PRESS-NEWS.org - Press Release Distribution
PRESS RELEASES DISTRIBUTION

New study clarifies concerns regarding commonly used anti-nausea drug ondansetron

2013-12-09
(Press-News.org) Contact information: Marta
mcyperli@ucalgary.ca
403-210-3835
University of Calgary
New study clarifies concerns regarding commonly used anti-nausea drug ondansetron For the past two years, warnings regarding the possible link between a commonly used anti-nausea and vomiting drug ondansetron and heart arrhythmias have been a source of uncertainty in emergency departments. New research from The Hospital for Sick Children (SickKids) and the University of Calgary's Alberta Children's Hospital Research Institute helps to clarify the actual risk of ondansetron administration and cardiac arrhythmias in both children and adults. The study is published in the December issue of Annals of Emergency Medicine.

In 2011, the Food and Drug Administration notified health-care professionals and patients of an ongoing safety review and labelling changes for the anti-nausea drug linking its use to the possibility of inducing abnormal and potentially fatal arrhythmias. The warning also implied that doctors needed to rule out conditions that might place patients at risk for developing an abnormal heart rhythm prior to giving patients the drug. Screening all patients for such conditions requires ECG monitoring and blood testing, which are associated with discomfort, delayed care and may lead to additional unnecessary investigations and anxiety. In 2012, the FDA issued an update linking the risk only to the administration of the drug in high doses intravenously. However, there was no change in the universal screening recommendations to all patients before receiving ondansetron, in any dose or route.

Following the FDA, Health Canada issued a similar communication (October 9, 2012), warning health professionals about the risk of high-dose intravenous ondansetron and recommending that physicians assess patients for risk factors before administering the drug.

Through an in-depth post-marketing analysis which included a systematic review of published literature, the FDA Adverse Events Reporting System and the World Health Organization Individual Safety Case Reports Database, Drs. Yaron Finkelstein and Stephen Freedman explored this association. They did not find any reports of arrhythmia related to the administration of a single oral dose of ondansetron, the most common administration route, employed in over 85 per cent of doses given to children in emergency departments.

"The non-targeted screening recommendations have potential for patient harm on multiple levels, including withholding an effective treatment, delay of care, additional unnecessary procedures and misdiagnoses," says the study's principal investigator, Dr. Yaron Finkelstein, staff physician in Paediatric Emergency Medicine and Clinical Pharmacology and Toxicology and Associate Scientist at SickKids. "Despite more than 22 years of use and hundreds of millions of ondansetron doses administered worldwide, we did not find evidence to support screening of patients without known risk factors before administering a single oral ondansetron dose." Dr. Finkelstein is also an Associate Professor of Paediatrics, Pharmacology and Toxicology at the University of Toronto.

Dr. Stephen Freedman, lead author and physician in Pediatric Emergency Medicine and Gastroenterology at the Alberta Children's Hospital and researcher at the University of Calgary Alberta Children's Hospital Research Institute. "This issue has caused significant uncertainty in the emergency medicine community where single oral dose of ondansetron administration is a routine event. I think these findings add significant clarity to the warnings issues by regulatory authorities and can be employed to support current practice which does not include routine screening to search for high-risk patients." Dr. Stephen Freedman is also an associate professor at the University of Calgary.

The authors concluded that ECG screening and electrolyte testing should be targeted to patients with known risk factors such as patients with cardiac diseases or those concomitantly receiving other arrhythmia-inducing medications and those receiving ondansetron intravenously or repeated doses, while it is not warranted in low-risk individuals who are receiving a single oral dose.

### The work was supported by SickKids Foundation and the Alberta Children's Hospital Foundation.


ELSE PRESS RELEASES FROM THIS DATE:

From common colds to deadly lung diseases, 1 protein plays key role

2013-12-09
From common colds to deadly lung diseases, 1 protein plays key role An international team of researchers has zeroed in on a protein that plays a key role in many lung-related ailments, from seasonal coughing and hacking to more serious diseases such as MRSA infections ...

Aging and gene expression -- possible links to autism and schizophrenia in offspring

2013-12-09
Aging and gene expression -- possible links to autism and schizophrenia in offspring Advanced paternal age has been associated with greater risk for psychiatric disorders, such as schizophrenia and autism. With an increase in paternal age, there is a greater frequency ...

Optimal parameter of Neiguan acupuncture for cerebral infarction

2013-12-09
Optimal parameter of Neiguan acupuncture for cerebral infarction The individual difference and non-repeatability in acupuncture have not only restricted the development of acupuncture, but have also affected the specificity of acupoints. As reported in a recent ...

rTMS for hallucination in schizophrenia spectrum disorders

2013-12-09
rTMS for hallucination in schizophrenia spectrum disorders Repetitive transcranial magnetic stimulation uses a non-invasive and relatively painless tool to stimulate the human brain in vivo using very strong, pulsed magnetic fields. It is also used to explore and ...

Does zinc supplementation reduce aluminum-induced neurotoxicity?

2013-12-09
Does zinc supplementation reduce aluminum-induced neurotoxicity? Studies have shown that aluminum neurotoxicity can likely affect learning and memory function, and a diet containing 100–200 mg/kg zinc is adequate for maintaining learning and memory function in ...

Prion protein can trigger spongiform encephalopathy and neurodegeneration

2013-12-09
Prion protein can trigger spongiform encephalopathy and neurodegeneration Transmissible spongiform encephalopathy or prion disease is triggered by the conversion from cellular prion protein to pathogenic prion protein. Notably, C-transmembrane form of prion protein ...

Cockroach never seen before in US is identified in New York

2013-12-09
Cockroach never seen before in US is identified in New York Analysis by Rutgers researchers confirms an Asian species that can survive in cold and snow NEWARK, N.J. -- With winter's arrival comes the kind of news that may give New Yorkers the creeps. A species ...

JCI early table of contents for Dec. 9, 2013

2013-12-09
JCI early table of contents for Dec. 9, 2013 Breast cancer prognosis associated with oncometabolite accumulation The metabolic profile of cancer cells can be used to develop therapies and identify biomarkers associated with cancer outcome. In this issue ...

Breast cancer prognosis associated with oncometabolite accumulation

2013-12-09
Breast cancer prognosis associated with oncometabolite accumulation The metabolic profile of cancer cells can be used to develop therapies and identify biomarkers associated with cancer outcome. In this issue of the Journal of Clinical Investigation Stefan ...

Choloroquine reduces formation of bone resorbing cells in murine osteoporosis

2013-12-09
Choloroquine reduces formation of bone resorbing cells in murine osteoporosis Bone homeostasis requires precise balance between deposition of new bone by osteoblasts and resorption of old bone by osteoclasts. Bone diseases, including osteoporosis and ...

LAST 30 PRESS RELEASES:

Obesity treatment risks becoming a ‘two-tier system’, researchers warn

Researchers discuss gaps, obstacles and solutions for contraception

Disrupted connectivity of the brainstem ascending reticular activating system nuclei-left parahippocampal gyrus could reveal mechanisms of delirium following basal ganglia intracerebral hemorrhage

Federated metadata-constrained iRadonMAP framework with mutual learning for all-in-one computed tomography imaging

‘Frazzled’ fruit flies help unravel how neural circuits stay wired

Improving care for life-threatening blood clots

Yonsei University develops a new era of high-voltage solid-state batteries

Underweight and unbalanced: Gut microbial diversity in underweight Japanese women

Astringent, sharper mind: Flavanols trigger brain activity for memory and stress response

New editorial urges clinicians to address sex-based disparities in sepsis treatment

Researchers at MIT develop new nanoparticles that stimulate the immune system to attack ovarian tumors

Opening the door to a vaccine for multiple childhood infections

New clue to ALS and FTD: Faulty protein disrupts brain’s ‘brake’ system

Detailed map of US air-conditioning usage shows who can beat the heat — and who can’t

An electronic fiber for stretchable sensing

New image captures spooky bat signal in the sky

Cobalt single atom-phosphate functionalized reduced graphene oxide/perylenetetracarboxylic acid nanosheet heterojunctions for efficiently photocatalytic H2O2 production

World-first study shows Australian marsupials contaminated with harmful ‘forever chemicals’

Unlocking the brain’s hidden drainage system

Enhancing smoking cessation treatment for people living with HIV

Research spotlight: Mapping how gut neurons respond to bacteria, parasites and food allergy

Gordon and Betty Moore Foundation Experimental Physics Investigators awards to UCSB experimentalists opens the door to new insights and innovations

Meerkats get health benefit from mob membership

COVID-19 during pregnancy linked to higher risk of neurodevelopmental disorders in children

How a chorus of synchronized frequencies helps you digest your food

UAlbany researcher partners on $1.2 million NSF grant to explore tropical monsoon rainfall patterns

Checkup time for Fido? Wait might be longer in the country

Genetic variation impact scores: A new tool for earlier heart disease detection

The Lundquist Institute awarded $9 million to launch Community Center of Excellence for Regenerative Medicine

'Really bizarre and exciting': The quantum oscillations are coming from inside

[Press-News.org] New study clarifies concerns regarding commonly used anti-nausea drug ondansetron