In December 2007, John (not his real name) was in hospital with an infection and he was given Cipro. “Shortly after starting treatment with Cipro, I felt a "popping" in my shoulders,” he says. “At the time, I could barely move my arms and since then I have suffered constant pain; I am only now starting to improve thanks to physical therapy.”
Any patient taking these drugs and experiencing tendon pain should immediately stop taking them, stop any exercise, and contact their doctor.
Antibiotics can harm tendons, FDA warns [Reuters]
]]>I just found 4 "rare" side effects in my family; none of which ever made it into anyone's statistics because the DOCTORS REFUSED TO BELIEVE that fq antibiotics have any side effects to report.
YOU have to report it to MEDWATCH....I know that's the FDA but if they get enough reports of ADRS to FQs then they can't deny these drugs are doing what they do. Well...they can still deny it, but it just gets a little harder.
]]>I think having a black box warning should just be the first step in a total re-education program for doctors. When I was given ciprofloxin in January 2008 for a sinus infection, I had terrible side effects - tendon pain and stiffness being only the tip of the iceberg - which I promptly reported to my treating physician only to be told it couldn't be caused by the meds. When I pointed out that the warning sheet from the pharmacy said tendon issues were a side effect and to immediately report this to my treating physician, the doctor just shrugged it off and told me my problems were not caused by the cipro. I am sure if I went back to that same doctor today with my continued tendon pains and tendon stiffness and with a copy of the new black box warning, he wold still act as if this fq medication could never cause my issues. It is ridiculous how trained professionals act so completely clueless or brainwashed - you can choose which they are.
Also, everyone keeps going on and on about how "rare" the side effects are. What a complete distortion of the truth. First, anyone who browses the internet will find several sites where fluoroquinolone victims have been posting for years, and these sites contain thousands of members with allegedly "rare" side effects. Second, we also must factor in that doctors don't report the side effects of these drugs. I personally know that my doctor didn't report my side effects when I went back to him, and I have since discovered that several members of my immediate family have sustained "rare" injuries that were never reported to the FDA while they just happened to be taking fluoroquinolones: my paternal granfather had an achilles tendon rupture 4-5 years ago while taking levaquin; my maternal grandmother had severe central nervous system issues as well as debilitating deteoriation of her legs muscles after taking a course of levaquin and then avelox several years ago; and my mother-in-law had central nervous system issues with levaquin after 1 pill and refuses to take another fluoroquinolone. Wow I just found 4 "rare" side effects in my family; none of which ever made it into anyone's statistics because the DOCTORS REFUSED TO BELIEVE that fq antibiotics have any side effects to report.
So while I think the black box warning is a good baby step, I think the FDA has lots to do to straighten this fluoroquinolone nightmare up, because it is a nightmare that no one seems to want to admit is real nor wants to deal with.
]]>
**************Get fantasy football with free live scoring. Sign up for
FanHouse Fantasy Football today.
(http://www.fanhouse.com/fantasyaffair?ncid=aolspr00050000000020)
I don't blame the doctors for what happened to my husband. He's disabled now after the last 3 ruptures he had involving both his arms in 2005 after taking CiproXR. This started happening around 11 months after taking it. That was all he had left to work with. Both his legs were already badly damaged from when he took Cipro in 1998. He started having ruptures in both his legs around 11 months after taking Cipro 500mg. The ruptures came with no warning & also included the quadriceps & quadriceps muscle. A quadriceps muscle tore in half midway up his thigh. That's just the tendon & muscle damage. He also has neuropathies in his arms & legs among other things. He had 6 ruptures & not a single doctor knew why. That "rare occurrence of tendinitis & tendon ruptures can occur while or AFTER taking these medicines" probably had a lot to do with why the doctors didn't know. Who knew "AFTER" means that long. Someone asked "How does this(ruptures) happen?". I'm not a doctor. I have read through so many of my husband's medical records. There was mention of lack of blood in his tissue in a report after an operation he had. It was important enough that the doctor told me about it after the operation. My husband is a former Marine. He kept in shape over the years. He was in his early 40's when he took Cipro in 1998. He worked out with a world class weight lifter in the military. He once was so strong. When his legs were badly damaged, he told me that as long as he had 2 good arms, he was going to make a living for his family. The second round of Cipro took that away. Can you imagine how he must feel now because his little grandchildren are stronger than he is. I have been told that the benefits outweigh the risks. What about his life? Why isn't someone held responsible for this? If I made a product & sold it to people & some got hurt, I would be held responsibly. Why aren't they?
]]>I took avelox 3 plus years ago for a sinus infection, and three months later a barrage of ADRs hit me. Not connecting my condition to the use of a fluoroquinolone, I went around the med. establishment for 5 1/2 months looking for answers, none of which were forthcoming. The med. establishment does not look for ADRs to drugs in their diagnostic paradigm. And because they don't, alot of people are being mis-diagnosed. ADRs to FQs mimic alot of conditions; sojgrens, arthritis, diabetes; the list goes on.
These drugs are being abused by the medical community; they should not be given as a first line of defense against things like sinus infection or UTI.
Also, doctors are not aware that they should not mix FQs with NSAIDS or steroids. God forbid we should tell anybody that and risk the patient not wanting the drug! The profit margin is the bottom line here, not the patients' health and well-being. The FDA shares the responsibility for this negligence.
The recent black box warning for tendon tears is very inadequate. The warning should be for ALL the FQ ADRs….neurological, GI, musculoskeletal, endocrinal, renal, liver, heart problems, etc.
The other notable thing about these drugs is that the ADRs to FQs are often permanent. The warning to discontinue use and call your doctor is futile in that the damage has already been done by the time you get an ADR. Some people recover most of their lives back but it sometimes takes years.
It's time to get the word out regarding the danger of fluroquinolones before more people's lives are ruined.
Rick
]]>I have a big problem with the warnings on quinolones. The part of the warning that refers to "rare occurrence of tendonitis & tendon ruptures can occur while or AFTER taking these medicines" really needs more clarity. My husband took Cipro in 1998. Around 11 months "after" he started having ruptures to occur in his legs in 1999. He had another rupture in 2000 & 1 more in 2001. I notice the quadriceps isn't mentioned as 1 of those listed in the warning. He also had a quadriceps muscle to tear apart in the center of his thigh. I see no mention of muscles rupturing but they certainly can. The rupturing seemed to have stopped for several years. In 2005, they started again mysteriously. This time he had 3 ruptures involving both his arms and the pain became worse in his legs. It just so happens these ruptures started occurring around 11 months "after" he took CiproXr. This was the second time he had ever taken a Cipro medicine. I have taken him to see almost a dozen different doctors since the ruptures first began. None of them had any idea what was causing it. I can understand why. Who knows that "AFTER" means more than a few weeks or months after taking these medicines. Then there is the word "RARE". How do you know it's that rare when almost a dozen different doctors couldn't connect 6 ruptures in 1 man to quinolones? He was in his early 40's when he took Cipro in 1998. The warning says that people over 60 are more at risks. How about listing the age group that reported the most tendon ruptures after taking these meds. I don't believe they were over 60 years old. The warnings need to be more specific so doctors can recognize these injuries when they occur.
]]>**************Get fantasy football with free live scoring. Sign up for
FanHouse Fantasy Football today.
(http://www.fanhouse.com/fantasyaffair?ncid=aolspr00050000000020)
Regarding QT elongation which I am somewhat familiar with. Standard practice, from what I have seen in pharmacy, is that we do not generally worry about QT elongation unless the patient has cardio problems or the drug interacts with another, like TCA (tricyclic Antidepressants). However, when we do find then, we always and I do mean always, call the physician and request that he change it to another drug. This is taken from rxlist.com ...
"No cardiovascular morbidity or mortality attributable to QTc prolongation occurred with moxifloxacin treatment in over 9,200 patients in controlled clinical studies, including 223 patients who were hypokalemic at the start of treatment, and there was no increase in mortality in over 18,000 moxifloxacin tablet treated patients in a post-marketing observational study in which ECGs were not performed."
However, I have not looked up these studies myself. These studies may be funded directly from the drug company which gives me a HUGE RED FLAG as towards bias. However, note that one of these huge studies was done POST marketing which means it came out after it was approved by the FDA. I can only assume that in its clinical studies, it was looked at, but not to a very thorough extent as stated by the physicians in your post.
I will probably skim over that hearing a good bit more and see what else is in it. Nice find.
-Phex
-3rd Year PharmD / MBA Candidate
**************Get fantasy football with free live scoring. Sign up for
FanHouse Fantasy Football today.
(http://www.fanhouse.com/fantasyaffair?ncid=aolspr00050000000020)
My name is Leslea and I am a Clinical Laboratory Manager, have been a Medical Technologist for almost 30 years. I am very well respected by the medical staff at my facility because if I bring up a subject, perhaps a laboratory protocol that I want to put into place or changed, I have done my homework on the subject.
With that in mind, I want to urge physicians to take heed to the fact that fluoroquinolones are not safe for a very large segment of the population. There are literally thousands and thousands of people whose lives are forever changed because of the quinolones.
I know that most, if not all, facilities with microbiology departments put out an antibiogram, at least annually, for the medical staff to reference. Please use your antibiograms to pick the least toxic and most effective antibiotic for your patient.
Use the quinolone class only as a last resort, after other antibiotics have failed or the patient will expire if they aren't used. Using the quinolones routinely just doesn't make sense when other antibiotics will work. Keep in mind if this class of antibiotics continues to be used so nonchalantly they will become ineffective due to bacteria developing resistance to them.
I have personally experienced multiple system adr's to the quinolones, and know a multitude of people like me. That is why I am writing this, I want to prevent the number of people that are damaged by quinolones from growing exponentially.
The adr's to the quinolones are grossly under reported due to the fact that a lot of reactions aren't recognized, but are diagnosed as an unrelated problem. If the number of adr's to quinolones were accurately reported to the medical community, no physician would ever routinely prescribe quinolones again, unless he was some sort of sadist.
My motivation for writing this is honorable, our term would be risk management in the medical community, for the layperson it would be a passionate desire to prevent others from suffering like I am.
Just in case you are wondering, my first reaction to a quinolone caused damage to my tendons particularly my left knee. The tendons were so weak that my knee dislocated 6 times over a 7 month period, I probably should have been in a wheel chair, but I needed to work. I have a permanent baker's cyst in that knee. The tendonitis was so painful that walking was more like hobbling.
My second reaction made my first reaction seem like a walk in the park. When I mentioned multiple systems earlier, I meant CNS, muscular, skeletal, soft tissues and connective tissue damage. Four and a half years post two doses of Avelox, I still have a multitude of symptoms, some that are not going to resolve. Although I am in severe unrelenting pain, I consider the worst part of my reaction to be the CNS or brain damage.
I have debilitating depression, which I never had prior to this. But the thing that takes the cake is the following: I am sure you can imagine that I am or actually was above average in intelligence, Avelox has destroyed my short term memory and has made me struggle to find simple everyday words when carrying on a conversation. My nickname used to be "The Steel Trap" because I never forgot anything and could recall verbatim conversations no matter how long or short the amount of time that had elapsed. My memory was what is called photographic in nature. You might be tempted to say, well you are getting older, well I don't believe that CNS changes due to aging happen overnight unless there is a stroke involved. That, and the fact that I am not alone with this reaction, speaks very loudly to the truth of the matter.
I will quickly list the other damage I am dealing with; peripheral neuropathy, myofascial damage in my right hip that has lead to permanent gluteus median adhesions after tearing. I have chronic muscle spasms and knots in my right hip and shoulder, this is the cause of the severe unrelenting pain, the shoulder knots and spasms lead to horrible tension headaches. I also have to take Valtrex to keep shingles at bay, another wonderful symptom of the nerve damage. My tendons and ligaments in my right knee are tender to the touch and painful, my vision is altered due to floaters and blurring, luckily laboratories are notoriously noisy so I don't notice the tinnitus too much. I could go on and on, but you get the picture. By the way, I was a healthy active person prior to this reaction, I was 47 at the time and most people would guess my age at 35 because of my personality, strength and agility, they were always shocked to find out how old I was.
Please help me in preventing any other healthy individuals from experiencing this nightmare.
I also challenge you to do your own research into the real picture of this class of antibiotics, quit taking the word of the FDA or pharmaceutical companies, they have an agenda, but it is less than honorable. You can start by going to www.fluoroquinolones.org .
Thank you for your time.
Once again, you tell me that the reader, me, should sift through all this data. I can't make an informed idea about your argument without GOOD supporting data and quite frankly, I cannot sift through all that data myself. It is unreasonable to expect one to do that. This is why, when you argue a point, quality is worth more than quantity. Find the good studies and use those for your arguments. If you aren't sure which ones are good, see if you can find a friend who knows something about it to help you out or take a design outcomes statistics class which shows you how to do that.
Also, present your case to the AMA and the other groups that design the guidelines for medical practice. Arguing to the FDA is good as well, but it can only get you so far. The guildelines being changed is what will change medical practice and help people. If what you are stating is true and the rate is higher, by putting other safer antibiotics in at first line treatment instead of fluoroquinolones will help save people.
I hope you realize that I am not being negative to your cause. I am very critical though when it comes to statistics and medical research. It needs to be very transparent. I am treating you with the same rigor that I would treat a drug rep or a drug company so don't think I am singling you out. I am willing to believe it but there has to be data to support it that is of quality. And honestly, I don't like drug companies, and I like finding stuff like this that drug companies hide when they try to put their drug on the market, but once again, the data has to be of quality and easy to access. Good luck to you.
-Phex
-3rd Year PharmD / MBA Candidate
TENDONS: _http://tinyurl.com/6xk3mn_ (http://tinyurl.com/6xk3mn)
Tendon Ruptures / Animal Studies: _http://tinyurl.com/5g3zgg_
(http://tinyurl.com/5g3zgg)
DNA DAMAGE: _http://tinyurl.com/6dlg5d_ (http://tinyurl.com/6dlg5d)
IRREVERSILBE PERIPHERAL NUEROPATHY: _http://tinyurl.com/6o4wbt_
(http://tinyurl.com/6o4wbt)
VISION DAMAGE: _http://tinyurl.com/6684yh_ (http://tinyurl.com/6684yh)
CARDIAC EVENTS: _http://tinyurl.com/5engvh_ (http://tinyurl.com/5engvh)
Rhabdomyolysis: _http://tinyurl.com/6ghdbb_ (http://tinyurl.com/6ghdbb)
LIVER DAMAGE: _http://tinyurl.com/6brdyg_ (http://tinyurl.com/6brdyg)
KIDNEY DAMAGE: _http://tinyurl.com/6927yh_ (http://tinyurl.com/6927yh)
PROSTATITIS: _http://tinyurl.com/6b9583_ (http://tinyurl.com/6b9583)
VASCULITIS: _http://tinyurl.com/6ffoug_ (http://tinyurl.com/6ffoug)
TENS, SJS, Phototoxicity and Skin Damage: _http://tinyurl.com/5fda6p_
(http://tinyurl.com/5fda6p)
Toxic Psychosis: _http://tinyurl.com/65v5sv_ (http://tinyurl.com/65v5sv)
PEDIATRIC USE: _http://tinyurl.com/6r3kqo_ (http://tinyurl.com/6r3kqo)
REMOVED FROM CLINICAL USE: _http://tinyurl.com/5khtv4_
(http://tinyurl.com/5khtv4)
HUMAN AND ANIMAL STUDIES: _http://tinyurl.com/6x9nfl_
(http://tinyurl.com/6x9nfl)
Blood Disorders: _http://tinyurl.com/5m7wfp_ (http://tinyurl.com/5m7wfp)
Causation: _http://tinyurl.com/62dxab_ (http://tinyurl.com/62dxab)
Central Nervous and Peripheral Nervous System: _http://tinyurl.com/55wrzj_
(http://tinyurl.com/55wrzj)
Gastrointestinal: _http://tinyurl.com/69mo2b_ (http://tinyurl.com/69mo2b)
Hypoglycemia: _http://tinyurl.com/5quwpk_ (http://tinyurl.com/5quwpk)
Litigation: _http://tinyurl.com/5bfccj_ (http://tinyurl.com/5bfccj)
DRUG RESIDUE IN MEAT AND POULTRY: _http://tinyurl.com/6kzwhd_
(http://tinyurl.com/6kzwhd)
Misc Published / Newspaper Reports: _http://tinyurl.com/5vmr8d_
(http://tinyurl.com/5vmr8d)
Sleep Disturbances: _http://tinyurl.com/6ypvbx_ (http://tinyurl.com/6ypvbx)
False and Misleading Statements: _http://tinyurl.com/6gf43u_
(http://tinyurl.com/6gf43u)
Dear Doctor Letters / Medical Alerts: _http://tinyurl.com/62w56n_
(http://tinyurl.com/62w56n)
Scripting Abuse: _http://tinyurl.com/5f6fhg_ (http://tinyurl.com/5f6fhg)
Fluoroquinolone Fatalities: _http://tinyurl.com/5hobqn_
(http://tinyurl.com/5hobqn)
Post Marketing: _http://tinyurl.com/6ajryb_ (http://tinyurl.com/6ajryb)
As well as the following attachments:
_Attachment A Post Marketing Reports VIA Quinolone ADR Forums_
(http://fqresearch.org/attachments/Attachment_A.doc)
_Attachment B Vision Problems Reported Medications.com_
(http://fqresearch.org/attachments/Attachment_B.doc)
_Attachment C FDA Advisory Committee RE: Moxifloxacin Cardiac Events_
(http://fqresearch.org/attachments/Attachment_C.doc)
_Attachment D Vasculitis _
(http://fqresearch.org/attachments/Attachment_D.doc)
_Attachment E Toxic Psychosis (1 of 3)_
(http://fqresearch.org/attachments/Attachment_E.doc)
_Attachment F Toxic Psychosis (2 of 3)_
(http://fqresearch.org/attachments/Attachment_F.doc)
_Attachment G Toxic Psychosis (3 of 3)_
(http://fqresearch.org/attachments/Attachment_G.doc)
_Attachment H Mutagenicity (1 of 2)_
(http://fqresearch.org/attachments/Attachment_H.doc)
_Attachment I Pediatric MedWatch Reports (1 of 2) (w/ Fatalities)_
(http://fqresearch.org/attachments/Attachment_I.doc)
_Attachment J Breastfeeding and Quinolones_
(http://fqresearch.org/attachments/Attachment_J.doc)
_Attachment K 62nd Meeting of the Anti-Infective Drugs Advisory Committee_
(http://fqresearch.org/attachments/Attachment_K.doc)
_Attachment L QT Intervals Moxifloxacin_
(http://fqresearch.org/attachments/Attachment_L.doc)
_Attachment M Mechanism of Action_
(http://fqresearch.org/attachments/Attachment_M.doc)
_Attachment N Pneumonia Contra Indicated_
(http://fqresearch.org/attachments/Attachment_N.doc)
_Attachment O Pseudotumor Cerebi _
(http://fqresearch.org/attachments/Attachment_O.doc)
_Attachment P Mutagenicity (2 of 2)_
(http://fqresearch.org/attachments/Attachment_P.doc)
_Attachment Q Pediatric MedWatch Reports (2 of 2) _
(http://fqresearch.org/attachments/Attachment_Q.doc)
_Attachment R Guilty Plea in Drug Residue Case_
(http://fqresearch.org/attachments/Attachment_R.doc)
_Attachment S Detection of Drug Residue _
(http://fqresearch.org/attachments/Attachment_S.doc)
_Attachment T Warnings Ignored Raxar_
(http://fqresearch.org/attachments/Attachment_T.doc)
_Attachment U Bayer Accused of Fraud_
(http://fqresearch.org/attachments/Attachment_U.doc)
_Attachment V Lariam and Fluoroquinolones Chemical Structures_
(http://fqresearch.org/attachments/Attachment_V.doc)
_Attachment W Market Share Unapproved Usage_
(http://fqresearch.org/attachments/Attachment_W.doc)
_Attachment X Adverse Profile Quinolones_
(http://fqresearch.org/attachments/Attachment_X.doc)
_Attachment Y Post Marketing Reports Postal Workers_
(http://fqresearch.org/attachments/Attachment_Y.doc)
_Attachment Z Bayer; Fraud and Unethical Behavior_
(http://fqresearch.org/attachments/Attachment_Z.doc)
_Attachment AA Post Marketing Reports (1 of 3)_
(http://fqresearch.org/attachments/Attachment_AA.doc)
_Attachment BB Post Marketing Reports (2 of 3)_
(http://fqresearch.org/attachments/Attachment_BB.doc)
_Attachment CC Post Marketing Reports (3 of 3) _
(http://fqresearch.org/attachments/Attachment_CC.doc)
_Attachment DD Non Abating Vision Damage_
(http://fqresearch.org/attachments/Attachment_DD.doc)
_Attachment EE Quotes from Peter Ball and Glen Tillotson_
(http://fqresearch.org/attachments/Attachment_EE.doc)
_Attachment FF Ortho McNeil _
(http://fqresearch.org/attachments/Attachment_FF.doc)
_Attachment GG Moxifloxacin _
(http://fqresearch.org/attachments/Attachment_GG.doc)
_Attachment HH 62nd Advisory Meeting Pediatrics_
(http://fqresearch.org/attachments/Attachment_HH.doc)
_Attachment II Pediatric MedWatch Reports_
(http://fqresearch.org/attachments/Attachment_II.doc)
_Attachment A-1Warning Letters_
(http://fqresearch.org/attachments/Attachment_A-1.doc)
_Attachment A-2 DNA DAMAGE_
(http://fqresearch.org/attachments/Attachement_A-2.doc)
_Attachment A-3 Tendon Damage Associated with Fluoroquinolone Use, Reported
in the Literature (1972-2005)_
(http://fqresearch.org/attachments/Attachment_A-3.doc)
**************Get fantasy football with free live scoring. Sign up for
FanHouse Fantasy Football today.
(http://www.fanhouse.com/fantasyaffair?ncid=aolspr00050000000020)
3rd Study: Results of this study are not available even though they are
required to be posted on the clinicaltrials.gov website within one year of
completion. There is not conclusions posted on that site as of 3-26-2008
4th Study: Results of this study will not be available for about 15-20
years. Patients who develop one or more musculoskeletal disorders during the
first year will be monitored until they have completed puberty (15th birthday for
females and 17th birthday for males).
5th Study: Results of this study are not available even though they are
required to be posted on the clinicaltrials.gov website within one year of
completion. There is not conclusions posted on that site as of 3-26-2008. The
results of this study have not been posted on clinicaltrials.gov as required by
law. No results available to be posted as none can be found at this time, even
though Federal Law requires that they be available through the
clinicaltrials.gov website a through search failed to locate this study and the results
thereto.
Within the NDA (new drug application) for levofloxacin we find clinical
studies that revealed an adr rate in excess of 40% (one or more reactions) and a
number of listed fatalities. Citing to the NDA for levaquin, readily available
on the FDA website in a PDF format.
Bayer issued a European "Dear Doctor Letter" in February of 2008 in regards
to fatal liver injury as a result of being on Avelox. Citing to the letter
that is readily available on the research site under the Breaking News
heading. You can also follow this link to read the letter as well:
_http://tinyurl.com/5t23dm_ (http://tinyurl.com/5t23dm)
I fail to understand why you would have such a problem with the research
site. All you have to do is click on whatever adr you are interested in.
Choose any citation from the list presented, and then read it. If the full text
is not available that would be the result of copyright problems, or it is a â€
pay to view’ article, which most of the negative articles are exactly that.
So do a google search and spend some of your hard earn cash for the right to
read it. It is not I that makes you do that but either the author or the drug
company that does not want such information to be readily available. This
is NO different than what would be required of you on pubmed. They too
present a list, some with nothing more than the citation, others with just the
abstract, and if you are lucky the full article. If this is good enough for
pubmed, than I would it believe it to be good enough for you.
If the majority of these articles are to be considered â€crap’ then I would
imagine they fail to support the propaganda presented by the drug companies in
your view. And NO the site is balanced and shows all of the relevant data
that could be found concerning this class. The good, the bad, and the ugly.
Again it is not to be considered my fault that the majority of the articles
found there reveal a horrendous safety profile. I did not write them, I am
simply presenting them in their original form. If you care to I am more than
willing to flood this site with citations supporting everything that I have
stated. Just point out one of the listed adrs I mentioned that you feel have
nothing to do with fluoroquinolone therapy and I will do exactly that. You
are scaring me that a college kid can’t figure out how to click on a link and
then follow it to the list of citations.
**************Get fantasy football with free live scoring. Sign up for
FanHouse Fantasy Football today.
(http://www.fanhouse.com/fantasyaffair?ncid=aolspr00050000000020)
After a brief look at some of the research directly related to tendon rupture, most of them are only case reports or just articles that are in the news. Case reports are not considered substantial and are only there to say "Hey look at me! This could possibly be researched!!"
There are only a handful of actual research articles on tendon effects. This archive of research info is mostly crap. Half of the articles aren't completely there, and only give a brief overview.
Perhaps if this website wanted to be more effective, it would 1) do a better job of designing its website 2) make the research easier to access 3) not put up complete crap in the research archive section.
Perhaps you should, next time you post, cite some direct research. Thanks.
-Phex
-3rd Year PharmD / MBA Candidate
The only part of your post that had any substance was the time line regarding the FDA's actions to the petition. You did not really cite anything, but it is implied that it is accurate since it is pretty common knowledge and can be looked up easily.
Dr Plumbs post is quite informative and for the most part I agree with it. I must admit that I am not that familiar with the tendon problem side effect of the drug but am only familiar from rxlist.com that the rate of occurrence is less than 1%. This is what was reported to the FDA in clinical trials I would assume. This number could change after more of a population starts to take the drug, and thus the reason for post market research and surveillance. But, like the good doctor said, the FDA is antiquated in its reporting system, and as I have added in, are underfunded and understaffed. I would also like to add in that they have a revolving door policy with big pharma which is a huge conflict of interest. After one works for big pharma for a while, and they leave, they can get a job easily with the fda and vice versa.
Because the drug companies must pay "fees" yearly to the FDA, it has come to the point where big pharma is actually funding the drug companies. I would assume pretty close to the same amount as the tax payers are. This is creates another conflict of interest. The persons whom they are supposed to be regulating, are the ones that fund them.
If there is a higher rate than 1% for the tendon side effects, the FDA should state it blatantly. One must understand though, that us health care practitioners can only prescribe and go with the data that is given to us. If the AMA looked at all the literature on it, and regarded it as safe to prescribe and effective for certain disease states, then physicians must go by the guidelines given by the AMA. I would assume that the literature on FQresearch.org has been taken into account already though I could be wrong.
Until the guidelines change, prescribing habits of physicians are probably not going to change regarding this class of antibiotics. I hope at the least that this black box warning turns some heads.
-Phex
-3rd Year PharmD / MBA Candidate
As for not treating a sinus infection, that is false. If an infection is
bacterial, we pretty much always treat it. It so happens that most cases of
acute sinusitis are of viral origin, but if there is reason to suspect it is
bacterial, standard of care is to treat it with an antibiotic (Augmentin is
usually firt line but flouroquinolones are frequently used and quite effective as
well). Again, flouroquinolones are VERY GOOD, MOSTLY SAFE drugs. They aren't
nukes of the antibiotic world, just good broad coverage abx.
If a drug that can cripple a patient for life, cause irreversible peripheral
nueropathy, fatal damage to a patients vital organs, and totally trashes the
patient's DNA is to be considered a "VERY GOOD, MOSTLY SAFE DRUG," what is
to be considered a defective drug in comparison? Arsenic perhaps rather than
this proven toxic form of chemotherapy?
**************Get fantasy football with free live scoring. Sign up for
FanHouse Fantasy Football today.
(http://www.fanhouse.com/fantasyaffair?ncid=aolspr00050000000020)
**************Get fantasy football with free live scoring. Sign up for
FanHouse Fantasy Football today.
(http://www.fanhouse.com/fantasyaffair?ncid=aolspr00050000000020)
**************Get fantasy football with free live scoring. Sign up for
FanHouse Fantasy Football today.
(http://www.fanhouse.com/fantasyaffair?ncid=aolspr00050000000020)
I am also allergic to beta lactums, and have suffered a number of sinus infections that have been treated with some serious antibiotics. I agree that antibiotics are over prescribed and I try not to take them if at all possible. With my sinus problems this involves lots of steaming, decongestants and trying to put up with the pain for as long as possible. There are some instances however where I would not call a sinus infection simple. I have had meningitis, a bone infection and an infection in my eye all at separate times caused by a long standing sinus infection... I still continue to avoid anti biotics if at all possible though. It is a cost benefit analysis really!
]]>
**************Get fantasy football with free live scoring. Sign up for
FanHouse Fantasy Football today.
(http://www.fanhouse.com/fantasyaffair?ncid=aolspr00050000000020)
Yes, cholesterol can be lowered with more exercise and a better diet. Honestly, who the blame comes down to is the patients and the physicians. The patients think that if they just take this pill, they will instantly have better cholesterol. The physicians, care too lazy to counsel their patients and get to the real root of the problem, so they just dish out the statins. Not very many physicians that I have seen actually do this, but there are some. But once again, after the physician does their part, the patient has to do theirs.
Generally, a physician should tell a patient to try exercise and dieting for a few months, then come back and re test and see if the cholesterol is a little better. If it is improving, good, keep diet and exercising. If not, then they put them on a statin.
"If half the people taking statins don't need them, we've doubled the number of people who will suffer side effects."
That is an excellent point. And like you said, it comes down to physicians over prescribing drugs and patients wanting to take the easy way out.
"And how many people go to their doctor to report minor side effects and get blown off? How many don't even bother to report them?"
Many don't. That is another one of the reasons we have post market studies and clinical trials. Unfortunately, these kinds of statistics can become skewed and biased, but that is another discussion that I could probably write a book on.
-Phex
-3rd Year PharmD / MBA Candidate
Yikes.
]]>It's kinda like myopathy with statins (Lipitor or Zocor). It has a rate of 1 in 10,000 but people get really uppity about it.
Of all the people who take statins, how many of them could get their cholesterol down by using diet and exercise, which generally have the horrible side effects of making you lose weight and feel and look better?
My mother was prescribed Lipitor with a cholesterol level of 185 and LDL LT 100. WHY? (Aside from the fact that her doctor is a bleeding idiot.) To maintain, the idiot told her. Is there some reason he couldn't have told her to try mallwalking three or four times a week? Couldn't he have asked about her diet and suggested minor changes to be made? Why prescribe a statin?
If half the people taking statins don't need them, we've doubled the number of people who will suffer side effects. (And made the pharmaceutical companies even richer, but let's not go there.) And how many people go to their doctor to report minor side effects and get blown off? How many don't even bother to report them?
Statins are just one example, antibiotics are another. Doctors are prescribing meds that aren't needed.
]]>@mjsager:
We have been warned of the dangers of these drugs. Its literally drilled into our heads over and over in medical school. The fact remains, these are rare events for the most part. As the above poster mentioned, it is less than 1% in adult patients according to clinical trials and the benefit far outweighs the risks.
As for not treating a sinus infection, that is false. If an infection is bacterial, we pretty much always treat it. It so happens that most cases of acute sinusitis are of viral origin, but if there is reason to suspect it is bacterial, standard of care is to treat it with an antibiotic (Augmentin is usually firt line but flouroquinolones are frequently used and quite effective as well). Again, flouroquinolones are VERY GOOD, MOSTLY SAFE drugs. They aren't nukes of the antibiotic world, just good broad coverage abx.
When I had a severe reaction, the only reason I was taken seriously at the ER was because my doctor had experienced the exact same reaction herself when she took a sample pack of Levaquin for her own strep throat. No one else in the ER believed it was even possible to get that sick from taking an antibiotic. My primary was obviously doubting it , but eventually took the ER doc seriously. All of this told me that 1) I was incredibly lucky to get the doc I did in the ER, and 2) most docs have NO IDEA how serious and real some of these side effects are.
]]>For example, most doctors receive only minimal payment for an office visit, so there is a pressure to see as many patients as possible and spend as little time with each patient. There is little time to discuss side effects. Many only make money on the tests they order.
Chinese catfish farmers use these antibiotics because the conditions there are pretty bad in the farms. The use of this antibiotic puts our catfish farmers at a disadvantage. Its illegal to use, but the FDA doesn't do any testing.
There is a financial incentive for drug companies to minimally discloses risks so their drug will be used during the patent window. Vioxx, etc etc etc etc.
Farmed salmon outside of the U.S. makes extensive use of these antibiotics, which weakens their effectiveness and puts our fish farming operations in at a disadvantage. It also harms the environment.
And in my specific case, the doctor which prescribed the medicine absolutely denied that there was any connection between the side effects I was experiencing and the drug despite the fact that all the side effects were on the warning label.
The pharmacists I talked to were completely unaware of the drug side effects. Like completely clueless. I think this can partially be attributed to the fact that CVS under staffs their pharmacies.
Now I'm not saying that these antibiotics are horrible. They are quite amazing, its just that they are over used. Real life needs a major crimes unit like from the wire.
]]>Physicians and Pharmacists don't tell you about every side effect of the drug. If we did, we would be sitting there rattling off everything on a list for a few minutes. We generally only tell you about the most common side effects. This is why a drug insert comes with your medication the first time you get it. If it doesn't, you need to get it from your pharmacy or switch pharmacies.
It's kinda like myopathy with statins (Lipitor or Zocor). It has a rate of 1 in 10,000 but people get really uppity about it. Myopathy can be really bad, but it can also be just a slight case.
Perhaps the FDA is putting this black box warning on it because they think they drug company skewed the data. Perhaps it happens more than is reported in the clinical trials or post market studies. It was quite a while that the FDA took to respond to their complaint. However, one should realize that they are underfunded and understaffed. This is not a defense for them, just a reason why it could have taken so long. However, this is all speculation on my part.
Overall, Fluoroquinolones are good antibiotics. They are first line generally for people who are allergic to penecillins and cephalosporins, and are also first line for many UTI and respiratory infections because they work well.
-Phex
-3rd Year PharmD / MBA Candidate
Ask your doctor for the PDR print out for any new drug and ask them to review it with you. Make sure your doctor knows what other drugs you take (prescription, over the counter and vitamins). Most likely the doctor will cover the most common side effects (headaches, upset tummy, things like that) but the dicussion may lead to a risk factor that you were not aware of. All drugs have side effects, the doctor should be picking the best drug for the illness while also balancing the side effects.
]]>I was on Cipro just last week after a nasty reaction to Macrobid, and I made sure to read over the insert. The risk of tendon rupture was plainly stated. I'm not sure what more there is to be done, other than having a warning on the packaging.
In response to @crazybutch: , I would think that a warning to contact a doctor ASAP for a specific reaction is an indication that the reaction is a big deal.
]]>The problem is not that these drugs have side effects. Its not that these side effects are potentially dangerous.
The problem is that people are experiencing side effects at a higher than advertised rate. That doctors are using these serious antibiotics for things like, a sinus infection, which for the most part is pretty ridiculous as there are much much safer drugs around for those sorts of things.
The doctors underestimate the level of harm that can be caused because they haven't been warned.
I'm on the yahoo group of people who have had these reactions, and a majority of these people should have never been prescribed these drugs. Seriously, Cipro or Levaquin for a sinus infection? Unless its a resistant strain its like using a nuclear missile when you really just need a fly trap.
There are a couple thousand people on that list, most everyone with a pretty serious reaction.
I've been in excruciating pain for 6 months because of this drug and the doctors I talked to expressed the same attitude as you except at the university hospital.
]]>The list of drugs citd in the article is a list of brand names (and one manufacturer). Some of these can be given in generic form, so I've listed the generic names below. Also, Oscient is not a drug; it is the company that manufactures Factive. Floxin and Noroxin are two different drugs rather than being one dug with a wacky name. There should have been a comma in there.
Cipro = ciprofloxacin
Levaquin = levofloxacin
Avelox = moxifloxacin
Factive = gemifloxacin mesylate
Proquin XR = ciprofloxacin hydrochloride
Floxin = Ofloxacin
Noroxin = Norfloxacin
As others have said, most medications can have serious side effects, so it's always important to monitor yourself for unusual side effects while taking a drug. These warnings are good because they let you know of specific problems to look out for, but they shouldn't discourage most people from taking medications as prescribed. Tendon rupture sucks if it happens, but not treating a serious infection (which is what these drugs treat) can be much worse.
]]>The reviews for Cipro are terrible:
[www.askapatient.com]
Whoever said that there isn't a drug without a side effect is spot on. It's why you can't just stroll into a pharmacy and ask for whatever you want. The safety profile of some drugs is downright scary - it's not that they are bad drugs, it's that they are drugs and drugs can have very nasty side effects in some people. I really don't consider this side effect all that bad considering some other possible side effects of other drugs. When we decide to prescribe this, or any, drug it's because we think the danger of not treating is much worse than the danger of treating. I will still use flouroquinolones, they are fantastic drugs for most people.
Also, it should be noted as I see some people freaking out on here about knee pain, etc following abx use. The VAST VAST majority of tendon ruptures occur at the achilles tendon. And when it happens...you'll know.
this sucks. i'm taking the exact medicine in the picture right now. but i guess it might be better than me taking nothing. it's just that i'm pretty sure it will hurt if my tendon snaps, so this has me on edge....
]]>My husband was taking the Cipro and his knee became tender and swollen and his gout in his big toe became so bad he could hardly walk.
]]>I have the following:
neuropathy, which is numbness / tingling all over my body
Joint pain - at times I can barely walk
Tendon problems
Floaters
Now you might think that this only affects me. Its cost my medical plan probably $5k so far.
The other thing is that the doctors I encountered were absolutely clueless. So far as to absolutely deny the drug had anything to do with my ankle pain. Which if you read the side effects is listed as a serious side effect. It was only when I went to a major university hospital did anyone believe anything I was complaining about.
If you google joint pain + cipro there are almost a million hits, and if you ask your doctor about it they will deny there is any connection.
The worst part is that I should have never been given this drug. A much cheaper and safer drug was available ( $15 vs $800+ for a 60 day supply ).
]]>I have taken Levaquin and had a nasty reaction to the sun. You might remember they had an article that mentioned it here a while back. I had read the warning, but you never know if it's going to happen to you. And, I DO remember reading the monograph about sun sensitivity, but I didn't know it'd be like that. And, I DO specifically remember tendon rupturing and I thought "WTF?"
]]>@beavis88:
Yikes! That really knocks out a big range of drugs.
Last summer I contracted a nasty strain of strep throat, which after a round of antibiotics turned into a bronchitis. I went to urgent care, and they gave me Levaquin. After taking that round, it turned into a sinus infection. I went to my general physician (in Columbus Ohio, I recently moved to Cleveland), and told him what was going on (at this time I had been sick for almost a month). He prescribed another longer round of Levaquin. Fast forward a few weeks later and while I'm working my shoulder and back begin to hurt and my hand goes numb. I have been through over a month of physical therapy to cure this (and $500 out of my own pocket). If I had known this was a side effect I wouldn't have taken it and demanded something else. No one told me this would happen!!!!
]]>This is concerning...last year I took Levaquin after a dog bite, and it was never mentioned. Besides the tendon-rupturing risk, the drug also makes many people have psychotic dreams:(
]]>Oops, forgot the link.
]]>Patient-reported stories about one of the quinolones (Levaquin) and its side-effects. It's about time the FDA gave it a black box.
]]>because the government is controled by big business and their lobbyists. When they give big dollars to a member, they will vote with their wallets. Thats why.
@azntg:
]]>"Today I'm going to take over the city, and there's nothing you can do to stop me, Avelox!"
"Guys! We have to stop Floxin Noroxin before he destroys everything! Let's get to headquarters right away!!"
]]>You may trust your doctors and your pharmacist, but any time you take a new med, you should first look it up online so you are more clear on the risks vs. benefits.
]]>The pharmacist would seem to be the next line of defense, but I've never gotten good information out of a pharmacist unless I had done my research and had good questions to ask. When the pharmacy tech snaps "Got any questions?" while looking past me at the next person in line, I would never (until now) have come up with "Will this medication cause my tendons to rupture?"
]]>I don't see the fuss over a "black box" warning. Patients shouldn't be picking up high-strength antibiotics off the shelf. And doctors should know the side effects of what they're prescribing, and check a reference volume if they're not sure. I don't have a problem with my MD checking the Merck Manual to make sure I get the right dosage and info.
I am not a doctor, and this is not medical advice.
]]>She chose to take it anyway, and she was fine, but I still feel like she should have been told by a health professional, not the interwebs.
]]>See: every article about academic cheating.
]]>Same thing applies with Cipro, which I was taking last fall. I read through the literature that came with my script and there was what I considered adequate warning about tendon damage so I throttled back on my running and weights for the 10 days I was on it.
Always read through the information you get from the pharmacist. If you don't get any stapled to your script or as a sticker on the label, ask for it. If you still don't get any, get a new pharmacy. You can also go to a site like RxList and check it out there.
]]>Plus you'd be surprised at the level of knowledge that doctors lack when it comes to prescriptions. Not that I'm pointing the finger, since it is quite an overwhelming area to try and keep up with.
]]>I highly recommend not being allergic to penicillin. It's an expensive pain in the ass. :P
]]>I don't really see what the big deal with having the "black box warning" is. We have been well aware of the effects of flouroquinolones on tendons for some time. It's one of the classic possible side effects taught in medical school and the reason we really avoid using them in children. Luckily the side effect is quite rare and the safety profile is otherwise very good. I've yet to see a case of it (although we had a possible case in a geriatric patient with contracture of his hip).
]]>One nice society we live in.
]]>How does this happen, biologically, though?
]]>