Important Updates
The items below are brief notes of relevance - more information on our Links and Resources page or follow the links given here.
October 2023, The Daily Mail: “Why are doctors doling out so many of the antibiotics now officially linked to suicidal thoughts?”
https://www.dailymail.co.uk/health/article-12662953/Why-doctors-doling-antibiotics-officially-linked-suicidal-thoughts.html
September 2023: Healthcare professionals are reminded “to be alert to the risk of psychiatric reactions, including depression and psychotic reactions”.
https://www.gov.uk/drug-safety-update/fluoroquinolone-antibiotics-suicidal-thoughts-and-behaviour
August 2023: The MHRA release a reminder “to be alert to the risk of disabling and potentially long-lasting or irreversible side effects”.
https://www.gov.uk/drug-safety-update/fluoroquinolone-antibiotics-reminder-of-the-risk-of-disabling-and-potentially-long-lasting-or-irreversible-side-effects
24th July 2023: The MHRA inform us of the results of their review. In brief they are doing nothing except to remind professionals about the risks. They say they will look further at taking additional regulatory actions and will work with e.g. NICE so that they are aware of this review.
1st June 2023: The French medicine Agency (ANSM) issue a new warning leaflet about fluoroquinolone dangers to all health care professionals.
25th May 2023: The same 6 members of our group invited to make personal presentations to a (video) meeting of the Commission on Human Medicines.
12th May 2023: EMA issue a reminder of the warnings and restrictions first announced in 2019 (see below).
March and April 2023: Several magazine and radio articles appear in France, Italy and Belgium about the dangers of fluoroquinolones as a result of pressure from the EU support group members.
Feb 23rd 2023: MHRA invite 6 group members to a (video) meeting with their review team.
Feb 9th 2023: Miriam and 2 members of the EU Support group make a presentation to the EMA regarding the results of the DUS especially the dangers posed by the increase in off-label use. The meeting was called after a letter expressing alarm and signed by representatives of 11 European countries was sent to the EMA.
21st Dec 2022: MHRA notify us of their new review into FQ side effects and invite us to send in our views.
May 2022: DUS study results published which show little change in prescribing habits but (worryingly) an increase in off-label use in Europe.
Titled: Study of impact of EU label changes for fluoroquinolone containing medicinal products for systemic and inhalation use - post-referral prescribing trends. (Warning – it’s 111 pages!).
July 2021: Paper published: “Fluoroquinolones-Associated Disability: It Is Not All in Your Head.”
A good history and overview of FQ Toxicity plus discussion on physical as well as CNS side effects including the vagus nerve.
From Conclusions: “It is imperative to better educate and train physicians worldwide about the permanent dangers FQs can induce in vulnerable populations, and to limit the usage of these drugs to life-threatening infections only.”
December 2020: Paper by ANU HANGAS published titled “TISSUE SPECIFICITY AND TOPOISOMERASE FUNCTIONS IN MITOCHONDRIAL DNA MAINTENANCE”
From Final Remarks: “The findings of the present thesis emphasize the importance to assess mitochondrial side effects of therapeutic drugs such as fluoroquinolones. Although valuable in the treatment of life-threatening infections, the frequent use of these substances increases the risk of adverse side effects, especially in patients with already existing mitochondrial impairments.”
https://erepo.uef.fi/bitstream/handle/123456789/23857/1606816724878308086.pdf
September 2020: The EMA approve new Drug Usage Study (DUS). This was proposed in the 2019 Assessment Report of their Review into fluoroquinolones (below) to find out if the new label changes were having the desired effect.
March 21st 2019: The European Commission's final, legal decision on the EMA Review.
This PDF document from the EMA is the final text that was approved and made legally binding by the European Commission on 11 March 2019.
The original version of this item is in our Links & Resources page, in the section "EMA Review".
21st March 2019: MHRA Drug Safety Update and Central Alert.
MHRA Drug Safety Update (DSU)
https://www.gov.uk/drug-safety-update/fluoroquinolone-antibiotics-new-restrictions-and-precautions-for-use-due-to-very-rare-reports-of-disabling-and-potentially-long-lasting-or-irreversible-side-effects
MHRA Central Alert
https://www.cas.mhra.gov.uk/ViewandAcknowledgment/ViewAlert.aspx?AlertID=102852
More information about this update and alert is available in our Links & Resources page, in the section "MHRA and FDA".