MHRA Drug Safety Update
August 2023
Healthcare professionals prescribing fluoroquinolone antibiotics (ciprofloxacin, delafloxacin, levofloxacin, moxifloxacin, ofloxacin) are reminded to be alert to the risk of disabling and potentially long-lasting or irreversible side effects. Do not prescribe fluoroquinolones for non-severe or self-limiting infections, or for mild to moderate infections (such as in acute exacerbation of chronic bronchitis and chronic obstructive pulmonary disease) unless other antibiotics that are commonly recommended for these infections are considered inappropriate. Fluoroquinolone treatment should be discontinued at the first signs of a serious adverse reaction, including tendon pain or inflammation.
Photosensitivity reactions are known side effects of methotrexate treatment and can be severe. Patients should be advised to take precautions to protect their skin in the sun.
We are providing an update on a retrospective observational study on the risk to children born to men who took valproate in the 3 months before conception and on the need for the re-analysis of the data from this study before conclusions can be drawn. No action is needed from patients. It is vitally important that patients do not stop taking valproate unless they are advised by their specialist to do so. For female patients, healthcare professionals should continue to follow the existing strict precautions related to preventing the use of valproate in pregnancy (Valproate Pregnancy Prevention Programme).
A summary of recent letters and notifications sent to healthcare professionals about medicines.
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Drug Safety Update is a monthly newsletter from the Medicines and Healthcare products Regulatory Agency (MHRA) and its independent advisor the Commission on Human Medicines.
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