The Scottish Medicines Consortium (SMC) has issued its monthly advice on newly licensed medicines.
Eluxadoline (Truberzi®) has been rejected for use in adults for the treatment of irritable bowel syndrome with diarrhoea (IBS-D). The submitting company did not present a sufficiently robust economic analysis to gain acceptance
Metformin hydrochloride (Glucophage SR®) has been rejected for use to reduce the risk or delay of the onset of type 2 diabetes mellitus in adult, overweight patients with impaired glucose tolerance and/or impaired fasting glucose and/or increased HbA1C who are:
- at high risk for developing overt type 2 diabetes mellitus and
- still progressing towards type 2 diabetes mellitus despite implementation of intensive lifestyle change for 3 to 6 months
The manufacturer failed to make a submission.
Action: Clinicians should be aware of the recommendations of the SMC. Routine use of rejected and restricted medicines should be avoided.
The Medicines and Healthcare products Regulatory Agency (MHRA) has published Drug Safety Update for January 2018 (PDF).
This issue advised clinicians that Daclizumab (Zinbryta®) has new restrictions on use and strengthened liver monitoring recommendations due to the risk of severe liver injury. Awareness is also raised on the very rare risk of severe cutaneous adverse reactions associated with recombinant human erythropoietins; patients on these medicines should stop treatment and seek immediate medical attention if they develop widespread rash and blistering.
Clinicians are also reminded to take extra care when prescribing or dispensing drugs when there are other names that look or sound similar. For example: risperidone and ropinirole. Following recent cases, six new examples have been added.
This issue also advised that co-dydramol has recently been licensed in two new strengths. Previously it was available as 10mg/500mg of dihydrocodeine and paracetamol. It is now available as 20mg/500mg and 30/mg/500mg, although these have existed previously as paracetamol and dihydrocodeine (Remedeine®). It is therefore now recommended that when prescribing co-dydramol that the tablet strength and dose are clearly indicated.
Finally this month, readers are encouraged to report suspected adverse reactions to the Yellow Card Scheme for any patients taking herbal medicines. When an adverse reaction is suspected, clinicians are encouraged to ask patients whether they are taking any herbal medicines and report the reaction accordingly.
Action: Clinicians should be aware of this month's new guidance and implement any necessary changes to practice.
The manufacturer of Testim® has advised that it intends to cease production and supply of this product in 2018.
The product is currently out of stock but supplies are expected to be delivered in early 2018, currently estimated as February. However, once this delivery of stock has been made it seems the product will be discontinued with no further supplies being made. The manufacturer stresses that the decisions to discontinue this product is not due to issues regarding safety, quality or efficacy of the product.
Testim® contains 50 mg of testosterone in a 5g unit dose container. Testogel® would appear to be a reasonable replacement; it contains the same strength of testosterone in the same unit dose presentation.
Action: Clinicians should be aware of this product being discontinued. It would be prudent to run clinical system searches to identify any patients who are currently prescribed this product to allow suitable alternatives to be arranged.