The Medicines and Healthcare products Regulatory Agency (MHRA) has published Drug Safety Update for August 2019 (PDF).
This month clinicians are advised that naltrexone/bupropion (Mysimba®) has been linked with adverse reactions that could affect ability to drive. This medicine is licensed for the management of weight in obese adults and in overweight adults with one or more weight-related conditions. Usage levels in the UK are low and it is mainly issued on private prescription. Use has been linked with dizziness or somnolence, which can affect ability to drive, operate machinery, or perform dangerous tasks. Advise patients not to drive if they suspect their ability may be impaired.
The summary of letters to healthcare professionals this month includes details of two patient-level medicine recalls for Neupro 4mg/24hr patches and Vimpat 100mg tablets. Any patient that has any of these affected products is advised to continue taking their medicines and contacting their prescriber to arrange a new prescription. Patients should return the affected batches to their pharmacist once they have a new prescription.
Action: Clinicians should be aware of this month's new guidance and implement any necessary changes to practice.
The manufacturer of the Evorel® range of HRT patches has written healthcare professionals advising of an imminent supply shortage.
An increase in demand for the products is cited as one of the reasons for the shortage with the entire product range affected - Evorel®, Evorel® Sequi and Evorel® Conti. It is anticipated that supplies will be restored in mid-2020.
Alternative patches are available to switch from Evorel®, but alternatives to the Sequi and Conti products are going to be more complex, perhaps involving supply of oestrogen patches and progestogen tablets or a switch to tablet versions.
Action: Clinicians should be aware of this supply interruption and be prepared to supply appropriate alternatives.
The Scottish Medicines Consortium (SMC) has issued its monthly advice on newly licensed medicines.
Empagliflozin and linagliptin (Glyxambi®) has been accepted for restricted use in adults aged 18 years and older with type 2 diabetes mellitus:
- To improve glycaemic control when metformin and/or sulphonylurea (SU) and one of the monocomponents of Glyxambi do not provide adequate glycaemic control
- When already being treated with the free combination of empagliflozin and linagliptin
The restriction limits use in line with the previous SMC advice on empagliflozin and linagliptin.
Perampanel suspension (Fycompa®) has been accepted for restricted use for the adjunctive treatment of partial-onset seizures with or without secondarily generalised seizures in adult and adolescent patients from 12 years of age with epilepsy. The restriction limits use to second-line adjunctive treatment in patients with refractory partial onset epilepsy who are unable to swallow perampanel tablets. Treatment should be initiated only by physicians who have appropriate experience in the treatment of epilepsy.
Perampanel suspension (Fycompa®) has been rejected for the adjunctive treatment of primary generalised tonic-clonic seizures in adult and adolescent patients from 12 years of age with idiopathic generalised epilepsy. 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 July 2019 Clinical Knowledge Summaries were published or updated in the following areas.
The Autism in adults and Cerebral palsy topics are new. The Cholesteatoma and Gallstones topics have undergone reviews and minor restructures.
Action: Clinicians who see patients with any of these conditions may find the new and updated information useful when reviewing current clinical practice.