Talk:Ofloxacin

Urgent Rewrite Needed

This page, in its current form, is atrocious! Please, if you are able, try to edit it or rewrite it. Or you can try to contact someone knowledgeable about this drug and have them contribute. This article currently is a biased interpretation of the warning pamphlet sent out to health care providers and contains very little encylopedic fact. The article addresses nothing about uses, mechanisms, indications, biochemistry, pharmacokinetics, pharmacodynamics, bioavailability, benefits v.s. side effects, etc... Please help edit this page so that real and worthwhile information on this drug can be obtained!! (any chance any administrator out there is a pharmacologist?) —Preceding unsigned comment added by Roijuancarlos (talk • contribs) 02:03, 13 July 2008 (UTC)

This page, as well as all the pages concerning the drugs found within the fluoroquinlone class are currently being redone. At the moment we have made tremendous progress concerning the following articles, though they are not completed at the moment, significant progress has been made:

1. fluoroquinolone toxicity syndrome 2. quinolone 3. ciprofloxacin 4. levofloxacin (aka levaquin)

floxin, moxifloxacin (aka avelox), tequin, and factive are next inline for a revamp once the above pages are completed. But I can only do so much at a time so bear with me...we get to them all in due time.Davidtfull (talk) 07:47, 13 February 2009 (UTC)

I agree this page needs a rewrite. Until then the article should be tagged as Unbalanced. Nazgul02 (talk) 19:08, 23 September 2009 (UTC)

I will try to work on this article to resolve undue weight issues as well as ref formating issues over the next week.--Literaturegeek | T@1k? 02:12, 24 September 2009 (UTC)

Nazgul02, you may not have noticed but you had just responded to a comment that is well over a year old and no longer applicable to this article. It had been rewritten and revised a number of times since that comment had been originally made last year and the issues raised by Roijuancarlos had all been resolved since then. Davidtfull (talk) 05:43, 24 September 2009 (UTC)

OK. I have been prescribed Ofloxacin and I have looked at this article for some information on in. The article reads more like article about a poison. It focuses too much on the potential adverse effects, regulatory history, antibiotic abuse etc. Therefore I think the article is unbalanced. Nazgul02 (talk) 11:25, 24 September 2009 (UTC)

Nice

Hey, nice improvements to this page, since I last visited it - congratulations! Iridos 23:30, 9 February 2007 (UTC) will someone mention the dosage esp for urinary infection With all the listed adverse effect, it is better to avoid Ofloxacin completely. what is the alternative? Can somebody out there say something please. —Preceding unsigned comment added by 213.255.198.148 (talk) 17:43, 27 February 2008 (UTC)

The page is so demoralising. Whats there in the page apart from side effects. I was about to throw the medicine (which is close to a poison according to your information) but other websites saved it from the bin. —Preceding unsigned comment added by Rhythmdivine (talk • contribs) 14:18, 19 March 2008 (UTC)

This page, as well as all the pages concerning the drugs found within the fluoroquinlone class are currently being redone. At the moment we have made tremendous progress concerning the following articles, though they are not completed at the moment, significant progress has been made:

1. fluoroquinolone toxicity syndrome 2. quinolone 3. ciprofloxacin 4. levofloxacin (aka levaquin)

floxin, moxifloxacin (aka avelox), tequin, and factive are next inline for a revamp once the above pages are completed. But I can only do so much at a time so bear with me...we get to them all in due time.Davidtfull (talk) 07:47, 13 February 2009 (UTC)

Use in pregnancy

I have reworded the statement that "pregnant women are at risk of killing or damaging their unborn child" as it grossly misrepresented the cited reference (PMID 9624471). The authors of that study found a higher rate of therapeutic abortions among women exposed to quinolones during pregnancy, and suggested that it may be due to a misperception of the teratogenicity of quinolones, i.e. patients and doctors thinking that quinolones are more harmful in pregnancy than they actually are, and consequently performing unwarrented abortions. As a matter of fact, the article actually made it to JournalWatch as "Fluoroquinolones Appear Safe in Pregnancy".

Personally, I would rather see this information moved to the main Quinolone article, as none of it concerns ofloxacin in particular; information on class effects should be in the class article, not in individual articles about the members of the class. Fvasconcellos (t·c) 20:25, 13 May 2009 (UTC)

It is also a rather old paper, 1998.--Literaturegeek | T@1k? 22:56, 13 May 2009 (UTC)

Perhaps that citation was not the proper one to use to support that statement. I have numerous others however when viewed in total that perhaps would. Two cases come to mind, one in which the mother was full term with a normal viable pregnancy that ended in a still birth after taking a fluoroquinolone and another in which a miscarriage followed such therapy. I have no problem with the revisions you guys made regarding this issue as the citation used was a poor choice and taking another look at it, worded a bit too strongly. I will present the others here and we can take another look at it and go from there. I will try to find the ones I have that deal with ofoxacin specifically as well.Davidtfull (talk) 02:40, 14 May 2009 (UTC)

A few studies and qoutations regarding floxin specifically and this issue:

In a prospective follow-up study conducted by the European Network of Teratology Information Services (ENTIS), data on 549 pregnancies exposed to fluoroquinolones (93 to ofloxacin) were described in a 1996 study. Data on another 116 prospective and 25 retrospective pregnancy exposures to the antibacterials were also included. From the 549 follow-up cases, 509 were treated during the 1st trimester, 22 after the 1st trimester, and in 18 cases the exposure occurred at an unknown gestational time.

Of the 549 pregnancies, there were 415 live-born infants (390 exposed during the 1st trimester), 356 of which were normal term deliveries (including one set of twins), 15 were premature, 6 were small for gestational age (intrauterine growth retardation [IUGR], <10th percentile), 20 had congenital anomalies (19 from mothers exposed during the 1st trimester; 4.9%), and 18 had postnatal disorders unrelated to either prematurity, low birth weight, or malformations.

Of the remaining 135 pregnancies, there were 56 spontaneous abortions or fetal deaths with one malformed fetus, and 79 elective abortions due to malformed fetuses. Out of the 415 live births we find a total of 59 with some sort of birth defect as well as 135 deaths. 56 were spontaneous abortions and 79 were elective abortions due to malformed fetuses.

When we combine these two totals we find 194 defective or malformed babies. The malformation rate among the live-born babies in the prospective ENTIS cohort was approximately 4.8%. But if we were to include the elective abortions due to malformed fetuses this number increases dramatically from 19 to 98. Which would be 18% vs. 4.8%. If we were to include spontaneous abortions as well, then we are looking at a total of 154 defective children out of 549 ( 28%). According to the March of Dimes only about 3 to 5 percent of all pregnancies result in children born with birth defects. Allowing for this we would then reduce the above rate from 28% to 23%. Which would indicate that a greater than one in four chance of either death or malformation could be associated with the fluoroquinolones.

Number of pregnancies: 549

Normal births: 356

Premature: 15

Postnatal disorders: 18

Small for age: 6

Congenital anomalies: 20

Spontaneous abortions: 56

Elective abortions due to birth defects: 79

The authors of this study concluded that fluoroquinolones should be considered contraindicated in pregnancy, because safer alternatives are usually available.

The defects observed in seven infants followed up prospectively, all exposed to ofloxacin during the 1st trimester, were as follows:

Prospective ENTIS Myelomeningocele hydrocephaly Ureterostenosis Maldescensus testis Hypospadias Hernia inguinalis left side Bilateral hip dysplasia Small atrial septal defect.

The authors of the above study concluded that pregnancy exposure to quinolones was not an indication for termination, but that this class of antibacterials should still be considered contraindicated in pregnant women . Moreover, this study did not address the issue of cartilage damage from quinolone exposure, and the authors recognized the need for follow-up studies of this potential toxicity in children exposed in utero. Because of their own and previously published findings, they further recommended that the focus of future studies should be on malformations involving the abdominal wall and urogenital system, and on limb reduction defects.

The use of ofloxacin during human gestation revealed a number of birth defects having occurred in the offspring of women who had taken this drug during pregnancy. Because of this and the available animal data, the use of ofloxacin during pregnancy, especially during the 1st trimester, should be approached with caution. A 1993 review on the safety of fluoroquinolones concluded that these antibacterials should be avoided during pregnancy because of the difficulty in extrapolating animal mutagenicity results to humans and because interpretation of this toxicity is still controversial.

Reference:

Schaefer C, Amoura-Elefant E, Vial T, Ornoy A, Garbis H, Robert E, Rodriguez-Pinilla E, Pexieder T, Prapas N, Merlob P. Pregnancy outcome after prenatal quinolone exposure. Evaluation of a case registry of the European Network of Teratology Information Services (ENTIS). Eur J Obstet Gynecol Reprod Biol 1996;69:839.

http://www.ncbi.nlm.nih.gov/pubmed/8902438

In a prospective follow-up study of 93 women treated with ofloxacin during pregnancy, there was a higher than expected (11.9%) malformation rate among the infants; however, no specific patterns could be found (Schaefer et al, 1996).

See:

http://www.bkhc.moph.go.th/bk/modules.php?:name=Forums&file=posting&mode=topicreview&t=6&popup=1

Several studies have shown that women taking Floxin have shown birth defects including water on the brain, hernias and heart malformations in the fetus...and joint abnormalities have been noted in children exposed to this category of antibacterial during pregnancy...Floxin should absolutely NOT be taken during the first trimester because of the abnormalities observed in animals when exposed to this type of drug during this time.

See:

The expectant mother's guide to prescription and nonprescription drugs, vitamins, home remedies, and herbal products

By Donald L. Sullivan

Edition: illustrated

Published by Macmillan, 2001

ISBN 0312251904, 9780312251901

(pg 55-56)

Tetracyclines (e.g. doxycycline) and fluoroquinolones (e.g. ofloxacin) should not be used to treat women who are pregnant because of associated adverse events in the fetus.

See:

Compliance a Key Consideration: Fewer Options in Pregnancy

http://www.medscape.com/viewarticle/406494_9

The treatment for gonorrhea in pregnant women is essentially the same as in non-pregnant women. The notable exception is that quinolone antibiotics, like ciprofloxacin and ofloxacin, should not be used since these antibiotics inhibit DNA formation and can cause birth defects.

http://www.healthline.com/yodocontent/pregnancy/treatment-chlamydial-infection.html

These are the two cases I had mentioned earlier:

When she was eight and one-half months pregnant, Angela Morlino visited the emergency room at the Point Pleasant facility of the Medical Center of Ocean County (Medical Center) complaining of a sore throat. She had visited the Medical Center two weeks earlier for similar complaints and was given a prescription for amoxicillin, an antibiotic in the penicillin family. When she returned on this occasion, the emergency room physician, Dr. Dugenio took her history, examined her, and ordered a variety of tests. He diagnosed her condition as acute pharyngitis. Two days later, the results of Morlino's throat culture confirmed the presence of a bacteria that was resistant to numerous antibiotics, including penicillin. Before receiving those results, Dr. Dugenio considered prescribing Ciprofloxacin (Cipro), as the amoxicillin had not cured the infection.

Because he was concerned that the bacteria, left untreated, could lead to more serious illnesses to both Morlino and her fetus, he concluded that the potential risk to the fetus posed by prescribing Cipro outweighed the risks of more serious illnesses to Morlino and her fetus. He, therefore, gave Morlino a 500 milligram Cipro pill and a prescription for 250 milligrams of Cipro. He did not warn Morlino that Cipro might pose a risk to her fetus.

Thereafter, on March 21, 1990, Morlino's obstetrician, Dr. Thompson, was unable to detect a fetal heartbeat during a routine examination. A sonogram revealed that Morlino's fetus had died. Morlino sued Dr. Dugenio, the Medical Center, and Dr. Thompson, claiming that the ingestion of Cipro had caused the fetus's death.

Angela Morlino, etc.,

Plaintiff-Appellant,

v.

Medical Center Of Ocean County,

et al.,

Recently we had a member of the forum who had gotten pregnant, post quinolone exposure, and unfortunately the pregnancy ended in a miscarriage.Davidtfull (talk) 04:15, 14 May 2009 (UTC)

Schaefer et al and a few other studies/case reports, as they apply to the other fluoroquinolones:

Ofloxacin

Prospective cohort studies without controls: Schaefer et al (1996), ENTIS: 61 live births 7 of which (11.5%) showing congenital defects (myelomeningocele, urethral stricture, chriptorchism, hypospadias, inguinal hernia, bilateral hip dysplasia and defect of interatrial septum of heart).

Ciprofloxacin

Retrospective cohort studies without controls: Schluter (1989) and Bomford et al (1993): exposures reported to the manufacturer: 52 healthy newborns exposed in the first trimester, 11 healthy newborns exposed after the first trimester, 8 newborns with various different types of defects, 18 VIP, 10 miscarriages, 4 fetal deaths.

Retrospective cohort studies with internal controls: Rosa (1993), Michigan MSS: 132 first trimester exposures, 3 newborns with major defects.

Prospective cohort studies without controls: Schaefer et al (1996), ENTIS: 71 first trimester exposures, 50 live births, and 3 of whom showing congenital anomalies (angioma, dysplasia of the hip, trisomy). 6 out of 116 exposures to ciprofloxacin prospectively gathered by the manufacturer had congenital anomalies (hypospadias, dysplasia of the hip, CNS defect, and hypospadias with bilateral inguinal hernia, acaridae and forearm amputation).

Pefloxacin

Prospective cohort studies without controls: Schaefer et al (1996) ENTIS: 57 first trimester exposures, 43 live births 2 of whom showing congenital anomalies (4.7%) (phenylketonuria, pulmonary cardiopathy).

Norfloxacin

Prospective cohort studies without controls: Rosa (1993) Michigan MSS: 79 first trimester exposures, 5 newborns with major defects.

Nadilixic acid

Case report: Based on a study by Deonna and Guignard (1974) who reported 2 children with intracranial hypertension following the use of nalidixic acid, Asscher (1977) reviewed IVU treatment. He affirms that “nalidixic acid should not be prescribed in the second half of pregnancy since it may cause hydrocephaly also at low doses”.

Retrospective cohort studies without controls: Murray (1981): 1 newborn exposed in the third trimester with severe cardiac defect.

Case-control studies, nonspecific: Czeizel et al (2001) Hyngarian CCSCA: 22,865 newborns with congenital anomalies 242 of which exposed, 38,151 healthy newborns, 377 of which exposed. OR = 1.1 (CI 95%: 0.9-1.3). 7 cases of pyloric stenosis exposed in the late months of pregnancy. OR = 11.0 (CI 95%: 1.3-91.4).

Prospective cohort studies with internal controls: One single newborn with hemolytic anemia had been exposed in the second half of pregnancy (Belton and Jones 1965).Davidtfull (talk) 13:41, 14 May 2009 (UTC)

In response to the accusation of misrepresenting a citation

I would beg to differ with your assertion that “pregnant women are at risk of killing or damaging their unborn child” is to be considered a gross distortion of the article cited. The article in question (Loebstein et al) stated that:

Women treated with quinolones had a tendency for an increased rate of therapeutic abortions...There was a trend toward a higher rate of therapeutic abortions among the quinolone-exposed women (9 of 200 versus 2 of 200 for the control group). This is reflected in a lower live-birth rate among the quinolone-exposed women (173 of 200 versus 188 of 200 for the control group; P 5 0.02).

If you have 200 patients in the quinolone group, nine have a therapeutic abortion, and then you would have 191 patients as your adjusted live-birth rate in this group. Yet we find only 173. Making the same adjustments for the control group (200 – 2) you would have a 198, and yet we find only 188. The authors failed to note that there was a far higher number spontaneous abortions within the quinolone group (18) as compared to elective abortions, which reduced the number of live births to the 173. The spontaneous abortions had a far greater impact on the live birth rate than the therapeutic abortions had. Yet the author focused on the elective abortions while ignoring the spontaneous abortions. And there were also 10 spontaneous abortions found within the control group, which reduced their numbers to the adjusted 188 as well. Which also had a far greater impact on the live birth rate of the control group than the number of elective abortions (2). Furthermore Leobstien states that there may be other medical reasons that would account for the higher number of elective abortions in the quinolone group other than the hysteria he made reference to. Loebstein stated:

The higher rate of therapeutic abortions observed in the quinolone-exposed women compared to that observed in their controls may be secondary to misinformation and misperception of a major risk related to their use during pregnancy. However, other medical and especially nonmedical reasons can also account for this finding.

Perhaps elective abortions due to birth defects such as we found within Schaefer et al would have accounted for this higher rate, rather than the author’s bias opinions?

When we view that statement within the context of Schaefer et al it is NOT to be considered a gross misrepresentation due to the fact that within Schaefer we find 56 spontaneous abortions and 79 elective abortions due to birth defects. That is a total of 135 abortions out of 549 pregnancies. Which is about 25%. It is only logical to assume that the women who opted for a therapeutic abortion within Loebstein did so on the advice of their physician, who no doubt discovered that the fetus was defective (i.e. birth defects). And Loebsteint readily admits that he is expressing a personal opinion in regards to reasons for the high number of abortions found within the quinolone group, rather that the facts supported by his study. The study fails to reveal the reasons for the elective abortions and he admits later in the study that they may very well have been for other reasons. Hence the statement that had been added to this article regarding this should be removed.

Similarly, he stated that there were no differences in pregnancy outcome with respect to the rates of spontaneous abortions. Yet there were 18 spontaneous abortions found within the quinolone group as compared to 10 in the control group. This is almost DOUBLE. Hence the quinolone-induced spontaneous abortions had a far greater impact on live births that the elective abortions had, yet his focus was upon the elective abortions instead. Which would reveal the bias mentioned earlier in regards to his opinions regarding the cause of the elective abortions.

The facts presented within Loebstein are as follows:

1. There was a higher rate of therapeutic abortions among the quinolone-exposed women. 2. Gestational age at delivery was significantly lower among the quinolone-exposed women. There was a shorter length of gestation observed in the quinolone group 3. Rates of spontaneous abortions were higher in the quinolone group (18 vs. 10) 4. The major malformations noted in the quinolone group were two cases of ventricular septal defect and one case of patent ductus arteriosus. 5. The birth weight was lower in the quinolone group

When we combine the findings of Loebstein with the findings of Schaefer et al (incorporated by reference) you will find that this is NOT a gross distortion of the reference used. There was a significant higher rate of abortion (both spontaneous and elective due to birth defects) found within the quinolone group within Schaefer et al, as well as a significant higher rate of birth defects. There was also a higher rate of both spontaneous and elective abortions found within Loebstein as well. Hence the reference does support the statement that “...and pregnant women are at risk of killing or damaging their unborn child.” The risk of the fluoroquinolones killing the fetus, whether it be via spontaneous abortion or an elective abortion, which was significantly higher in both studies.

The gross distortion is to be found within the findings of Loebstien when you review the data and compare it to his statements, for the data does not support his suppositions regarding the reason that elective abortions took place. He had no medical records/information regarding them upon which to form such an opinion. The reasons for the elective abortions taking place were never stated. Where as within Schaefer they were. The reason being birth defects.

Furthermore Loebstein stated that:

The possible high misperceived risk related to quinolone use during gestation probably stems from several statements found in the literature: the Compendium of Pharmaceuticals and Specialties (1a) states that "ciprofloxacin should not be used in pregnant women unless the likely benefits outweight the possible risk to the fetus." Another recent publication (11) claims that "quinolones should still be regarded as contraindicated during pregnancy," although these data were from an uncontrolled study. It is our experience that such information often leads to excess anxiety and unnecessary therapeutic abortions.

Here he is stating that such information, IN HIS EXPERIENCE, leads to "unnecessary therapeutic abortions". I find this very difficult to believe when one considers the gross ignorance found within the medical community in regards to the common adverse reactions associated with this class. Few, if any, treating physicians are even aware of the well known adverse events such as spontaneous tendon ruptures and peripheral nueropathy. The odds are extremely slim that they would be aware of the risk of these birth defects and suggest an unneccasary abortion. And as far as the patient goes, even slimmer. Within this study he is disputing the facts found within Schaefer and other studies, subsituting his own perceptions with no supporting data to back them up. Davidtfull (talk) 01:12, 15 May 2009 (UTC)

Questions asked regarding J and J shareholder meetings

It had been asked:

http://www.investor.jnj.com/webcasts-presentations.cfm --which webcast is this? Can you cite when during the meeting these statements were made, e.g. "minute:seconds"?

Answer:

The web cast took place on Apr 23, 2009 10:00 AM ET The statements are made at the end of that meeting when comments from the audience are heard. This can be accessed at:

http://www.investor.jnj.com/webcasts-presentations.cfm

Then clicking on the archive: Johnson & Johnson 2009 Annual Meeting of Shareholders. The meeting is several hours long. The time stamp is at 1 hour and 42 minutes.

The 2008 meeting is no longer available on that site but the comments made by Paul Cahaan in 2008 is referenced within the statements made by John Fratti in 2009. I also have a copy of the statements made by Paul which was recorded during that meeting in 2008 in my possession.

The original recordings of these two speechs, the 2008 by Paul Cahan and the 2009 by John Fratti can be accessed by following this link:

http://fqresearch.org/j_and_j

In the United States ofloxacin is rarely used, having been discontinued by the manufacturer (Ortho McNeil Janssen).when? can we cite an Ortho-McNeil source for this?

The FDA website, http://www.accessdata.fda.gov/scripts/cder/drugsatfda/ list floxin as being discontinued.

http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.DrugDetails

No date is given as to when this took place. To access this information log unto drugs@fda following the above link then type in Floxin in the search window, click on the first Floxin in the list presented, then click on FLOXIN (NDA # 019735).Davidtfull (talk) 02:30, 15 May 2009 (UTC)

I have found this link which gives a time stamp on the removal of floxin.

http://www.tradingmarkets.com/.site/news/Stock%20News/2335053/ see also FDA docket number FDA-2009-N-0211

It sets the published date at April 30, 2009 and the effective date to be June 18, 2009.Davidtfull (talk) 03:07, 21 May 2009 (UTC)

Ofloxacin other names?

What other names is ofloxacin called? is it called oflocine? what other names is it called? Machn (talk) 13:45, 1 April 2010 (UTC)

ofloxacin those used to treat eye infection found much irritation to those people uses repeatedly —Preceding unsigned comment added by 117.204.102.98 (talk) 10:11, 11 April 2011 (UTC)

European Patent Daiichi ???

This phrase at the begining of the second paragraph does not seem to have any sense.

Daiichi seems to be a Japanese word (https://en.wikipedia.org/wiki/Dai-ichi). Maybe this reflects the fact that this molecule was discovered by Japanese reseachers ? (http://www.ncbi.nlm.nih.gov/pubmed/?term=12111564)

— Preceding unsigned comment added by Herix (talk • contribs) 15:20, 23 June 2014 (UTC)

Where's Hypersensitivity Pneumonitis?

This potential side effect is no where mentioned in the article, that I can find. Why is that?Godofredo29 (talk) 01:17, 22 March 2017 (UTC)