Nursing News

Sanofi-aventis withdraws its marketing authorisation application for Mulsevo (semuloparin sodium)

 

London, UK (July 9, 2012) - The European Medicines Agency has been formally notified by Sanofi-aventis of its decision to withdraw its application for a centralised marketing authorisation for the medicine Mulsevo (semuloparin sodium), 20 mg, solution for injection. Mulsevo was intended to be used for the primary prophylaxis of venous thromboembolism (VTE) in cancer patients receiving chemotherapy for locally-advanced or metastatic solid tumours.

 

HPV vaccine reduces infection, even in unvaccinated

Study shows evidence of herd protection

 

Cincinnati, Ohio, USA (July 9, 2012) - The HPV vaccine not only has resulted in a decrease in human papillomavirus infection in immunized teens but also in teens who were not immunized.

The study is believed to be the first to show a substantial decrease in HPV infection in a community setting as well as herd protection – a decrease in infection rates among unimmunized individuals that occurs when a critical mass of people in a community is immunized against a contagious disease.

 

FDA introduces new safety measures for extended-release and long-acting opioid medications

Strategy emphasizes education for prescribers, patients on highly potent pain relievers

 

Silver Spring, MD, USA (July 9, 2012) -The U.S. Food and Drug Administration (FDA) today approved a risk evaluation and mitigation strategy (REMS) for extended-release (ER) and long-acting (LA) opioids, highly potent drugs approved for moderate to severe, persistent pain that requires treatment for an extended period.

 

European Medicines Agency updates guideline on drug interactions

 

London, UK (July 6, 2012) - The European Medicines Agency has finalised the update to its guideline on the investigation of drug interactions (http://www.ema.europa.eu/ema/pages/includes/document/open_document.jsp?webContentId=WC500129606).  The update, published today, is a major revision of the previous document adopted in 1997. It includes information on how pharmaceutical companies should study potential interactions between new medicines and medicines that are already on the market, as well as covering the effects of food intake.

European Medicines Agency finalises update to Parkinson's disease guideline

 

London, UK (July 6, 2012) - The European Medicines Agency has published an update to its guidance for pharmaceutical companies developing medicines for Parkinson's disease.

The update to the guideline on clinical investigation of medicinal products in the treatment of Parkinson's disease (http://www.ema.europa.eu/ema/pages/includes/document/open_document.jsp?webContentId=WC500129601), published today, covers how companies should design and carry out studies of medicines that aim to improve the disease's symptoms in patients and to modify the progress of the disease itself.

 

Methadone linked to 30 percent of prescription painkiller overdose deaths

 

Atlanta, GA, USA (July 3, 2012) - The prescription drug methadone accounted for 2 percent of painkiller prescriptions in the United States in 2009, but was involved in more than 30 percent of prescription painkiller overdose deaths, according to a CDC Vital Signs report released today by the Centers for Disease Control and Prevention.

 

FDA approves first over-the-counter home use HIV test kit

 

Silver Spring, MD, USA (July 3, 2012) - The U.S. Food and Drug Administration today approved the OraQuick In-Home HIV Test, the first over-the-counter, self-administered HIV test kit to detect the presence of antibodies to human immunodeficiency virus type 1 (HIV-1) and type 2 (HIV-2). HIV is the virus that causes acquired immune deficiency syndrome (AIDS).

 

Janssen-Cilag International NV withdraws its application for an extension of the indication for Velcade (bortezomib)

 

London (July 3, 2012) - The European Medicines Agency has been formally notified by Janssen-Cilag International NV of its decision to withdraw its application for an extension of the therapeutic indication for the centrally authorised medicine Velcade (bortezomib).

 

FDA allows marketing of first test to identify certain bacteria associated with bloodstream infections

 

Test makes it possible to identify potentially serious illness causing bacteria hours after a positive blood culture

 

Silver Spring, MD, USA (June 27, 2012) - The U.S. Food and Drug Administration today allowed marketing of the first nucleic acid test that can identify 12 different bacterial types known to cause bloodstream infections. The test allows for simultaneous identification of the bacteria and three associated resistance genes in just a few hours after the first sign of bacterial growth. Traditional methods may require two to four days to produce bacterial identification and resistance results.

 

FDA approves Belviq to treat some overweight or obese adults

 

Silver Spring, MD, USA (June 27, 2012) - The U.S. Food and Drug Administration today approved Belviq (lorcaserin hydrochloride), as an addition to a reduced-calorie diet and exercise, for chronic weight management.

 

FDA approves Myrbetriq for overactive bladder

 

Silver Spring, MD, USA (June 27, 2012) - The U.S. Food and Drug Administration today approved Myrbetriq (mirabegron) to treat adults with overactive bladder, a condition in which the bladder muscle cannot be controlled, squeezes too often or squeezes without warning.

 

European Medicines Agency finalises first set of guidelines on good pharmacovigilance practices

 

London, UK (June 25, 2012) - The European Medicines Agency has published the first set of finalised modules of the guideline on good pharmacovigilance practices (GVP) today.

The finalisation of these seven modules is a key deliverable of the 2010 pharmacovigilance legislation, which will apply from Monday 2 July 2012. Each of the modules covers one major process in the safety monitoring of medicines. These are:

European Medicines Agency advises doctors treating patients with nosocomial pneumonia with Doribax

 

Current dosing recommendations may not be enough for serious cases; no change in advice for all other approved indications

 

London, UK (June 22, 2012) - The European Medicines Agency has given new advice for the treatment of patients with nosocomial pneumonia, also known as hospital-acquired pneumonia, with Doribax (doripenem). A review of available data raises concerns that the currently approved dose of Doribax of 500mg every 8 hours may not be sufficient to treat all patients with nosocomial pneumonia, including ventilator-associated pneumonia.

 

EMA recommends restricting use of tolperisone medicines

 

Benefit-risk profile for oral tolperisone considered positive only for adults with post-stroke spasticity and negative for injectable tolperisone

 

London, UK (June 22, 2012) - The European Medicines Agency has recommended restricting the use of tolperisone, a muscle relaxant authorised to treat a variety of different conditions, including spasticity due to neurological disorders and muscle spasms associated with diseases of the spine and large joints in several European Union countries since the 1960s.

 

European Medicines Agency recommends restricting use of trimetazidine-containing medicines

 

Restricted indication for patients with stable angina pectoris and deletion of existing indications for treatment of vertigo, tinnitus and vision disturbance

 

London, UK (June 22, 2012) - The European Medicines Agency has recommended restricting the use of trimetazidine-containing medicines in the treatment of patients with angina pectoris to second-line, add-on therapy. For all other indications the Agency’s Committee for Medicinal Products for Human Use (CHMP) concluded that the benefits of these medicines were not sufficiently demonstrated and did not outweigh the risks. The CHMP therefore recommended their deletion from the marketing authorisation.

 

Celgene Europe Limited withdraws its application for an extension of the indication for Revlimid (lenalidomide)

 

Lndon, UK (June 21, 2012) - The European Medicines Agency has been formally notified by Celgene Europe Limited of its decision to withdraw its application for the centrally authorised medicine Revlimid for an extension of the therapeutic indication in patients with newly diagnosed multiple myeloma and for the addition of new pack sizes.

 

Does night work put women's health at risk?

 

Paris, France (June 19, 2012) - Breast cancer is the number one cause of female mortality. It affects 100 out of 100,000 women per year in developed countries. Each year, more than 1.3 million new cases are diagnosed, 53,000 of these in France. The risk factors of breast cancer are varied. They include genetic mutations, late first pregnancy, low parity or hormone therapy, but other causes of breast cancer such as way of life, environmental or professional causes have not yet been completely identified.

 

Weight-loss surgery increases alcohol use disorders over time

 

NIH-funded study sheds light on risk of bariatric procedures

 

Bethesda, MD, USA (June 18, 2012) - Adults who had a common bariatric surgery to lose weight had a significantly higher risk of alcohol use disorders (AUD) two years after surgery, according to a study by a National Institutes of Health research consortium.

Researchers investigated alcohol consumption and alcohol use disorders symptoms in 1,945 participants from the NIH-funded Longitudinal Assessment of Bariatric Surgery (LABS), a prospective study of patients undergoing weight-loss surgery at one of 10 hospitals across the United States. Within 30 days before surgery, and again one and two years after surgery, study participants completed the Alcohol Use Disorders Identification (AUDIT) test. The test, developed by the World Health Organization, identifies symptoms of alcohol use disorders, a condition that includes alcohol abuse and dependence, commonly known as alcoholism.

 

Top risk of stroke for normal-weight adults: Getting under 6 hours of sleep

 

Stroke risk greatest for employed middle to older ages, normal weight and no sleep apnea, habitually sleeping less than 6 hours each day

 

Darien, IL, USA (June 11, 2012) – Habitually sleeping less than six hours a night significantly increases the risk of stroke symptoms among middle-age to older adults who are of normal weight and at low risk for obstructive sleep apnea (OSA), according to a study of 5,666 people followed for up to three years.

Quick, simple test developed to identify patients who will not respond to the painkiller tramadol

 

Paris, France (June 10, 2012) -  French researchers have found a way to identify quickly the 5-10% of patients in whom the commonly used painkiller, tramadol, does not work effectively. A simple blood test can produce a result within a few hours, enabling doctors to switch a non-responding patient on to another painkiller, such as morphine, which will be able to work in these patients.

 

Aspirin before heart surgery reduces the risk of post-operative acute kidney failure

 

Paris, France (June 10, 2012) -  Aspirin taken for five days before a heart operation can halve the numbers of patients developing post-operative acute kidney failure, according to research presented at the European Anaesthesiology Congress in Paris today (Sunday).

 

Fixed-dose combination therapies in hypertension offer improved adherence as well as cost savings according to new data

 

Rome, Italy (June 8, 2012) - For patients with hypertension, fixed-dose combination (FDC) therapies offer not only improved patient adherence translating into better blood pressure control but cost savings as well, according to new data presented at a Daiichi Sankyo press briefing in Rome today. The data, based on the Sokol economic model, showed potential yearly cost savings of €1.8 million if 10,000 hypertensive patients in each of the five EU countries (Spain, UK, Italy, Germany and France) were switched from a free dose combination of two hypertension treatments to a respective FDC containing the same compounds.1 The savings were based on improved adherence to treatment translating into better blood pressure control and subsequent reduced risk of hospitalisation and associated medical costs.

 

Sleepy medical staff run increased risks of accidents driving home after a night shift

 

Paris, France (June 8, 2012) - The drowsiness experienced by medical staff who have been on night duty can make their driving dangerous, French researchers have found. The first study to use simulated driving tests on medical staff returning home after a night shift showed that, under the monotonous driving conditions similar to those experienced on autoroutes (motorways or highways), it was more difficult for them to hold a straight line while driving than it was when they had not been working overnight. They also had greater difficulty in controlling their speed when driving in monotonous conditions.

 

European Medicines Agency boosts EU transparency with online publication of suspected side effect reports

 

Member States and the Agency release data on medicines in compliance with EudraVigilance access policy

 

London, UK (May 31, 2012) - The European Medicines Agency has today begun publishing suspected side effect reports for medicines authorised in the European Economic Area (EEA) on a new public website: www.adrreports.eu. The reports come directly from the European Union (EU) medicines safety database EudraVigilance, and are one of the many types of data used by regulators to monitor the benefits and risks of a medicine once authorised. The launch of the new website is part of the Agency’s continuing efforts to ensure EU regulatory processes are transparent and open and is a key step in the implementation of the EudraVigilance access policy.

 

Benefits of hypothermia for infants continue through early childhood

 

NIH study shows increased survival from treatment for oxygen deficiency at birth

 

Bethesda, MD, USA (May 30, 2012) - A treatment to reduce the body temperatures of infants who experience oxygen deficiency at birth has benefits into early childhood, according to a follow-up study by a National Institutes of Health research network.

Children who received the hypothermia treatment as infants were more likely to have survived to ages 6 and 7, when they were evaluated again, than were children who received routine care, the study found. They were no more likely than the routine care group to experience a physical or cognitive impairment, it said. The report appears in the New England Journal of Medicine.

 

ERA-EDTA Congress 2012

The Gift of Life

 

Darren J. Cawley (Ireland)

 

Paris, France (25. Mai 2012) - I have had CKD (chronic kidney disease) since I was twenty. I was studying for a degree in Sports & fitness Studies in college in England at that time and had no idea I was having a health problem. I was very enthusiastic about sport competing in soccer, rugby, Gaelic football and I also won provincial titles in boxing and handball. But then while studying I started to get lots of headaches and blurred visions. I put off seeing a doctor as long as I could. When I finally did see a doctor, she did not take it seriously, she just sent me to an optician – my exams were coming up and maybe she thought I was trying to get out of them. The optician, however, sent me straight into hospital. There they discovered my blood pressure was so high – it was bursting the blood vessels in my eyes. They did all the tests and a biopsy. A few days later the doctor came to my bedside and said he was very sorry, but I had end-stage renal failure. I did not know what that was all about and therefore I asked him if I was going to die. He assured me I would not but I would be starting on this strange thing called dialysis!

 

Chronic Kidney Disease (CKD)

The forgotten illness

 

  • Prof. Raymond Vanholder (University Hospital Ghent, Belgium), President of the European Renal Association – European Dialysis and Transplant Association (ERA-EDTA)

 

Paris, France (May 25, 2012) - At least 70 million Europeans (> 10%) have lost more than half of their kidney function, a condition named chronic kidney disease (CKD). Below this threshold, CKD causes a dramatic increase of general and cardiovascular mortality. Survival chances at the start of dialysis, one of the treatment modalities for replacement of severely damaged kidneys, is currently worse than when colon carcinoma are diagnosed. Risk calculations demonstrate that CKD is a negative cardiovascular prognostic factor as such, irrespective of the traditional mortality risks such as cholesterol or blood pressure. CKD should thus be considered a crucial health issue, necessitating specific preventive and therapeutic approaches.

 

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 21-24 May 2012

 

London, UK (May 25, 2012) - This page lists the opinions adopted at the May 2012 meeting of the Committee for Medicinal Products for Human Use (CHMP) and other important outcomes.

 

NICE guideline to standardise opioid use in palliative care and address patients' concerns

 

London, UK (May 23, 2012) - A new clinical guideline published today (23 May) by the National Institute for Health and Clinical Excellence (NICE), will help ensure safe and consistent prescribing of opioids as a first-line treatment option to relieve pain for patients receiving palliative care for chronic or incurable illnesses.

 

Committee for Orphan Medicinal Products (COMP) May 2012 highlights

 

London, UK (May 22, 2012) - During its May 2012 meeting, the Committee for Orphan Medicinal Products (COMP) adopted a total of 16 recommendations for orphan designation. Orphan designation can be granted early in the development process to substances that are intended for diagnosis, prevention or treatment of life-threatening or very serious conditions that affect not more than 5 in 10,000 people in the European Union (EU) or that would not be developed without incentives.

 

Blood pressure drugs don't protect against colorectal cancer

 

Heidelberg, Germany (May 14, 2012) - A new study has found that, contrary to current thinking, taking beta blockers that treat high blood pressure does not decrease a person's risk of developing colorectal cancer. Published early online in CANCER, a peer-reviewed journal of the American Cancer Society, the study also revealed that even long-term use or subtypes of beta blockers showed no reduction of colorectal cancer risk.

 

How to minimize stroke damage

 

Maywood, Il., USA (May 14, 2012) - Following a stroke, factors as varied as blood sugar, body temperature and position in bed can affect patient outcomes, Loyola University Medical Center researchers report. In a review article in the journal MedLink Neurology, first author Murray Flaster, MD, PhD and colleagues summarize the latest research on caring for ischemic stroke patients. (Most strokes are ischemic, meaning they are caused by blood clots.)

 

Reducing post-traumatic stress after ICU

 

Stockholm, Sweden (May 13, 2012) - Women are more likely to suffer post-traumatic stress than men after leaving an intensive care unit (ICU), finds a new study published in BioMed Central's open access journal Critical Care. However, psychological and physical 'follow-up' can reduce both this and post-ICU depression.

 

International Nurses Day 2012: Closing the gap: from evidence to action International Nurses Day 2012

Closing the gap: from evidence to action

 

Geneva, Switzerland (May 12, 2012) - International Nurses Day is celebrated around the world every May 12, the anniversary of Florence Nightingale's birth. The International Council of Nurses commemorates this important day each year with the production and distribution of the International Nurses' Day (IND) Kit. The IND Kit 2012 contains educational and public information materials, for use by nurses everywhere.

 

FDA issues alert on potential dangers of unproven treatment for multiple sclerosis

 

Silver Spring, MD, USA (Mai 10, 2012) - The U.S. Food and Drug Administration is alerting health care professionals and patients (http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm303318.htm) about injuries and death associated with the use of an experimental procedure sometimes called “liberation therapy” or the “liberation procedure” to treat chronic cerebrospinal venous insufficiency (CCSVI).

 

Researchers Say Urine Dipstick Test is Accurate Predictor of Renal Failure in Sepsis Patients

 

Detroit, Mich., USA (May 10, 2012) – Henry Ford Hospital researchers have found that the presence of excess protein in a common urine test is an effective prognostic marker of acute renal failure in patients with severe sepsis.

High-risk behaviors for skin cancer common among young adults

 

Half of adults younger than age 30 report being sunburned; indoor tanning rates highest among white women

 

Atlanta, GA, USA (May 10, 2012) - Young adults are increasing their risk for developing skin cancer, according to two studies by the Centers for Disease Control and Prevention and the National Cancer Institute.

One study, of people aged 18-29, found that 50 percent reported at least one sunburn in the past year, despite an increase in protective behaviors such as sunscreen use, seeking shade, and wearing long clothing to the ankles. Another report found that indoor tanning is common among young adults, with the highest rates of indoor tanning among white women aged 18-21 years (32 percent) and 22-25 years (30 percent). Both reports evaluated data from the National Health Interview Survey’s Cancer Control Supplement. They are published in today’s issue of CDC’s Morbidity and Mortality Weekly Report.

 

European Centre for Disease Prevention and Control (ECDC)

New joint risk assessment on risks to human health of the Schmallenberg virus

 

Stockholm, Sweden (May 8, 2012) - ECDC, in conjunction with the Robert Koch Institute (RKI) in Germany and National Institute of Public Health and the Environment (RIVM) in the Netherlands, has published a new risk assessment on the risks to human health of the Schmallenberg virus.

 

Researchers unveil new assessment for diagnosing malnutrition

 

A new systematic assessment of malnutrition, created by researchers at Penn State, will aid dietitians and other health care providers in diagnosis and treatment

 

Washington, DC, USA (May 3, 2012) - Up to 50 percent of patients in hospitals and nursing facilities are estimated to be malnourished, according to Gordon Jensen, professor and head of nutritional sciences, Penn State. Although malnutrition is widespread, confusion exists in the clinical community on how to best make this diagnose. Malnourished patients are frequently not identified as such, and those not affected are sometimes thought to be malnourished.

 

How to get a good night's sleep

Earplugs in the intensive care unit ward off confusion

 

(Mai 3, 2012) - Patients in an intensive care unit (ICU) often become confused or delirious soon after, or within a few days of, admittance to the ICU. New research published in BioMed Central's open access journal Critical Care shows that use of earplugs can result in better sleep (as reported by the patients), lower the incidence of confusion, and delay the onset of cognitive disturbances.

 

Bladder tests before urinary incontinence surgery in women may be unnecessary

 

NIH-funded study finds pre-operative office visit alone sufficient for comparable outcomes

 

Bethesda, MD, USA (May 2, 2012) - An invasive and costly test commonly done in women before surgery for stress urinary incontinence may not be necessary, according to a study funded by the National Institutes of Health. The study compared results after both a pre-operative check-up in a doctor's office and bladder function tests to results after only the office check-up. Women who had only the office check-up had equally successful outcomes after surgery.