The Medicines and Healthcare products Regulatory Agency (MHRA) has published Drug Safety Update for June 2012 (PDF).
This update contains drug safety information reminding clinicians to prescribe oral tacrolimus by brand name. The growing number of brands available has increased the risk of inadvertent switches between products that may have different release profiles. Inadvertent switches have been associated with reports of toxicity and graft rejection. The currently available brands are:
- Immediate-release capsule taken twice daily (including Adoport®, Aletris®, Capexion®, Evenil®, Miloprosan®, Prograf®, Tacni®, Takon®, Taliximun®, Tamitect® and Vivadex®)
- Prolonged-release capsule taken once daily (Advagraf®)
- Granules for oral solution taken twice daily (Modigraf®)
The Stop Press section also reminds clinicians that tacrolimus ointment (Protopic®) may be associated with a possible risk of malignancy. Clinicians are reminded that this product should not be used in children under 2 years old and only the lower strength product should be used in children under 16 years old. Furthermore, the product should not be used on lesions that may be malignant or pre-malignant and used in individuals who are immunosuppressed through drug therapy or congenital or acquired disorders should not be prescribed this product.
Action: Clinicians will find this publication to be a useful review of current issues in drug safety.