Drug Safety Update - August 2023
The Medicines and Healthcare products Regulatory Agency (MHRA) has published Drug Safety Update for August 2023 (PDF).
This issue reminds clinicians of the risk of the risk of disabling and potentially long-lasting or irreversible side effects associated with the use of fluoroquinolone antibiotics. Clinicians are advised to not use these antibiotics in non-severe or self-limiting infections and reserve use in mild and moderate infections unless other antibiotics that are commonly recommended for these infections are considered inappropriate.
Clinicians are also recommended to counsel patients taking methotrexate to take precautions in the sun in order to avoid photosensitivity reactions. This advice is subsequent to a Coroner’s report that identified this reaction as a contributory factor in a patient death. Patients should be advised to use a sun protection product, cover up in the sun and avoid strong UV light such as strong sunlight between 11am and 3pm, sunbeds and tanning equipment.
Also in this issue, a reanalysis of data from a retrospective observational study examining the risk posed to children born to men who took valproate in the 3 months before conception. Errors have been identified in the original analysis. During the reanalysis, no action is needed from patients and it is vitally important that patients do not stop taking valproate unless they are advised to do so by their specialist.
Lastly in this issue is a summary of letters to healthcare professionals in July. These generally related to supply issues and recalls.
Action: Clinicians should be aware of this month's new guidance and implement any necessary changes to practice.
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