FOI release

Freedom of Information request on history of the drug safety alerts and label additions for fluoroquinolone and macrolide medicines (FOI 22/685)

Published 22 March 2023

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This publication is available at https://www.gov.uk/government/publications/freedom-of-information-responses-from-the-mhra-week-commencing-30-may-2022/freedom-of-information-request-on-history-of-the-drug-safety-alerts-and-label-additions-for-fluoroquinolone-and-macrolide-medicines-foi-22685

FOI 22/685

31 May 2022

Dear

Thank you for your information request, dated 28 April 2022, where you asked for full history of the drug safety alerts and label additions for fluoroquinolone and macrolide medicines.

I am pleased to provide you with some of the information requested, see below.

The current GOV.UK website includes issues of the MHRA’s Drug Safety Update (DSU) bulletin from January 2015 (Volume 8 Issue 6) onwards. Earlier issues of DSU, from October 2007 (Volume 1 Issue 3) to December 2014 (Volume 8 Issue 5), inclusive, are available in pdf format on the National Archives here: http://webarchive.nationalarchives.gov.uk/20150122075153/http://mhra.gov.uk/Safetyinformation/DrugSafetyUpdate/DrugSafetyUpdatePDFarchive/index.htm.

The search function on the Drug Safety Update GOV.UK page will return results of key DSU articles published before 2015 that were transferred from the previous website – including the ones below. However, some relevant older or short updates may only be in the PDFs on the National Archives.

From the information we have available, we can supply details of the following DSU safety communications concerning fluoroquinolones or macrolides (in order of most recent publication date):

  • February 2022 (Volume 15 Issue 7): Hydroxychloroquine, chloroquine: increased risk of cardiovascular events when used with macrolide antibiotics; reminder of psychiatric reactions
  • December 2020 (Volume 14 Issue 5): Systemic and inhaled fluoroquinolones: small risk of heart valve regurgitation; consider other therapeutic options first in patients at risk
  • December 2020 (Volume 14 Issue 5): Erythromycin: caution required due to cardiac risks (QT interval prolongation); drug interaction with rivaroxaban
  • December 2020 (Volume 14 Issue 5): Erythromycin: update on known risk of infantile hypertrophic pyloric stenosis
  • March 2019 (Volume 12 Issue 8): Fluoroquinolone antibiotics: new restrictions and precautions for use due to very rare reports of disabling and potentially long-lasting or irreversible side effects
  • November 2018 (Volume 12 Issue 4): Systemic and inhaled fluoroquinolones: small increased risk of aortic aneurysm and dissection; advice for prescribing in high-risk patients
  • December 2014 (Volume 6 Issue 2): Levofloxacin: some indications restricted
  • January 2011 (Volume 4 Issue 6): Moxifloxacin: increased risk of life-threatening liver reactions and other serious risks
  • December 2008 (Volume 2 Issue 5): Norfloxacin: restricted use in urinary infections

Please also note that from 1976 up to July 2007, the MHRA published pharmacovigilance safety notices in ‘Current Problems in Pharmacovigilance’. Digital versions of Current Problems in Pharmacovigilance are available via the National Archive: https://webarchive.nationalarchives.gov.uk/ukgwa/20141205221708/http://www.mhra.gov.uk/Publications/Safetyguidance/CurrentProblemsinPharmacovigilance/index.htm

Regarding your request for the history of additions to the product information for fluoroquinolones and macrolides, we are preparing a separate response to your e-mail enquiry of 17 February, where you requested information on the dates for the addition of specific ADRs to the product information (uveitis, retinal detachment, cardiac disorders (QT prolongation), renal failure, hepatic failure, tendon rupture). Please accept our apologies for the delay in responding to this part of your enquiry.

The Freedom of Information Act only entitles you to access to information – the information supplied is subject to Crown copyright, and there are some restrictions on its re-use. For information on the reproduction or re-use of MHRA information, please visit https://www.gov.uk/government/publications/reproduce-or-re-use-mhra-information/reproduce-or-re-use-mhra-information.

If you have a query about the information provided, please reply to this email.

If you disagree with how we have interpreted the Freedom of Information Act 2000 in answering your request, you can ask for an internal review. Please reply to this email, within two months of this reply, specifying that you would like an Internal Review to be carried out.

Please remember to quote the reference number above in any future communications.

If you were to remain dissatisfied with the outcome of the internal review, you would have the right to apply directly to the Information Commissioner for a decision. Please bear in mind that the Information Commissioner will not normally review our handling of your request unless you have first contacted us to conduct an internal review. The Information Commissioner can be contacted at:

Information Commissioner’s Office
Wycliffe House
Water Lane
Wilmslow
Cheshire
SK9 5AF

Yours sincerely

MHRA Customer Experience Centre

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