The Medicines and Healthcare products Regulatory Agency (MHRA) has published Drug Safety Update for September 2024 (PDF).
This issue contains the precautionary recommendations for men taking valproate containing medicines that was published earlier this month. Due to the potential for an increased risk of neurodevelopmental disorders it is recommended that men on valproate are made aware of these risks and that effective contraception is used during treatment and for three months after treatment stops.
Lastly, this issue contains a summary of letters to healthcare professionals in August. These generally related to supply issues and recalls.
Action: Clinicians should be aware of this month's new guidance and implement any necessary changes to practice.
The National Institute for Health and Care Excellence (NICE) have published new or updated guidance for the month of September 2024. This month there are two technology appraisals that impact upon primary care.
The Vibegron for treating symptoms of overactive bladder syndrome technology appraisal has been published. This treatment is an option for treating the symptoms of overactive bladder syndrome in adults. It is only recommended if antimuscarinic medicines are not suitable, do not work well enough or have unacceptable side effects. It is recommended that the range of suitable treatments are discussed with consideration given to the advantages and disadvantages of all the options, then the least expensive suitable treatment should be used.
The Empagliflozin for treating type 2 diabetes in people 10 to 17 years technology appraisal has been terminated. The manufacturer did not provide an evidence submission and therefore NICE is unable to make a recommendation for empagliflozin for this indication.
Action: Clinicians should be aware of this month's new guidance and implement any necessary changes to practice.
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.
During August 2024 Clinical Knowledge Summaries were published or updated in the following areas.
All of the topics have been reviewed and updated with minor structural and layout changes. The Retinal detachment topic has been updated to align with current evidence in the recommendations on the diagnosis, assessment and management. The Superficial vein thrombosis (superficial thrombophlebitis) topic has been updated and includes a recommendation to consider arranging urgent duplex ultrasound scan if there is suspected superficial vein thrombosis of the lower limb.
Action: Clinicians who see patients with any of these conditions may find the new and updated information useful when reviewing current clinical practice.
