EMA to review persistence of side effects known to occur with quinolone and fluoroquinolone antibiotics

I hope I’m not too late in posting this. The following notice was published by the European Medicines Agency (EMA) in February, 2017 (and I’m posting it in March). I want to encourage all of my European “floxie” friends to contact the EMA to report your reaction, and to inquire about testifying. Even if testifying isn’t a possibility, we should all pay attention to what the EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) decides.

The contact person listed on the EMA notice is:

Monika Benstetter
Tel. +44 (0)20 3660 8427
E-mail: press@ema.europa.eu

HOWEVER, the EMA has given us the contact information for the UK representatives of PRAC (the EMA’s Pharmacovigilance Risk Assessment Committee). Please contact them instead. They are:

julie.williams@mhra.gsi.gov.uk
and
patrick.batty@mhra.gsi.gov.uk

European floxie friends, please reach out to Ms. Benstetter to share your story, or to find out who you should share your story with. The patient testimony at the FDA hearing was moving, powerful, and I believe that it made a difference. Hopefully patient testimony will be allowed by the EMA, and it will make a difference too.

Here is the EMA announcement:

EMA to review persistence of side effects known to occur with quinolone and fluoroquinolone antibiotics: Review to focus on long-lasting effects mainly affecting musculoskeletal and nervous systems

The European Medicines Agency (EMA) is reviewing systemic and inhaled quinolone and fluoroquinolone antibiotics to evaluate the persistence of serious side effects mainly affecting muscles, joints and the nervous system. These side effects are of particular importance when the medicines are used for less severe infections.

The review is at the request of the German medicines authority (BfArM) following reports of longlasting side effects in the national safety database and the published literature. There has been no previous EU-wide review specifically focusing on the persistence of the side effects, but the side effects themselves are known and covered in the EU prescribing information for these medicines.

EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) will now evaluate all available data and determine whether there is a need to introduce new measures to minimise these risks or modify how the medicines are used.

Quinolones and fluoroquinolones are widely prescribed in the EU and are important options for treating serious, life-threatening bacterial infections. Healthcare professionals using these medicines should continue to follow the official prescribing information.

Patients who have any questions about their treatment should speak to their doctor.

More about the medicines

Quinolones and fluoroquinolones are a class of broad spectrum antibiotics that are active against so-called Gram-negative and Gram-positive bacteria.

The review covers the following medicines: cinoxacin, ciprofloxacin, enoxacin, flumequine, levofloxacin, lomefloxacin, moxifloxacin, nalidixic acid, norfloxacin, ofloxacin, pefloxacin, pipemidic acid, prulifloxacin and rufloxacin.

More about the procedure

The review of quinolone and fluoroquinolone antibiotics was initiated on 9 February 2017 at the request of German medicines authority (BfArM), under Article 31 of Directive 2001/83/EC.

The review will be carried out by the Pharmacovigilance Risk Assessment Committee (PRAC), the Committee responsible for the evaluation of safety issues for human medicines, which will issue recommendations. The PRAC recommendations will then be sent to the Committee for Medicinal Products for Human Use (CHMP), responsible for questions concerning medicines for human use, which will adopt the Agency’s opinion. The final stage of the review procedure is the adoption by the European Commission of a legally binding decision applicable in all EU Member States.

I hope that the EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) decides to acknowledge the serious adverse reactions caused by fluoroquinolones, and that they restrict the use of fluoroquinolones in Europe.

European friends, if you hear of anything that you can do to push the EMA’s PRAC to to decide to restrict fluoroquinolone use in Europe, please let me know. I’ll update this post if I hear anything new. Thank you!

 

 

 

 

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3 thoughts on “EMA to review persistence of side effects known to occur with quinolone and fluoroquinolone antibiotics

  1. Tracy Whiteside March 20, 2017 at 8:39 am Reply

    Too little, way too late, as per usual, not floxxie Hope, but, the eu regulators, Margaret Hamburg, the former head of the FDA is under indictment, for Levaquin, according to the indictment, she bribed Hillary and OBAMA, with $100 million dollars, to become the head of the FDA, and, used Levaquin as her own personal eugenics program, she has made herself more than a billion dollars profit, off of our hell, death, and, misery, through her husbands hedge fund, and, is still, while under indictment, still earning huge profits, over, and, above the more than a billion dollars profit, she is still reaping huge profits, for herself, while under indictment, she has been involved in 9 or 10 Eugenics programs, this mass murdering monster, can’t quit murdering people, she recently become head of the AAAS, another Eugenics Society, Google, Margaret Hamburg indicted, then Google , both of Margaret Hamburgs Parents were former Presidents of the American Eugenics Society, Hamburg is Hitler 2.0, Trump will do nothing to stop the mass murder of people through Levaquin, as he is a stockholder in Johnson and Johnson, so Trump, Hillary , OBAMA, and, Hamburg have all profited mightily, from our deaths, and, despite the fact that the indictment states , over and over, that Levaquin is inherently deadly , 27 million prescriptions, for Levaquin have gone out , to kill 27 million more people, so Hamburg and , Trump , will continue to reap huge financial gains, while we die, for their greed.

  2. Barbara Arnold March 20, 2017 at 9:01 am Reply

    Thanks Lisa,
    Just sent off my story, plus all the information I have to the EMA. Like you said please all european floxies do the same. It’s the only way we will eventually be heard.

  3. Lisa March 24, 2017 at 6:59 am Reply

    I received this from the EMA:

    Dear Lisa Bloomquist,

    Thank you for writing to us about EMA’s review of quinolones and fluoroquinolones.

    We have not specifically asked for comments on the review and so there is no deadline. However, we do advise patients who have experienced side effects with these medicines to report them to their national authorities as soon as possible.

    http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/general/general_content_000155.jsp&mid=WC0b01ac0580036d63

    For those who have reported their side effects, we will already have information about their suspected side effects and will be taking it into account along with data from other patients across the EU.

    Once our review is complete, we will publish the outcome on our website, alongside recommendations on how these medicines should be used in the EU.

    Thank you for taking the time to write to us.

    Kind regards

    Nacho Mbaeliachi

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