New warning on common antibiotic

  • Thread starter edward
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In summary: Some of the diseases that were or are currently treated in last resort circumstances are with fluroquinolones. They are damn good antibiotics, which is more than you can say about Linezolid (and linezolid-like abx) and vancomycin, which are trash.
  • #1
edward
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FDA Drug Safety Communication: FDA requires label changes to warn of risk for possibly permanent nerve damage from antibacterial fluoroquinolone drugs taken by mouth or by injection.

The problem concerns peripheral neuropathy during and after taking the drugs. The most common fluoroquinolone is Cipro sometimes called ciprofloxacin. It is a broad spectrum antibiotic.

http://www.fda.gov/Drugs/DrugSafety/ucm365050.htm

Previous to this warning there was a black box warning that the drug can cause inflammation and even rupture of the Achilles tendon.

It is the antibiotic that the government bought millions of doses of during the anthrax scare.

It is also the drug that thousands of soldiers were given during the Gulf War. Could it be the cause of Gulf War syndrome? The Army Times seems to think so.

http://www.armytimes.com/article/20131101/NEWS/311010018/New-FDA-warnings-Cipro-may-tie-into-Gulf-War-illness

This could really open up a can of worms. There is no treatment to cure peripheral neuropathy.

Ciprofloxacin was patented by Bayer in 1983 and approved by the FDA in 1987.

http://en.wikipedia.org/wiki/Ciprofloxacin

What is that sound I hear? I think it may be the lawyers coming.

Edit. I just noted the below in the link.

Ciprofloxacin is commonly used for urinary tract and intestinal infections (traveler's diarrhea), and was once considered a powerful antibiotic of last resort
 
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  • #2
I just recently took cipro, was afraid due to the hype around it, I actually waited 2 weeks to take it. Had zero problems. Not even sure why it was prescribed, but took in the hopes that maybe it would help in case there was some underlying undetected infection. I think there is too much scare mongering going on.
 
  • #3
As with many medications, a physician has to weight the risk vs. benefit. Permanent nerve damage risk or death from sepsis?
 
  • #4
gravenewworld said:
As with many medications, a physician has to weight the risk vs. benefit. Permanent nerve damage risk or death from sepsis?

IMO that's a good way to look at medicine as a whole, it's swapping one larger risk for a smaller one. Having said that there should be an inquiry around things me this to see if there was any negligence; either in the case of approval if the original trials were not performed correctly or in the case of regulation if it was being prescribed incorrectly. If either cases show that there was no problem then this has to be chalked up to an unavoidable accident.
 
  • #5
The big difference with Cipro and side effects is that they can be disabling and permanent.

Adverse effects associated with the use of ciprofloxacin (Cipro) and other fluoroquinolone antibiotics are not always benign. Not infrequently, they can be severe and permanently disabling, and they may occur following just one or a few doses, according to a study posted on the Annals of Pharmacotherapy Web site. Scheduled for publication in December 2001, this article was released early online because of the threat of anthrax and subsequent heightened interest in Cipro.

http://www.medscape.com/viewarticle/411159

This article is from 2001.:eek:
 
  • #6
edward said:
The big difference with Cipro and side effects is that they can be disabling and permanent.



http://www.medscape.com/viewarticle/411159

This article is from 2001.:eek:
Chemotherapies for cancer can end up causing cancer. Would death from a secondary cancer be considered a disabling and permanent side effect? Again, what's the benefit vs. risk? If there was negligence during clinical trials, then I could see lawsuits coming.
 
  • #7
gravenewworld said:
Chemotherapies for cancer can end up causing cancer.

While you're not wrong, statements like this should be backed up by reliable sources. Not surprisingly, radiation therapy leads the list. As with any treatment of serious diseases, one can choose not to have the available treatments. Approved therapies, at least in developed countries, must have a strong benefit to risk profile (when properly used) to be approved.

http://www.cancer.org/acs/groups/cid/documents/webcontent/002043-pdf.pdf
 
  • #8
gravenewworld said:
Chemotherapies for cancer can end up causing cancer. Would death from a secondary cancer be considered a disabling and permanent side effect? Again, what's the benefit vs. risk? If there was negligence during clinical trials, then I could see lawsuits coming.

That is apple and oranges comparing a sinus infection to cancer. WOW is it ever apples and oranges.
 
  • #9
I'm not sure what the deal is, really. Is this something unique to ciprofloxacin or can all fluoroquinolones cause lasting peripheral neuropathy?

Some of the diseases that were or are currently treated in last resort circumstances are with fluroquinolones. They are damn good antibiotics, which is more than you can say about Linezolid (and linezolid-like abx) and vancomycin which is trash.
 
  • #10
And you support your statements about linezolid and vancomycin with what research? Please do not simply throw around 'statements of "fact" ' with no citations. Thanks.
 
  • #11
sozme said:
I'm not sure what the deal is, really. Is this something unique to ciprofloxacin or can all fluoroquinolones cause lasting peripheral neuropathy?

Some of the diseases that were or are currently treated in last resort circumstances are with fluroquinolones. They are damn good antibiotics, which is more than you can say about Linezolid (and linezolid-like abx) and vancomycin which is trash.

Cipro made by Bayer was in the news big time during the 2001 anthrax scare. The federal government bought 20 million doses. Soldiers during the gulf war were given large doses.

Since then it has become widely prescribed even though it originally was intended as a drug of last resort.

The unique thing about this current situation is that is that Ciprofloxacin had a black box warning for causing Achilles tendon inflammation and rupture put in the prescribing info in 2008. And now after still being prescribed routinely it has the added peripheral neuropathy warning.

Peripheral neuropathy is a totally devastating side effect considering other antibiotics may have worked. Ironically as Cipro's use was going up it's efficacy was going down.

http://news.sciencemag.org/2002/05/cipro-use-efficacy-down
 
  • #12
I've taken medicine that had side effects of "sudden death" listed. When I read the side effects of my meds, it scares me, some have very serious side effects, but I've needed them.

Cipro seems relatively safe, according to your Wiki link.

The safety of fluoroquinolones is similar to that of other antibiotics.[35] In most, adverse reactions are mild to moderate; but serious adverse effects occur on occasion.[35][36]

49,038 patients received courses of ciprofloxacin in pre-approval clinical trials.[37] Most of the adverse events reported were described as only mild or moderate in severity, abated soon after the drug was discontinued, and required no treatment. Ciprofloxacin was discontinued because of an adverse event in 1% of orally treated patients.

As for tendon rupture, the incidence was 0.1%.

To be honest, after I got past the scare mongering and looked at the actual occurrence of side effects, I felt the drug was pretty safe and took it.
 
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  • #13
Evo said:
I've taken medicine that had side effects of "sudden death" listed. When I read the side effects of my meds, it scares me, some have very serious side effects, but I've needed them.

Cipro seems relatively safe, according to your Wiki link.



As for tendon rupture, the incidence was 0.1%.

To be honest, after I got past the scare mongering and looked at the actual occurrence of side effects, I felt the drug was pretty safe and took it.

It is relatively safe. The severe side effects were really rare when it was only prescribed as a last resort. The point that I have been trying to make is that since 2001 it has been prescribed millions of times. Millions of times means many more people are afflicted by the low incidence side effects.

You yourself mentioned taking cipro, but couldn't remember what for. If it had been a life threatening infection you probably would remember.

But are the side effects really that rare? As far as I can tell the FDA relied on Bayer's information.

The link below is from 1996.:eek:

http://www.ncbi.nlm.nih.gov/pubmed/8913349
 
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  • #14
edward said:
It is relatively safe. The severe side effects were really rare when it was only prescribed as a last resort. The point that I have been trying to make is that since 2001 it has been prescribed millions of times. Millions of times means many more people are afflicted by the low incidence side effects.

You yourself mentioned taking cipro, but couldn't remember what for. If it had been a life threatening infection you probably would remember.
I have recurring, prolonged serious bouts of pain in my colon and diarrhea, although my doctor never said why he was prescribing it, it was probably a stab in the dark in hopes that it would help.

It is the 5th most prescribed antibiotic in the US, there don't seem to be many cases of peripheral neuropathy which can be directly linked.

Edward said:
The link below is from 1996.:eek:

http://www.ncbi.nlm.nih.gov/pubmed/8913349

A 2013 paper

Bactericidal antibiotics induce mitochondrial dysfunction and oxidative damage in Mammalian cells.

We show that clinically relevant doses of bactericidal antibiotics-quinolones, aminoglycosides, and β-lactams-cause mitochondrial dysfunction and ROS overproduction in mammalian cells. We demonstrate that these bactericidal antibiotic-induced effects lead to oxidative damage to DNA, proteins, and membrane lipids.

http://www.ncbi.nlm.nih.gov/pubmed/23825301

aminoglycosides

Several aminoglycosides function as antibiotics that are effective against certain types of bacteria. They include amikacin, arbekacin, gentamicin, kanamycin, neomycin, netilmicin, paromomycin, rhodostreptomycin,[2] streptomycin, tobramycin, and apramycin.[3]

http://en.wikipedia.org/wiki/Aminoglycoside

β-lactams

β-Lactam antibiotics (beta-lactam antibiotics) are a broad class of antibiotics, consisting of als that contains a β-lactam ring in their molecular structures. This includes penicillin derivatives (penams), cephalosporins (cephems), monobactams, and carbapenems.[1] Most β-lactam antibiotics work by inhibiting cell wall biosynthesis in the bacterial organism and are the most widely used group of antibiotics. Up until 2003, when measured by sales, more than half of all commercially available antibiotics in use were β-lactam compounds.[2]

http://en.wikipedia.org/wiki/Β-Lactam_antibiotic

I believe that people should be aware of and discuss potential side effects with their doctor.
 
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  • #15
jim mcnamara said:
And you support your statements about linezolid and vancomycin with what research? Please do not simply throw around 'statements of "fact" ' with no citations. Thanks.

Sorry, I shouldn't assume everyone here is an MD or in the medical sciences in some capacity.
Since you are not, I'll try to explain. It is well known that:
Vancomycin = mostly bacteriostatic, poor/sloppy pharmacokinetics, toxic, poor tissue penetration. And oral vancomycin is through the roof expensive.

Bacteriostatic = limit bacterial growth, as opposed to bacteriocidal agents which kill bacteria directly.

Also for inhalational anthrax (which is fatal if untreated by the way),
Ciprofloxacin vs. doxycycline plus rifampin (you must use both) vs. raxibacumab

I'd still say cipro plus the small possibility of long-term transient peripheral neuropathy is better than the alternatives.
 
  • #16
Evo said:
I have recurring, prolonged serious bouts of pain in my colon and diarrhea, although my doctor never said why he was prescribing it, it was probably a stab in the dark in hopes that it would help.

It is the 5th most prescribed antibiotic in the US, there don't seem to be many cases of peripheral neuropathy which can be directly linked.



A 2013 paper



http://www.ncbi.nlm.nih.gov/pubmed/23825301

aminoglycosides



http://en.wikipedia.org/wiki/Aminoglycoside

β-lactams



http://en.wikipedia.org/wiki/Β-Lactam_antibiotic

I believe that people should be aware of and discuss potential side effects with their doctor.

I had previously read the links that you posted above. None of the antibiotics studied in those links even come close to Cipro in the number of prescriptions written.

I personally have serious peripheral neuropathy. Two years ago I had a moderate case of pneumonia. On a Friday afternoon and with symptoms getting worse my wife took me to an urgent care. It was either go to the urgent care or wait four hours in a crowded emergency room.

The urgent care Dr. took an x ray and prescribed Cipro. I took all of the Cipro 500 mg twice a day. My lung symptoms remained and I had developed a strange numbness in my toes. I went to my family doctor and he said that it was viral pneumonia.

He couldn't explain the numbness in my toes which soon spread to both feet. As time passed I developed an incredible burning sensation in my feet even though they still felt numb to the touch.

To make a short story long I am now seeing a 2nd neurologist. This spring 1 and 1/2 years into the pain and discomfort and taking pain medication that did nothing I also started falling a lot. I finally got a referral to a neurologist.

The first neurologist ran a battery of blood tests along with a nerve conduction tests and diagnosed peripheral neuropathy of unknown etiology. I started to ask the jerk if the Cipro taken just before the symptoms started could be the cause. The jerk got up and left the room mid-sentence.

The second neurologist said yes it was possible for Cipro to cause PN. She also said, in defense of neurologist number 1, that with PN it is usually diagnose and adios since there is no cure.

Bear in mind I had no idea about Cipro and the FDA's peripheral neuropathy warning until about a week ago. I just had a gut feeling.

The only connection I was aware of was the vague tingling and numbness in my feet. There was no AH HA moment. I am now wondering if this could be the case with other people. I am also wondering if urgent care facilities and emergency rooms may be more apt to prescribe Cipro because of the broad spectrum of the antibiotic. They usually will not be seeing that patient again and may be a bit too eager to go with the shotgun approach.

This may open a real can of worms. I have already noticed a number of Cipro lawsuit web sites come online.

Personally I have stepped up my physical activity. I threw the damn cane away and I intend to be as physically active as I can for as long as I can. The odd thing is that despite the pain, which I control with meds only at night, and the fact that the PN has spread to my upper legs and even my hands and lower arms, I seldom fall anymore. have I discovered something new?

I could mention several other things I do but that may fall under the giving medical advice clause.:approve:
 
  • #17
sozme said:
I'd still say cipro plus the small possibility of long-term transient peripheral neuropathy is better than the alternatives.

Cipro is a better alternative than what? and for what illness. Few people have had anthrax. The postal workers who were exposed to anthrax were treated with Cipro.

On the other hand bacteria are becoming resistant to Cipro, especially urinary tract bacteria. When that happens with an antibiotic it is usually due to over use.

http://health.usnews.com/health-new...t-infections-becoming-more-resistant-to-drugs
 
  • #18
edward said:
I had previously read the links that you posted above. None of the antibiotics studied in those links even come close to Cipro in the number of prescriptions written.

I personally have serious peripheral neuropathy. Two years ago I had a moderate case of pneumonia. On a Friday afternoon and with symptoms getting worse my wife took me to an urgent care. It was either go to the urgent care or wait four hours in a crowded emergency room.

The urgent care Dr. took an x ray and prescribed Cipro. I took all of the Cipro 500 mg twice a day. My lung symptoms remained and I had developed a strange numbness in my toes. I went to my family doctor and he said that it was viral pneumonia.

He couldn't explain the numbness in my toes which soon spread to both feet. As time passed I developed an incredible burning sensation in my feet even though they still felt numb to the touch.

To make a short story long I am now seeing a 2nd neurologist. This spring 1 and 1/2 years into the pain and discomfort and taking pain medication that did nothing I also started falling a lot. I finally got a referral to a neurologist.

The first neurologist ran a battery of blood tests along with a nerve conduction tests and diagnosed peripheral neuropathy of unknown etiology. I started to ask the jerk if the Cipro taken just before the symptoms started could be the cause. The jerk got up and left the room mid-sentence.

The second neurologist said yes it was possible for Cipro to cause PN. She also said, in defense of neurologist number 1, that with PN it is usually diagnose and adios since there is no cure.

Bear in mind I had no idea about Cipro and the FDA's peripheral neuropathy warning until about a week ago. I just had a gut feeling.

The only connection I was aware of was the vague tingling and numbness in my feet. There was no AH HA moment. I am now wondering if this could be the case with other people. I am also wondering if urgent care facilities and emergency rooms may be more apt to prescribe Cipro because of the broad spectrum of the antibiotic. They usually will not be seeing that patient again and may be a bit too eager to go with the shotgun approach.

This may open a real can of worms. I have already noticed a number of Cipro lawsuit web sites come online.

Personally I have stepped up my physical activity. I threw the damn cane away and I intend to be as physically active as I can for as long as I can. The odd thing is that despite the pain, which I control with meds only at night, and the fact that the PN has spread to my upper legs and even my hands and lower arms, I seldom fall anymore. have I discovered something new?

I could mention several other things I do but that may fall under the giving medical advice clause.:approve:
Edward, I have been treated for peripheral neuropathy for 15 years, I have to sleep with my arms in braces. That was 15 years before I took Cipro. Sorry for your problems, but unless you can prove they were caused by Cipro, I can't give credence to anything you say. Sorry. Sounds to me like you are looking to make some money.

I am currently 100% physically disabled. I am not bitter and I'm not looking for something to pin the blame on to make a profit.

The fact, as you point out, that millions of prescriptions for Cipro have been made with extremely rare serious side effects just emphasizes how little harm this drug does. A warning that there can be side effects doesn't mean there is a high percentage of these side effects.
 
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  • #19
Evo said:
Edward, I have been treated for peripheral neuropathy for 15 years, I have to sleep with my arms in braces. That was 15 years before I took Cipro. Sorry for your problems, but unless you can prove they were caused by Cipro, I can't give credence to anything you say. Sorry. Sounds to me like you are looking to make some money.

There is no treatment for PN, except pain medication. Only two really work. True nerve pain is excruciating and unrelenting.

EVO I have no intention of suing anyone period got it! Where did I even mention that I intended to do that. Admittedly a lot of other people will, and I made reference to that fact. How about showing a bit of respect?

The OP was intended to make others aware and to perhaps establish a scientific based dialog including the complexity of mitochondria and PN. Instead I get ridiculous posts and an outrageous accusation from you.
I have intensely researched PN for the last six months.

I am currently 100% physically disabled. I am not bitter and I'm not looking for something to pin the blame on to make a profit. I'm glad to hear that you are not as bad off as I am. I have to say I find your rant a bit embarrassing.

I have money EVO and I find your accusation quite embarrassing. Now this was a rant.

Edit. BTW I wear braces on both arms and both knees, are we having a contest?
 
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  • #20
edward said:
EVO I have no intention of suing anyone period got it! Were did I even mention that I intended to do that Admittedly a lot of other people will, and I made reference to that fact. How about showing a bit of respect?

The OP was intended to make others aware and to perhaps establish a scientific based dialog including the complexity of mitochondria and PN. Instead I get ridiculous posts and an outrageous accusation from you.



I have money EVO and I find your accusation quite embarrassing. Now this was a rant.

Edit. BTW I wear braces on both arms and both knees, are we having a contest?
Your personal opinions don't match the facts edward. The facts speak for themselves.

I apologize if you think this is a personal attack, it isn't, it's about the facts, and appearances. I will retract that you're intent is a lawsuit, it certainly sounded that way to me since you made such a point of it.
 
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  • #21
Evo said:
Your personal opinions don't match the facts edward. The facts speak for themselves.

I apologize if you think this is a personal attack, it isn't, it's about the facts.

No it isn't about the facts. The facts are only your interpretation of the facts. You have old data on frequency of side effects. They may be true, or not, but when a drug is give to millions when it was meant as a last drug of choice for thousands there will be more people with those side effects.

I have researched PN extensively for the last six months.
 
  • #22
edward said:
No it isn't about the facts. The facts are only your interpretation of the facts. You have old data on frequency of side effects. They may be true, or not, but when a drug is give to millions when it was meant as a last drug of choice for thousands there will be more people with those side effects.

I have researched PN extensively for the last six months.
My study is 2013, the most recent, your link was almost a decade old.

So, you don't want to sue, just why are you on such a rant about it?
 
  • #23
Evo said:
My study is 2013, the most recent. your link was more than a decade old.

My link indicated that certain researchers knew that Cipro could cause PN in the lab a decade ago. I posted it to make that point. To hell with it think whatever you want. I don't need this. Apparently you do.
 
  • #24
edward said:
My link indicated that certain researchers knew that Cipro could cause PN in the lab a decade ago. I posted it to make that point. To hell with it think whatever you want. I don't need this. Apparently you do.
Many drugs have much worse side effects, so my question about why you keep bringing up lawsuits puzzles me.
 
  • #25
Evo said:
Many drugs have much worse side effects, so my question about why you keep bringing up lawsuits puzzles me.

Because they are popping up all over the net since the FDA announcement.

BTW

http://www.ncbi.nlm.nih.gov/pubmed/23825301

BTW This 2013 link refers to antibiotics that are rarely used, not the 5th most used. I did mention that previously. Seriously are you OK? On a misery index of one to ten I am about an 8. How about you?
 
  • #26
OK so please forgive me because I got miffed when I felt that you had insulted me. How does that sound? I have to go try to get some sleep.
 
  • #27
edward said:
OK so please forgive me because I got miffed when I felt that you had insulted me. How does that sound? I have to go try to get some sleep.
I'm very sorry that I upset you, I shouldn't have.

Of course lawsuits have been popping up with the recent news. Previous lawsuits have failed, but ambulance chasing is big business.

My 2013 link is of the most widely used antibiotics.
 
  • #28
Evo said:
I'm very sorry that I upset you, I shouldn't have.

Of course lawsuits have been popping up with the recent news. Previous lawsuits have failed, but ambulance chasing is big business.

My 2013 link is of the most widely used antibiotics.

OOPS sorry I didn't look up what drugs are in the class of aminoglycosides, and β-lactams.

On the other hand the first sentence of the article states "prolonged use" not one time use.

Edited
 
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  • #29
I've taken Cipro a couple dozen times in all my traveling :(
 

What is the new warning on common antibiotics?

The new warning on common antibiotics is about the potential risk of developing antibiotic resistance.

What is antibiotic resistance?

Antibiotic resistance is when bacteria become resistant to the effects of antibiotics, making them less effective in treating infections.

Why is antibiotic resistance a concern?

Antibiotic resistance is a major public health concern because it can lead to infections that are difficult or even impossible to treat, resulting in longer illness, increased healthcare costs, and in some cases, death.

Which common antibiotics are affected by this warning?

The warning applies to all commonly prescribed antibiotics, including penicillin, amoxicillin, and erythromycin.

What can be done to prevent antibiotic resistance?

To prevent antibiotic resistance, it is important to only take antibiotics when prescribed by a doctor, follow the prescribed dosage and duration, and never share antibiotics with others. It is also important to practice good hygiene and infection control measures, and to explore alternative treatments for non-serious infections when possible.

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