The Medicines and Healthcare products Regulatory Agency (MHRA) has published Drug Safety Update for May 2018 (PDF).
This issue advises that Pregnancy Prevention Programme materials relating to the recent valproate medicines safety update are now available online.
This is also notifies readers of the risk of inhalation of capsules if placed in the mouthpiece of the Braltus® inhaler. It is recommended that patients are shown how to use the inhaler using a placebo device from the manufacturer. Patients should also be advised to store capsules in the screw-cap bottle provided (never in the inhaler) and to always check the mouthpiece is clear before inhaling.
The summary of letters to healthcare professionals includes information about the risk of mix-ups between Fiasp®▼ and Tresiba®. Fiasp are coloured yellow while Tresiba is light green; they are visually quite similar. Any patient concurrently using these two products should be advised to be extra vigilant in ensuring they are using the correct product. To strengthen the differentiation between the products, from June 2018 Fiasp® will be available coloured red and yellow.
Attention is also drawn to a recent field safety notice regarding faulty batches of Accu-Chek Aviva and Performa test strips. These batches have a higher risk of strip error messages and false high and low blood glucose results.
Action: Clinicians should be aware of this month's new guidance and implement any necessary changes to practice.
The Scottish Medicines Consortium (SMC) has issued its monthly advice on newly licensed medicines.
Naltrexone / bupropion (Mysimba®) has been rejected for use as an adjunct to a reduced-calorie diet and increased physical activity, for the management of weight in adult patients (≥18 years) with an initial Body Mass Index (BMI) of:
- ≥ 30 kg/m² (obese), or
- ≥ 27 kg/m² to < 30 kg/m² (overweight) in the presence of one or more weight-related co-morbidities (e.g., type 2 diabetes, dyslipidaemia, or controlled hypertension)
The manufacturer failed to make a submission for this indication.
Action: Clinicians should be aware of the recommendations of the SMC. Routine use of rejected and restricted medicines should be avoided.
During April 2018 Clinical Knowledge Summaries were updated in the following areas.
The following topics were all reviewed:
The majority of topics have undergone reviews and minor restructures.
The most significant changes are to the Balanitis and Fungal nail infection topics which have had the management recommendations updated in line with current literature and also the Parkinson's disease topic which has been updated in line with NICE guidance with several sections updated and expanded.
Action: Clinicians who see patients with any of these conditions may find the new and updated information useful when reviewing current clinical practice.