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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. [[Special:Contributions/96.254.65.104|96.254.65.104]] ([[User talk:96.254.65.104|talk]]) 22:42, 26 November 2008 (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. [[Special:Contributions/96.254.65.104|96.254.65.104]] ([[User talk: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? [[User:Fvasconcellos|Fvasconcellos]]<small>&nbsp;([[User talk:Fvasconcellos|t]]·[[Special:Contributions/Fvasconcellos|c]])</small> 10:46, 29 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? [[User:Fvasconcellos|Fvasconcellos]]<small>&nbsp;([[User talk:Fvasconcellos|t]]·[[Special:Contributions/Fvasconcellos|c]])</small> 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.[[Special:Contributions/96.254.65.104|96.254.65.104]] ([[User talk: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?)[[Special:Contributions/96.254.65.104|96.254.65.104]] ([[User talk:96.254.65.104|talk]]) 22:46, 26 November 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?)[[Special:Contributions/96.254.65.104|96.254.65.104]] ([[User talk:96.254.65.104|talk]]) 22:46, 26 November 2008 (UTC)

Revision as of 19:30, 7 December 2008

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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)[reply]

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.

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.

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

http://www.askapatient.com/viewrating.asp?drug=20635&name=LEVAQUIN

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).[reply]

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 (talkcontribs) 17:32, 9 April 2008 (UTC)[reply]

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)[reply]

More websites about adverse effects.

http://www.fqresearch.org

http://www.drugvictims.org/index.html

http://www.geocities.com/quinolones/

http://www.medicationsense.com/articles/july_sept_03/reactions_cipro_other.html

http://fqvictims.org/fqvictims/index.htm

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)[reply]

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)[reply]

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)[reply]


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)[reply]

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)[reply]

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)[reply]

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)[reply]

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