Europe’s Antibiotic Warnings
I suppose antibiotics can’t catch a break this month. A few weeks ago, FDA asked manufacturers of fluoroquinolone antimicrobial drugs to add black box warnings to the products due to increased risk of tendonitis and tendon rupture (see related story). Last week, FDA’s European counterpart, the European Medicines Agency (EMEA), recommended strengthening the warnings for oral moxifloxacin medicines.
Moxifloxacin is a fluoroquinolone antibiotic. EMEA concluded that these drugs should only be prescribed to treat acute bacterial sinusitis, acute exacerbation of chronic bronchitis, and community-acquired pneumonia when other antibiotics cannot be used or have failed.
The recommendation came out of EMEA’s Committee for Medicinal Products for Human Use (CHMP) after committee members reviewed information on the safety of moxifloxacin-containing medicines for oral use, following concerns over their liver safety, according to an EMEA press release.
CHMP concluded that “the benefits of oral moxifloxacin medicines continue to outweigh its risks.” However, due to safety concerns, mainly related to an increased risk of adverse hepatic reactions, CHMP recommended restricting their use in these indications. CHMP also recommended that the warnings of oral moxifloxacin-containing medicines be strengthened concerning the risk of diarrhea, heart failure in women and older patients, severe skin reactions and fatal liver injury.
The committee’s recommendation will be considered by the full European Commission (EC). If the EC agrees with the committee, additional warnings may soon be applied to all authorized oral moxifloxacin-containing medicines in the European Union.
Affected fluoroquinolone drugs include: Cipro, Cipro XR and Proquin XR, Factive, Levaquin, Avelox, Noroxin and Floxin, and generic ofloxacin. Affected moxifloxacin drugs include Actimax, Actira, Avelox, Havelox, Infekt, Izilox, Moxifloxacin, Octegra and Proflox.
Angie,
You suppose antibiotics can’t catch a break this month? Are you finally starting to see a trend? Before you wrote this story did you do any research? Did you search for any clinical trials that were not funded by a pharmaceutical agency? Do you think these agencies are just bored and have nothing else to do but to pick on antibiotics? Your first sentence should have read, I guess, fluoroquinolones can’t get a break.
It’s nice that fluffy little articles like this get published but it’s mainly a slap in the face to those of us who are suffering the SEVERE SIDE EFFECTS from this class of drugs. Are INVESTIGATIVE JOURNALIST an extinct breed? This debate has been going on for over two decades. They have withdrawn over half of this class of drugs. Doctors are just shrugging there shoulders at these warnings. The winning example of this would be Paul G. Auwaerter, MD, Clinical Director, Division of Infectious Diseases, Johns Hopkins University School of Medicine, Baltimore, MD. You can view his response at http://www.medscape.com/viewarticle/577526 He deserves an Emmy for keeping a straight face while taping this.
Paul Auwaerter, MD, MBA, has disclosed that he owns stock, stock
options, and bonds in Johnson & Johnson, and has received grants for
educational activities from Pfizer, Schering-Plough, Tibotec, and
Wyeth. Dr. Auwaerter has also disclosed that he has served as an
advisor or consultant to Johnson & Johnson and Schering-Plough.
He is a Consultant – Schering Plough, Adamas Pharmaceuticals,
Genzyme, Novartis
He owns Stock in- Merck, JNJ, Pfizer
He is a part of the Speaker Bureau for Schering Plough
CME – Pfizer, Wyeth
A qualified and unbiased professional point of view? I think not. He should be ashamed.
I’m sorry I sound cynical. I am over so-called reporters who go into the Pharmaceutical spin-room and come out with there stories.
If you happen to run into a real investigative journalist, do us both a favor and ask him or her to roll up their sleeves and publish a real piece on this subject.
Until then I am following the debate over whether cigarette smoking is harmful to one’s health.
EMEA has also restricted the use of Oral Norfloxacin drugs in UTIs.
To wit:
LONDON — July 24, 2008 — The European Medicines Agency has recommended restricting the use of oral norfloxacin-containing medicines in urinary infections.
The Agency’s Committee for Medicinal Products for Human Use (CHMP) has concluded that the marketing authorisations for oral norfloxacin-containing medicines, when used in the treatment of acute or chronic
complicated pyelonephritis, should be withdrawn because the benefits of these medicines do not outweigh their risks in this indication.
This is based on the fact that the efficacy has not been adequately demonstrated for this type of infection.
The CHMP review of norfloxacin medicines was initiated on the request of the Belgian medicines regulatory agency. They questioned the efficacy of oral formulations of the medicine for complicated pyelonephritis in comparison with other fluoroquinolones.
Following evaluation of information provided by the companies, the CHMP, at its July 2008 meeting, noted that there was not enough clinical data to demonstrate the efficacy of oral treatment with norfloxacin-containing medicines in complicated pyelonephritis.
Therefore, the CHMP concluded that the use of oral norfloxacin-containing medicines in the treatment of acute or chronic complicated pyelonephritis could no longer be supported.
The recommendation of the CHMP does not have an impact on the use of oral norfloxacin-containing medicines in other types of infection.
Doctors should not prescribe oral norfloxacin for complicated pyelonephritis and should consider switching patients already taking oral norfloxacin for this type of infection to an alternative antibiotic.
One has to wonder when the FDA is going to get on the stick here. The label changes that prompted the European Dear Doctor letter as well as the restrictions placed on Avelox took place here in the States a YEAR prior to them taking place in Europe. Once again the FDA does nothing while the world turns. And of course we see no Dear Doctor letter in the States either.
As far as this class catching a break, I believe they have enjoyed that for the past twenty five years. Surely it is about time that the true safety profile becomes public knowledge. After two and half decades of destroying peoples lives one has to wonder just what the FDA is thinking. Rhetorical question as we all know the answer to that one. Protect the drug manufacturers profits rather than the health and well being of the patient appears to be at the top of the list.
For we found no mention of ANY of these recent developments within any of the press releases written by the FDA regarding the futile Black Box Warning, though they were well aware of them at that time, nor will we in the foreseeable future either.
Just a matter of time before Avelox get’s yanked overseas, and when this happens we will continue to prescribe it here in the States. Just like we saw in the past with Trovan. Banned by everybody but the FDA.
I am a 39 year old male suffering from multiple reactions from just one course of Levaquin. All FQ class medicines have to be banned. They are causing misery and pain to hundreds of people.
The Fluoroquinolone antibiotics can be severely toxic to kidneys also. I have been having major problems for the 2 years since I finished my script of Cipro. I have had most of all the adverse drug reactions associated with this class and now I have recently been diagnosed with Diabetes Insipid. I used to have perfect kidney and liver function, but since Cipro, I have lost about 20% of my kidney’s function. The injuries just goes on and on after you
have taken one of these FQ’s. I firmly believe that the risks outweigh the benefits BY FAR!
These ABX are just too toxic to take that chance. You are better off taking something else that is much safer.
In 2003 I ingested 20 pills total of AVELOX (moxifloxacin) and LEVAQUIN (levofloxacin), as prescribed by my doctor to treat a sinus infection. My life has been hell on earth ever since, w/ the progression of severe, disabling adverse reactions. Today as I post these words, I can add Premature Ventricular Contractions to the never-ending list of ADR’s, as well as neck pain so severe that I can hardly hold up my head and type this.
Every morning when I open my eyes, I awaken to this nightmare. There is a “sickness” that feels like my body has been poisoned. My hands and feet are swelled and sore…my entire body is stiff and painful…heart-palpitations, vibrations throughout my body…ringing in my ears…bleeding specks of sores on my skin…and a full, bloated feeling in my gut…I feel like I should be dead. It is only by the grace of God, and the love of my 2 children that I am able to pull myself up out of bed, and make it painfully down the stairs. Crying will do no good, as I know I must be strong to fight this horrendous ordeal that has become my life. Knowing that there are others who are living this nightmare gives me a sense of strength…and compassion. There are no more words to described what we are going through emotionally, let alone physically. How could something so unbelievably criminal have happened to us?? And why is this insanity being allowed to continue?? How many more innocent people will have their lives destroyed…how many more must suffer…how many more must die….before something is done?? Someone tell me, what will it take??
Diagnosed w/ arthralgia, trigeminal neuralgia, tendinitis both elbows, enlarged lymph nodes…
still seeing doctor after doctor, and specialists who can only treat the “symptoms”, not the cause.
The Black-Box warning for tendon damage is hardly sufficient and long-overdue.
The poisons that robbed my children of a mother were AVELOX and LEVAQUIN…20 pills. I traded a sinus infection for this life of pain and misery.
http://blog.garymoller.com/2008/03/my-doctor-has-poisoned-me-with.html
Thank you
~Shells~
I was a fairly normal, happy and healthy 51 y/o male enjoying life, and full of energy until I took a 10 day course of Cipro to treat a minor UTI. That was 2 years ago. I am now struggling to survive the damage and multiple injuries inflicted on me by Cipro. The Cipro did clear up my UTI like any other simple antibiotic would have, but the difference is that Cipro has left me crippled and in intense pain 24/7. Cipro damaged my joints, tendons, nerves in feet and legs, and has done CNS damage that gave me insomnia, anxiety and depression. I just received my lab tests recently, and they now show that I have Diabetes Insipidus as well. I traded a simple UTI that could have been cleared by any number of simple and safe antibiotics, but since Dr’s have been using the fluoroquinolones like Cipro as a first line treatment for these minor infections, I now have all these health problems, including a life threatening condition, all brought on by Cipro. Basically, Cipro has destroyed my health and ruined my life. The new warnings on FQ ABX are way too weak and way overdue. The FQ class of ABX is extremely toxic and dangerous. I now feel like my life is over and I am living on borrowed time. Every day is a struggle to get through and there is no sign of improvement. The victims injured by these toxic drugs live with the daily horror of what has happened to them, and would give anything to be able to go back in time and not have let their ignorant Dr. poison them. Every day I think about all the others suffering like me, and the new unsuspecting ones yet to be poisoned. Something has to be done to stop this insanity and waste of human life. That weak Black Box warning only covers tendon rupture and doesn’t list all the real dangers associated with the FQ’s. I only wish that my Dr. had warned me of all the possible side effects, and I would have taken something else and not be in this daily hell. Gary TBY
I’m actually glad that my posts about antibiotics have attracted so much attention. The issue is clearly important and as Ty Taylor points out, been ongoing for many years. If this were an investigative article or report, I would have definitely included more research, statistics, and perhaps even some feedback from experts, but this is just a blog.
I’m also glad so many individuals who have been affected by these types of antibiotics have shared their experiences and spoken their minds. I hope they continue to do so. Perhaps FDA will pay closer attention to this issue as so many have suffered adverse effects.
The sad fact is that, ultimately, patients have to be more careful than ever when taking medications and researching (or bombarding their doctors and pharmacists with questions) what may have a potential negative effect. It’s quite scary that drug consumers can’t just “trust” that their prescriptions are safe.
Angie,
I’m sorry that my first posting was negative. It’s frustrating to see how some of these doctors are ignoring the new warnings. While in the mean time I am sitting here recovering from a rotator cuff tear and bicep tendon surgery on my right side. Only to face the same surgery again on the left side in October.
I just think this is an unfair trade to treat a sinus infection. All the while knowing that fall is approaching quickly which brings along with it cold and flu season. And I dread seeing one more person walking out of a doctors office with a script in hand for one of these dangerous drugs.
Angie, I appreciate you allowing people to respond about these medicines. I usually write about my husband who became disabled after taking Cipro & CiproXR. He had seen almost a dozen different doctors who never had any idea that his 6 ruptures & avulsions were connected to these medicines. They had no idea what caused this at all. My brother took only 1 Levaquin pill several years ago & still suffers from adverse reactions after taking it. My husband’s aunt took 2 Cipro pills & ended up in the ER. I faxed the ER doctor on duty all my informtion on how to treat her condition & thankfully he believed me & used it. I also took a quinolone several years ago & had terrible pain in both my calves for months. I don’t believe these reactions are “rare” considering what we have experienced in our own family. I doubt the FDA will pay much attention to the injuries people are having because they didn’t before. I used to believe the FDA protected people from harmful drugs. I have lost my belief in them. They have failed to protect my family & so many others.
I never would have believed that doctors could perscribe anything that was bad for us before they put me on a course of flouroquinolones (Ofloxacin 500mg twice daily for 14 days). They made me so ill I thought that I was going to die. The doctors assure me that it was not the pills but I know that 3-4 hours after taking each one I started to feel worse. I even waited an extra 4 hours before taking one and sure enough, I felt worse 4 hours later. I was hardly ever ill before. Now, barely a week can go buy without me feeling at least mildly unwell. Warn your friends and families. Do not take them, one day they will have more than a ‘black label’ warning – they will be banned.
If the FDA is not in business to oversee and protect the public then what are they doing? Everyone makes excuses and I am sick of it. I’m sick of the rhetoric from the medical community, the flat out lies from the pharmaceutical companies, and the inadequacy of the FDA. Tie that to over-simplified reporting in the media and we have a recipe for disaster.
I speak from experience. I’m a 48 yr. old male who WAS extremely active and healthy. Now, after 4 days on Levaquin, my life has been significantly altered. From the distal bicep tendon rupture to the ongoing psychological symptoms that continue to plague me on a daily basis after 22 months. My blood sugar is all over the place, I have high levels of protein in my urine and I never had problems like this before. I was prescribed Levaquin for a suspected sinus infection by an allergist. I truly believe that if these people do not have the capacity to understand the implications of their treatments then they shouldn’t be allowed to prescribe them.
I’ll die at home from a minor problem before I will trust another doctor. Please someone…. report the truth about this poison before too many others get hurt.
Until then I am following the debate over whether cigarette smoking is harmful to one’s health
I’m sorry but with my warped sense of humor I just had to point out that in today’s newspaper it was stated that the FDA just got permission to oversee the tobacco industry. Anybody want to bet that within a year cigarettes will carry the following warning?
Cigarettes have been found to be both safe and well tolerated by those who choose to smoke.
This is the problem we face in a nutshell. The FDA has failed MISERABLY when it comes to protecting the patients. I realize Angie that you are just presenting a blog, and by no means a full-blown expose. But it just drives one nuts to read the same misinformation over and over and over and over and over and over again. For two and a half decades I might add.
Whom ever is responsible for keeping these adverse reactions such a secret needs to be working at the CIA. It just blows my mind the ignorance found not only in the medical community, but within the media as well. Fact checking takes but a few moments with the advent of the Internet. Yet we find factual error after factual error in just about every story and blog concerning these issues. One blog stated that Levaquin was approved in 2004, and Avelox in 2005, when actually they were both approved in the late nineties. People are acting as if this is something new when it has been ongoing since 1982.
Then we have people citing to the figures found in MedWatch regarding the number of reports concerning this saying what’s the big deal here? Just a few patients are having this problem. But I have YET to read ANYWHERE, on any site that is blogging or commenting on this, that the FDA had excluded all of the reports filed between 1982-1996 from this database. Fourteen friggin years worth of data is NOT even being considered by anyone. If it was then the numbers would be going right through the roof. By excluding this data the FDA is excluding over 60% of the reports that had been filed.
With all due respect you have absolutely NO CLUE regarding the true safety profile of this class. If you did you would be absolutely outraged that such a drug is even being used for any reason. It is not a matter of due vigilance by the patient, this is a matter that has reached criminal proportions. This is what needs to be blogged about, not the latest attempt by the FDA to once again trivialize and minimize these adverse reactions.
Having been abandoned by the medical community and media yet again regarding these issues I guess it is just a matter of time before the legal community steps in. They seem to be the only ones who get it other than the patients. Perhaps with a couple of million lawsuits filed someone may sit up and finally take notice.
All this being said I do appreciate your efforts and I am not criticizing them. At the very least you did something while your peers do nothing at all. And for that I give you credit for effort. At least you are trying to do the right thing here. As such I give you an A for effort and a D- for content, for you are repeating the same [...] lies I have been hearing since 1984. Which just drives a person nuts.
I have been disabled for 3 years from these terrible antibiotics. I had just about every side effect except for a tendon rupture. 3 years later I am on narcotics because all of the pain.
John
This class of drugs are very very toxic, they should be banned. The fluoride content on a 10 day course of such drugs (especially moxifloxacin but also ciprofloxacin) could be lethal for a horse let alone a human being.
I dont understand the thinking of these manufacturers. It is well known that such a fluoride content causes major diabetes insipidus and changes in brain neuropeptide structure, this is basic pathobiochem lessons. Moreover tendon ruptures are also a direct problem from too much fluoride. It is impossible to keep such drugs in the market with such a side effect potential. These people must go onto trial, they have literally damaged irreversibly thousands of peoples lives.
The FDA should do more than just black box these drugs, they should be banned. What is so difficult to understand.
Morever, i have gone back and forth and checked all necessary info regarding trials and approval of this class of drugs, especially regarding cipro, the drug seems to have gotten an approval/license within just a few weeks after inquiring for one.
This is just ridiculous.
Nothing was really done to ensure for the stability and health risks imposed to patients after using it for so many years. Authorities should check on FDAs intentions
Paris T,
You are mistaken regarding the fluoride content of the fluoroquinolone class. This class does not even contain flouride, but rather the fluorine atom. You ingest far more fluoride just brushing your teeth than you do with these drugs. Hundreds if not thousands of drugs contain the fluorine atom and you do not see these kinds of adverse events associated with their use. This class is toxic all unto itself without adding things that are a non issue. Fluoride indeed is a questionable chemical, but you are mixing apples and oranges here as it has absolutely nothing to do with these severe adverse reactions we find with the fluoroquinolones.
What is the best way to treat/manage patients with quinolone toxicity. Are there any specialists/experts to refer them to? Any help is appreciated. ciprovictim also mentioned faxing treatment recommendations to an ER doctor – what are they? Thank you
I have been on Cipro since the first week of Sept.because of what the urologist diagnosed as a uti(this was a phone call,he happened to be on call. Iwas on 500mg twice daily. After the 3rd week I was feeling but some residual symptoms, testicular pain. As the Dr.had prescribed andsince I try to trust Doctors which is getting increasingly hard for me to do, I continued the cipro until my appt. with him 1 week ago,sept.23. I told him when I saw him that I was much better but still having some groin burning around the testicle. He said that it was probably my prostate(I do have BPH) and gave another RX for cipro at a lower dose, 500mg daily instead of the 1000mg I was on. Also gave me Avodart to shrink the prostate. For a few days prior to the appt. I had finished the previous 3 rounds of cipro. A couple of days after starting my 4th round of cipro I began to have abdominal burning and moderate pain,getting worse each day. I really began to get worried that something serious was wrong with me! I placed a call into my urologist’s office. My Doctor was in surgery . I explained to the nurse what was happening and that I really felt that the cipro was
affeting me. Either that or else the infection had suddenly got worse. I never felt that bad in my life. I told her that I had decided to stop the
cipro that morning until I checked with the Doctor. She was nice and talked to another urologist in the office and he prescribed Macrobid.
That was yesterday October 30th. Within 24 hours all the burning pain and pressure in my upper abdomen had subsided and most of the pain in my stomach area. I am pretty convinced that the cipro was causing some or most of my SX. I had been doing a lot of research on uti,s and cipro (fluoroquinolones) in particular. Cipro may may be okay for short term use but I believe that the prolonged use not only failed to clear up all my original symptoms but raelly messed my whole system up. On top of that the 40,000mg or so I took killed a lot of good bacteria in my colon and digestive system. I am now taking probiotics.I can’t enough about the probable hazards of extended use of cipro. I am probably going to change urologists in near future.