Report: Responses from cancer survivors survey on quality of life after diagnosis and treatment
This report summarises text responses from cancer survivors on how they feel about their quality of life following diagnosis and treatment. It complements the Cancer survivorship patient reported outcome measures pilot survey (December 2012), where respondents could voice their opinions in a free text comments section.   The report is aimed at commissioners, commissioning support units and providers to help them understand how services may offer appropriate education, advice and support to the growing numbers of people who are living well, following completion of cancer treatment. Please see the link below for det...
Source: NeLM - News - February 4, 2013 Category: Drugs & Pharmacology Source Type: news

FDA approves glycerol phenylbutyrate (Ravicti®) for the chronic management of some urea cycle disorders
Source: FDA Area: News The US FDA has approved the orphan drug glycerol phenylbutyrate (Ravicti®) for the chronic management of some urea cycle disorders (UCDs) in patients ages 2 years and older.   UCDs are genetic disorders that involve deficiencies of specific enzymes involved in the urea cycle, a series of biochemical steps normally required to remove ammonia from the blood. This leads to accumulation of ammonia, which can travel to the brain and cause brain damage, coma or death. Glycerol phenylbutyrate helps dispose of ammonia in the body and is intended for patients whose UCD cannot be managed by a protei...
Source: NeLM - News - February 4, 2013 Category: Drugs & Pharmacology Source Type: news

GSK fights compensation claims from UK patients who took rosiglitazone
Source: BMJ Area: News According to a report in the British Medical Journal (BMJ), GlaxoSmithKline is fighting compensation claims from UK patients who allege that rosiglitazone (Avandia®) harmed them. The company has already paid billions of dollars to settle tens of thousands of similar claims in the United States.   It is thought that around 90,000 patients in the United Kingdom were taking rosiglitazone when it was taken off the European market in 2010. A solicitor has claimed that GSK has been fighting litigation in the UK and has himself launched proceedings for four claimants and have another 20 or so po...
Source: NeLM - News - February 4, 2013 Category: Drugs & Pharmacology Source Type: news

Pegloticase (Krystexxa®) approved in the EU for treatment of severe debilitating chronic tophaceous gout
Source: EMA Area: News Pegloticase (Krystexxa®) has been approved by the European Commission for the treatment of severe debilitating chronic tophaceous gout in adult patients who may also have erosive joint involvement and who have failed to normalise serum uric acid with xanthine oxidase inhibitors at the maximum medically appropriate dose or for whom these medicines are contraindicated.   Treatment should be initiated and supervised by specialist physicians experienced in the diagnosis and treatment of severe refractory chronic gout. The recommended dose is 8mg given as an intravenous infusion every two week...
Source: NeLM - News - February 4, 2013 Category: Drugs & Pharmacology Source Type: news

Company restores restricted access to alemtuzumab for MS after pressure from neurologists
Source: BMJ Area: News According to a report in the British Medical Journal (BMJ), Genzyme has agreed to restore a limited supply of alemtuzumab to enable patients with multiple sclerosis (MS) who had already started a course to complete their treatment. The company previously withdrew off-label use of alemtuzumab for patients with MS, with supply through a patient access scheme for oncological and transplant indications only (see previous NeLM report).   According to the report, Isabelle Izzard (principal pharmacist at the Department of Health for England) has written a letter to the NHS saying that Genzyme has...
Source: NeLM - News - February 4, 2013 Category: Drugs & Pharmacology Source Type: news

NHS Choices 'Behind the Headline' assessment of reports that a charity has called for boys to get HPV jab
Source: NHS Choices Area: News The 'Behind the Headlines' service from NHS Choices has produced an assessment of recent press reports that boys as well as girls should receive the human papilloma virus (HPV) vaccine, according to experts. These reports were based on recommendations made by the Throat Cancer Foundation that the HPV vaccination programme be extended to boys to give a "gender neutral vaccination". However the Department of Health currently has no plans to extend the vaccination programme, based on consideration of the currently available evidence.   The assessment looks at the following: . Wh...
Source: NeLM - News - February 4, 2013 Category: Drugs & Pharmacology Source Type: news

Direct Healthcare Professional Communication on association between anagrelide (Xagrid®) therapy and cardiovascular risk
Source: MHRA Area: News Shire has issued a Direct Healthcare Professional Communication regarding the association of anagrelide hydrochloride (Xagrid®) with cardiovascular risk in patients with essential thrombocythaemia (ET), regardless of the patient's medical history, and to remind healthcare professionals that it is indicated as a second-line therapy in at risk patients.   Shire recently conducted a review of all cardiac adverse events in patients <50 years treated with anagrelide, which showed that serious events have occurred in these younger patients, despite them having no suspected heart disease, no...
Source: NeLM - News - February 4, 2013 Category: Drugs & Pharmacology Source Type: news

Direct Healthcare Professional Communication: Interaction between sodium stibogluconate (Pentostam®) and amphotericin B deoxycholate
Source: MHRA Area: News GlaxoSmithKline has issued a Direct Healthcare Professional Communication regarding new interaction details for sodium stibogluconate (Pentostam®), which have been added to the product information.   An increased risk of fatal cardiac arrhythmias has been observed when amphotericin B deoxycholate is administered soon after sodium stibogluconate during retreatment of visceral leishmaniasis. Although the mechanism is unknown, it is suggested that sodium stibogluconate increases the susceptibility of the myocardium to damage by amphotericin B deoxycholate.   Sections 4.4 and 4.5 h...
Source: NeLM - News - February 4, 2013 Category: Drugs & Pharmacology Source Type: news

Infant outcomes among pregnant women who used oseltamivir for treatment of influenza during the H1N1 epidemic
Source: American Journal of Obstetrics and Gynecology Area: News According to research reported early online in the American Journal of Obstetrics and Gynecology, use of oseltamivir to treat or prevent H1N1 influenza during pregnancy does not appear to increase the risk of early birth, poor foetal growth or a low Apgar score at birth.   The researchers note that only a few studies have examined the association between maternal use of oseltamivir and pregnancy outcomes. Although the benefit of treatment of pregnant women with antivirals is presumed to outweigh its risks, the limited information available is challe...
Source: NeLM - News - February 4, 2013 Category: Drugs & Pharmacology Source Type: news

MHRA launches public health campaign to urge reporting of side-effects through the Yellow Card Scheme
Source: MHRA Area: News The Medicines and Healthcare products Regulatory Agency (MHRA) has launched a campaign to highlight the need for the public to report any suspected side effects from medicines through the Yellow Card Scheme. Figures show that reports from members of the public have declined from a high of 3,584 in 2006 to 1,789 in 2012, and that GP reporting has fallen steadily over a nine-year period - from 5,578 in 2003 to 3,511 in 2012.   The aims of the campaign are to ensure health professionals recognise the importance of reporting adverse reactions via the Yellow card Scheme and to increase public a...
Source: NeLM - News - February 4, 2013 Category: Drugs & Pharmacology Source Type: news

WHO issues guidelines for sodium intake for children
Source: Reuters Health News Area: News The World Health Organisation (WHO) has published guidance recommending limits on children's daily consumption of sodium.  The guidelines vary depending on the child's size, age and energy needs, and apply to children over the age of two. The WHO has also revised its recommendations for adults, down to less than 2,000mg of sodium intake per day, from the current 2,000 mg, in addition to a recommendation of at least 3,510 mg of potassium a day.   Sodium is found naturally in many foods such as milk products and eggs but is present in much higher levels in processed foods...
Source: NeLM - News - February 1, 2013 Category: Drugs & Pharmacology Source Type: news

Charity calls for universal HPV vaccination
Source: BBC Health News Area: News Schoolboys in the UK should receive the human papillomavirus (HPV) vaccine to protect against throat cancer, a charity has urged.   The jab was introduced in 2008 for girls, to immunise them against the virus that causes cervical cancer. The Throat Cancer Foundation says the vaccine protects against other cancers and has urged the government to extend the programme to all 12-year-olds.   A Department of Health representative said: "There are currently no plans to extend HPV vaccination to males, based on an assessment of available scientific evidence.   (Source: NeLM - News)
Source: NeLM - News - February 1, 2013 Category: Drugs & Pharmacology Source Type: news

EMA opens consultation on draft guideline on biosimilars containing low-molecular-weight heparins
Source: European Medicines Agency (EMA) Area: News The European Medicines Agency has launched a six-month public consultation on the revised guideline on non-clinical and clinical development of similar biological medicinal products containing low-molecular-weight heparins (LMWHs).   This guideline describes the non-clinical and clinical requirements for a LMWH-containing medicinal product claiming to be similar to another one already on the market. The non-clinical section addresses the pharmacotoxicological requirements and the clinical section describes the requirements for pharmacokinetic, pharmacodynamic, ef...
Source: NeLM - News - February 1, 2013 Category: Drugs & Pharmacology Source Type: news

Intravenous immunoglobulin for treatment of mild-to-moderate Alzheimer's disease: a phase 2 dose-finding trial
Source: Lancet Neurology Area: News It has been suggested in three small trials that intravenous immunoglobulin can affect biomarkers and symptoms of mild-to-moderate Alzheimer's disease.   A multicentre, placebo-controlled phase II study at sites in the USA and Germany was carried out to test the safety, effective dose and infusion interval of immunoglobulin in patients with mild-to-moderate Alzheimer's disease. Patients aged 50-85 years were randomly assigned to infusions every 4 weeks (0.2, 0.5, or 0.8g intravenous immunoglobulin per kilogram bodyweight, or placebo) or infusions every 2 weeks (0.1, 0.25, or 0....
Source: NeLM - News - February 1, 2013 Category: Drugs & Pharmacology Source Type: news

Department of Health publishes health services non-mandatory contract and guidance
Source: Department of Health (DH) Area: News The Department of Health has published the non-mandatory public health services contract which is designed to be used by local authorities in commissioning services to meet their new public health functions.   It is adaptable for use for a broad range of public health services and delivery models. The contract provides a robust framework to hold providers to account for the delivery of high quality public health funded services to achieve improved health outcomes. (Source: NeLM - News)
Source: NeLM - News - February 1, 2013 Category: Drugs & Pharmacology Source Type: news