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Interim restriction on lumiracoxib prescribing The COX‐2 selective NSAID lumiracoxib (Prexige) should no longer be prescribed for patients with liver disease or those at risk of liver disease due to their history or concurrent medication, the MHRA has announced. Patients taking the drug should now undergo liver function tests. The drug's manufacturer, Novartis, is writing to health professionals to advise them of the new restrictions. Eleven cases of severe liver reactions have been reported worldwide, including two deaths and three liver transplants, mostly associated with doses above the 100mg used in the UK. The MHRA has received 16 yellow cards reporting liver reactions with lumiracoxib, none fatal. Patients, unless unwell, have been advised to complete their current course of treatment before contacting their GP. The restrictions are an interim measure pending a full safety review by the European regulatory authorities in September. MHRA restricts supply of pseudoephedrine The MHRA has reduced the maximum quantity of the decongestants pseudoephedrine and ephedrine that can be supplied over the counter at one time and asked pharmacists to make sales personally. The move follows concerns that the two sympathomimetics can be used in the manufacture of methylamphetamine (crystal meth), a Class A drug. The Agency has decided to limit pack sizes to a maximum of 12 60mg tablets or capsules or 24 of the 30mg strength; only one pack may be supplied at one time. The MHRA has recommended that supplies are made by pharmacists themselves. The new regulations will be kept under review to monitor effectiveness and a review of the effectiveness and safety of all decongestants in this class will be carried out. Pseudoephedrine and ephedrine will be reclassified as prescription‐only medicines in 24 months, or earlier if necessary, unless it can be shown these measures ‘contain the risk of misuse’. The Royal Pharmaceutical Society has advised pharmacists to implement the changes before the new packaging is introduced; the larger packs will only be available on prescription. Lower CV risk with perindopril combination Perindopril plus indapamide for lowering blood pressure (BP) significantly reduces the relative risk of major vascular events, including death, in both normotensive and hypertensive patients with type 2 diabetes ( The Lancet online: September 2007; DOI:10.1016/S01406736(07)61303‐8). ADVANCE (Action in Diabetes and Vascular Disease: PreterAx and DiamicroN MR Controlled Evaluation), a multicentre, randomised, placebo‐controlled trial involved routine BP lowering among 11 140 normotensive and hypertensive patients with type 2 diabetes. Treatment included a fixed combination of the ACE inhibitor perindopril and the thiazide diuretic indapamide‐Preterax (Coversyl Plus in different doses) – in addition to any medication already being taken including ACE inhibitors and other antihypertensive drugs, statins and other lipid lowering agents, and aspirin and other antiplatelets. The relative risk of cardiovascular‐related death was reduced by 18 per cent compared with placebo (3.8 vs 4.6 per cent, p =0.03), and death from any cause was reduced by 14 per cent (7.3 vs 8.5 per cent, p =0.03). Benefits were similar in both normotensive and hypertensive patients in the presence and absence of other treatments at baseline. The study demonstrates that lowering BP in patients with type 2 diabetes significantly reduces the risk of death and cardiovascular events irrespective of initial blood pressure status or other related treatments. Biologicals increase skin cancer risk Biological agents for rheumatoid arthritis are associated with an increased risk of skin cancer, a US study suggests ( Arth Rheum 2007;56:2886‐95). The analysis of the US National Databank for Rheumatic Diseases included 13 000 patients, half of whom had been treated with etanercept (Enbrel), infliximab (Remicade), adalimumab (Humira) or anakinra (Kineret). Compared with national cancer rates, the overall risk of all cancers among patients who had received biological therapy was not significantly raised. However, the risk of nonmelanotic skin cancer was 50 per cent higher and that of melanoma was more than doubled (though this was not statistically significant). Malaria still increasing The number of cases of malaria in the UK is still increasing, according to the latest report from the Health Protection Agency ( www.hpa.org.uk ). In 2005, the latest year for which data are available, there were 1754 cases of malaria in the UK – an increase of 6 per cent over 2004. Three‐quarters of cases were due to Plasmodium falciparum . Of the 53 per cent of cases for which information was available, 78 per cent of patients took no or inappropriate prophylaxis. This was similar to 2004, when 77 per cent of patients failed to take adequate medication to prevent infection. There were 16 deaths in 2004/05, of which eight were known to have taken no prophylaxis. The HPA concludes there is a need to promote awareness of the risks of malaria, particularly among UK residents visiting their families in Africa and the Indian subcontinent. Travellers need to account for the time required to take proper precautions and the travel industry should remind travellers to seek medical help. COCs may worsen HRT breast cancer risk Women with a history of using combined oral contraception may be at higher risk of developing breast cancer after using HRT, say Norwegian investigators ( Int J Cancer 2007;121: 645‐8). The Norwegian Women and Cancer study included follow‐up on 30 118 postmenopausal women. Between 1996 and 2004 there were 540 new cases of breast cancer in this group. Compared with never‐users, HRT was associated with an increased risk of breast cancer that was higher among women who had used a COC (relative risk, RR, 2.45) than those who had not (RR 1.67). Use of oestrogen‐only or combined HRT did not alter the findings. Optometrists prescribe Optometrists will soon be able to train as independent prescribers, the Department of Health has announced. Once trained, optometrists will only prescribe for conditions of the eye and surrounding tissues, referring on to an ophthalmologist when more specialised care is indicated. Optometrists' prescribing will be subject to guidelines from the College of Optometrists and qualified practitioners will need to apply for specialty registration with the General Optical Council. Health Inequalities Intervention Tool targets low life expectancy The Department of Health has launched a website to help health services and local authorities target low life expectancy in deprived areas. The Health Inequalities Intervention Tool was commissioned from the Association of Public Health Observatories ( www.apho.org.uk ) to provide rapid assessments of the impact of health interventions in the most deprived areas of the country (the ‘Spearhead’ areas). The tool provides data on local life expectancy, the difference in life expectancy from the national average, and a breakdown of the diseases causing low life expectancy in each area. A ‘ready reckoner’ then provides a quick estimate of the likely effect of high‐impact interventions such as prescribing statins, smoking cessation and prescribing antihypertensive drugs for people with no cardiovascular disease. The tool can be downloaded from the London Health Observatory ( www.lho.org.uk ) or the Yorkshire and Humber Public Health Observatory websites ( www.yhpho.org.uk ).BNF now on mobiles The BNF is now available on digital mobile devices such as the Blackberry, the new Apple iPhone and Palm OS. The new configuration is intended to increase access at the point of care. The BNF is now working with other systems developers such as EMIS and Map of Medicine to integrate its services more closely with medical and pharmacy e‐systems. New from NICE Adalimumab for the treatment of psoriatic arthritis. Technology Appraisal Guidance No. 125, August 2007 Adalimumab (Humira) is a monoclonal antibody that binds to tumour necrosis factor‐alpha (TNF‐alpha), a cytokine that is believed to play a role in swelling, pain, bone destruction and skin plaques in psoriatic arthritis. The recommended dose is 40mg by subcutaneous injection on alternate weeks. Treatment costs £9295 per year. NICE recommends adalimumab for adults with active and progressive psoriatic arthritis who meet two criteria: three or more swollen joints and three or more tender joints, and no response to an adequate trial of treatment with two standard disease‐modifying antirheumatic drugs (DMARDs) either in combination or separately. These criteria are identical to those in NICE guidance on etanercept (Enbrel). Treatment with adalimumab should be initiated by a specialist and discontinued after 12 weeks if there is no adequate response (defined as improvement in two of the four psoriatic arthritis response criteria, one of which must be joint tenderness or swelling, with no deterioration in any of these criteria). There are no direct comparisons of the three anti‐TNF agents ‐ adalimumab, etanercept and infliximab (Remicade) – in psoriatic arthritis. Consultees suggested they appear to be broadly equally effective against the arthritis components but have different efficacies against the skin component. NICE did not consider the evidence sufficiently robust to establish a hierarchy of effectiveness.Urinary tract infection in children. Clinical guideline No. 54, August 2007 This guidance covers diagnosis, acute management, imaging and surgical intervention, and follow‐up of urinary tract infection (UTI) in children aged under 16. Treatment and care should be child centred, taking into account the preferences of the child and parents/carers. Feverish children should be assessed according to NICE Clinical Guideline 47. Infants and children with unexplained fever (38°C) or symptoms suggestive of a UTI should have a urine test within 24 hours; those with an alternative site of infection should not be tested unless they remain unwell. Acute treatment depends on age. Infants under three months old with suspected UTI should be referred to a paediatrician. Referral should also be considered for older children with suspected acute pyelonephritis or upper UTI, for whom a 7‐ to 10‐day course of an antibiotic such as coamoxiclav or a cephalosporin is recommended. Older children with suspected lower UTI or cystitis should receive a three‐day course of an antibiotic such as trimethoprim in accordance with local guidance and followed up after one to two days. Dysfunctional elimination syndromes should be addressed and children should be encouraged to drink adequate fluids to prevent recurrence; antibiotic prophylaxis is not recommended. Ultrasound imaging is recommended within six weeks for all children under six months with a first infection, and for older children with recurrent or atypical UTI. Surgery is not routinely recommended for vesicoureteric reflux. Copyright © 2007 Wiley Interface Ltd