Antibiotics: Side-effects

(asked on 9th March 2021) - View Source

Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, whether he has made an assessment of the potential merits of establishing fluoroquinolone toxicity as a diagnosis in response to the negative side effects attributed to fluoroquinolone usage by some patients.


Answered by
Nadine Dorries Portrait
Nadine Dorries
This question was answered on 16th March 2021

Serious side effects of fluoroquinolone antibiotics can be varied, potentially affecting several different parts of the body. The review of the safety of fluoroquinolone antibiotics by the European Medicines Agency (EMA) and the Medicines and Healthcare products Regulatory Agency (MHRA) focussed on the potential for serious side effects and did not specifically assess the potential advantages or disadvantages of using a specific definition for fluoroquinolone toxicity. Regulatory actions taken as a result of this review have focussed on giving healthcare professionals and patients the information they need to identify any potential side effects for appropriate action and on encouraging the reporting of any suspected side effects to the Yellow Card Scheme. A specific diagnosis is not required.

On 21 March 2019 the MHRA published a Drug Safety Update (DSU) bulletin on the potential serious side effects of fluoroquinolone antibiotics, which may be potentially long-lasting or irreversible. The DSU also emphasised the restrictions and precautions for use of these medicines that were introduced after the review of their safety by the EMA and the MHRA. The DSU bulletin includes a link to a patient sheet designed to help healthcare professionals and patients discuss potential side effects, patients’ questions about these medicines and what patients should do if they experience a suspected side effect. The DSU also includes a link to guidance for managing common infections from Public Health England and the National Institute for Health and Care Excellence.

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