulted in fatal outcomes.†Within the second study it is stated that “Of the 204 subjects evaluable for safety, 122 experienced one or more adverse events…. Twelve subjects (6%) discontinued study drug due to an adverse event…. Seven subjects (3%) experienced 8 serious adverse events.†(circa 2007)
Comment By: T Lucas
Date & Time: May 14, 2010 at 10:12 pm
Ciprofloxacin, a fluoroquinolone antibacterial agent, is not recommended in pediatric population on account of its possible adverse effect on growing cartilage. It is being commonly used for treatment of variety of infections in children in our country and very little information is available on the risks involved in its use. A questionnaire was sent to 750 pediatricians in the last week of November 1990, to retrospectively judge over the previous 2 month period the extent of its use and identify the adverse drug reactions (ADRs). One hundred and fifty-four pediatricians replied, of which 147 had prescribed ciprofloxacin in a total of 3341 patients under 18 years of age, enteric fever being the commonest indication for its use. One hundred and fifty-nine ADRs were reported in 104 (3.1%) patients. They were: gastrointestinal in 50% of these 104 patients, CNS in 23%, skin and allergic in 19.1%, musculoskeletal in 8.6%, hematological in 3.8%, CVS in 2.9% and nephrological in 0.9% cases. Of 159 ADRs, 8 (5%) were severe, 76 (47.8%) were moderate and 75 (47.2%) were mild. Therapy needed discontinuation in only 9 (0.3%) patients. Two new ADRs were identified, viz., sudden death after intravenous ciprofloxacin and sinus nodal arrest causing bradycardia.
Comment By: Chris Peters
Date & Time: May 19, 2010 at 4:00 am
My son had sinusitis and was given many rounds of anti-biotics… still never stopped his nasal drip…..his immune system was compromised and now is facing possible blood Cancer. He does live in Denver with 17-28% less oxygen… and Cancer grows in a 60% oxygen environement..
This would not have even got to this point if the sinus would have been treated as a fungal infection….Mayo Clinic, where he is going for evaulation knows that sinusitis is a fungal disease, but, still treats with a an anti-biotic…
Grapefruit Seed Extract is one natural fungal killer…Instead, he listened to his Doctor and had his splen removed and now looks at possible blood Cancer,when it should have been treated as a fungal problem…Now, with the fungal problem, plus all the antibiotics given, and his spleen removed….he has NO IMMUNE SYSTEM. SYSTEMIC FUNGAL INFECTIONS NEED TO BE TREATED AS SUCH..
Comment By: T Lucas
Date & Time: May 23, 2010 at 5:37 pm
Wow Chris I am so sorry to hear about this. We have a facebook site with a petition at the top of the page trying to get more warnings put on these drugs.
Please join this group and sign the petition.
Other great helpfulsites:
http://www.fqresearch.org/
http://www.myquinstory.com
Many people trust their doctors and never think an antibiotic could kill you.
Comment By: Chris Peters
Date & Time: May 23, 2010 at 10:30 pm
T lucas,
The problem with all antibiotics…They kill bacteria, but, when your immune system is weakened to begin with….It will cause Cancers…and other bacterial and antifungal diseases.and problems…THEY KILL ALL BIOLOGY….THEUY KILL THE IMMUNE SYSTEM…
I just read that Dr. Angell former editor-in-chiefof the prestegious New England Journal of Medicine says that there are flaws in the approval process of ALL CHEMICALS AND DRUGS, NOT JUST ANTI-BIOTICS..
Dr. Angell says that the studies are not complete..They do not address all the circustances of the study, and do not take into consideration the drug interactions of the many drugs individuals take in conjunction with the drug being approved…
She says the Political influence of the Chemical Companies, not only flaw the results, but, the studies are for too short of a time period.
There is little to no SCIENCE BEHIND THE FDA APPROVAL AND MARKETING OF THE DRUGS..
Psychiatric drugs have as little as 6 weeks of testing….before approval and marketing…
If this is the case, that would include The Antiboitics you are speaking of here, as well..
Only two positive trials are required for FDA approval of a drug…There may be as many as 16 negative trials on the same drug, but, that does not matter…It will still be approved by the FDA…
Knowing this, I SAY ALL drugs are dangerous, if only 2 positive trials are required
for FDA approval ( WHEN THER MIGHT BE 16 NEGATIVE TRIALS ON THE SAME DRUG )
AND DOCTORS ARE SCREAMING FOR SCIENCE BEHIND NATURAL CURES THAT HAVE MILLIONS OF TRIALS, OVER THE COURSE OF THOUSNADS OF YEARS…
They should be screaming for REAL science behind the chemicals that are damaging and killing folks..
Comment By: T Lucas
Date & Time: May 24, 2010 at 10:30 pm
Chris I agree with you.
It is a shame these pharmaceutical companies get away with murder. They should be responsible for all the deaths, injuries and illness they cause then maybe they would be careful. There is a pill for everything.
If you have a facebook account please join our group.
I hope your son gets better soon. How old his he?
http://www.facebook.com/?ref=home#!/pages/Fluoroquinolone-Antibiotic-Toxicity-Cipro-Levaquin-Avelox-Floxin/106912045999263?ref=ts
Comment By: Donna Shields
Date & Time: September 9, 2010 at 8:41 pm
I had surgery for malignant melanomo on 8/2/10, was not healing and went back two weeks later and after taking kephalaxin? I had developed an infection at the site. They cultured it and waited 1 week when I was supposed to have sutures removed but, couldn't due to infection. They then put me on Cipro for 10 days 500mg twice a day. Three days later they removed sutures. Four days later, feeling like I was going to die I went to my pcp's office where he saw that the incision was not totally closed and pus came out when squeezed. He thought it was mrsa and because dermatologist would not fax culture report he put me on Levaquin. Three days later I HAD TO stop taking that due to unbelievable tendon pain in my lower legs and feet. In the meantime I found out after calling dermatologists office that the infection is Pseudomona so, back to pcp and nurse practitioner put me back on Cipro for 7 days. Finally finished them yesterday and I feel like death! I can barely walk, get winded easily and am in so much pain. Oh, did I forget to mention that on top of this I have Fibromyalgia. I truly feel and, mentioned this to pcp that cancer has somehow spread inside of me, I am not a "doom
Comment By: T Lucas
Date & Time: October 4, 2010 at 10:27 pm
Fluoroquinolone Antibiotic Toxicity (Cipro, Levaquin, Avelox, Floxin)
Facebook join us and sign the petition please..
http://www.facebook.com/topic.php?topic=149
Comment By: T Lucas
Date & Time: October 4, 2010 at 10:29 pm
Donna Shields…Did you have Fibro before Cipro?
National Fibromyalgia Association on facebook booted me off many of the members did not agree with the connection.
Comment By: Nicole Mark
Date & Time: February 28, 2011 at 5:21 pm
Thank you for the exposure to this topic here. I have signed the petition and have been spreading the word for others to do so. I too am a fluoroquinolone toxicity victim and I spend a lot of my free time searching the web for places to discuss this topic and bring awareness to the dangers of fluoroquinolones. I maintain a survivor's website here: http://www.survivingcipro.com, if anyone is interested. THANK YOU! Nikki