The Scottish Medicines Consortium (SMC) has issued its monthly advice on new medicines.
Naproxen 500mg and esomeprazole 20mg (Vimovo®) has been rejected for use in the symptomatic treatment of osteoarthritis, rheumatoid arthritis and ankylosing spondylitis. The economic analysis submitted was not sufficiently robust to gain approval.
Golimumab (Simponi®) has been accepted for restricted use in combination with methotrexate, for the treatment of moderate to severe, active rheumatoid arthritis in adult patients where the response to other treatments has been inadequate. The restriction applies to use of the product in accordance with the British Society for Rheumatology guidance at a maximum dose of 50mg.
Adalimumab (Humira®) has been accepted for restricted use in combination with methotrexate for the treatment of active polyarticular juvenile idiopathic arthritis, in children and adolescents aged 4 to 17 years. The restriction applies to use within specialist rheumatology services.
Abatacept (Orencia®) has been accepted for restricted use in combination with methotrexate, abatacept is indicated for the treatment of moderate to severe active polyarticular juvenile idiopathic arthritis in paediatric patients 6 years of age and older. The restriction applies to use within specialist rheumatology services.
Action: Clinicians should be aware of the recommendations of the SMC. Routine use of rejected and restricted medicines should be avoided.
The manufacturer of citalopram (Cipramil®) has written to healthcare professionals to raise awareness of a dose dependent association between this drug and prolongation of the QT interval. The letter, written in collaboration with the Medicines and Healthcare products Regulatory Agency (MHRA), contains some new recommendations.
This new information comes from electrocardiogram (ECG) studies designed to assess QT interval in adults taking citalopram or placebo as well as from spontaneous reporting of QT interval prolongation and ventricular arrhythmias. Additionally, efficacy studies have failed to show additional benefits at doses above 40mg per day.
The new recommendations are as follows:
- The maximum dose of citalopram is now 40mg daily
- In the elderly and in patients with reduced hepatic function the maximum dose is lowered to 20mg daily
- Citalopram is contraindicated in patients with known QT interval prolongation or congenital long QT syndrome
- Use of citalopram with other medicinal products known to prolong QT interval is contraindicated
- Caution is advised in patients at higher risk of developing Torsade de Pointes
It is suggested that patients who are now on doses above those being recommended are reviewed and gradually reduced. Other selective serotonin reuptake inhibitors (SSRIs) including escitalopram (Cipralex) have also been associated with prolongation of QT interval so simply changing treatment may be unwise.
Action: Clinicians should be aware of these new recommendations. Patients who are on higher doses will need to be identified, reviewed and gradually reduced.
Prodigy (formerly CKS) has been updated in November 2011 for the following clinical areas:
Action: Clinicians who see patients with any of these conditions may find the new and updated information useful when reviewing current clinical practice.
The manufacturer of dabigatran (Pradaxa®) has written to healthcare professionals advising of new recommendations relating to the assessment of renal function in patients who are being considered for or who are already taking this drug.
This new advice follows reports of fatal bleeding events in Japan, some of which occurred in elderly patients with severe renal impairment.
It is now recommended that:
- Renal function is assessed in all patients prior to initiating treatment
- Dabigatran is contraindicated in patients with severe renal impairment (creatinine clearance less than 30ml/min)
- Renal function should be reassessed where declines are suspected (hypovolaemia, dehydration)
- Patients over 75 years of age and those with existing renal impairment should have annual checks of renal function
Action: Clinicians should be aware of these monitoring requirements. The place of dabigatran in therapy, compared to warfarin, is still being debated; these new recommendations may need consideration as part of that debate.
The New England Journal of Medicine has published the results of an analysis that aimed to assess the cardiovascular risks posed by drugs used for the treatment of attention deficit–hyperactivity disorder (ADHD).
Adverse event reporting in North America has raised some concerns so a retrospective cohort analysis involving data for 1,200,438 children and young adults between the ages of 2 and 24 years from four managed health systems was conducted. This cohort provided 2,579,104 person-years of data which included 373,667 years of data for current users of ADHD drugs. The mean length of follow up was 2.1 years.
When compared to non users of ADHD drugs the rate of serious cardiovascular events was not statistically different for current users (hazard ratio 0.75, 95% CI 0.31-1.85) or former users (HR 1.03, 95% CI 0.57-1.89). There was also no difference in the rates of the individual end points of sudden cardiac death, acute myocardial infarction or stroke.
The authors do note however that the low number of events in the cohort means that the results are of limited statistical power. A further limitation relates to the sparse data for use over longer durations.
The authors therefore conclude that, "the point estimates of the relative risks for ADHD drugs did not indicate increased risk" but "a doubling in the risk could not be ruled out".
Action: Clinicians who prescribe medication for ADHD should be aware of this analysis. The results are reassuring but more research is needed to confirm long term safety.