SIGN
A new guideline on the management of patients with stroke or TIA has been published. It covers investigation, immediate management, and secondary prevention, emphasising the importance of getting patients to specialist stroke services quickly to ensure prompt diagnosis and treatment. Stroke is the third biggest cause of death and the main cause of disability in Scotland and 15% of stroke patients die within 30 days.
NICE
The prescribers’ ‘bible,’ the British National Formulary (BNF), and its sister publication the BNF for Children, will be available on the new NHS Evidence web portal when it launches in April 2009. The portal is hosted by NICE, which will take over responsibility from the Department of Health for distribution of BNF publications in England.
The Agency has published guidance on the use of febuxostat for the treatment of hyperuricaemia in people with gout. The guidance recommends that febuxostat can be prescribed for people who are unable to take allopurinol.
New guidance recommends the use of infliximab for the sudden worsening of severe ulcerative colitis only when cyclosporin is contraindicated or clinically inappropriate, and only after a careful assessment of the advantages and disadvantages of treatment in the individual patient. Otherwise, infliximab should be used only as part of clinical trials, it says.
NICE is developing a clinical practice guideline on when to suspect child maltreatment. Registered stakeholders can submit their comments on the provisional recommendations using the Comments pro-forma.The consultation runs from 16 December to 10 February 2009.
FDA
The US Food and Drug Administration is asking manufacturers developing new treatments for type 2 diabetes to provide ‘robust’ phase II and III trial evidence that the product will not boost the risk of cardiovascular problems, especially when patients are older or have kidney disease. It applies to all diabetes drugs currently under development, and will require manufacturers to submit details of any heart attacks or strokes occurring in clinical trials for analysis by committees of external cardiologists. Diabetes Mellitus – Evaluating Cardiovascular Risk in New Antidiabetic Therapies to Treat Type 2 Diabetes
Manufacturers of antiepileptic drugs will be required to include warnings about the increased risk of suicidal thoughts/behaviours in their products' prescribing information and labelling. The move, which includes drugs used to treat psychiatric disorders and migraine headaches, follows a review of 199 clinical trials of 11 antiepileptic drugs, which showed that treatment almost doubled the risk of suicidal behaviours/thoughts.
HPA
The latest figures from the Agency's mandatory surveillance of MRSA bloodstream infections show that there were 725 cases reported in England between July and September 2008. The figures represent a 13% fall on the previous quarter’s figures and a 33% fall on those for the equivalent quarter of 2007 when 1,082 reports were received. Reports for individual Trusts are available at: HPA
EMEA
The Agency’s Paediatric Committee (PDCO) has agreed that several medicines can be developed for use in children: Apixaban for cardiovascular disease; Casopitant for cancer; Ceftobiprole medocaril sodium, Colistimethate sodium inhalation powder, and Etravirine for infectious diseases; Corifollitropin alfa and Rosuvastatin calcium for endocrinological, gynaecological, fertility and metabolic problems.
Meanwhile the Committee for Medicinal Products for Human Use (CHMP) has recommended the granting of marketing authorisations for the following new medicines: Efient (prasugrel) for the prevention of atherothrombotic cardiovascular events in patients undergoing PCI; Fablyn (lasofoxifene) for osteoporosis in postmenopausal women; Firmagon (degarelix) for advanced prostate cancer; Intanza and IDflu for the prevention of influenza. Ixiaro for immunisation against Japanese encephalitis in adults; and Mepact (mifamurtide) for non-metastatic osteosarcoma.
The CHMP has recommended the granting of a marketing authorisation under exceptional circumstances, and subject to specific obligations that will be reviewed annually, for the pandemic influenza vaccine Celvapan. And it has approved extensions of treatment for TachoSil (human fibrinogen and human thrombin) to promote tissue sealing and for suture support in vascular surgery; and Zavesca (miglustat) to treat progressive neurological signs in adults and children with Niemann-Pick type C disease.
Additionally the committee recommended updating the product information on antiepileptic medicines Keppra (levetiracetam), Lyrica (pregabalin), Vimpat (lacosamide) and Zonegran (zonisamide) to include the available evidence on the increased risk of suicidal thoughts/behaviour and advice to closely monitor patients during treatment. The move follows a review of the Pharmacovigilance Working Party (PhVWP) of all antiepileptic medicines available in the European Union.
Janssen-Cilag International has formally notified the Agency of its decision to withdraw an application to extend the use of Invega (paliperidone) prolonged release tablets to the treatment of acute manic episodes associated with bipolar disorder. Invega was first authorised in the European Union last June for the treatment of schizophrenia. The company said that its current data were not sufficient to support approval for this indication.
From March 2009 onwards, all non-confidential Management Board documents will be accessible to the public in a dedicated area on the EMEA website. The move is the first in a number of steps over the next few years, designed to enhance the Agency’s transparency. The EMEA has also started to look at the way it provides information about medicines.
MHRA
Healthcare professionals are being warned to check anaesthesia kits and epidural filters manufactured by Becton Dickinson for holes in the packaging. There is a risk of infection as the sterile barrier of the unit pack may have been compromised, says the Agency. Delays in the resumption of drug infusion and in the logging of motor stall events after MRI scanning may also occur with implantable drug pumps manufactured by Medtronic (SynchroMed EL 8626 and 8627 and SynchroMed II 8637). There have been nine reported incidents of motor stall and 70 reports of event logging errors worldwide to date, but no deaths or serious injuries, it says.