The National Institute of Health and Clinical Excellence (NICE) has published new guidance on the use of dabigatran (Pradaxa®) in the prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation (AF).
Dabigatran is recommended as an option, within its licensed indication, in people with non-valvular atrial fibrillation with one or more of the following risk factors:
- previous stroke, transient ischaemic attack or systemic embolism
- left ventricular ejection fraction below 40%
- symptomatic heart failure of New York Heart Association (NYHA) class 2 or above
- age 75 years or older
- age 65 years or older with one of the following: diabetes mellitus, coronary artery disease or hypertension
It is recommended that the treatment initiation decision includes a discussion of the risks and benefits of dabigatran compared with warfarin.
It is also suggested that for patients who are already taking warfarin, the potential risks and benefits of switching to dabigatran are discussed with consideration of their level of international normalised ratio (INR) control.
Action: Clinicians should be aware of this new guidance and implement any necessary changes to practice.
The Scottish Medicines Consortium (SMC) has issued its monthly advice on new medicines.
Atorvastatin chewable tablets (Lipitor®) have been accepted as an adjunct to diet in the treatment of adults, adolescents and children aged 10 years or older with primary hypercholesterolaemia. The review notes that this chewable presentation is currently cost equivalent to regular tablets but that less expensive generics are expected in the near future.
Asenapine (Sycrest®) has been rejected for the treatment of moderate to severe manic episodes associated with bipolar I disorder. The manufacturer failed to make a sufficiently robust economic case.
Fingolimod (Gilenya®) has been rejected for use as monotherapy in highly active relapsing remitting multiple sclerosis (RRMS) in patients with high disease activity despite treatment with a beta-interferon or rapidly evolving severe RRMS defined by two or more disabling relapses in one year with specified MRI changes. The manufacturer failed to make a sufficiently robust economic case.
Action: Clinicians should be aware of the recommendations of the SMC. Routine use of rejected and restricted medicines should be avoided.
The Medicines and Healthcare products Regulatory Agency (MHRA) has published Drug Safety Update for March 2012 (PDF).
This update contains drug safety information regarding the new contraindications and cautions added to aliskiren (Rasilez®) after a recent study found no benefit and an increased risk of harm when this drug was used in combination with either an angiotensin converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB) in patents with type 2 diabetes.
The stop press section informs clinicians that the marketing authorisation (licence) for levothyroxine 100 microgram tablets manufactured by Teva has been suspended due to the potential for reduced efficacy and evidence of manufacturing difficulties. Clinicians should be aware that recent use of this product may result in a change in a patient’s symptoms and TSH status. Other brands of levothyroxine and other strengths from the same manufacturer are unaffected.
This sections also advises that Vigantoletten® and Dekristol® vitamin D (colecalciferol) capsules imported from Germany contain soya oil and arachis (peanut) oil respectively. Osto D2® capsules from Canada and Drisdol capsules® from the USA also contain soya oil. The packaging for these products may not explicitly list these ingredients and usage by susceptible individuals may lead to severe allergic reactions. It is recommended that doctors and pharmacists should check whether patients have any relevant allergies before prescribing or supplying these medicines.
Action: Clinicians will find this publication to be a useful review of current issues in drug safety.
Prodigy has been updated in March 2012 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.