The Medicines and Healthcare products Regulatory Agency (MHRA) has published Drug Safety Update for October 2019 (PDF).
This month clinicians are advised that ingenol mebutate gel (Picato®▼) has been associated with an increased incidence of skin tumours seen in some clinical studies. It is recommended that patients are advised to be vigilant for new skin lesions and to seek medical advice immediately should any occur. Use with caution in patients with a history of skin cancer.
Clinicians are also advised that consideration should be given to the most appropriate estimate of renal function when prescribing medicines in renal impairment. In most cases estimated Glomerular Filtration Rate (eGFR) is an appropriate. However, in the following situations the Cockcroft-Gault formula should be used to calculate creatinine clearance (CrCl).
- direct-acting oral anticoagulants (DOACs)
- patients taking nephrotoxic drugs (examples include vancomycin and amphotericin B)
- elderly patients (aged 75 years and older)
- patients at extremes of muscle mass (BMI <18 kg/m2 or >40 kg/m2)
- patients taking medicines that are largely renally excreted and have a narrow therapeutic index, such as digoxin and sotalol
Readers are advised of the alerts and letters issued about adrenaline auto-injectors in September and October 2019. In summary, Emerade® may fail to activate, advice has been given on how to manage this should the pens need to be used. EpiPen and Jext have had the expiry date extended by 4 months to support adequate supply of adrenaline auto-injectors in the UK.
The summary of letters to healthcare professionals this month includes letters sent in September 2019 about ingenol mebutate gel and adrenaline auto-injectors as mentioned above.
Action: Clinicians should be aware of this month's new guidance and implement any necessary changes to practice.
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