Talk:Levofloxacin/Archive 1

Archive 1

Helicobacter pylori

The page on Helicobacter pylori claims Levofloxacin can be used in the treatment of clarithromycin-resistant strains of HP. Could this be aded to the list of bacteria? --85.204.119.88 09:18, 30 July 2006 (UTC)

Levofloxacin currently has no official indication against H. pylori. However, there are numerous and mounting evidence that it is useful as second line treatment of PUD when first line therpy (typically with PPI + Amox + Clarithromycin) fails. Meta-analyses have demonstrated that levofloxacin containing regimens are superior to Bismuth-based quadruple therapy as second line therapy, both in terms of efficacy (eradication of H. pylori) and tolerability.

More websites about adverse effects.

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More Potent than Ofloxacin?

Just to promote a little healthy scepticism, this page claims twice the potency of ofloxacin. However, given that it is in fact the active enantiomer of ofloxacin, I would suggest that it is in fact just the active component of ofloxacin with the inactive component taken out. Therefore, the potency is basically exactly the same and unless the inactive component had adverse side-effects, would probably be exactly the same as ofloxacin.

This is a tactic commonly employed by drug companies to gain a new patent for an old drug. So i would suggest having a close look at the literature before believing that this drug is any more potent than ofloxacin.

Well, yes, but that would make it twice as potent, milligram for milligram. --Galaxiaad 03:02, 20 October 2007 (UTC)

Please go to this site and read all the horrible side effects this drug has given.

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Please think twice before taking this drug. It also has many negative reactions with other drugs. —The preceding unsigned comment was added by 68.17.215.167 (talk) 16:10, 11 January 2007 (UTC).

None of the articles above or below appear to be from peer reviewed or even somewhat scientific sources. The article itself claims the drug causes many of the side effects listed on the pages linked to from here, but is there any actual scientific evidence that this is the case? —Preceding unsigned comment added by TomlinAS (talk • contribs) 17:32, 9 April 2008 (UTC)

You will find more than 4000 published peer reviewed articles, case reports, clinical studies, etc., that document the horrendous safety profile of this class, sorted by specific adverse reactions, on the www.fqresearch.org home page. All of which meet or exceed the current scientific standards employed today. 96.254.65.104 (talk) 22:54, 26 November 2008 (UTC)

Major Revisions of this article

I have made major revisions to this article following discussions with some of the members involved in wikipedia pharmacy initiative. Additional changes are planned in the very near future, similar to the recent update of the ciprofloxacin article. For the moment this update includes changes to the introduction and adverse event section. As well as the removal of superficial information. Additional stubs are in the works concerning approved uses, mechanism of action, regulatory history, etc, etc., etc.Davidtfull (talk) 18:32, 9 February 2009 (UTC)

double potentcy of levaquin

A member recently edited the levaquin article to include a statement that "Therefore it doubles it potency" in reference to levaquin being a mirror image of floxin. This statement can be found on a lot of the drug companies propaganda, but this is only been proven in vitro for certain bacteria. As such I changed the wording of this addition to reflect that, as well as adding citable sources. But I am really not comfortable mentioning this at all within the article as it is a bit misleading. I have not been able to find any reference that verifies that this statement is true in vivo. What works in a test tube does not always work in the patient. Additionally, of even more of a concern, is the fact that the manufacturer used floxin, rather than levofloxacin, in a number of studies concerning the potency of levofloxacin that they submitted to the FDA with their new drug application. I find this to be highly unusual for if levofloxacin were truly more potent than floxin then logic would dictate that the manufacturers would use levofloxacin in these studies. And the FDA accepted these studies stating that they found no difference between the two drugs and substituting one for the other raised no concerns. As such I think any reference to this should be removed from the article unless we can find a citable source to support this statement being true in vivo. Twice as potent in vitro is meaningless and irrelevant to both the patient and the physician if this does not take place while the patient is undergoing therapy (in vivo).Davidtfull (talk) 02:00, 13 February 2009 (UTC)

Editing for Brevity

I believe that all of the relevant data has been added to this article with my last update. However, the article now needs to be severely edited for brevity. We are currently at about 97 kbs, and as such we need to reduce the total article length to less than 80 kb by elminiating duplicate information, excessive verbage, frivolous information, etc. I thought it best to present all of the relevant data first, before attempting to pair the article down to size, so that we would be able to make intellegent decisions regarding what to leave in and what to leave out, as well as leave room for future revisions. We should shoot for an article about 60-70kb in lenght when it is all said and done. It is not my intention to leave this article this bloated and will be making surgical edits of each stub as I find the time, or other editors may do the same.Davidtfull (talk) 08:17, 15 February 2009 (UTC)

corrective editing currently in progress

Editing of this article is in progress to remove inadvertent OR as well as provide for a more NPOV. Citations are in the process of being verified, added or changed as needed, text not supported by citations will be removed. Would ask other editors not to edit the article while this task is in progress. Please post any concerns on this talk page, rather than editing, as they may have already been addressed and corrected, but the changes not yet completed and applied. Please allow us time to correct what needs to be corrected in an orderly fashion as we are aware of the articles numerous shortcomings and are working diligently to correct them as time allows.Davidtfull (talk) 06:24, 3 March 2009 (UTC)

enantiomer error

"Levofloxacin is a “mirror image” or enantiomer of Ofloxacin. Ofloxacin is a racemic mixture of which levofloxacin is the active component. The biologically active enantiomer is sold separately under the chemical name of levofloxacin."

If levo~ is the enantiomer of oflo~, then oflo~ cannot be a racemic mixture. EITHER levo~ is the enantiomer of oflo~ OR oflo~ is a racemic mixture.

195.74.145.252 (talk) 16:35, 28 April 2009 (UTC)DavidW

This error is an artifact left over from the orginal author of this article years ago. I have made the neccassary corrections, as well as appreciate you bringing this to our attention. Thanks.Davidtfull (talk) 22:07, 28 April 2009 (UTC)

trade names

It had been stated that: there is a long-standing saying in Wikipedia (it may even be codified somewhere) that "redirects are cheap". Therefore it had been suggested that: redirects for trade names are a more appropriate solution than in-article "laundry" lists, because 1) they avoid clutter in the article body, 2) they prevent issues such as an ever-growing list that may be "expanded" with inaccurate information and 3) they make it much easier for someone looking for a particular generic formulation of the drug to get to the actual article. Since this suggestion is both practical and logical I have removed the list of trade names and used redirects instead. As such someone searching Wikipedia using a brand name would simply be taken directly to the levaquin article.

I would now ask that editors not expand the trade name list, but create redirects instead. Those not familiar with this process may find the following article helpful:

http://en.wikipedia.org/wiki/Wikipedia:Redirect

Davidtfull (talk) 18:52, 18 May 2009 (UTC)

Revisions of the regulator section

It has been suggested that the regulatory historys be eliminated from the fluoroquinolone article due to concerns of "undue weight", by some parties, and others who do not share those concerns have suggested this to be beneficial as a means to reduce the overall size of the article. As a workable compromise that I believe addresses both of these concerns I am suggesting that we incorporate the time line presented as references instead. For example under licensed uses all of the approved uses are listed. We can then use the regulatory history as references for each approved use. For example UTI is a listed approved use and the time line could be incorporated as follows:

Urinary Tract Infections Approved by the FDA on 12/17/1998

Uncomplicated urinary tract infections Approved by the FDA on 6/23/2006

Complicated urinary tract infection and acute pyelonephritis (Limited to Levaquin 750mg once daily for five days) Approved by the FDA on 9/14/2007

So on and so forth for each licensed use. The time line that makes reference to additional warnings can be incorporated in the adverse section in the same manner. The regulator action that is neither an additional use or an additional warning could be incorporated into the history section. By doing this all of this information is still available to the reader and the regulatory time line list is eliminated thereby negating the allegations of undue weight as well as reducing the overall size of the article. I am proposing that we do this for all of the fluoroquinolone drug specific articles.Davidtfull (talk) 19:30, 18 July 2009 (UTC)

Sounds ok to me. I would reword it though, like on "date" X drug was approved by the FDA for the treatment of X condition. I am working on the quinolone articles now, going to try and spend half an hour to an hour each day doing it.--Literaturegeek | T@1k? 18:48, 20 July 2009 (UTC)

OK, waiting on onepotato to weigh in on this before going forward. I recently did some heavy duty edits of the avelox article in regards to approve uses, mechanisms of action, and moved some text around. As such those two sections should need just a once over from you. They are now in line with the other quinolone articles we have been working on. Onepotato did a nice job on the mechanism of action within the cipro article and since it is the same as avelox I did a cut and paste of it. Take a look and see what you think.Davidtfull (talk) 08:58, 21 July 2009 (UTC)

Haven't had any response from those who had originally raised these issues, though I had served notice to them regarding this plan, so I would assume there are no objections to this solution. I will give it another day or two and if I hear nothing further then I will make these edits starting with the avelox article where someone has added a clean up tag to this section and then move on to the other quinolone articles.Davidtfull (talk) 04:26, 24 July 2009 (UTC)

I have finished researching the ADR section and have combined this with the regulatory history section as we have discussed here. I still have to go through the references used to make sure that they are still active as well as related to levaquin. Sometimes since these drugs are so identical I may use a reference for cipro (or another quinolone) when I mean to use the one for levaquin. But I will check each reference and repair or replace as needed within the next few weeks. Davidtfull (talk) 04:54, 27 September 2009 (UTC)

The article has major issues to be considered.First of all ,the article is written like an anti levofloxacin campaign,and language is not neutral as it should be as "drug x ,though used for many conditions ,have major adverse effects like y,z ; and therefore FDA has only allowed. . .". Secondly ,the article has written too much on lawsuits for a pharma article. Thirdly ,the article seems too concerned for drug regulations but too lax for denoting the proper uses.Basically,reading the article seems like reading about a poisonous drug which should never be taken.While,had it been that,FDA would have banned it completely.—The preceding unsigned comment was added by 125.20.13.82 (talk) 19:05, 12 April, 2010 (UTC)

I had previously resolved alot of problems with the article but I did not do an indepth review of this article. When I get a chance I shall give the article another review and resolve any remaining issues that may be present. The article is over the WP:SIZE limit and could do with some refining and pruning which would be able to resolve any WP:UNDUEWEIGHT issues.--Literaturegeek | T@1k? 16:30, 13 April 2010 (UTC)

References

I want to know how it works

I am having a problem understanding this article. It is very technical, and yet, we are average joe people trying to make an educated decision. The comments in the talk section have a lot of scare talk, but I prefer facts. Unfortunately, when the facts are written as follows, I am left feeling that the article is written only to show off to the professionals, while average joes and janes are being told every day to stop trusting doctors to care, and do their own medical research. This requires laymen's terms. Can't this be accomplished? Read the following excerpt and then act like you are explaining it to someone who has never heard of an antibiotic before.

I want to know HOW it works. What it does to destroy the bacteria, does it latch on to them or does it trigger reactions against the bacteria some other way? I still don't know. This portion didn't help at all, because although it briefly explains that Levofloxacin inhibits DNA Gyrase, it is up to me to then spend hours looking that term and every other technical term and since every writer wants to show off for the professionals, this is almost never accomplished:

Mechanism of action

Levofloxacin is a broad-spectrum antibiotic that is active against both Gram-positive and Gram-negative bacteria. It functions by inhibiting DNA gyrase, a type II topoisomerase, and topoisomerase iv,[97] which is an enzyme necessary to separate replicated DNA, thereby inhibiting cell division.

The fluoroquinolones interfere with DNA replication by inhibiting an enzyme complex called DNA gyrase. This can also affect mammalian cell replication. In particular, some congeners of this drug family display high activity not only against bacterial topoisomerases but also against eukaryotic topoisomerases, and are toxic to cultured mammalian cells and in vivo tumor models. Although the quinolone is highly toxic to mammalian cells in culture, its mechanism of cytotoxic action is not known. Quinolone-induced DNA damage was first reported in 1986.[98]

Recent studies have demonstrated a correlation between mammalian cell cytotoxicity of the quinolones and the induction of micronuclei.[99][100][101][102] As such some fluoroquinolones may cause injury to the chromosome of eukaryotic cells.[103][104][105][106][107][108]

There continues to be debate as to whether or not this DNA damage is to be considered one of the mechanisms of action concerning the severe and non-abating adverse reactions experienced by some patients following fluoroquinolone therapy.

---

Okay, now that you have read that part, tell me what it means. If you know what it means, then you didn't really need to read it did you? I need to. Write articles for me. For all the me's in the world.

99.102.250.115 (talk) 20:33, 25 February 2012 (UTC)

style guide compliance

I added the stubs concerning overdose and pharmacology, etc., in an effort to comply with the style guide. I would ask those with a bit more knowledge of pharmacology to review these additions and correct any errors or omissions as needed. I believe them to be correct and in compliance, but a review would be appreciated if I may have made some inadvertent error(s).Davidtfull (talk) 08:21, 19 February 2009 (UTC)

the sentence: "Prescribing a fluoroquinolone to treat an unapproved use within the pediatric (as well as the adult population) exposes the treating physician to the risk of being sued for malpractice should the treating physician fail to both warn the patient of this fact, as well as the risks of any adverse drug reactions the patient may experience." is true for any prescription drug !! therefore it is unnecessary to let it in this article. —Preceding unsigned comment added by 83.206.162.141 (talk) 11:19, 28 April 2009 (UTC)

It is neccassary in this article due to the outrageous and very real risk faced by the pediatric population of being crippled for life. Which is NOT something you find with any prescription drug. Hence the relevance.

Davidtfull (talk) 21:55, 28 April 2009 (UTC)

Any doctor who practices medicine using Wikipedia as his main reference is committing malpractice. If a doctor doesn't know enough to read the complete package insert (or an equally reliable source) for a drug as dangerous as fluoroquinolone, then he or she shouldn't be practicing medicine.

More to the point, Wikipedia isn't supposed to be a package insert. WP:MEDMOS: "Extract the pertinent information rather than just dumping low-level facts in a big list." This page needs a massive winnowing of low-level facts. A careful reading of WP:MEDMOS would be useful.

(Technical point: It's not malpractice to use a drug off-label. Especially when nothing else is working.) --Nbauman (talk) 00:14, 23 September 2013 (UTC)

Source and content updates

Many of these sources are either linking to the same page, or are linking to different pages that all say the same thing. For example, sources 8 and 21 link to exactly the same pdf. I believe also that sources 28, 29, 32, and 41 all link to the drug label or similar pdf's. I am very new to editing and could not figure out how to correct this by eliminating the duplicates. Someone with more skill then I may be able to fix this. Additionally, I noted 2 additional broken links. Should the sections that those links be referred to be deleted? I was unable to find another link to replace the broken ones with.

I additionally tried to clean up some of the technical jargon and non-neutral wording. Some of these sections have now gotten longer, and could probably do with some pruning down, but they appear to be easier to understand. SeanPhilippo (talk) 00:35, 21 April 2014 (UTC)

Yeah, the multiple references to the same paper reflect the high expectations here that statements be tied to a reliable source. There are ways to cite the same reference multiple times without having it come up with a new number each time, but to be honest there's enough other stuff that needs to be done around here that I haven't paid much attention to these details.

I rewrote much of this article (partly while operating under a previous user name) starting in 2011. At that time, it was a lengthy anti-fluoroquinoline diatribe written by a guy who was engaged in litigation against JNJ. Once I got it to the point where it was a reasonably balanced and informative article, I moved on. Your edits are a nice addition.

I'll see if I can find some references for the broken links. If you have an interest in antibiotics, anything you can do with the cephalosporin articles would be a nice contribution, as many of these are pretty much stubs at this point.Formerly 98 (talk) 02:12, 21 April 2014 (UTC)

External links modified

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Generics

I'm curious as to when the equivalents or generic brands will come on the market. Do any exist now aside from Levaquin?

I was told certain antibiotics cannot be cut (half dosed), is this true for levaquin? it is one of the stronger antibiotics out there.

Levaquin is currently still currently under patent protection. There are no generics available in the market until its patent expires. This is generally the same in most countries around the world that respect intellectual property rights.

Levaquin's most commonly used dose is 500mg once-daily. The dose is halved (250mg once-daily) only for certain indications, mostly in uncomplicated (mild) Urinary Tract Infections, or when a patient has impared renal clearance.

Ofloxacin is available as a generic and can in many ways be considered exactly the same thing; see the discussion below for details.--Elvey^(t•c) 01:59, 10 January 2016 (UTC)

Adverse Events vs. Side Effects and Adverse Drug Reactions

A serious error running throughout this article and other fluoroquinolone articles is the confusion of adverse events with side effects/adverse drug reactions. Side effects implies causality. Adverse events, which are what investigators record when running a clinical trial, are any unfavorable medical event irrespective of cause.

The importance of this difference is shown in therapeutic trials in which the control group is treated with placebo (which would be unethical in an antibiotic study). In the clinical trials of Prozac, 21% of patients treated with Prozac experienced headache. Sounds pretty bad? Well 19% of the patients treated with placebo experienced headache also. Overall, it sounds very scary to say that 40% of patients treated with levofloxacin experienced an AE. But when you look at the control arm (a cephalosporin in this case), the AE rate is almost exactly the same. AEs are not necessarily "side effects", and in fact most are not. — Preceding unsigned comment added by Alfred Bertheim (talk • contribs) 00:26, 9 September 2012 (UTC)

this was comment was struck here with edit note "strike comments by sockpuppet" - however this user has no blocks for sockpuppeting, so i have restored. Jytdog (talk) 02:28, 10 January 2016 (UTC)

allergic reaction

Warning: approximately 25% of all patients prescribed Levaquin will experience an allergic reaction. Redness of the skin, uncontrollable itching, and swelling of some tendons may occur. Steroids will need to be prescribed to counter these affects. -- 71.225.83.109 (Talk) at 07:36, 16 May 2007

this is a pretty serious and unsubstantiated claim. please supply a citation. it's also important to distinguish between an allergic reaction and a side effect. -bob 01:10, 21 May 2007 (UTC)

Please reference the NDA for Levaquin found on the FDA site. http://www.fda.gov/cder/foi/nda/96/020634_levaquin_toc.htm You will find an ADR rate (one or MORE adverse reactions) exceeding 40% within the studies submitted to the FDA at that time. As well as a number of fatalities. Additionally the manufacturer did NOT supply vitro efficacy data concerning levofloxacin but rather floxin instead. This grievous error was ignored by the FDA. This too is stated within the NDA. The reference made above regarding 25% I believe to be in reference to Factive not levaquin. Serious and disfiguring rashes as described above are a known, listed and published adverse reaction to factive where the treatment protocal is indeed the use of steroids and stated as such with the package insert. http://www.fda.gov/cder/foi/nda/2003/21158_Factive.htm96.254.65.104 (talk) 22:42, 26 November 2008 (UTC)

Nowhere in the NDA does it say that there is an ADR (adverse drug reaction) rate of 40%. There are number of studies in which the AE (adverse event) rate is as high as 50% but an AE is not usually an ADR. An AE is any adverse medical effect irrespective of causality. If you look at clinical trials of drugs such as antidepressants that are performed using placebo controls, it is very common for the AE rate in the placebo arm to be >30%. AE rates include not only headaches and other events that patients would have experienced if not exposed to drug, they also include the medical consequences of the underlying disease. AE rates are only meaningful when compared to the AE rate of the control arm of the study. 24.152.161.140 (talk) 18:12, 9 September 2012 (UTC)Alfred Bertheim

the preceding quote was struck here with edit note "strike comments by sockpuppet" - however i see no record of socking, so i have restored. Jytdog (talk) 02:30, 10 January 2016 (UTC)

The article is in error. Levaquin was approved by the FDA in 1996, NOT 1997. Additionally the Black Box Warnings were NOT mandated by the FDA. This was something that the FDA requested as a result of a Federal Lawsuit filed against the FDA for failure to respond to several petitions seeking the Black Box Warnings. Compliance by the various manufacturers is voluntary. They could very well have refused and provided the FDA with an explanation as to why they felt the additional warnings were frivolous. Additionally NONE of the generics found in this class have been updated to include this Black Box Warning as of 11-27-08. The new warning for Levaquin was not added until November 2008, almost six months after the FDA had made it's request. 96.254.65.104 (talk) 22:42, 26 November 2008 (UTC)

I have corrected the approval date, thank you for pointing that out. Where does the article say the warnings were "mandated" by the FDA? Fvasconcellos (t·c) 10:46, 29 November 2008 (UTC)

The sentence "Since July 2008, all systemic fluoroquinolones (those taken internally, not as eye drops or ear drops) available in the United States must carry a boxed warning warning of the risk of tendon damage." The term "MUST CARRY" clearly impies this to be mandated by the FDA and this is what I was referring to. The FDA has NOT legally required these warnings to date and litigation concerning this issue continues as Public Citizen as well as the Attorney General of Illinois have not found this response by the FDA to be the least bit satisfactory.96.254.65.104 (talk) 19:30, 7 December 2008 (UTC)

Why did Wikipedia remove the text of the Black Box Warning from this page, (as well as the rest of fluoroquinolone pages) and the links to the Dear Doctor Letters and subsitute the pathetic reference to the FDA requesting such action six months ago instead? (Absent of the text of the new warning?)96.254.65.104 (talk) 22:46, 26 November 2008 (UTC)

Replied at your talk page. Fvasconcellos (t·c) 10:46, 29 November 2008 (UTC)

Pictures of text

File:Levofloxacin-black-box.png

Have removed as it is simply a picture of text.Doc James (talk · contribs · email) 23:41, 9 January 2016 (UTC)

Doc James What part of "Let the XfD run its course" do you not understand? Why do you ignore that (edit summary) comment? Why do you revert and provide no reason for doing so? That's all not good dispute resolution practice. Jytdog too: You are violating WP:FORUMSHOP policy. The reverts are a violation of the one forum for a discussion principle. Let the FfD run its course. You ganging up/pursuing/taking personally the SPI I opened and am pursuing against your serial socking friend/ally, User:Alfred Bertheim, FKA Formerly 98's sock farm? --Elvey^(t•c) 01:51, 10 January 2016 (UTC)

See WP:BRD. You added the picture. The picture was reverted. Now it is time to discuss and get consensus before re adding it.Doc James (talk · contribs · email) 03:33, 10 January 2016 (UTC)

You violated WP:FORUMSHOP policy. Not I. Now is the time to apologize and respond to my last discussion point. Tu pete thres haut. Something wrong with your link; I can find no policy at WP:BRD. I'm not going to stoop to your level and edit war as you have done. --Elvey^(t•c) 07:49, 10 January 2016 (UTC)

RFC: WP:FORUMSHOP policy interpretation

If a file is up for FFD is it forum shopping, that is, a violation of WP:FORUMSHOP policy, to, while the FFD is open, delete the image from the page where it's in use (and flagged with {{deletable image-caption}} ) and / or try to ALSO speedy it by tagging it with {{di-orphaned fair use}} even while it's still in use? Is it forum shopping, that is, a violation of WP:FORUMSHOP policy, to, while the FFD is open, ignore a user who argues it's forum shopping and keep re-deleting and re-flagging?--Elvey^(t•c) 01:51, 10 January 2016 (UTC)

other discussions

an RfC is not an appropriate way to bring issues you have with other editors' behavior to the community's attention. whatever. Jytdog (talk) 02:31, 10 January 2016 (UTC)

My intention is to bring an issue of policy interpretation to the community's attention. An RfC is an appropriate way to to that. In contrast, hounding me is not appropriate. WT? I wonder how many discussions you'll follow me to this month. --Elvey^(t•c) 03:13, 10 January 2016 (UTC)

I have been watching these SSRI and antibiotic articles for a long time. i am not following you around. (actually I have no edit history on this particular article, but it and the other fluoroquinoline articles have been on my watchlist a long time). again, whatever. Jytdog (talk) 01:21, 11 January 2016 (UTC)

I leave it to others to judge the reliability of your claims, based on past performance - e.g. your frequent just-in-time defense of serial sockpuppeter Formerly 98. --Elvey^(t•c) 08:23, 11 January 2016 (UTC)

• Elvey just closed the deletion discussion as "delete" and placed a speedy delete tag on the image, which he had uploaded and added to this article. This RfC has even less purpose now, if that is possible. Please remove the RfC tag, Elvey. Again if your issue is with editors' behavior the Talk page is not the place to have the community deal with that. Jytdog (talk) 04:37, 11 January 2016 (UTC)

You failed to ping me. Please, Pay Attention. Again, "my intention is to bring an issue of policy interpretation to the community's attention". If you want the community to deal with an identified issue of editors' behavior violating WP:FORUMSHOP, feel free to ask for that in the appropriate forum. --Elvey^(t•c) 08:23, 11 January 2016 (UTC)

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ABC News and unsourced content

User:2601:644:401:F2B0:4903:4130:1B07:9806 please stop using media reports for health information and adding unsourced content. Please see WP:MEDRS. If you don't understand the problem please ask. Thanks. Jytdog (talk) 14:43, 22 August 2016 (UTC)

Hi, I did not know media reports were not acceptable for health information on wikipedia. As that is the case, I certainly do not want to add an abc story, and am sorry about putting it on.

However, two others of my edits were removed. Can you please explain why they should not go on? They were quotations from medical articles, and i gave the full references, following the style of other medical papers referenced in the articles.

The two articles were (I am just giving the links here, not the full wikipedia style because I don't want to type it all in yet again, but you can look at them): http://www.ncbi.nlm.nih.gov/pubmed/21333952 Musculoskeletal complications of fluoroquinolones: guidelines and precautions for usage in the athletic population. Hall MM1, Finnoff JT, Smith J.

and

Lee, C. et al. (2015). Risk of Aortic Dissection and Aortic Aneurysm in Patients Taking Oral Fluoroquinolone. JAMA. http://archinte.jamanetwork.com/article.aspx?articleid=2451282

The paper which is referenced in the page about the other dangers is in german and a medical article too, it seemed.

also, there are references saying that it is controversial whether they are more dangerous than other drugs (referencing much older papers,from 2003). It would seem that statement is outdated given the updated FDA warning. I think this should go out. Of course, the whole class of fluoroquinolones is dangerous, so maybe this is sort of referring to that? That cipro is worse? But that is misleading, they are all apparently dangerous for similar reasons.

Also, the FDA warning says that the occurrence of some of the more adverse side effects (I think tendinitis) is 0.1-1%, which isn't quoted, although the other side effects are given occurrence percentages.

I also wanted to add from the fda warning that people got the adverse side effects even with no known risk factors.

Are there reasons to leave these out? I understand them to be facts, given their source. They seem appropriate and important for people to know. Jdbrook (talk) 16:47, 24 August 2016 (UTC)jdbrook

The second article by Lee also mentions a study about the increased risk of tendinitis and tendon rupture in a sample of 6.4 million people, the reference is Wise BL, Peloquin C, Choi H, Lane NE, Zhang Y. Impact of age, sex, obesity, and steroid use on quinolone-associated tendon disorders. Am J Med. 2012;125(12):1228.e23-1228.e28. I would like to add this too. Can you please explain why you think they should not be added, if you do not wish me to add them? They give important warnings about the dangers and statistics of studies, much like what is in the article already, except that the dangers are now known to be much worse, so the current article is incomplete (and might make the medicine seem safer than it is). Thank you. Jdbrook (talk) 17:25, 24 August 2016 (UTC)jdbrook

There are too many things here to respond to, so I will respond to the first. We use literature reviews or statements by major medical or scientific bodies (we classify each of those as "secondary sources") for sourcing about health, not papers reporting research (which we call "primary sources"), and we don't use news sources, as you now understand. This is all explained in WP:MEDRS. The scientific (non news) papers you cited were reporting research - they are primary sources. Jytdog (talk) 19:32, 24 August 2016 (UTC)

1) Musculoskeletal complications of fluoroquinolones: guidelines and precautions for usage in the athletic population.

Hall MM, Finnoff JT, Smith J.

PM R. 2011 Feb;3(2):132-42. doi: 10.1016/j.pmrj.2010.10.003. Review. It is a review.

2) Risk of Aortic Dissection and Aortic Aneurysm in Patients Taking Oral Fluoroquinolone.

Lee CC, Lee MT, Chen YS, Lee SH, Chen YS, Chen SC, Chang SC.

JAMA Intern Med. 2015 Nov;175(11):1839-47. doi: 10.1001/jamainternmed.2015.5389.

PMID: 26436523 It appears to be a primary source.[1] QuackGuru (talk) 20:50, 24 August 2016 (UTC)

the one by mayo clinic doctors is a set of guidelines....but it is not a national study.

they are highly reputable though.

I suggest this is a common sense exception. please advise? the conclusions are in plain English and many studies are combined.

is the German article a review? my German is insufficient to check...

this stuff is very dangerous so it is too bad you can't tell people...

Jdbrook (talk) 02:36, 25 August 2016 (UTC)jdbrook

Rather than fussing over sources, would you please tell us what content you want to see changed? We can check out the sourcing afterwards. Thanks. Jytdog (talk) 02:54, 25 August 2016 (UTC)

(PMID 21333952) is a review. QuackGuru (talk) 03:37, 25 August 2016 (UTC)

he one by mayo clinic doctors is a set of guidelines....but it is not a national study. they are highly reputable though. I suggest this is a common sense exception. please advise? the conclusions are in plain English and many studies are combined.

is the German article a review? my German is insufficient to check... Jdbrook (talk) 04:01, 25 August 2016 (UTC)jdbrook

Which German article? (PMID 26436523) is not review. QuackGuru (talk) 04:06, 25 August 2016 (UTC)

Again would you please discuss the content you want to change? thanks. Jytdog (talk) 04:48, 25 August 2016 (UTC)

Hi, given all the context (thank you all for explaining), I would like to add

1. Something indicating the statement "Athletes should avoid all use of fluoroquinolone antibiotics unless no alternative is available." from the Hall, Finnoff, Smith article (in that paper, last section before conclusions, guideline 1) under contraindications.

2. The FDA label also says (page 58): "Tendon problems can happen in people who do not have the above risk factors when they take LEVAQUIN."

And (again, the FDA report, right below the above comment and echoing the athletic guideline): 3. "Other reasons that can increase your risk of tendon problems can include: physical activity or exercise " (this does not state activity in the tendon that is harmed, that doesn't seem to be how it works...)

I would like to have these comments somehow in the article. Under adverse reactions or contraindications, or maybe some paraphrasing of 1&3, as they are similar. (Maybe adding 1 and 2 is sufficient?)

[Also, in table 5,page 18 of the fda label, one sees that the tendinitis, etc., are 0.1-1% occurrence. This is small but not when you consider the number of doses administered. I would like this in the wikipedia page if the percentages of occurrences for the other things (headache, etc.) are listed. But this isn't as important as noting that people who are in excellent physical condition are at risk if they take this, not just people whose bodies are weakened by prior health stress (kidney problems or whatever). But this is secondary.]

Thank you, 2601:644:401:F2B0:7079:8F6D:8F16:D853 (talk) 06:06, 25 August 2016 (UTC)jdbrook

also, the black box warning was again updated in july, , looks stronger at a quick glance, that reference should be updated. Thank you.

2601:644:401:F2B0:7079:8F6D:8F16:D853 (talk) 06:09, 25 August 2016 (UTC)jdbrook

I'll have a look at the first batch of things. As for the FDA label being updated, I took care of that a few days ago. Jytdog (talk) 06:16, 25 August 2016 (UTC)

Hi, thank you. I see the May FDA label is linked, there is a new label (July), http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020634s067,020635s073,021721s034lbl.pdf (I know people don't want to link to the page that lists all the labels so that you get the latest one, but information on Levaquin seems to be changing quickly, not sure what to do about that)?

The warnings are much stronger now: the new label black box starts with "WARNING:SERIOUS ADVERSE REACTIONS..." unlike the older one.

Also, Ref 19 is the regular FDA label http://www.fda.gov/downloads/Drugs/EmergencyPreparedness/BioterrorismandDrugPreparedness/UCM133684.pdf, but from 2008 (the reference is for a sentence about safety for nursing mothers, although the statements in that section of the warning are unchanged, i.e. that adverse effects may pass to the fetus, the adverse effects more generally have changed to be more severe)

Thanks, 2601:644:401:F2B0:7079:8F6D:8F16:D853 (talk) 12:11, 25 August 2016 (UTC)jdbrook

Also, to answer an earlier question, about german references, reference 32 is in german. Reference 33 seems to be the report of one medical response (but a very dangerous one, so I totally understand why it is included, but don't understand why the Lee et al report on aortic aneurysms, also very dangerous conditions and possibly fatal, is not included). Please respond? Thank you. 2601:644:401:F2B0:5540:4EA1:F366:DC6F (talk) 18:57, 25 August 2016 (UTC)jdbrook

I am having trouble responding to you because you are writing way too much in each post. Each section on a talk page should address one thing. Fixing the label thing now. Jytdog (talk) 19:50, 25 August 2016 (UTC)

thank you for fixing the label.

Jdbrook (talk) 01:58, 26 August 2016 (UTC)jdbrook

• I took care of the german ref, which wasn't adding any value, and also dealt with liver tox primary source, which was also redundant. the drug is not formally contradicticated in the UK nor in the US for people with a history of liver problems - the content was wrong there. Jytdog (talk) 02:17, 26 August 2016 (UTC)

• with respect to the aortic dissection/aortic aneurysm paper, I did a pubmed search to see if there are any reviews (MEDRS sources) that discuss this. here are the results. Three papers. Two of them old, and about how bacterial infection used to kill people following dissection and didn't after we got better drugs, and the other one off topic. For this we should wait to see how the field reacts to that paper. I will be interested to see! Jytdog (talk) 02:25, 26 August 2016 (UTC)

• i added stuff from the Hall review. I think that is everything you raised. Jytdog (talk) 03:57, 26 August 2016 (UTC)

hi, thank you- that looks great. Jdbrook (talk) 14:45, 26 August 2016 (UTC)jdbrook Jdbrook (talk) 14:45, 26 August 2016 (UTC)

nursing

one more comment--the nursing statement in the latest fda label says: Based on data on other fluoroquinolones and very limited data on LEVAQUIN®, it can be presumed that levofloxacin will be excreted in human milk. Because of the potential for serious adverse reactions from LEVAQUIN® in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

that is, either you stop nursing or you stop taking it, not that you take it and nurse at the same time....strong statement. page 25 of http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020634s067,020635s073,021721s034lbl.pdf

could you please add it (i'm not sure i am allowed to)? Thanks! 2601:644:402:6380:8084:A253:5190:3FE5 (talk) 05:28, 3 September 2016 (UTC)jdbrook  Done Jytdog (talk) 03:50, 6 September 2016 (UTC)

Injuries & fatalities

can this journal result be added? FDA reporting system had 210,705 reported injuries and 2991 fatalities article abstract reference is Fluoroquinolone-related neuropsychiatric and mitochondrial toxicity: a collaborative investigation by scientists and members of a social network published in a journal of oncology. (PMID:26955658, DOI: 10.12788/jcso.0167 ) again, i'm not sure i'm allowed to edit. thank you!

References

Jdbrook (talk) 14:28, 3 September 2016 (UTC)jdbrook

no, that is a primary source and per MEDRS we don't use them. Jytdog (talk) 03:51, 6 September 2016 (UTC)

== Production of Levaquin ceased == needs confirmation from better sources.

https://arentzlaw.com/defective-drug/jj-stops-levaquin-sales/ Tampasailor (talk) 02:59, 10 September 2018 (UTC)

article inconsistency wrt safety during pregnancy and breastfeeding

The main header section of the article contains information regarding the safety of this drug during pregnancy and breastfeeding that is contradicted by a subsection on that topic later in the article. I don't know enough about the safety of this drug to be able to reconcile the sections responsibly. — Preceding unsigned comment added by 161.55.164.11 (talk) 21:10, 28 November 2018 (UTC)

Thanks for pointing this out. Should be fixed now. --ἀνυπόδητος (talk) 07:36, 30 November 2018 (UTC)

There is no mention of death as a side effect

Recently was prescribed. one 500 mg tablet of Levofloxacin for a medical procedure and the information that came with it mentioned death as a possble side effect. This article does not mention anything about this possible side effect but a clinical trial comparing the risk of death and Cardiac Arrhythmia with Levo and other antibiotics was published here: https://pubmed.ncbi.nlm.nih.gov/24615307/#:~:text=Compared%20with%20patients%20receiving%20amoxicillin%2C%20patients%20receiving%20levofloxacin%20for%20days,%25%20CI%2C%201.32%2D2.88)

Theres also link regarding an FDA disclosed report of mitochondrial toxicity allegedly link to levofloxacin 71.178.185.35 (talk) 19:12, 30 August 2023 (UTC)