Mallinckrodt receives FDA approval for Xartemis XR
DUBLIN — Mallinckrodt Plc last week announced that the Food and Drug Administration approved Xartemis XR (oxycodone hydrochloride and acetaminophen) Extended-Release Tablets (CII), for the management of acute pain severe enough that it requires opioid treatment.
The drug also is indicated for patients for whom alternative treatments have shown to be ineffective. Xartemis XR, previously known as MNK-795, is the first and only extended-release oral combination of two clinically proven pain medications — oxycodone and acetaminophen.
Pain that is left uncontrolled or unmanaged results in significant costs to U.S. business in terms of lost productivity, according to the company. Data from the Institute of Medicine showed that in 2011, 80% of patients undergoing surgery experienced postoperative pain. Eighty-eight percent reported the pain to be moderate, severe or extreme.
“Acute pain doesn’t last for only four to six hours, and neither should its treatment. With the extended-release profile of XARTEMIS XR, patients may not need to wake in the night to take a dose,” said Nathaniel Katz, MD, MS, adjunct assistant professor of anesthesia at Tufts University School of Medicine. “A long-acting combination analgesic that can effectively deliver oxycodone and acetaminophen for acute pain patients experiencing pain throughout the day and night is a welcome addition to the treatment landscape.”
New study challenges benefits of fish oil
CAMBRIDGE, England — A new study published in the March 18 journal Annals of Internal Medicine raises questions about current guidelines which generally restrict the consumption of saturated fats and encourage consumption of polyunsaturated fats, or fish oils, to prevent heart disease.
"These are interesting results that potentially stimulate new lines of scientific inquiry and encourage careful reappraisal of our current nutritional guidelines," suggested Rajiv Chowdhury, lead author of the research at the University of Cambridge.
"This systematic review and meta-analysis raises an interesting viewpoint, but an unfortunate, and potentially irresponsible one, for consumers who will once again be subject to nutritional guidance whiplash," countered Duffy MacKay, SVP scientific and regulatory affairs for the Council for Responsible Nutrition. “There are thousands of studies and decades of recommendations from government, academic, nutritional and medical organizations and experts supporting the important heart health benefits associated with diets high in polyunsaturated fats, low in saturated fats and avoidance of trans fats."
An international research collaboration led by the University of Cambridge analyzed existing cohort studies and randomized trials on coronary risk and fatty acid intake. They showed that current evidence does not support guidelines which restrict the consumption of saturated fats in order to prevent heart disease. The researchers also found insufficient support for guidelines that advocate the high consumption of polyunsaturated fats, such as omega 3 and omega 6, to reduce the risk of coronary disease.
For the meta-analysis, the researchers analyzed data from 72 unique studies with more than 600,000 participants from 18 nations. The investigators found that total saturated fatty acid, whether measured in the diet or in the bloodstream as a biomarker, was not associated with coronary disease risk in the observational studies. Similarly, when analysing the studies that involved assessments of the consumption of total monounsaturated fatty acids, long-chain omega-3 and omega-6 polyunsaturated fatty acids, there were no significant associations between consumption and cardiovascular risk.
"Their conclusions, if taken to heart, leave consumers to rely on genetics and fate to avoid coronary heart disease, an unacceptable situation given the fact that the scientific literature contains so many studies that point to benefit for omega-3 fatty acids," MacKay said.
The investigators did find that different subtypes of circulating long-chain omega-3 and omega-6 fatty acids had different associations with coronary risk, with some evidence that circulating levels of eicosapentaenoic and docosahexaenoic acids (i.e., two main types of long-chain omega-3 polyunsaturated fatty acids), and arachidonic acid (i.e, an omega-6 fat) are each associated with lower coronary risk.
"This analysis of existing data suggests there isn’t enough evidence to say that a diet rich in polyunsaturated fats but low in saturated fats reduces the risk of cardiovascular disease," noted Jeremy Pearson, associate medical director at the British Heart Foundation, which helped fund the study. "But large scale clinical studies are needed, as these researchers recommend, before making a conclusive judgement."
Study: Occupations that interact with the public at greatest risk for flu
ATLANTA — The highest prevalence of influenza happens among those professions that are exposed to the general public, such as real estate and rental and leasing (10.5% in this profession were at risk of flu, according to a recent study published Friday in the Morbidity and Mortality Weekly Report) and accommodation and food services (10.2%). As many as 11% of workers in the food preparation and serving related sectors were at risk of flu and 8.3% of those employed in community and social services.
Both seasonal influenza and H1N1 vaccination coverage were relatively low in all of these groups of workers.
"During an influenza pandemic, information about the industry and occupation of persons likely to be infected with influenza virus is important to guide key policy decisions regarding vaccine prioritization and exposure-control measures," the report noted. "[For example], healthcare personnel might have increased opportunity for exposure to influenza infection, and they have been prioritized for influenza vaccination because of their own risk and the risk that infected HCP pose to patients."
So the Centers for Disease Control and Prevention set out to find other groups of workers that might be at increased risk for pandemic influenza infection. To feed the analysis, influenza-like illness and vaccination coverage data from the 2009 National H1N1 Flu Survey, which was conducted during October 2009 through June 2010, were reviewed.
In a representative sample of 28,710 employed adults, 5.5% reported ILI symptoms in the month before the interview and 23.7% received the 2009 pandemic H1N1 influenza vaccine.
Adults not in the labor force (i.e., homemakers, students or retired persons) had ILI prevalence and H1N1 vaccination coverage similar to those found in all employed adults combined. In contrast, ILI prevalence was higher and H1N1 vaccination coverage was lower among those looking for work. "These results suggest that adults employed in certain industries and occupations might have increased risk for influenza infection, and that the majority of these workers did not receive seasonal or H1N1 influenza vaccine," the report noted. "Unemployed adults also might be considered a high-risk group for influenza."