The Medicines and Healthcare products Regulatory Agency (MHRA) has published Drug Safety Update for October 2012 (PDF).
This update contains drug safety information advising clinicians that there a risk of dose-related hepatotoxicity and liver failure with agomelatine. It is already recommended that liver tests are performed before starting treatment and frequently after initiation. This recommendation has now been extended to include testing periodically after a dose increase. Treatment should be stopped if there are symptoms or signs of potential liver injury or if serum transaminases levels exceed three times the upper limit of normal.
The hot topic section contains a summary of the evidence that supports the recent advice to restrict the daily dose of simvastatin when used in conjunction with amlodipine or diltiazem. It also contains a review of the impact of sales restrictions placed on pseudoephedrine and ephedrine in 2008 with the aim of reducing use of these agents in the illicit manufacture of the Class A controlled drug methylamphetamine.
Finally, the stop press section contains information from a recent safety review that provides further evidence that diclofenac carries a higher cardiovascular risk than other non-selective NSAIDs and similar to selective COX-2 inhibitors.
Action: Clinicians will find this publication to be a useful review of current issues in drug safety.
Aclidinium bromide (Eklira Genuair®▼) has been launched as a new inhaled treatment for use in adults with chronic obstructive pulmonary disease (COPD).
This new product is an inhaled anticholinergic in the same class as tiotropium. It is intended for twice daily administration in a novel inhaler device. The NHS list price is £28.60 for 60 doses.
In clinical studies lasting for 6 months it has been shown to provided a clinically significant improvement in FEV1, reduce breathlessness (as assess by the Transition Dyspnoea Index) and improve quality of life (as assessed by the St. George’s Respiratory Questionnaire). Additionally, a pooled analysis of 6-month and 3-month controlled studies indicated a reduction in the rate of exacerbations requiring treatment with antibiotics or steroids or resulting in hospital admission when compared to placebo.
No studies have been performed to compare this new medication with tiotropium and the product is also subject to intensive safety monitoring as only limited data are available from the clinical trials.
Action: Clinicians should be aware of this new product. As with any new product, initial use should be cautious while clinical experience develops.
The National Institute of Health and Clinical Excellence (NICE) has published new guidance for the month of October 2012. This month there are two clinical guidelines that impacts upon primary care.
The Crohn’s Disease clinical guideline discusses the management of Crohn’s disease in adults, children and young people. The guideline covers the induction and maintenance of remission, surgery and maintaining remission after surgery. Additionally, the guideline discusses the impact of Crohn’s disease on pregnancy and fertility as well as considering monitoring for osteopenia and assessing fracture risk.
The Psoriasis clinical guideline discussess the assessment and management of psoriasis in adults, young people and children. The guideline covers topical and systemic therapies and phototherapy. Attention is also drawn to ‘difficult-to-treat sites’ that include the face, flexures, genitalia, scalp, palms and soles. Psoriasis at these sites may result in functional impairment and be more difficult to treat.
Action: Clinicians should be aware of this month’s new guidance and implement any necessary changes to practice.
Details of the Psoriasis guideline were added 24th October 2012
The Scottish Medicines Consortium (SMC) has issued its monthly advice on newly licensed medicines.
Fluticasone and formoterol inhaler (flutiform®) has been accepted for use in the regular treatment of asthma where the use of a combination product is appropriate. It is noted that this product has been shown to be non-inferior to another combination product and may offer cost savings.
Ivabradine (Procoralan®) has been accepted for restricted use in the treatment of chronic heart failure of New York Heart Association (NYHA) class II to IV in patients in sinus rhythm and in combination with standard therapy. Use is restricted to patients whose resting heart rate remains ≥75 beats per minute despite optimal standard therapy.
Strontium ranelate (Protelos®) has been rejected for the treatment of osteoporosis in men at increased risk of fracture. The manufacturer failed to make a submission.
Tocofersolan oral solution (Vedrop®) has been rejected for the treatment of vitamin E deficiency due to digestive malabsorption in paediatric patients. The manufacturer failed to make a sufficiently robust economic case.
Zonisamide (Zonegran®) has been rejected for use as monotherapy for the treatment of partial seizures. The manufacturer failed to make a submission.
Action: Clinicians should be aware of the recommendations of the SMC. Routine use of rejected and restricted medicines should be avoided.
The Drugs and Therapeutics Bulletin has published an article reviewing the teaching of good inhaler technique.
The article notes that over 45 million prescriptions for inhalers were dispensed in 2011 and account for four of the top ten drugs when assessed by cost.
It is also noted that even with good technique at best 20–35% of the drug reaches the lungs. Despite this is seems that little attention is paid to teaching, checking and re-checking inhaler technique.
Perhaps of greater concern, there is evidence that a high proportion of healthcare professionals cannot demonstrate inhaler technique and therefore are not in a position to teach the correct technique adequately.
Action: Clinicians who teach inhaler technique should regularly assess their own knowledge to ensure it remains accurate. A wide range of video clips and leaflets supporting correct usage are available from eMC Medicines Guides.
Thanks to Jane Dickson for spotting this article