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:
Tel. +44 (0)20 3660 8427
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:
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:
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!
March 2018 Update
The following is from the EMA Press Release, “Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 5-8 March 2018”
Public hearing to be organised for quinolone and fluoroquinolone antibiotics
The PRAC decided to organise a public hearing as part of its review of quinolone and fluoroquinolone antibiotics, to listen directly to the experience of interested parties with these medicines, so this can be taken into account in the Committee’s recommendation.
In February 2017 the PRAC started a review of oral, injectable and inhaled quinolone and fluoroquinolone antibiotics to evaluate the persistence of rare serious side effects mainly affecting muscles, joints and the nervous system, some of which may be of long duration. As the review progressed, EMA observed an increased public interest in the safety of these medicines. The PRAC, taking into account this increased interest, considered it would be useful to hold a hearing to better understand the public’s views on the risks associated with these antibiotics and the feasibility of certain measures to optimise their safe use.
This public hearing will take place during the Committee’s meeting of June 2018. Further information, including a summary of the safety concerns, a list of specific questions on which information from the public is sought, as well as practical information on how to participate and an application form will be published soon on the Agency’s website.
It is the second time that the PRAC will hold a public hearing during a safety review of a medicine, following the first public hearing held in September 2017 to inform the review of valproate – a medicine that treats epilepsy, bipolar disorder and migraine.
If you would like to attend the public hearing, please see THIS DOCUMENT for instructions. Thank you!
April 2018 Update
The following email was received from the EMA:
The European Medicines Agency (EMA) would like to let you know it is going to hold a Public Hearing on 13 June 2018 at its offices in London.
The hearing is part of an ongoing review of Quinolone and fluoroquinolone medicines being carried out by the Agency’s safety committee – the Pharmacovigilance Risk Assessment Committee (PRAC).
The EMA is reviewing these antibiotics due to reports of serious persistent side effects mainly affecting muscles, joints and the nervous system.
The PRAC would like to hear the public’s view on acceptability of risks associated with quinolones and fluoroquinolones in both mild and severe infections, and to explore what further measures could be taken to ensure that these antibiotics are used as safely as possible.
The public hearing will focus on several questions on which the PRAC is seeking the views of different stakeholders who have experience in the use of these medicines within Europe (e.g. patients, consumers, carers, general practitioners/family physicians, urologists, respiratory specialists, pharmacists, nurses).
The questions, together with an overview of the safety issues are published on the EMA website together with a link to the electronic application form, guidance documents and a video.
Those wishing to participate at the hearing need to register in advance and may request to speak in front of the Committee or simply observe the proceedings. The hearing will also be broadcast live via our website.
The deadline for applications is 30 April 2018.
Please share this email with anyone else who might be interested to participate, and if you have any questions please do not hesitate to contact us at:PublicHearings@ema.europa.eu
If you are available, please participate. Thank you!