The Medicines and Healthcare products Regulatory Agency (MHRA) has published Drug Safety Update for July 2021 (PDF).
This month readers are advised that, following a review of the available toxicological data, chloramphenicol eye drops can be safely administered to children aged 0 to 2 years where antibiotic eye drop treatment is indicated. Some licences for chloramphenicol eye drop products containing borax or boric acid buffers were recently updated to restrict use in children younger than 2 years of age to reflect warnings on maximum daily limits for boron exposure. The product information for affected chloramphenicol products is being updated to reflect the revised advice and remove restrictions for use in infants. In the meantime, healthcare professionals should reassure parents and carers that these products can be safely given to children aged 0 to 2 years at the time of prescribing.
Readers are also reminded to be vigilant for suspected adverse reactions to herbal and homeopathic medicines and to report them to the Yellow Card scheme. It is recommended to specifically ask patients who present with adverse reaction symptoms if they are taking a herbal or homeopathic medicines.
This issue also contains an update on COVID-19 vaccines and medicines that includes emerging information on a very small risk of myocarditis and pericarditis associated with the Modern and Pfizer/BioNTech vaccines. It seems to affect younger men after the second vaccine is administered and cases are typically mild with affected individuals tending to recover within a short time following standard treatment and rest. The advice continues to be that the benefits of getting vaccinated outweigh the risks in the majority of people.
Finally in this issue is a summary of letters to healthcare professionals sent in June that were regarding product recalls. There were also letters noting a change in appearance and formulation for the ViePax 150 XL® brand of venlafaxine and release of some Clenil® inhalers with no dose counter.
Action: Clinicians should be aware of this month's new guidance and implement any necessary changes to practice.
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