The MHRA has published the findings (PDF) of a public assessment report into the effects of atomoxetine (Strattera®) on heart rate and blood pressure.
In January, the Drug Safety Update reminded clinicians of the clinically important increases in heart rate and blood pressure seen in some patients and of the need to screen before starting treatment.
This assessment has concluded that heart rate and blood pressure should be monitored regularly throughout treatment. It is also recommended that atomoxetine is not used in patients with severe cardiovascular or cerebrovascular conditions including:
- severe hypertension
- heart failure
- inherited heart conditions or disease
- heart attack or stroke
- cardiomyopathy
- cerebral aneurysm
Patients are advised to tell their doctor immediately if they develop chest pain, shortness of breath or an irregular or faster-than-normal heart beat.
Action: Clinicians should be aware of these new recommendations. Patients who are prescribed atomoxetine may need to be added to routine recall for assessment of blood pressure and pulse.
The National Institute of Health and Clinical Excellence (NICE) has published new guidance for the month of May 2012. This month there is one technology appraisal and one clinical guideline that impact upon primary care.
Rivaroxaban has been assessed for the prevention of stroke and systemic embolism in people with atrial fibrillation. The treatment is recommended as an option in patients with non-valvular atrial fibrillation and at least one of the following:
- congestive heart failure
- hypertension
- age 75 years or older
- diabetes mellitus
- previous stroke or transient ischaemic attack
The Opioids in palliative care clinical guideline offers evidence-based advice on safe and effective prescribing of strong opioids for pain relief in adults with advanced and progressive disease. Oral sustained-release morphine is recommended as the first line option in patients who are suitable for oral treatment. Where the oral route is not suitable, patches are recommended where pain relief requirements are stable and subcutaneous delivery is recommended where pain relief requirements are unstable. The guideline also offers advice about the management of constipation, nausea and drowsiness.
Action: Clinicians should be aware of this month's new guidance and implement any necessary changes to practice.
The European Medicines Agency (EMA) has recommended (PDF) several updates to prescriber and patient information for dabigatran (Pradaxa®).
A recent assessment of the available data, including post-marketing surveillance sources, found that reported levels of serious or fatal bleeds in the post-marketing data were lower than reported in clinical trials. This information is reassuring but dabigatran remains under close EMA surveillance.
The updated information is contained in an FAQ document and is as follows.
Clinicians are reminded to:
- Assess bleeding risk, including renal function, before staring treatment and to reassess risk on dose changes and if renal function deteriorates
- Dabigatran must not be used in patients with a lesion or condition putting them at significant risk of major bleeding
- Dabigatran must not be used in patients using any other anticoagulant, unless the patient is being switched to or from dabigatran
Additionally, patients are advised to seek urgent medical attention if they fall or injure themselves during treatment, especially if they hit their head, due to the increased risk of bleeding.
Action: Clinicians should be aware of these recommended changes to the prescribing information and implement any necessary changes to practice.
The Medicines and Healthcare products Regulatory Agency (MHRA) has published Drug Safety Update for May 2012 (PDF).
This update contains drug safety information regarding an association between domperidone and an increased risk of serious ventricular arrhythmia and sudden cardiac death. Caution is advised in patients with existing prolongation of cardiac conduction intervals. The risk also seems to be higher in individuals over the age of 60 and in those taking more than 30mg daily. It is advised that the lowest effective dose is used where necessary.
The drug safety section also draws attention to the new contraindications for strontium relating to venous thromboembolism (VTE) and serious skin reactions.
The hot topic section draws attention to a national initiative to reduce antipsychotic prescribing to older people with dementia. Recent prescribing data indicates a fall in prescribing since 2007 but further work is needed to achieve aspirational targets.
Action: Clinicians will find this publication to be a useful review of current issues in drug safety.
The Scottish Medicines Consortium (SMC) has issued its monthly advice on newly licensed medicines.
Etanercept (Enbrel®) has been accepted for restricted use the treatment of chronic severe plaque psoriasis in children and adolescents from the age of 6 years. The restriction applies to disease severity and intolerance or inadequate response to other treatments.
Etanercept (Enbrel®) has also been accepted for restricted use in the treatment of active polyarticular juvenile idiopathic arthritis in children and adolescents from the age of 2 years. The restriction applies to use in specialist rheumatology services when there has been intolerance or inadequate response to methotrexate.
Insulin detemir (Levemir®) has been accepted for restricted use in the treatment of diabetes mellitus in adults, adolescents and children aged 2 years and above. The restriction applies to patients unable to achieve good glycaemic control with established insulins. The SMC note that this advice has been issued previously with a lower age limit of 6 years old.
Action: Clinicians should be aware of the recommendations of the SMC. Routine use of rejected and restricted medicines should be avoided.
