Nursing News

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 14-17 January 2013

 

London, UK (January 18, 2013) - This page provides an overview of the opinions adopted at the January 2013 meeting of the CHMP and other important outcomes. In the table below, readers can view the main opinions adopted at the meeting, as well as information on referral procedures. The new public-health communication document on Agency’s recommendation to suspend Tredaptive, Pelzont and Trevaclyn combines the press release and question-and-answer document previously published following CHMP meetings. The Agency publishes a new page following the CHMP meeting each month.

FDA approves Botox to treat overactive bladder

 

Silver Spring, MD, USA (January 18, 2013) - The U.S. Food and Drug Administration today expanded the approved use of Botox (onabotulinumtoxinA) to treat adults with overactive bladder who cannot use or do not adequately respond to a class of medications known as anticholinergics.

Overactive bladder is a condition in which the bladder squeezes too often or squeezes without warning. Symptoms include leaking urine (urinary incontinence), feeling the sudden and urgent need to urinate, and frequent urination.

 

FDA approves Octaplas to treat patients with blood clotting disorders

 

Silver Spring, MD, USA (January 17, 2013) - The U.S. Food and Drug Administration today approved Octaplas, a pooled plasma (human) blood product for the replacement of clotting proteins (coagulation factors) in certain medical conditions where patients have insufficient levels. Clotting protein deficiencies can cause excessive bleeding or excessive clotting.

 

Deodorants: Do we really need them?

 

Bristol, UK (January 17, 2013) - New research shows that more than 75 per cent of people with a particular version of a gene don't produce under-arm odour but use deodorant anyway. The study was based on a sample of 6,495 women who are part of the wider Children of the 90s study at the University of Bristol. The researchers found that about two per cent (117 out of 6,495) of mothers carry a rare version of a particular gene (ABCC11), which means they don't produce any under-arm odour.

 

FDA permits marketing of first test that can simultaneously identify 11 causes of infectious gastroenteritis

 

Silver Spring, MD, USA (January 15, 2013) - On Jan. 14, the U.S. Food and Drug Administration allowed marketing for the first test that can simultaneously detect 11 common viral, bacterial, and parasitic causes of infectious gastroenteritis from a single patient sample. Infectious gastroenteritis is an inflammation of the stomach and intestines caused by certain viruses, bacteria, or parasites. Common symptoms include vomiting and diarrhea, which can be more severe in infants, the elderly, and people with suppressed immune systems. Gastroenteritis can be spread easily through person-to-person contact and contaminated food, water, and surfaces.

 

Major step toward an Alzheimer's vaccine

 

Quebec City, Canada (January 15, 2013) — A team of researchers from Université Laval, CHU de Québec, and pharmaceutical firm GlaxoSmithKline (GSK) has discovered a way to stimulate the brain's natural defense mechanisms in people with Alzheimer's disease. This major breakthrough, details of which are presented today in an early online edition of the Proceedings of the National Academy of Sciences (PNAS), opens the door to the development of a treatment for Alzheimer's disease and a vaccine to prevent the illness.

 

Reminder about risk of impaired activities the morning after use for all insomnia drugs

FDA requiring lower recommended dose for certain sleep drugs containing zolpidem

 

Silver Spring, MD, USA (January 10, 2013) - The U.S. Food and Drug Administration today announced it is requiring the manufacturers of Ambien, Ambien CR, Edluar and Zolpimist, widely used sleep drugs that contain the active ingredient zolpidem, to lower current recommended doses. Ambien and Ambien CR are also available as generics. New data show that zolpidem blood levels in some patients may be high enough the morning after use to impair activities that require alertness, including driving.

 

FDA issues draft guidance on abuse-deterrent opioids

 

Silver Spring, MD, USA (January 9, 2013) - The U.S. Food and Drug Administration today issued a draft guidance document to assist industry in developing new formulations of opioid drugs with abuse-deterrent properties.

The document “Guidance for Industry: Abuse-Deterrent Opioids – Evaluation and Labeling,” explains the FDA’s current thinking about the studies that should be conducted to demonstrate that a given formulation has abuse-deterrent properties, how those studies will be evaluated by the agency, and what labeling claims may be approved based on the results of those studies.

 

Can blood pressure drugs reduce the risk of dementia?

 

San Diego, Cal., USA (January 7, 2013) – People taking the blood pressure drugs called beta blockers may be less likely to have changes in the brain that can be signs of Alzheimer's disease and other types of dementia, according to a study released today that will be presented at the American Academy of Neurology's 65th Annual Meeting in San Diego, March 16 to 23, 2013.

 

New pathway to reduce paradoxical pain

The pain puzzle: Uncovering how morphine increases pain in some people

 

Quebec City & Toronto, Canada (January 6, 2013) - For individuals with agonizing pain, it is a cruel blow when the gold-standard medication actually causes more pain. Adults and children whose pain gets worse when treated with morphine may be closer to a solution, based on research published in the January 6 on-line edition of Nature Neuroscience.

 

Telestroke networks can be cost-effective for hospitals, good for patients

 

Augusta, Ga., USA (December 17, 2012) – Telestroke networks that enable the remote and rapid diagnosis and treatment of stroke can improve the bottom line of patients and hospitals, researchers report. A central hub hospital delivering rapid stroke diagnosis and treatment partnering with typically smaller spoke hospitals in need of those services means more patients recover better and the network – and hospitals – make money, according to a study in the American Heart Association journal Circulation: Cardiovascular Quality and Outcomes.

 

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 10-13 December 2012

 

London, UK (December 14, 2012) - This page provides an overview of the opinions adopted at the December 2012 meeting of the CHMP and other important outcomes. In the table below, readers can view the main opinions adopted at the meeting, as well as information on referral procedures.

To review the individual press releases, question-and-answer documents and other documents, please click on the links under ‘more information’. The Agency publishes a new page following the CHMP meeting each month.

 

Positive recommendations on new medicines

Selincro offers treatment in conjunction with psychosocial support

EMA recommends approval of medicine for reduction of alcohol consumption

 

London, UK (December 14, 2012) - The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended the granting of a marketing authorisation for Selincro, a medicinal product intended for the reduction of alcohol consumption in adults with alcohol dependence.

 

Updated advice to reduce risk of gas embolism during spray application

EMA recommends new advice on safer use of fibrin sealant spray applications

 

London, UK (December 14, 2012) - The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended a number of new instructions for healthcare professionals using the fibrin sealants Tisseel, Tissucol, Artiss and Beriplast P (and associated names) to optimise the safe use of these medicines when applied as spray during surgery.

 

Drug approved 3 months ahead of schedule

FDA approves Iclusig to treat two rare types of leukemia

 

Silver Spring, MD, USA (December 14, 2012) - The U.S. Food and Drug Administration today approved Iclusig (ponatinib) to treat adults with chronic myeloid leukemia (CML) and Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL), two rare blood and bone marrow diseases.

 

First monoclonal antibody approved using the Animal Efficacy Rule

FDA approves raxibacumab to treat inhalational anthrax

 

Silver Spring (December 14, 2012) - The U.S. Food and Drug Administration today approved raxibacumab injection to treat inhalational anthrax, a form of the infectious disease caused by breathing in the spores of the bacterium Bacillus anthracis. Raxibacumab also is approved to prevent inhalational anthrax when alternative therapies are not available or not appropriate.

 

Drug can now be used before treatment with chemotherapy

FDA expands Zytiga’s use for late-stage prostate cancer

 

Silver Spring, MD, USA (December 10, 2012) - The U.S. Food and Drug Administration today expanded the approved use of Zytiga (abiraterone acetate) to treat men with late-stage (metastatic) castration-resistant prostate cancer prior to receiving chemotherapy.

 

Sharp spike in computer-related injuries predicted for medical workers

 

ITHACA, N.Y. (December 3, 2012) – As U.S. health care goes high tech, spurred by $20 billion in federal stimulus incentives, the widespread adoption of electronic medical records and related digital technologies is predicted to reduce errors and lower costs – but it is also likely to significantly boost musculoskeletal injuries among doctors and nurses, concludes a Cornell University ergonomics professor in two new papers.

 

NICE recommends depth of anaesthesia monitors

 

London, UK, (November 21, 2012) - Healthcare guidance body NICE has today (21 November) published final guidance recommending the use of the Bispectral Index (BIS, Covidien), E-Entropy (GE Healthcare) and Narcotrend-Compact M (MT MonitorTechnik GmbH & Co) EEG-based depth of anaesthesia monitors as options in patients receiving total intravenous anaesthesia and in patients who are considered at higher risk of adverse outcomes during any type of general anaesthesia. This includes patients who are at higher risk of unintended awareness and patients who are at higher risk from excessively deep anaesthesia.

 

Alcohol provides protective effect, reduces mortality substantial

 

Chicago, Ill., USA (November 19, 2012) - Injured patients were less likely to die in the hospital if they had alcohol in their blood, according to a study from the University of Illinois at Chicago School of Public Health -- and the more alcohol, the more likely they were to survive. "This study is not encouraging people to drink," cautions UIC injury epidemiologist Lee Friedman, author of the study, which will be published in the December issue of the journal Alcohol and is now online. That's because alcohol intoxication -- even minor inebriation -- is associated with an increased risk of being injured, he says.

 

EMA Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 12-15 November 2012

 

London (November 16, 2012) - This page provides an overview of the opinions adopted at the November 2012 meeting of the CHMP and other important outcomes.
In the table below, readers can view the main opinions adopted at the meeting, as well as information on referral procedures.
To review the individual press releases, question-and-answer documents and other documents, please click on the links under ‘more information’.

The Agency publishes a new page following the CHMP meeting each month.


New measures to minimise the risk of gas embolism during spray application

European Medicines Agency recommends new advice to surgeons on safer use of fibrin sealants Evicel and Quixil

 

London (November 16, 2012) - The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended a number of risk-minimisation measures for the fibrin sealants Evicel and Quixil to minimise the risk of gas embolism when these medicines are applied as spray during surgery.

 

EMA recommends approval of first vaccine for meningitis B

Vaccine to provide broad coverage against meningococcal group B infections

 

London (November 16, 2012) - The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended the granting of a marketing authorisation for Bexsero, a new vaccine intended for the immunisation of individuals over two months of age against invasive meningococcal disease caused by Neisseria meningitidis group B. There is currently no authorised vaccine available in the European Union (EU) for bacterial meningitis caused by Neisseria meningitidis group B.

Advocacy for planned home birth not in patients' best interest

 

  • Home-birth-like experience in hospitals ultimately safer, more satisfying, and more cost effective for patients

 

Philadelphia, PA (November 13, 2012) – Advocates of planned home birth have emphasized its benefits for patient safety, patient satisfaction, cost effectiveness, and respect for women's rights. A clinical opinion paper published in the American Journal of Obstetrics and Gynecology critically evaluates each of these claims in its effort to identify professionally appropriate responses of obstetricians and other concerned physicians to planned home birth.

 

Xarelto® (Rivaroxaban)

Landmark Phase III Study of Bayer’s Xarelto® (Rivaroxaban) Initiated for the Secondary Prevention of Myocardial Infarction and Death in Patients with Coronary or Peripheral Artery Disease

 

  • 20,000-patient study will be conducted in collaboration with Population Health Research Institute
  • Composite of cardiovascular death, myocardial infarction and stroke as primary efficacy endpoint
  • Rivaroxaban is the first novel oral anticoagulant under assessment in this high risk patient population

 

Berlin, Germany (November 13, 2012) – Bayer HealthCare announced today the initiation of the COMPASS study, the largest clinical study of its oral anticoagulant Xarelto® (rivaroxaban) to date, investigating the prevention of major adverse cardiac events (MACE) including cardiovascular death, myocardial infarction and stroke in patients with coronary artery disease (CAD) or peripheral artery disease (PAD).

 

Patients shy away from asking healthcare workers to wash hands

Patient empowerment seen as possible tool to raise hand hygiene behaviors

 

Chicago, Ill., USA (November 12, 2012) – According to a new study published online today, most patients at risk for healthcare-associated infections (HAIs) agree that healthcare workers should be reminded to wash their hands, but little more than half would feel comfortable asking their physicians to wash. The study is published in the December issue of Infection Control and Hospital Epidemiology, the journal of the Society for Healthcare Epidemiology of America. The study points to the need for patient empowerment to improve hand hygiene of healthcare workers.

 

FDA approves Xeljanz for rheumatoid arthritis

 

Silver Spring, MD, USA (November 6, 2012) - The U.S. Food and Drug Administration today approved Xeljanz (tofacitinib) to treat adults with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response to, or who are intolerant of, methotrexate.

 

National Senior Safety Week – Drug safety for seniors

Is your memory playing tricks on you? Check your medicine cabinet!

 

Montreal, Canada (November 6, 2012) - Common medication to treat insomnia, anxiety, itching or allergies can have a negative impact on memory or concentration in the elderly, according to Dr. Cara Tannenbaum, Research Chair at the Institut universitaire de gériatrie de Montréal (IUGM, Montreal Geriatric University Institute) and Associate Professor of Medicine and Pharmacy at the University of Montreal (UdeM). Up to ninety percent of people over the age of 65 take at least one prescription medication. Eighteen percent of people in this age group complain of memory problems and are found to have mild cognitive deficits. Research suggests there may be a link between the two.

 

Drug doesn't significantly lower risk of major heart problems in dialysis patients

 

Stanford, CA, USA (November 5, 2012) - In one of the largest and longest trials involving patients with kidney failure, a study led by an international team of researchers found that cinacalcet — a drug commonly prescribed to patients with kidney failure and a disturbance of bone and mineral metabolism known as secondary hyperparathyroidism — does not significantly reduce the risk of death or major cardiovascular events.

 

FDA expands use of Xarelto to treat, reduce recurrence of blood clots

 

Silver Spring, MD, USA (November 2, 2012) - The U.S. Food and Drug Administration today expanded the approved use of Xarelto (rivaroxaban) to include treating deep vein thrombosis (DVT) or pulmonary embolism (PE), and to reduce the risk of recurrent DVT and PE following initial treatment.

 

Study suggests too much risk associated with SSRI usage and pregnancy

 

Antidepressants should only be prescribed with great caution

 

Boston, MA, USA (October 31, 2012) – Elevated risk of miscarriage, preterm birth, neonatal health complications and possible longer term neurobehavioral abnormalities, including autism, suggest that a class of antidepressants known as selective serotonin reuptake inhibitors (SSRI) should only be prescribed with great caution and with full counseling for women experiencing depression and attempting to get pregnant, say researchers at Beth Israel Deaconess Medical Center, Tufts Medical Center and MetroWest Medical Center.

 

Researchers invent a quick-release medical tape that minimizes neonatal skin injury

No more tears from tears

 

Boston, MA, USA (October 29, 2012) Commercial medical tapes on the market today are great at keeping medical devices attached to the skin, but often can do damage—such as skin tissue tearing—once it's time to remove them. A research team from Brigham and Women's Hospital (BWH) has invented a quick-release tape that has the strong adhesion properties of commercial medical tape, but without the ouch factor upon removal.

The team was led by Jeffrey Karp, PhD, BWH Division of Biomedical Engineering, Department of Medicine, senior study author in collaboration with The Institute for Pediatric Innovation which defined the need and requirements for a new neonatal adhesive based on national surveys of neonatal clinicians.

 

Hot flashes can come back after SSRI

 

Cleveland, Ohio, USA (October 24, 2012) - Hot flashes and night sweats can return after women stop using escitalopram—an antidepressant—to treat these menopause symptoms, according to a study published online this month in Menopause, the journal of the North American Menopause Society. This is typical of stopping hormone therapy as well.

 

Can Diabetes Devices be Damaged by Airport Security Scanners?

 

New Rochelle, NY(October 24, 2012) — Full-body or X-ray scanners used for airport security screening may affect the function of insulin pump or continuous glucose monitoring (CGM) devices. People with diabetes can present a travel letter obtained from their physicians to avoid possible damage caused by exposure to imaging equipment in airports. The risk to these sensitive devices posed by scanners and the low-pressure conditions on airplanes are the focus of the Editorial “Navigating Airport Security with an Insulin Pump and/or Sensor,” published in Diabetes Technology & Therapeutics, a peer-reviewed journal from Mary Ann Liebert, Inc., publishers. The Editorial is available free on the Diabetes Technology & Therapeutics website.

 

Results of the TRILOGY ACS Angiographic Cohort presented at TCT 2012

Study finds that prasugrel may reduce cardiovascular events among patients managed medically after an angiogram for acute coronary syndrome

 

Miami, FL, USA (October 24, 2012) – A study has found that the anti-clotting medication prasugrel reduced cardiovascular events among patients who present with an acute coronary syndrome and are managed medically after an angiogram is performed to determine coronary anatomy. Results of the TRILOGY ACS trial, Angiographic Cohort were presented today at the 24th annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium. Sponsored by the Cardiovascular Research Foundation (CRF), TCT is the world's premier educational meeting specializing in interventional cardiovascular medicine.

 

Challenging Parkinson's dogma

 

Boston, MA, USA (October 24, 2012) - Scientists may have discovered why the standard treatment for Parkinson's disease is often effective for only a limited period of time. Their research could lead to a better understanding of many brain disorders, from drug addiction to depression, that share certain signaling molecules involved in modulating brain activity.

 

Study of Heavily Pre-Treated Myeloma Patients

Pomalidomide Demonstrated Significant Progression-Free Survival and Overall Survival Advantages in Phase III

 

Boudry, Switzerland (October 23, 2012) - Celgene International Sàrl, a subsidiary of Celgene Corporation (NASDAQ: CELG) today announced that its phase III, multi-center, randomized, open-label study (MM-003) of pomalidomide plus low-dose dexamethasone compared to high-dose dexamethasone in patients with relapsed and/or refractory multiple myeloma was reviewed by a data safety monitoring board (DSMB). The DSMB determined MM-003 met the primary endpoint of improvement in progression-free survival (PFS) at the PFS final analysis. Additionally, at the OS interim analysis, the study crossed the superiority boundary for overall survival (OS), a key secondary endpoint that the study was also powered to evaluate. Improvements in PFS and OS were both highly statistically significant and clinically meaningful. As a result, the DSMB recommended that patients who had not yet progressed in the high-dose dexamethasone arm should be crossed-over to the pomalidomide plus low-dose dexamethasone arm.

 

Excessive ICU noise may harm patients

 

Atlanta, Georgia, USA (October 22, 2012) - New research shows that overnight noise levels in the medical ICU (MICU) often exceed recommended levels, which could potentially lead to worse outcomes. Researchers from Yale University School of Medicine reviewed 70 MICU patient charts and recorded in-room activities between midnight and 4:00 AM. Based on this chart review and via direct observation, they also identified the key elements of nocturnal patient disruption.

 

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 15-18 October 2012

London (October 19, 2012) - At the start of its October 2012 meeting, the Committee for Medicinal Products for Human Use (CHMP) elected Dr Ian Hudson as its new vice-chair for a three-year mandate.
Dr Hudson brings outstanding experience and expertise from a long career in regulatory medicine and drug development, particularly in the areas of anti-infectives and oncology. He currently holds the position of Director of the Licensing Division at the Medicines & Healthcare Products Regulatory Agency in London. Dr Hudson has been a member of CHMP since 2004.
The opinions adopted by the CHMP at the October 2012 meeting and other important outcomes are listed in the table below.

European Medicines Agency finalises review of recent published data on cardiovascular safety of NSAIDs

 

Pharmacovigilance Risk Assessment Committee (PRAC) to consider need for updated treatment advice for diclofenac in follow-on review

 

London, UK (October 19, 2012) - The European Medicines Agency has finalised a review of recently published information on the cardiovascular safety of non-steroidal anti-inflammatory drugs (NSAIDs).

The Agency’s Committee for Medicinal Products for Human Use (CHMP) concluded that evidence from newly available published data sources, including meta-analysis of clinical trials and observational studies, and the results of a European Union-funded independent research project, the ‘safety of non-steroidal anti-inflammatory drugs' (SOS) project, on the cardiovascular safety of this class of medicines confirm findings from previous reviews, conducted in 2005 and 2006.

 

European Medicines Agency reviews hypothesis on Pandemrix and development of narcolepsy

 

No new concerns for Pandemrix or other vaccines on the basis of available evidence

 

London (October 19, 2012) - The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP), at the request of the Agency’s Executive Director Guido Rasi, has reviewed preliminary research results by the Finnish National Institute of Health and Welfare (THL) investigating differences in the immunological response triggered by different pandemic influenza vaccines as a potential root cause for the development of narcolepsy in persons vaccinated with Pandemrix.