EMA Recommends Restriction of Fluoroquinolones in Europe

The EMA (European Medicines Agency) just released a statement regarding fluoroquinolone use. It can be found through THIS LINK. The press release states:

Fluoroquinolone and quinolone antibiotics: PRAC recommends restrictions on use

Press release 05/10/2018

New restrictions follow review of disabling and potentially long-lasting side effects

EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) has recommended restricting the use of fluoroquinolone and quinolone antibiotics (used by mouth, injection or inhalation) following a review of disabling and potentially long-lasting side effects reported with these medicines. The review incorporated the views of patients, healthcare professionals and academics presented at EMA’s public hearing on fluoroquinolone and quinolone antibiotics in June 2018.

Very rarely, patients treated with fluoroquinolone or quinolone antibiotics have suffered long-lasting and disabling side effects, mainly involving muscles, tendons and bones and the nervous system.

Following its evaluation of these side effects, the PRAC has recommended that some medicines, including all those that contain a quinolone antibiotic, should be removed from the market. This is because they are authorised only for infections that should no longer be treated with this class of antibiotics.

The PRAC recommended that the remaining fluoroquinolone antibiotics should:

  • not be used
    • to treat infections that might get better without treatment or are not severe (such as throat infections);
    • for preventing traveller’s diarrhoea or recurring lower urinary tract infections (urine infections that do not extend beyond the bladder);
    • to treat patients who have previously had serious side effects with a fluoroquinolone or quinolone antibiotic;
    • to treat mild or moderately severe infections unless other antibacterial medicines commonly recommended for these infections cannot be used;
  • be used with caution especially for the elderly, patients with kidney problems, patients who have had an organ transplantation or those who are being treated with a systemic corticosteroid. These patients are at higher risk of tendon injury caused by fluoroquinolone and quinolone antibiotics.

The PRAC also recommended that healthcare professionals should advise patients to stop treatment with a fluoroquinolone antibiotic at the first sign of a side effect involving muscles, tendons or bones (such as inflamed or torn tendon, muscle pain or weakness, and joint pain or swelling) or the nervous system (such as feeling pins and needles, tiredness, depression, confusion, suicidal thoughts, sleep disorders, vision and hearing problems, and altered taste and smell).

Prescribing information of individual fluoroquinolone antibiotics will be updated to reflect the restricted use.

The PRAC recommendations will now be sent to EMA’s Committee for Medicinal Products for Human Use(CHMP), which will adopt the Agency’s final opinion.

This outcome from the PRAC of the EMA is due to the advocacy work of many European victims of fluoroquinolones, and especially the brave people who testified before the EMA on June 13, 2018. Here is a video that shows the hearing, and all the moving testimonials:

There is so much more work that needs to be done for those who have been floxed. We need remedies for fluoroquinolone toxicity, and more needs to be done to prevent people from being victimized by these drugs.

Still, the acknowledgement from the EMA, and the recommendations that they have given, are greatly appreciated, and I hope that they will prevent many unnecessary fluoroquinolone prescriptions.

 

 

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18 thoughts on “EMA Recommends Restriction of Fluoroquinolones in Europe

  1. Barbara Arnold October 5, 2018 at 7:39 am Reply

    Doesn’t go anywhere near far enough. I’m dissapointed but not surprised. They are still saying it’s ‘rare’ and the FDA warnings are way better. Not that anyone takes any notice.

    • Steve W. October 5, 2018 at 9:39 am Reply

      Amen to that. What a huge kick in our behinds and a real mess for humanity. And not ever enough being done. I believe if it were not for Lisa and a few other great advocates, we wouldn’t be as far as we are. Peace be to the sufferers…

      • L October 5, 2018 at 10:38 am Reply

        I second that Steve, I imagine hundreds, maybe even thousands would still be suffering and in pain, wondering what the hell was wrong with them, had it not been for Lisa and Floxie Hope. When I was first hit, I had NO IDEA what was going on. (If I did I would have stopped after the first pill, but I thought, when I woke up with eye issues and numb fingers that I had slept so weird that I pinched nerves.) After 4 pills when my life was sliding into a bodywide mental and physical nightmare I started finding some things online. The first clues I got were from the late DR David Flockhart, of the Indiana School of Medicine in a PBS video on flqs. He had suggested milk of magnesia, so I started taking it in copious amounts. Then I finally found Floxie Hope. It was here I found the name of a naturopath that did IVs, who I credit with saving my life, after being thrown under the bus by a dozen different allopaths. Had it not been for Lisa and this site, I have no idea where I would be right now. I am still dealing with side effects, more than 3 1/2 years later, but I am light years from where I was at my worst.

    • Debs October 5, 2018 at 1:05 pm Reply

      Nope they are saying it is VERY rare & THAT is a VERY BIG elephant in the room . If this goes through with VERY rarely in writing Drs will latch onto this VERY rarely, convince themselves that it is SO VERY RARE that THEIR patient could not be floxed, & it will of course feed into the gaslighting effect, where those of us already injured seeking validation, & also the newly floxed we are going to be dismissed, disbelieved further, & it will also give Drs a ‘ get out’ & feed into the almost universal non acceptance & denial they carry already that they could ever injure a patient . They will not for a minute believe that they have injured THEIR patient with a FQ. as it happens so VERY RARELY . MY GOD if only they knew just HOW many they have injured !! Don’t get me wrong here, every little step forward is much appreciated, every little helps, this VERY RARELY however, it truly makes me mad as hell Barbara, & I agree with you re the FDA warning.

      • L October 5, 2018 at 6:03 pm Reply

        yeah, the whole “rare” thing is absurd. Millions of people injured? hundred of thousands died? NOT RARE. grrrrrrrrrr

    • Madge hirsch October 8, 2018 at 9:16 am Reply

      Absolutely Barbara. There is nothing new here – nothing that has not been in the patient info leaflet here in France or in the recommendations made by the ANSM ( our equivalent of the MHRA in Btitain) since the FDA hearings. It makes me suspect that the Germans asked for this enquiry , knowing this would be the likely result in order to protect the likes of Bayer.
      Has your husband had his op yet?

      • Barbara Arnold October 11, 2018 at 8:39 am Reply

        Just found out that the EMA receive 80% funding from Bayer. Says it all really.
        Yes Madge he had his op a week ago, He’s doing well but we have a long road to go.
        Thanks for asking.

        • L October 11, 2018 at 9:21 am

          FDA also receives most of its funding from big pharma. Not to mention it is a revolving door or ex big pharma people. The current head had the bulk of his salary while at Duke, underwritten by pharmaceutical companies.

        • Madge hirsch October 13, 2018 at 10:54 am

          Hope he continues to do well. Where did you find this info about Bayer funding the EMA?

        • Barbara Arnold October 13, 2018 at 10:16 pm

          Thanks Madge. Got the info from fluroquine toxicity victims in Europe on facebook.

  2. Phoebe October 5, 2018 at 8:06 am Reply

    So how many doctors across the nation will know about this? Only we floxies that have this coming through our facebook feeds are learning this. The FDA still defend the useage of this drug.

    • L October 5, 2018 at 10:40 am Reply

      NONE. Doctors don’t get the notices directly, or new black box warnings, and they never seem to investigate on their own.

  3. L October 5, 2018 at 9:07 am Reply

    Right direction, but I am sorry, after DECADES of these toxins, it is not enough. “be used with caution especially for the elderly, patients with kidney problems, patients who have had an organ transplantation or those who are being treated with a systemic corticosteroid. These patients are at higher risk of tendon injury caused by fluoroquinolone and quinolone antibiotics.” NO. Not with caution. NOT AT ALL.

  4. Steve W. October 5, 2018 at 9:25 am Reply

    It’s all too late but better late than never ayy Lisa? Thank You for the post. You made my day despite pain. Bless You and Your Family.

  5. Steve W. October 5, 2018 at 9:26 am Reply

    It’s all too late, but better late than never ayy Lisa? Thank You for the post. You made my day despite pain. Bless You and Your Family.

    • Steve W. October 5, 2018 at 9:28 am Reply

      Sorry about the double post but it deserves double Thanks.

  6. sarah October 5, 2018 at 2:16 pm Reply

    Very sad to see this word YET AGAIN…. “rarely”, I want to scream so loud.

  7. krabiwi October 9, 2018 at 9:37 am Reply

    It’s a punch in the face of every flox victim, especially those who traveled to London to speak. I am not surprised as don’t expect anything anymore from this corrupt medical system and their quacks.

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