EMA Committee Recommends Restricting Fluoroquinolones

The European Medicines Agency (EMA) put out the press release entitled “Disabling and potentially permanent side effects lead to suspension or restrictions of quinolone and fluoroquinolone antibiotics” on November 16, 2018. It goes over the recommendations of the EMA’s Committee for Medicinal Products for Human Use (CHMP), and expands on the earlier recommendations of the Pharmacovigilance Risk Assessment Committee (PRAC). Following are some highlights from “Disabling and potentially permanent side effects lead to suspension or restrictions of quinolone and fluoroquinolone antibiotics.”

“The CHMP confirmed that the use of the remaining fluoroquinolone antibiotics should be restricted. In addition, the prescribing information for healthcare professionals and information for patients will describe the disabling and potentially permanent side effects and advise patients to stop treatment with a fluoroquinolone antibiotic at the first sign of a side effect involving muscles, tendons or joints and the nervous system.”

This is a strong statement from the EMA. It is recommended that the fluoroquinolones that remain on the market in Europe (including, but not limited to, ciprofloxacin, levofloxacin, moxifloxacin, ofloxacin, and norfloxacin) will be restricted, and patients and healthcare providers alike will be given information about the disabling effects of these drugs. That’s a HUGE step in the right direction!

“Restrictions on the use of fluoroquinolone antibiotics will mean that they should not be used:

  • to treat infections that might get better without treatment or are not severe (such as throat infections);
  • to treat non-bacterial infections, e.g. non-bacterial (chronic) prostatitis;
  • for preventing traveller’s diarrhoea or recurring lower urinary tract infections (urine infections that do not extend beyond the bladder);
  • to treat mild or moderate bacterial infections unless other antibacterial medicines commonly recommended for these infections cannot be used.”

This list is great, and if it, combined with the US FDA’s list of ailments for which fluoroquinolones should not be used, is followed, fluoroquinolone prescriptions will be cut significantly.

I am particularly pleased to see that the EMA is recommending against use of fluoroquinolones for treatment of chronic prostatitis. Too many men have been severely injured by fluoroquinolones given to them for treatment of non-bacterial prostatitis, a condition for which fluoroquinolones are no better than a placebo.

It is also wonderful to see that the EMA is recommending against the prescription fo fluoroquinolones for prevention of traveller’s diarrhea/diarrhoea. No one should ever be prescribed a drug as dangerous and consequential as fluoroquinolones “just in case” they get traveller’s diarrhea.

“Importantly, fluoroquinolones should generally be avoided in patients who have previously had serious side effects with a fluoroquinolone or quinolone antibiotic. They should be used with special caution in the elderly, patients with kidney disease and those who have had an organ transplantation because these patients are at a higher risk of tendon injury. Since the use of a corticosteroid with a fluoroquinolone also increases this risk, combined use of these medicines should be avoided.”

Yes – exactly – fluoroquinolones should be avoided in people who have previously experienced side-effects from fluoroquinolones. More information about that can be found in “The Next Time Will be Worse: Cross-Reactivity of Fluoroquinolones.”

I would say that fluoroquinolones should never be used on patients who are elderly, who have kidney disease, or who have had an organ transplant, but use “with special caution” is a step in the right direction.

“The CHMP opinion will now be forwarded to the European Commission, which will issue a final legally binding decision applicable in all EU countries. National authorities will enforce this decision for the fluoroquinolone and quinolone medicines authorised in their countries and they will also take other appropriate measures to promote the correct use of these antibiotics.”

Stay tuned. I’ll highlight the final decision made by the EMA once it is published.

The EMA press release, “Disabling and potentially permanent side effects lead to suspension or restrictions of quinolone and fluoroquinolone antibiotics” also contains the following guidance for patients:

Information for patients

  • Fluoroquinolone medicines (which contain ciprofloxacin, levofloxacin, lomefloxacin, moxifloxacin, norfloxacin, ofloxacin, pefloxacin, prulifloxacin and rufloxacin) can cause long-lasting, disabling and potentially permanent side effects involving tendons, muscles, joints and the nervous system.
  • These serious side effects include inflamed or torn tendon, muscle pain or weakness, and joint pain or swelling, walking difficulty, feeling pins and needles, burning pain, tiredness, depression, problems with memory, sleeping, vision and hearing, and altered taste and smell.
  • Tendon swelling and injury may occur within 2 days of starting treatment with a fluoroquinolone but may even occur several months after stopping treatment.
  • Stop taking a fluoroquinolone medicine and contact your doctor at once in the following cases:
    • at the first sign of tendon injury, such as tendon pain or swelling – rest the painful area;
    • if you get pain, feel pins and needles, tingling, tickling, numbness or burning, or weakness especially in the legs or arms;
    • if you get swelling in the shoulder, arms or legs, have walking difficulty, feel tired or depressed or have problems with your memory or with sleeping or you notice changes with your vision, taste, smell or hearing. You and your doctor will decide if you can continue treatment or if you need to take another type of antibiotic.
  • You may be more prone to joint pain or swelling or tendon damage if you are aged over 60 years, your kidneys do not work well or you have received organ transplantation.
  • Speak with your doctor if you are taking a corticosteroid (medicines such as hydrocortisone and prednisolone) or need to have treatment with a corticosteroid. You may be especially prone to tendon damage if you are taking a corticosteroid and a fluoroquinolone medicine at the same time.
  • You should not take a fluoroquinolone medicine if you have ever had a serious side effect with a fluoroquinolone or a quinolone medicine and you should speak with your doctor immediately.
  • If you have any questions or concerns about your medicines, speak to your doctor or pharmacist.

And it also contains the following guidance for prescribers:

Information for healthcare professionals

  • Fluoroquinolones are associated with prolonged (up to months or years), serious, disabling and potentially irreversible drug reactions affecting several, sometimes multiple, systems, organ classes and senses.
  • The serious side effects include tendonitis, tendon rupture, arthralgia, pain in extremities, gait disturbance, neuropathies associated with paraesthesia, depression, fatigue, memory impairment, sleep disorders, and impaired hearing, vision, taste and smell.
  • Tendon damage (especially to Achilles tendon but also other tendons) can occur within 48 hours of starting fluoroquinolone treatment but the damage may be delayed several months after stopping treatment.
  • Patients who are older, have renal impairment or have had solid organ transplantation and those being treated with a corticosteroid are at higher risk of tendon damage. Concomitant treatment with a fluoroquinolone and a corticosteroid should be avoided.
  • Fluoroquinolone treatment should be discontinued at the first sign of tendon pain or inflammation and patients should be advised to stop treatment with a fluoroquinolone and speak with the doctor in case of symptoms of neuropathy such as pain, burning, tingling, numbness or weakness so as to prevent development of potentially irreversible condition.
  • Fluoroquinolones should generally not be used in patients who have had serious adverse reactionsassociated with the use of quinolone or fluoroquinolone medicines.
  • Up-to-date summary of product characteristics should be consulted for authorised indications when considering treatment with a fluoroquinolone medicine. This is because the indications for these medicines have been restricted.
  • The benefits and risks of fluoroquinolones will be monitored continuously and a drug utilisation study will evaluate the effectiveness of the new measures to reduce inappropriate use of fluoroquinolones by investigating changes in prescribing behaviour.

Healthcare providers should also be informed that there is no known cure or remedy for fluoroquinolone toxicity, and that the effects of these drugs can be permanent.

This information should also be given to patients.

Overall, I’m pleased with the CHMP recommendations, and I’m hopeful that the final, binding ruling from the EMA is as strongly worded, and even more comprehensive.

*****

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10 thoughts on “EMA Committee Recommends Restricting Fluoroquinolones

  1. Barbara November 20, 2018 at 8:46 am Reply

    This is a good result and better than we expected. But even better news is, my local pharmacist told me this morning he has received a notice from the Spanish Government to restrict fluroquinolone’s and he believes they will be stopped in a year. The EMA PRAC CHMP machine is working. My pharmacist also said there was research being undertaken around Europe which is why he thinks they will be stopped in a year.
    All our hard work is paying off, with our Floxie friends around the world getting the word out there. We are the collateral damage that will save others in the future from the terrible life changing effects of these drugs.

    • Madge hirsch November 21, 2018 at 1:41 pm Reply

      That’s excellent news Barbara. Let’s hope they follow suit here. I’m not holding my breath though. The ANSM website so far has no news of the latest EMA pronouncement BUT has just sent a letter out to doctors warning of the danger of aortic aneurysm with FQs. That should give them a kick up the butt.
      Hope you are well and that your husband is making good progress.

      • Barbara Arnold November 22, 2018 at 4:38 am Reply

        Hi Madge,
        I went to my Doctor this morning with a copy of the Spanish Medicines Agency and he had already been informed via his computer. I presume it will happen in all EU Countries, but may take a little time. If you hear nothing in the next few weeks you could email the EMA and ask when your Country will be informed as the whole of Spains Doctors have had the recommendations also Spains Pharmacists. Even though they only recommend restrictions, my Doctor and health centre will never prescribe them again, I hope others follow.
        My husband starts chemo and radiotherapy next week. His operation went well thank goodness, but we have a bumpy road ahead. I’m just waiting for the time we can get back to reasonable health. Thanks for asking Madge.

        • L November 22, 2018 at 11:04 am

          hey, could you send it over to the doctors in the US too? They are BEYOND UNINFORMED. Gotta say…you have a much better communication system

        • Madge hirsch November 25, 2018 at 7:45 am

          Hope the chemo and radio go well. The stress of your husband ‘s illness can’t be good for your floxing symptoms. I know that was true for me when my husband had health problems which started a year ago but which ( fingers crossed ) seem to have resolved.
          Still no sign on the ANSM website and its now over a week since the press release from the EMA. i am beginning to get suspicious. Good that Spain is acting so quickly. I have not looked to see what the UK reaction is. A friend of ours has recently been diagnosed with Motor Neurone Disease ( ALS for the Americans) . He has suffered many years from Crohns for which he has probably had to have antibiotics from time to time. One wonders how many times he might have had Cipro given how much used it has been here for gastro problems. It is still the ” gold standard ” for diverticulitis. Grrr!!!

  2. L November 20, 2018 at 11:19 am Reply

    What bothers me about this is that it STILL seems to focus primarily on the whole tendon issue. It mentions depression….but I see nothing regarding vision issues, heart issues, nerve damage, and so many more. Better than nothing, but so limited.

    • nmartinez1938 November 20, 2018 at 4:36 pm Reply

      The for profit bottom lined health industry become weak in the knees when you speak of their neglect to protect our hearts, eyes, kidneys, liver, brains;–as you said; –“and so many others”! The list is to long for them to give credit to.

    • Madge hirsch November 21, 2018 at 1:45 pm Reply

      They do mention damage to the nervous system but that is too vague . They should be more specific about what type of damage. Vision issues should definitely be highlighted especially retinal detatchment. Also there should be more emphasis on the possibility of having damage to all systems simultaneously.

  3. nmartinez1938 November 20, 2018 at 4:30 pm Reply

    What a wonderful moment this is, for those who have struggled to get this awareness both in the public and where the pen meets the small scribbling white pad.

    Now in a total joint effort we must find affordable or subsidized treatments for all. I beg the pardon of all, being a ‘Johnny’ come lately to the Floxie crisis. It is only by sheer grace that I and millions of others have not be so victimized by this family of drugs. You have my concerns and prayers. Thanks for the concerned letter of Mark that brought me here.

  4. Steven W. November 21, 2018 at 3:09 am Reply

    Alright now I can breath again. Over ten years ago my life and many others have been altered or completely changed in a negative way. I admit that I might have never prayed as hard as I ended up praying over those years had I not taken these flouroquinolone bombs. It brought me to a crawl and with no medical treatment, diagnosis, or job, all my Family has had to suffer watching while Doctors have pushed me away intentionally. I understand they cannot pay back every person, but every person that has taken this before the major warnings should have healthcare assurance without having to pay for insurance any longer. Shame on them. My precious Family and I have been robbed of our health and social life overall. I blame all of our major health problems on these medications. My Son’s lack of attention because I can’t interact physically most of the time. My Daughters seizure a year ago from lack of excersise, rest due to worry of me, and lack of proper time out in the sun, with arithmatic struggles. Also lack of positive physical activity and odd work scheduals with on-call hours for years because She had to take a travel job to cover our finances(leaving our Family), has led my Wife to heart heart disease. Depression/anxiety and loss of will to live became normalsy for me. I handled waves of Levaquin and Cipro, steroids, Motrin/whatever others, and given for non-bacterial prostititis/surgeries, already having undiagnosed health concerns even before then, and many other monster hardships; but seeing my Family spiral down from the affects of FQs has made me beyond furious for a very long time. And then to see once productive people take thier own lives away from these affects really makes us churn with wonder. God be with thier Families as well. My own Brother left this life with depression from His inability to help me and perform well in life because He too had meds on-board. Lack of sleep for years from FQs affects can sure try a heart, mind, and soul as I well know. Please carry well Your burdens, our fellow Floxies, as I surely know the depth that You reside in. Thoughtfully will all heart as God sees, Steven L Weyenberg & Family… P.S. Chew on fresh ginger, take lots of curcuminoids, drink lemon-water, have culinary lavender in your coffee, educate each other on wellness with God’s provisions, spread the word, and find somehow meditate. Power and stength to all opressed humanity. FQs, You shall not take our wit with Spirit.

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