The Medicines and Healthcare products Regulatory Agency (MHRA) has published Drug Safety Update for July 2024 (PDF).
This issue advises clinicians about reports of ocular surface toxicity and ocular chemical injury associated with use of Epimax Ointment and Epimax Paraffin-Free Ointment. It is recommended to avoid prescribing or advising these products for use on the face. Patients should be advised to wash their hands after using these products and avoid touching their eyes. It is noted that the irritation should resolve on discontinuation but symptoms should but treatment with topical lubricants, topical antibiotics or topical steroids may be required.
Lastly, this issue contains a summary of letters to healthcare professionals in June. 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 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:
- an estimated glomerular filtration rate (eGFR) of 20 mL/min/1.73m2 up to 45 mL/min/1.73m2, or
- an eGFR of 45 mL/min/1.73m2 up to 90 mL/min/1.73m2 and either:
- A urine albumin-to-creatinine ratio (uACR) of 22.6 mg/mmol or more, or
- Type 2 Diabetes Mellitus
Action: Clinicians should be aware of the recommendations of the SMC. Routine use of rejected and restricted medicines should be avoided.
During June 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 Atrial fibrillation topic now includes information about the further assessment of device-detected atrial fibrillation, including use of patient-initiated mobile or wearable devices. The management section has also been split to cover new presentations and routine reviews separately. The Autism in adults topic has amended terminology to be consistent with NICE guidance from 2021. The Crohn's disease topic includes recent epidemiology figures and more detail on the management of a flare-ups. The Opioid dependence topic has been restructured with a focus on the generalist management of opioid dependency in primary care and information on what to expect from specialist drug services is included.
Action: Clinicians who see patients with any of these conditions may find the new and updated information useful when reviewing current clinical practice.
The National Institute for Health and Care Excellence (NICE) have published new or updated guidance for the month of June 2024. This month there is one technology appraisal that impacts upon primary care.
The Voxelotor for treating haemolytic anaemia caused by sickle cell disease technology appraisal has been published. This treatment is recommended as an option for treating haemolytic anaemia caused by sickle cell disease in people 12 years and over under certain conditions. This recommendation is contingent on a commercial agreement and as such it is expected prescribing would remain with a specialist.
Action: Clinicians should be aware of this month's new guidance and implement any necessary changes to practice.
The Medicines and Healthcare products Regulatory Agency (MHRA) has published Drug Safety Update for June 2024 (PDF).
This issue advises clinicians about the introduction of new safety measures, including a Pregnancy Prevention Programme for topiramate. This treatment is now contraindicated in pregnancy and in women of childbearing potential unless the conditions of a Pregnancy Prevention Programme are fulfilled. Maternal use of topiramate during pregnancy is associated with significant harm to the unborn child including a higher risk of congenital malformation, low birth weight and a potential increased risk of intellectual disability, autistic spectrum disorder and attention deficit hyperactivity disorder. It is recommended that topiramate is not be used in pregnancy for migraine and should only be used in epilepsy if there is no other suitable treatment. The Pregnancy Prevention Programme aims to ensure that all women of childbearing potential are using highly effective contraception, have a pregnancy test to exclude pregnancy before starting topiramate and are aware of the risks from use of topiramate.
This issue also warns clinicians of a potentially fatal interaction between warfarin and tramadol. This warning is being made after the MHRA received a Coroner’s report following the death of a patient. Concurrent use of tramadol and warfarin can increase the risk of bleeding through an increased INR. Ideally this combination should be avoided. Patients who are prescribed this combination should be advised to seek medical treatment and have an urgent INR test should they experience:
- prolonged nose bleeds (more than 10 minutes)
- blood in vomit, sputum (phlegm), stool or urine
- severe or unexplained bruising
- severe bleeding gums
- unusual headaches (headaches with blurred vision, slurred speech, loss of movement, feeling or being sick, fits, loss of consciousness, dizziness)
- women who experience heavy or increased bleeding during their menstrual period or any other heavy vaginal bleeding
Lastly, this issue contains a summary of letters to healthcare professionals in May. 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.
