The Medicines and Healthcare products Regulatory Agency (MHRA) has published Drug Safety Update for October 2015 (PDF).
Clinicians are advised that mirebegron (Betmiga®) is now contraindicated in patients with severe uncontrolled hypertension (systolic blood pressure ≥180 mm Hg or diastolic blood pressure ≥110 mm Hg, or both) following an EU-wide review of the latest safety data. It is also recommended that blood pressure should be measured before starting treatment and monitored regularly during treatment, especially in patients with hypertension.
It is also noted in this edition that a letter informing of a risk of severe hypertension and associated cerebrovascular and cardiac events linked with mirebegron use was sent to healthcare professionals in September.
Action: Clinicians should be aware of this month's new guidance and implement any necessary changes to practice.
The 70th Edition of the British National Formulary has been published. As previously noted, the BNF will now only be distributed annually in the NHS.
Some of the significant content updates in this edition include:
- New safety information about reducing the risk of QT interval prolongation and Torsade de Pointes with hydroxyzine
- New advice about the risk of lymphopenia and potential risk of progressive multifocal leukoencephalopathy with dimethyl fumarate
- Further guidance on the restricted use of codeine for the treatment of cough and cold symptoms in children
- Addition of new indications for omalizumab for treating chronic spontaneous urticaria and for lenalidomide in certain patients with multiple myeloma
- Updated dosing information for the use of tramadol in the treatment of acute and chronic pain
- Guidance about dose reduction for lisdexamfetamine mesilate for patients with severe renal impairment
- Updated contra-indications for aceclofenac in patients with certain established cardiovascular diseases
- Addition of new preparations, including DuoResp Spiromax® (budesonide with formoterol), Envarsus® (tacrolimus), Fostair NEXThaler® (beclometasone with formoterol), Jaydess® (levonorgestrel), Ketoconazole HRA® (ketoconazole) and Lonquex® (lipegfilgrastim)
The web version is updated monthly but requires registration or an Athens account for continued access. The printed version is available for purchase.
Action: All clinicians should start using BNF 70 via electronic methods were possible. The web version can be used to access the latest information if necessary.
The Scottish Medicines Consortium (SMC) has issued its monthly advice on newly licensed medicines.
Abiraterone (Zytiga®) has been accepted for use in combination with prednisone or prednisolone for the treatment of metastatic castration resistant prostate cancer (mCRPC) in adult men who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated.
Budesonide (Cortiment®) has been rejected for induction of remission in patients with mild to moderate active ulcerative colitis (UC) where 5-ASA treatment is not sufficient. Similar clinical effectiveness compared to standard treatment with rectally applied budesonide has not been demonstrated.
Ciclosporin (Ikervis®) has been accepted for the treatment of severe keratitis in adult patients with dry eye disease, which has not improved despite treatment with tear substitutes.
Everolimus (Afinitor®) has been rejected for the treatment of hormone receptor-positive, HER2/neu negative advanced breast cancer, in combination with exemestane, in postmenopausal women without symptomatic visceral disease after recurrence or progression following a non-steroidal aromatase inhibitor. The submitting company did not present a sufficiently robust economic analysis
Insulin degludec / Liraglutide (Xultophy®) has been accepted for restricted use in the treatment of adults with type 2 diabetes mellitus to improve glycaemic control in combination with oral glucose-lowering medicinal products when these alone or combined with a GLP-1 receptor agonist or with basal insulin do not provide adequate glycaemic control. The restriction limits use to who those who are uncontrolled on basal insulin analogues (HbA1c > 59mmol/mol [7.5%]) and for whom a GLP-1 receptor agonist is appropriate as an add-on intensification therapy to basal insulin to obtain glucose control.
Midodrine (Bramox®) has been accepted for use in adults for the treatment of severe orthostatic hypotension due to autonomic dysfunction when corrective factors have been ruled out and other forms of treatment are inadequate.
Travoprost (Travatan®) has been accepted for use to decrease of elevated intraocular pressure in paediatric patients aged 2 months to > 18 years with ocular hypertension or paediatric glaucoma.
Action: Clinicians should be aware of the recommendations of the SMC. Routine use of rejected and restricted medicines should be avoided.
The National Institute of Health and Care Excellence (NICE) have published new guidance for the month of September 2015. This month there is one clinical guideline and one technology appraisal that impact upon primary care.
The Coeliac Disease guideline covers the recognition, assessment and management of coeliac disease in children, young people and adults.
The Edoxaban technology appraisal recommends this treatment as an option for preventing stroke and systemic embolism in people with non-valvular atrial fibrillation who have one or more risk factors.
Action: Clinicians should be aware of this month's new guidance and implement any necessary changes to practice.
The FDA has issued a safety announcement warning the DPP-4 inhibitors or gliptins may cause joint pain that can be "severe and disabling".
A review of adverse events reported to the FDA and also medical literature identified cases of severe joint pain associated with the use of DPP-4 inhibitors. The pain may begin soon after starting treatment or after several years.
Arthralgia is listed as a known side effect in the current SPCs for sitagliptin, saxagliptin and vildagliptin. However, alogliptin and linagliptin are also mentioned in the FDA announcement.
Patients are advised to report severe and persistent joint pain to a healthcare professional. If appropriate the healthcare professional should consider stopping treatment; symptoms usually improve within a month.
Action: Clinicians should be aware of this apparent side effect and take appropriate action when it is encountered.
