FDA Calls for More Restrictions on Fluoroquinolone Use (comments)
By Kristin J. Kelley
Edited by Susan Sadoughi, MD, and André Sofair, MD, MPH
The risks for "disabling and potentially permanent" side effects associated with systemic fluoroquinolone antibacterials (e.g., ciprofloxacin, moxifloxacin) generally outweigh the benefits in patients with sinusitis, bronchitis, and uncomplicated urinary tract infections, the FDA warned late last week. Fluoroquinolones should only be used for these indications when patients don't have other treatment options, the agency said.
Side effects can compromise the nerves, central nervous system, tendons, muscles, and joints. Symptoms may include confusion; hallucinations; joint, muscle, and tendon pain; or a tingling sensation (i.e., "pins and needles"
.
The action follows advisory panel recommendations made in late 2015 for stronger label warnings. The labels were previously updated in 2013 to warn of increased risk for peripheral neuropathy. Additionally, in 2008, a boxed warning was added to note risks for tendinitis and tendon rupture.
See the linked FDA drug safety communication for a full list of fluoroquinolones currently approved for systemic use.
Link(s):
FDA MedWatch safety alert (Free)
FDA drug safety communication (Free)
FDA briefing document on benefits and risks of systemic fluoroquinolones (Free PDF)
Background: Physician's First Watch coverage of 2015 advisory panel vote (Free)
Reader Comments (11)
Reply
Russell N. Other, Other, Retired
27 May 2016 2:19 PM
I am a victim of Levofloxacin, 4 Achilles tendon tears, Have tried to find Attorney for that, but that ship sailed. However did retain one recently for an aortic aneurysm I suffered about 8 months later. I was blessed it was found on a CT scan for back issues (I have Rheumatoid Disease) If you anyone you know has had issues there is a Facebook page "Fluoroquinolone toxicity Group" Good place for support and references.
Reply
Mark A Girard Other, Disabled by fluoroquinolones!
27 May 2016 4:09 AM
Thanks for reporting on the FDAs much needed warnings that fluoroquinolones, or FQs, should only be used when other options have run out. These drugs are not nearly as safe as once believed. The short list of damage that fluoroquinolones (FQs) did to me includes blood clots, broken blood vessels, bloated failing veins carved from 13 entry points, erratic blood pressure, hemochromatosis, liver damage, kidney damage, pulmonary edema, collapsed lung, hernia, torn lumbar muscle, half dozen bulging discs when I had none a few years before, shrinking eyeballs, tinnitus, multi-chemical sensitivity, gastrointestinal distress, hair loss, crumbling teeth, nosebleeds, nails fall off, spontaneous tendon ruptures, a cartilage transplant, ligament damage, cognitive impairment and other indescribably horrific mental anguish and psychosis, anxiety attacks that had me cowering in a corner, from nothing, and one of the worst, was wicked altitude sickness which forced me to bail abruptly from the town I loved so much, Leadville, Colorado, and now I can't even come to the lower parts of the state without becoming terribly sick. There were/are about a hundred or so other "symptoms" of my fluoroquinolone toxicity, but that gives a quick snapshot of what the last 8.5 yrs have been all about. I cannot tell you how important it is for everyone to learn what the names of these drugs are and to make sure you do not take them, unless you are exposed to anthrax or the plague, and I would actually try my luck with the plague, seriously. I really wish they would have done something less drastic than giving me Levaquin, like cutting off my leg. That is how awful being "floxed" really is. Amputation is less drastic than Levaquin.
Reply
Tracy Jean Other, disabled
19 May 2016 12:28 AM
Thank you FDA .This is overdue. Cipro disabled me 2 years ago. I was unable to work in my profession as a social worker. I had no idea an antibiotic could wreck my body, my career, my social life, and my family counting on me. Wayyyyyy overdue. Wake up.
Reply
Debbie
18 May 2016 1:36 PM
Call your health Insurance requesting that they turn down prescriptions for Floxin medicines for urinary tract and sinus infections as the FDA says doctors need not to prescribe for this ! Tell them they will save money afterwards with all the damage the cause ! Maybe the message will get out to doctors and hospitals to rid or at least slow down these meds . I hope to at least make the doctors comply with these findings ! Let us do our part in getting the word out to our Health insurance they have to clean up what the FDA refuses to see that this medicine needs to be pulled !!
Reply
Cassie Other, Other
18 May 2016 12:17 PM
In 2012 I was prescribed Cipro. No way would I have ever believed the outcome and especially that the one stupid pill I took could hurt me so bad. If someone else had told me that, I'd have probably been like some of the other people I've met, in disbelief. It's impossible to fathem the amount of pain it put me in or describe my pain in details that could be felt, but it was so bad that I had to have an MRI on my knee the following day, which cost us over $400 after insurance. Doctors have told me repeatedly it wasn't the Cipro, but unfortunately their simply saying that can't change the facts to fit their response. I was there! I have kept all of my records. I'm not a hypochondriac and rarely see the doctor more than once a year for my annual thyroid test. I was physically fit and in perfect health, minus a stomach pain that wound up being diagnosed as IBS, taking Cipro "just in case" it might be diverticulitis at 34. It was a very huge mistake on my part, that has caused me to fear all prescription drugs. I still have joint, muscle and tendon pain four years later that can't be cured. It moves around and comes in flares. Sometimes remitting for a while, only to come back. I'm not sure it'll ever go away permanently, but I continue to work and am doing way better than most. Thank you for your coverage on the FDA's new warnings. I'm glad others might be saved going through the same.
Reply
Rose Schmidt, M.S., P.G. Other, Other
18 May 2016 12:52 AM
Thank you for covering this story within the medical community. Like others, I was first met with denial and disbelief when I went to my PCP describing my 'flox' symptoms. I brought her journal articles, etc., detailing how fluoroquinolones damage collagen. She was kind, caring, and compassionate. After she read the material, I could tell that she was shocked and saddened, that this commonly prescribed antibiotic could inflict so much harm, when she had dedicated her career to patient care. Even once she acknowledged the FQs as the cause, she still felt helpless, because she didn't know what to do for me, as there is no established treatment protocol to reverse the damage. The FDA has finally acknowledged the damage FQs cause, which is a step in the right direction.
Reply
Donna Sumner Other, Other, St George, Utah
17 May 2016 2:35 AM
Has there been any myelitis as a result of the cipro
Reply
Mandy
16 May 2016 9:35 PM
Thank you for covering this important and potentially life saving story! I have been suffering from levaquin poisoning since 2006. More than 9 years after taking my final fluoroquinolone pill, I still can not function as well as many 80 year olds. I am 48 and I have a good friend who is 84 and she has had to help me carry groceries because her back and joints are healthier than mine. I was very athletic the until the day I got postnasal drip and took levaquin. Doctors are NOT aware of how dangerous these drugs are. In fact, when I have gone to doctors for help to find treatment for the levaquin side effects, many of those doctors have literally laughed at me and they insisted that levaquin is extremely safe and couldn't possibly cause any long term side effects. SOMEONE has worked hard to convince doctors that these drugs are as safe a candy. Something MUST be done to correct that very dangerous and very wrong perception among so many doctors. They need to know that these antibiotics can completely disable (and even kill) a young, healthy and athletic person. They are far from safe drugs and this has been known for many years. Just look at the peer reviewed studies on mitochondrial toxicity from fluoroquinolones. Thank you for helping to spread awareness.
Reply
Simo Other
16 May 2016 6:28 PM
This announcement by the FDA is a huge step in the right direction. These fluoroquinolone antibiotics can ruin your life. Cipro changed me from a very athletic and active person to one that averages a major tendon/joint surgery every 2 years. Seven surgeries in 13 years with more needed all thanks to the permanent damage this antibiotic did to my tendons. The FDA is now admitting how dangerous these drugs are and hopefully doctors take heed and don't dismiss these severe adverse reactions as rare because they aren't. Bravo FDA, now please educate the medical industry so that our kids and their kids can avoid this nightmare.
Reply
Berry, BA Other, Other
16 May 2016 4:53 PM
Disabled since 2001 after taking 5 Cipro tablets
Reply
Elizabeth Lo Geriatrics
16 May 2016 4:44 PM
Long overdue! Too many have been permanently and severely injured by these chemotherapeutic drugs disguised as antibiotics. Hopefully, these drugs will now only be prescribed in life threatening situations after all other options have been exhausted.
By Kristin J. Kelley
Edited by Susan Sadoughi, MD, and André Sofair, MD, MPH
The risks for "disabling and potentially permanent" side effects associated with systemic fluoroquinolone antibacterials (e.g., ciprofloxacin, moxifloxacin) generally outweigh the benefits in patients with sinusitis, bronchitis, and uncomplicated urinary tract infections, the FDA warned late last week. Fluoroquinolones should only be used for these indications when patients don't have other treatment options, the agency said.
Side effects can compromise the nerves, central nervous system, tendons, muscles, and joints. Symptoms may include confusion; hallucinations; joint, muscle, and tendon pain; or a tingling sensation (i.e., "pins and needles"
. The action follows advisory panel recommendations made in late 2015 for stronger label warnings. The labels were previously updated in 2013 to warn of increased risk for peripheral neuropathy. Additionally, in 2008, a boxed warning was added to note risks for tendinitis and tendon rupture.
See the linked FDA drug safety communication for a full list of fluoroquinolones currently approved for systemic use.
Link(s):
FDA MedWatch safety alert (Free)
FDA drug safety communication (Free)
FDA briefing document on benefits and risks of systemic fluoroquinolones (Free PDF)
Background: Physician's First Watch coverage of 2015 advisory panel vote (Free)
Reader Comments (11)
Reply
Russell N. Other, Other, Retired
27 May 2016 2:19 PM
I am a victim of Levofloxacin, 4 Achilles tendon tears, Have tried to find Attorney for that, but that ship sailed. However did retain one recently for an aortic aneurysm I suffered about 8 months later. I was blessed it was found on a CT scan for back issues (I have Rheumatoid Disease) If you anyone you know has had issues there is a Facebook page "Fluoroquinolone toxicity Group" Good place for support and references.
Reply
Mark A Girard Other, Disabled by fluoroquinolones!
27 May 2016 4:09 AM
Thanks for reporting on the FDAs much needed warnings that fluoroquinolones, or FQs, should only be used when other options have run out. These drugs are not nearly as safe as once believed. The short list of damage that fluoroquinolones (FQs) did to me includes blood clots, broken blood vessels, bloated failing veins carved from 13 entry points, erratic blood pressure, hemochromatosis, liver damage, kidney damage, pulmonary edema, collapsed lung, hernia, torn lumbar muscle, half dozen bulging discs when I had none a few years before, shrinking eyeballs, tinnitus, multi-chemical sensitivity, gastrointestinal distress, hair loss, crumbling teeth, nosebleeds, nails fall off, spontaneous tendon ruptures, a cartilage transplant, ligament damage, cognitive impairment and other indescribably horrific mental anguish and psychosis, anxiety attacks that had me cowering in a corner, from nothing, and one of the worst, was wicked altitude sickness which forced me to bail abruptly from the town I loved so much, Leadville, Colorado, and now I can't even come to the lower parts of the state without becoming terribly sick. There were/are about a hundred or so other "symptoms" of my fluoroquinolone toxicity, but that gives a quick snapshot of what the last 8.5 yrs have been all about. I cannot tell you how important it is for everyone to learn what the names of these drugs are and to make sure you do not take them, unless you are exposed to anthrax or the plague, and I would actually try my luck with the plague, seriously. I really wish they would have done something less drastic than giving me Levaquin, like cutting off my leg. That is how awful being "floxed" really is. Amputation is less drastic than Levaquin.
Reply
Tracy Jean Other, disabled
19 May 2016 12:28 AM
Thank you FDA .This is overdue. Cipro disabled me 2 years ago. I was unable to work in my profession as a social worker. I had no idea an antibiotic could wreck my body, my career, my social life, and my family counting on me. Wayyyyyy overdue. Wake up.
Reply
Debbie
18 May 2016 1:36 PM
Call your health Insurance requesting that they turn down prescriptions for Floxin medicines for urinary tract and sinus infections as the FDA says doctors need not to prescribe for this ! Tell them they will save money afterwards with all the damage the cause ! Maybe the message will get out to doctors and hospitals to rid or at least slow down these meds . I hope to at least make the doctors comply with these findings ! Let us do our part in getting the word out to our Health insurance they have to clean up what the FDA refuses to see that this medicine needs to be pulled !!
Reply
Cassie Other, Other
18 May 2016 12:17 PM
In 2012 I was prescribed Cipro. No way would I have ever believed the outcome and especially that the one stupid pill I took could hurt me so bad. If someone else had told me that, I'd have probably been like some of the other people I've met, in disbelief. It's impossible to fathem the amount of pain it put me in or describe my pain in details that could be felt, but it was so bad that I had to have an MRI on my knee the following day, which cost us over $400 after insurance. Doctors have told me repeatedly it wasn't the Cipro, but unfortunately their simply saying that can't change the facts to fit their response. I was there! I have kept all of my records. I'm not a hypochondriac and rarely see the doctor more than once a year for my annual thyroid test. I was physically fit and in perfect health, minus a stomach pain that wound up being diagnosed as IBS, taking Cipro "just in case" it might be diverticulitis at 34. It was a very huge mistake on my part, that has caused me to fear all prescription drugs. I still have joint, muscle and tendon pain four years later that can't be cured. It moves around and comes in flares. Sometimes remitting for a while, only to come back. I'm not sure it'll ever go away permanently, but I continue to work and am doing way better than most. Thank you for your coverage on the FDA's new warnings. I'm glad others might be saved going through the same.
Reply
Rose Schmidt, M.S., P.G. Other, Other
18 May 2016 12:52 AM
Thank you for covering this story within the medical community. Like others, I was first met with denial and disbelief when I went to my PCP describing my 'flox' symptoms. I brought her journal articles, etc., detailing how fluoroquinolones damage collagen. She was kind, caring, and compassionate. After she read the material, I could tell that she was shocked and saddened, that this commonly prescribed antibiotic could inflict so much harm, when she had dedicated her career to patient care. Even once she acknowledged the FQs as the cause, she still felt helpless, because she didn't know what to do for me, as there is no established treatment protocol to reverse the damage. The FDA has finally acknowledged the damage FQs cause, which is a step in the right direction.
Reply
Donna Sumner Other, Other, St George, Utah
17 May 2016 2:35 AM
Has there been any myelitis as a result of the cipro
Reply
Mandy
16 May 2016 9:35 PM
Thank you for covering this important and potentially life saving story! I have been suffering from levaquin poisoning since 2006. More than 9 years after taking my final fluoroquinolone pill, I still can not function as well as many 80 year olds. I am 48 and I have a good friend who is 84 and she has had to help me carry groceries because her back and joints are healthier than mine. I was very athletic the until the day I got postnasal drip and took levaquin. Doctors are NOT aware of how dangerous these drugs are. In fact, when I have gone to doctors for help to find treatment for the levaquin side effects, many of those doctors have literally laughed at me and they insisted that levaquin is extremely safe and couldn't possibly cause any long term side effects. SOMEONE has worked hard to convince doctors that these drugs are as safe a candy. Something MUST be done to correct that very dangerous and very wrong perception among so many doctors. They need to know that these antibiotics can completely disable (and even kill) a young, healthy and athletic person. They are far from safe drugs and this has been known for many years. Just look at the peer reviewed studies on mitochondrial toxicity from fluoroquinolones. Thank you for helping to spread awareness.
Reply
Simo Other
16 May 2016 6:28 PM
This announcement by the FDA is a huge step in the right direction. These fluoroquinolone antibiotics can ruin your life. Cipro changed me from a very athletic and active person to one that averages a major tendon/joint surgery every 2 years. Seven surgeries in 13 years with more needed all thanks to the permanent damage this antibiotic did to my tendons. The FDA is now admitting how dangerous these drugs are and hopefully doctors take heed and don't dismiss these severe adverse reactions as rare because they aren't. Bravo FDA, now please educate the medical industry so that our kids and their kids can avoid this nightmare.
Reply
Berry, BA Other, Other
16 May 2016 4:53 PM
Disabled since 2001 after taking 5 Cipro tablets
Reply
Elizabeth Lo Geriatrics
16 May 2016 4:44 PM
Long overdue! Too many have been permanently and severely injured by these chemotherapeutic drugs disguised as antibiotics. Hopefully, these drugs will now only be prescribed in life threatening situations after all other options have been exhausted.
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