The Scottish Medicines Consortium (SMC) has issued its monthly advice on newly licensed medicines.
Magnesium glycerophosphate (Neomag®) has been accepted for use as an oral magnesium supplement for the treatment of patients with chronic magnesium loss or hypomagnesaemia as diagnosed by a doctor. Magnesium glycerophosphate is also indicated for adult patients with hypomagnesaemia due to the concomitant administration of loop and thiazide diuretics or other drugs which cause hypomagnesaemia. It is noted that unlicensed tablet formulations of magnesium glycerophosphate are available but this product provides a licensed preparation at a similar cost.
Roflumilast (Daxas®) has been rejected for maintenance treatment of severe chronic obstructive pulmonary disease (COPD) (forced expiratory volume in one second [FEV1]) post-bronchodilator less than 50% predicted) associated with chronic bronchitis in adult patients with a history of frequent exacerbations as add on to bronchodilator treatment. The addition of roflumilast did not reduce the annual rate of moderate or severe COPD exacerbations in two double-blind, randomised studies of COPD patients with severe airflow limitation and history of at least two moderate or severe exacerbations in the previous year. The manufacturer did not present a sufficiently robust clinical or economic analysis to gain acceptance.
Stiripentol (Diacomit®) has been accepted for use in conjunction with clobazam and valproate as adjunctive therapy of refractory generalised tonic-clonic seizures in patients with severe myoclonic epilepsy in infancy (SMEI; Dravet’s syndrome) whose seizures are not adequately controlled with clobazam and valproate. It would be expected that children with this condition would be under the care of a tertiary paediatric epilepsy specialist.
Action: Clinicians should be aware of the recommendations of the SMC. Routine use of rejected and restricted medicines should be avoided.