The Scottish Medicines Consortium (SMC) has issued its monthly advice on newly licensed medicines.
Drospirenone (Slynd®) has been rejected for use as a progestogen only contraceptive. 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.
The MHRA has issued advice ahead of the September issue of the Drug Safety Update advising that men taking valproate use effective contraception throughout the valproate treatment period and for three months after stopping valproate. This recommendation has been reported in the general media (BBC).
This advice is based on the results of a retrospective observational study that has indicated a possible association between valproate use by men around the time of conception and an increased risk of neurodevelopmental disorders in their children. It is recommended that men on valproate are informed of this new recommendation at initiation of treatment and at reviews. Effective contraception is recommended, specifically condoms, plus contraception used by the female sexual partner, and they should not donate sperm during valproate treatment and for three months after stopping. This three month window allows for one completed sperm cycle while not exposed to valproate. At routine reviews, men on oral treatment should be asked if they are planning a family in the next year and if they are, a referral to a specialist to discuss alternative treatment options should be made.
Action: Clinicians should be aware of this new guidance and implement the recommended changes to practice.
The Scottish Medicines Consortium (SMC) has issued its monthly advice on newly licensed medicines.
Fezolinetant (Veoza®) has been rejected for the treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause. 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.
The Scottish Medicines Consortium (SMC) has issued its monthly advice on newly licensed medicines.
Empagliflozin (Jardiance®) has been accepted for restricted use in adults for the treatment of chronic kidney disease. The restriction limits use to patients on individually optimised standard care (with ACEi or ARB) and, at the start of treatment, either:
Action: Clinicians should be aware of the recommendations of the SMC. Routine use of rejected and restricted medicines should be avoided.
The Scottish Medicines Consortium (SMC) has issued its monthly advice on newly licensed medicines.
Tirzepatide (Mounjaro®) has been accepted for restricted use for weight management, including weight loss and weight maintenance, as an adjunct to a reduced-calorie diet and increased physical activity in adults. The restriction limits use to adults with BMI ≥30 kg/m2 and at least one weight-related comorbidity. It is noted that a lower BMI may be more appropriate for members of minority ethnic groups known to be at equivalent risk of the consequences of obesity at a lower BMI than the white population. NICE guidance is expected to be published on October, and it is expected that specialist weight management services would be responsible for providing this medication for this indication.
Last month, budesonide/formoterol (Symbicort®) was accepted for restricted use as a reliever therapy for adults and adolescents (12 years and older) with mild asthma. The restriction limits use to for use in patients who would otherwise receive low dose inhaled corticosteroid (ICS) maintenance therapy plus short-acting beta-2 adrenoceptor agonist (SABA) as needed.
Action: Clinicians should be aware of the recommendations of the SMC. Routine use of rejected and restricted medicines should be avoided.
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