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FDA approves Hetlioz: first treatment for non-24 hour sleep-wake disorder in blind individuals 

 

Silver Spring, MD, USA (January 31, 2014) - The U.S. Food and Drug Administration today approved Hetlioz (tasimelteon), a melatonin receptor agonist, to treat non-24- hour sleep-wake disorder (“non-24”) in totally blind individuals. Non-24 is a chronic circadian rhythm (body clock) disorder in the blind that causes problems with the timing of sleep. This is the first FDA approval of a treatment for the disorder.

 

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Columbia University School of Nursing study first to link pay to patient outcomes

China's reliance on lower-paid contract nurses may compromise patient care

 

New York, NY, USA (January 29, 2014) – Economic and health system reforms in China in recent decades have dramatically reduced the number of traditional hospital nursing jobs, known as "bianzhi" or "iron rice bowl" positions, which are guaranteed for life. Instead, more than half of nursing posts in many Chinese hospitals are now filled with contract-based nurses who do the same work as "bianzhi" for lower pay, fewer benefits and limited job security. A new study from Columbia University School of Nursing, published in the journal Human Resources for Health, found significantly higher levels of compensation-related dissatisfaction among contract nurses than their "bianzhi" peers. Hospitals with a disproportionate number of contract nurses also had significantly higher levels of patient dissatisfaction, which prior research has linked to lower quality care and worse outcomes.

 

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Caffeine is the most widely used drug, but little is known about helping those who depend on it

Caffeine use disorder: A widespread health problem that needs more attention

 

Washington, D.C., USA (January 28, 2014) - "I'm a zombie without my morning coffee." "My blood type is Diet Coke." "Caffeine isn't a drug, it's a vitamin." Most people make jokes like these about needing a daily boost from their favorite caffeinated beverage—whether first thing in the morning or to prevent the after-lunch slump.

But a recent study coauthored by American University psychology professor Laura Juliano indicates that more people are dependent on caffeine to the point that they suffer withdrawal symptoms and are unable to reduce caffeine consumption even if they have another condition that may be impacted by caffeine—such as a pregnancy, a heart condition, or a bleeding disorder.

 

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Sleepy immune system tips balance toward tumors

Fragmented sleep accelerates cancer growth

 

Chicago, ILL., USA (January 27, 2014) - Poor-quality sleep marked by frequent awakenings can speed cancer growth, increase tumor aggressiveness and dampen the immune system's ability to control or eradicate early cancers, according to a new study published online January 21, 2014, in the journal Cancer Research. The study is the first to demonstrate, in an animal model, the direct effects of fragmented sleep on tumor growth and invasiveness, and it points to a biological mechanism that could serve as a potential target for therapy.

 

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EMA

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 20-23 January 2014

 

London, UK (January 24, 2014) - This page provides an overview of the opinions adopted at the January 2014 meeting of the Committee for Medicinal Products for Human Use (CHMP) and other important outcomes.

 

Six new medicines recommended for approval

 

The CHMP recommended granting a marketing authorisation for Eperzan (albiglutide), for the treatment of type 2 diabetes. The Committee gave a positive recommendation for Adempas (riociguat) for the treatment of chronic thromboembolic pulmonary hypertension and pulmonary arterial hypertension. Adempas has an  orphan designation. The Committee recommended the granting of a marketing authorisation for Latuda (lurasidone) for the treatment of schizophrenia. The Committee gave a positive recommendation for Bemfola (follitropin alfa), a new biosimilar medicine for the treatment of infertility. Two generic medicines were also recommended for approval by the CHMP: Rivastigmine 3M Health Care Ltd for the treatment of Alzheimer’s dementia and Zoledronic acid Teva Generics for the treatment of osteoporosis and Paget’s disease of the bone.

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Anti-Swine Flu Vaccination Linked to Increased Risk of Narcolepsy in Young Adults

 

Stockholm, Sweden (January 21, 2014) - Pandemrix is an influenza vaccination, created in 2009 to combat H1N1, known as Swine Flu. Now, a team of Swedish clinicians testing the vaccine for links to immune-related or neurological diseases have linked Pandemrix to an increased risk of narcolepsy in young adults.

 

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PRAC recommends suspending use of Protelos/Osseor

 

  • Recommendation by PRAC to be considered by CHMP for final opinion

 

London, UK (January 10, 2014) - The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) has recommended that Protelos/Osseor should no longer be used to treat osteoporosis. In April 2013 the Agency had recommended restricting the use of Protelos/Osseor to reduce the risk of heart problems. These recommendations were the result of a routine benefit-risk assessment and it was also decided at the time that there was a need for a further in-depth review.

 

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Prescription opioid abusers prefer to get high on oxycodone and hydrocodone

 

Researchers investigate factors that influence the choice of abused drugs, reports PAIN®

 

Philadelphia (December 2, 2013) – Prescription opioid abuse has reached epidemic levels in the past 15 years. Scientists investigating why people favor one drug over another have found that oxycodone and hydrocodone are the drugs of choice for 75% of opioid-dependent individuals. Their results, published in the current issue of PAIN®, show that oxycodone was the most popular drug overall because of the quality of the high for those who sought such effects. Nonetheless, hydrocodone remains one of the most popular primary drugs, even though it has lower euphoric qualities. In addition, users say they are concerned about acetaminophen poisoning since, until recently, all hydrocodone products contained non-steroidal anti-inflammatory drugs.

 

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Vitamin D Decreases Pain in Women with Type 2 Diabetes and Depression

 

Loyola Health Sciences research demonstrates additional benefits of supplement

 

Mayood, Ill., USA (December 2, 2013) – Vitamin D decreases pain in women with type 2 diabetes and depression, according to a study conducted at Loyola University Chicago. These findings were presented at an Oct. 24, 2013 research conference at Loyola’s Health Sciences Campus.

 

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Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 18-21 November 2013

 

London, UK (November 22, 2013) - This press release provides an overview of the opinions adopted at the November 2013 meeting of the Committee for Medicinal Products for Human Use (CHMP) and other important outcomes.

 

 

Seven medicines recommended for approval

 

The CHMP recommended granting a marketing authorisation for Sovaldi (sofosbuvir) in combination with other medicines for the treatment of chronic (long-term) hepatitis C in adults. Please see press release for more information.

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NICE opens consultation on a new device for managing acute or chronic wounds

 

London, UK (November 14, 2013) - The National Institute for Health and Care Excellence (NICE) today (14 November), starts consulting on its draft medical technology guidance on a device that aims to help improve the treatment of wounds. The draft medical technology guidance supports the case for adopting the Debrisoft monofilament debridement pad as part of the management of acute or chronic wounds in community settings.

 

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Neuropace: FDA approves medical device to treat epilepsy. U.S. Food and Drug Administration, 14.11.2013.Neuropace

FDA approves medical device to treat epilepsy

 

Silver Spring, MD, USA (November 14, 2013) - The U.S. Food and Drug Administration today approved a device to help reduce the frequency of seizures in epilepsy patients who have not responded well to medications. The RNS Stimulator consists of a small neurostimulator implanted within the skull under the scalp. The neurostimulator is connected to one or two wires (called electrodes) that are placed where the seizures are suspected to originate within the brain or on the surface of the brain.

 

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Touch May Alleviate Existential Fears for People With Low Self-Esteem

 

Washington, DC, USA (November 6, 2013) - As human beings, we all know that we are going to die some day. Most of us deal with this knowledge by trying to live meaningful lives, but people with low self-esteem tend not to see their lives as particularly meaningful. Now, research suggests that touch may help people with low self-esteem in confronting their own mortality.

 

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Conversations between lovers about STIs are important in theory but difficult in bed

 

BOSTON, MA, USA (November 6, 2013) - Having sex can be fun; and talking about sex can be fun. Talking about sexually transmitted infections (STI)  with a sexual interest, however, is a totally different matter, according to new research from Indiana University's Center for Sexual Health Promotion.

 

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Following simple steps can help reduce surgical-site infections, saving lives and money, says NICE in new standards

 

London, GB (November 1, 2013) - The National Institute for Health and Care Excellence (NICE) has issued standards to help prevent and treat surgical site infection in adults, children and young people undergoing surgical incisions through the skin.

 

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Drug is first with breakthrough therapy designation to receive FDA approval

FDA approves Gazyva for chronic lymphocytic leukemia

 

Silver Spring, MD, USA (November 1, 2013) - The U.S. Food and Drug Administration today approved Gazyva (obinutuzumab) for use in combination with chlorambucil to treat patients with previously untreated chronic lymphocytic leukemia (CLL). CLL is a blood and bone marrow disease that usually gets worse slowly. According to the National Cancer Institute, 15,680 Americans will be diagnosed and 4,580 will die from the disease this year.

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Better use of lighting in hospital rooms may improve patients' health

 

Cleveland, Ohio, USA (October 30, 2013) - A new study suggests that changing the lighting patterns in hospital rooms so that they're more aligned with normal sleep-wake cycles could help patients feel better with less fatigue and pain. Published early online in the Journal of Advanced Nursing, the findings point to a simple and inexpensive way to potentially improve patient care.

 

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Kessler Foundation MS study correlates fMR with negative effect of warmer weather on cognitive status

 

  • Leavitt et al. link fMRI findings with cognitive declines during warmer outdoor temperatures. Results have implications for patients and researchers

 

WEST ORANGE, N.J., USA (October 28, 2013) - Kessler Foundation scientists correlated functional magnetic resonance imaging (fMRI) findings with the negative impact of outdoor temperature on cognitive functioning in multiple sclerosis (MS). This study, “Warmer outdoor temperature is associated  with task-related increased BOLD activation in patients  with multiple sclerosis,” (http://dx.doi.org/10.1007/s11682-013-9267-7) released by Brain Imaging & Behavior as epub ahead of print, corroborates the group’s previous study that established that people with MS performed worse on processing speed and memory tasks during warmer outdoor temperatures versus during cooler outdoor temperatures.

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Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 21-24 October 2013

 

London, GB (October 25, 2013) - This press release provides an overview of the opinions adopted at the September 2013 meeting of the Committee for Medicinal Products for Human Use (CHMP) and other important outcomes.

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FDA approves second brain imaging drug to help evaluate patients for Alzheimer’s disease, dementia

 

Silver Spring, MD, USA (October 25, 2013) - The U.S. Food and Drug Administration today approved Vizamyl (flutemetamol F 18 injection), a radioactive diagnostic drug for use with positron emission tomography (PET) imaging of the brain in adults being evaluated for Alzheimer's disease (AD) and dementia.

 

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Measuring blood sugar with light

 

  • Technology designed in Germany may help people with Type 1 and Type 2 diabetes; described in Review of Scientific Instruments

 

WASHINGTON, D.C., USA (October 25, 2013) - One of the keys to healthful living with Type 1 and Type 2 diabetes is monitoring blood glucose (sugar) levels to ensure they remain at stable levels. People can easily and reliably do this at home using electronic devices that read sugar levels in a tiny drop of blood.

 

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Cologne Academic has examined the psychology of physical cleansing

Washing your hands makes you optimistic

 

Cologne, Germany (October 24, 2013) - The Junior Professor for Social and Media Psychology Dr. Kai Kaspar from the University of Cologne has examined how physical cleansing affects us after failure. The result: test subjects who washed their hands after a task were more optimistic than those who did not wash their hands, but it hampered their future performance in the same task domain. The findings of the study were published in the renowned journal Social Psychological and Personality Science. For his experiment, Kaspar took 98 subjects in three groups. In the first part of the experiment, participants from two groups had to solve an impossible task. Both the group who after failing washed their hands as well as the one that did not wash their hands were optimistic that they would do better the second time. The optimism of the group who washed their hands was, however, much greater.

 

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Warning of potential side effects of a product can increase its sales

 

Washington, DC, USA (September 24, 2013) - Drug ads often warn of serious side effects, from nausea and bleeding to blindness, even death. New research suggests that, rather than scaring consumers away, these warnings can improve consumers' opinions and increase product sales when there is a delay between seeing the ad and deciding to buy or consume the product.

 

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EMA

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 16-19 September 2013

 

London (September 20, 2013) - This page provides an overview of the opinions adopted at the September 2013 meeting of the Committee for Medicinal Products for Human Use (CHMP) and other important outcomes. This month, the Committee recommended 11 new medicines for approval – the most medicines recommended for approval at a CHMP meeting so far in 2013.

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FDA approves Abraxane for late-stage pancreatic cancer

 

Silver Spring, MD, USA (September 6, 2013) - The U.S. Food and Drug Administration today expanded the approved uses of Abraxane (paclitaxel protein-bound particles for injectable suspension, albumin-bound) to treat patients with late-stage (metastatic) pancreatic cancer.

Pancreatic cancer is the fourth leading cause of cancer death in the United States. An estimated 45,220 patients will be diagnosed and 38,460 will die from the disease in 2013, according to the National Cancer Institute. Surgery is the only option to permanently remove or cure pancreatic cancer, but it usually is too late for surgery by the time the cancer is diagnosed.

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More than one-third of populations worldwide may have low levels of vitamin D, study shows

 

Nyon, Suisse (September 4, 2013) - New systematic review published in the British Journal of Nutrition analyzes close to 200 population-based vitamin D studies from 44 countries; highest vitamin D values found in North America

A new systematic review published in the British Journal of Nutrition*, is one of the first to focus on patterns of vitamin D status worldwide and in key population subgroups, using continuous values for 25(OH)D to improve comparisons.

 

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NICE: Breast cancer drug everolimus not cost-effective

 

London, UK, (August 29, 2013) - The National Institute for Health and Care Excellence (NICE) has found that a breast cancer treatment should not be recommended for use by the NHS because it is not a good use of limited NHS money. The new guidance advises that the drug everolimus (also called Afinitor and manufactured by Novartis Pharmaceuticals) should not be routinely provided as a treatment for postmenopausal women[1] with HER2 negative, hormone-receptor-positive advanced breast cancer[2].

 

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NICE

New kidney guideline to save thousands of lives

 

London, UK (August 28, 2013) - The National Institute for Health and Care Excellence (NICE) has published a new guideline which promises to save thousands of lives and hundreds of millions of pounds each year. The new guideline will help prevent, detect and treat acute kidney injury (AKI), a condition that affects one in six people who are admitted to hospital and although it is completely preventable, can lead to death in one in four of those.

 

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Study examines risk of severe blood sugar swings among diabetics taking fluoroquinolones

 

Arlington, VA, USA (August 15, 2013) - Diabetic patients taking oral fluoroquinolones, a frequently prescribed class of antibiotics, were found to have a higher risk of severe blood sugar-related problems than diabetic patients taking other kinds of antibiotics, according to a recent study from Taiwan published in Clinical Infectious Diseases. The increased risk was low—hyperglycemia (high blood sugar) or hypoglycemia (low blood sugar) related to the drugs occurred in fewer than one in 100 patients studied—but clinicians should consider the higher risk when treating diabetic patients with fluoroquinolones, especially moxifloxacin, and prescribe them cautiously, the study's authors concluded.

 

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Without restful sleep, health of spouses of osteoarthritis patients may be at risk

Does chronic pain affect a spouse's sleep?

 

Philadelphia, PA, USA (August 15, 2013) – Research suggests that a patient's chronic pain affects a spouse's emotional well-being and marital satisfaction. In a novel study of behavioral health outcomes published in the journal PAIN®, researchers examined the effects of patients' daily knee osteoarthritis pain on their spouses' nightly sleep. They determined that couples who expressed a high degree of closeness in their marriage experienced a stronger association between pain levels and the spouse's ability to sleep restfully. Findings further illustrated that chronic pain may place the spouse's health at risk and suggest an important therapeutic target for couples.

 

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Specialist nurses as good as doctors in managing rheumatoid arthritis patients

 

Leeds,  UK (August 15, 2013) - The results of the multi-centre trial at the University of Leeds, funded by Arthritis Research UK, showed that there may be some clinical benefit to people with rheumatoid arthritis, whose condition is managed in clinics run by rheumatology clinical nurse specialists, especially with respect to their disease activity, pain control, physical function and general satisfaction with their care.

 

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Hitting the treadmill today won't help you sleep tonight; it takes 4 months to kick in

Exercise is no quick cure for insomnia

 

CHICAGO, ILL, USA (August 15, 2013) -  Exercise is a common prescription for insomnia. But spending 45 minutes on the treadmill one day won't translate into better sleep that night, according to new Northwestern Medicine® research.

"If you have insomnia you won't exercise yourself into sleep right away," said lead study author Kelly Glazer Baron, a clinical psychologist and director of the behavioral sleep program at Northwestern University Feinberg School of Medicine. "It's a long-term relationship. You have to keep at it and not get discouraged."

 

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Women of childbearing age, Asian patients may require alternative medications

Many neurologists unaware of safety risks related to anti-epilepsy drugs

 

Baltimore, Maryland, USA (August 14, 2013) - A study by Johns Hopkins researchers shows that a fifth of U.S. neurologists appear unaware of serious drug safety risks associated with various anti-epilepsy drugs, potentially jeopardizing the health of patients who could be just as effectively treated with safer alternative medications.

 

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Who benefits from vitamin D?

 

Kuopio, Finland (August 13, 2013) - Studying the expression of genes that are dependent on vitamin D makes it possible to identify individuals who will benefit from vitamin D supplementation, shows a University of Eastern Finland study published recently in PLoS One.

 

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Quick survey to assess risk for disturbances in mental cognition

New tool helps detect delirium in hospital patients

 

San Francisco, Cal., USA (August 7, 2013) - UC San Francisco researchers have developed a two-minute assessment tool to help hospital staff predict a patient’s risk of delirium, a change in mental cognition characterized by severe confusion and disorientation that can prolong hospital stays. The condition, which occurs in as many as one in five hospitalized patients, tends to develop rapidly and can lead to higher death rates and increased health care costs. The new tool is designed to be simple, efficient and accurate in helping to assess and treat patients at risk of developing delirium, the scientists said. The tool also can be used to identify patients who might be most suitable for new targeted interventions to prevent delirium, the authors reported.

 

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Recommendations consider new drugs and tests

New federal guidelines for managing occupational exposures to HIV

 

CHICAGO, ILL, USA (August 6, 2013) – New guidelines from the United States Public Health Service update the recommendations for the management of healthcare personnel (HCP) with occupational exposure to HIV and use of postexposure prophylaxis (PEP). The guidelines, published online today in Infection Control and Hospital Epidemiology, the journal of the Society for Healthcare Epidemiology of America (SHEA), emphasize the immediate use of a PEP regimen containing three or more antiretroviral drugs after any occupational exposure to HIV.

 

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NICE sets new standards to improve care for people with psoriasis

 

London, UK (August 6, 2013) - The National Institute for Health and Care Excellence, NICE, has today set new standards for the quality of care for people with psoriasis - an irritable skin condition characterised by red, flaky crusty patches of skin covered with silvery scales. More than 1.3 million people in the UK are living with psoriasis, which mainly develops in people who are under 35 years old. Although incurable, psoriasis can be managed.

 

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Antibiotic resistance among hospital-acquired infections is much greater than prior CDC estimates

 

  • FDA 'reboot' of antibiotic development rules falls short

 

LOS ANGELES, CA, USA – (August 1, 2013) – The rise of antibiotic resistance among hospital-acquired infections is greater than the Centers for Disease Control and Prevention (CDC) found in its 2008 analysis, according to an ahead-of-print article in the journal, Antimicrobial Agents and Chemotherapy. The article also finds that the Food and Drug Administration's (FDA) promise to "reboot" antibiotic development rules a year ago to combat the rise in resistance has fallen short.

 

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Exercise May be the Best Medicine for Alzheimer's

 

COLLEGE PARK, Md., USA (July 30, 2013) – New research out of the University of Maryland School of Public Health shows that exercise may improve cognitive function in those at risk for Alzheimer’s by improving the efficiency of brain activity associated with memory. Memory loss leading to Alzheimer’s disease is one of the greatest fears among older Americans. While some memory loss is normal and to be expected as we age, a diagnosis of mild cognitive impairment, or MCI, signals more substantial memory loss and a greater risk for Alzheimer’s, for which there currently is no cure. 

 

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Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 22-25 July 2013

 

London, UK (July 26, 2013) - This page provides an overview of the opinions adopted at the July 2013 meeting of the Committee for Medicinal Products for Human Use (CHMP) and other important outcomes. At its July meeting, the CHMP welcomed Ivana Mikačić as the Croatian member of the Committee following the accession of Croatia to the European Union on 1 July 2013. Ana Dugonjić has been appointed as the Croatian alternate. This addition brings the total number of CHMP members to 33.

 

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European Medicines Agency recommends changes to the use of metoclopramide

 

  • Changes aim mainly to reduce the risk of neurological side effects

 

London, UK (July 26, 2013) - The European Medicines Agency’s Committee on Medicinal Products for Human Use (CHMP) has recommended changes to the use of metoclopramide-containing medicines in the European Union (EU), including restricting the dose and duration of use of the medicine to minimise the known risks of potentially serious neurological (brain and nerve) side effects.

 

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