HEALTH

CDC refutes reports that influenza vaccine poses risk of developing H1N1

BY Michael Johnsen

ATLANTA The Centers for Disease Control and Prevention on Wednesday played down recent media reports describing unpublished findings from seasonal influenza vaccine studies conducted in Canada.

The findings from these studies suggest that receiving the 2008-09 seasonal influenza vaccine (which is the vaccine offered last influenza season) was a risk factor for developing influenza caused by the 2009 H1N1 virus. In the studies done in Canada, the increase in risk among persons vaccinated with a seasonal influenza vaccine was approximately double the risk for those who were not vaccinated with seasonal influenza vaccine.

“However, the research findings from Canada have not been published in the medical literature or presented at any public scientific meetings. There has not yet been an opportunity to fully review the studies in detail,” CDC stated.

“Preliminary results of studies conducted in the United States using methods similar to the Canadian studies did not indicate that receiving a seasonal influenza vaccine increased the risk of developing influenza caused by the 2009 H1N1 influenza virus,” the agency added. “No other country has reported that seasonal influenza vaccine increases the risk of developing influenza caused by the 2009 H1N1 influenza virus.”

One one study has been published on this issue — an Australian study that did not find any association between receipt of seasonal influenza vaccine and risk of developing influenza caused by the 2009 H1N1 influenza virus.

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Ulcerative colitis treatment reduces need for surgery by almost half, study suggests

BY Allison Cerra

NEW YORK A new study led by Mayo Clinic researchers found that ulcerative colitis patients had a 41% reduction in colectomy when treated with infliximab for one year, according to a study published in the October 2009 issue of Gastroenterology.

Ulcerative colitis, an inflammatory bowel disease that causes chronic inflammation of the colon, is characterized by abdominal pain and diarrhea. Like Crohn’s disease, another common IBD, ulcerative colitis can be debilitating and often lead to colectomy, or surgical removal of the colon.

In the study, 728 patients received placebo or infliximab (5 or 10 mg/kg) for 46 weeks and were monitored for hospitalization or surgical outcomes. Eighty-seven percent had complete follow-up for the endpoint of whether or not they had colectomy, while the remaining 13% of patients had follow-up for less then a year, with a median follow-up of 6.2 months in these patients. The research showed that treatment with infliximab at zero, two, six and then every 8 weeks, reduced the incidence of colectomy through 54 weeks by 41% in outpatients with moderately-to-severe active ulcerative colitis.

Infliximab is an artificial antibody that works by blocking tumor necrosis factor alpha, a chemical messenger and a key part of the immune reaction. Infliximab blocks the action of TNF alpha by preventing it from binding to its receptor in the cell.

“Our purpose in this study was to see if the use of infliximab for ulcerative colitis would reduce the need for surgery,” said William Sandborn, M.D., a Mayo Clinic gastroenterologist and lead author of the study. “We found that treatment with infliximab reduced the need for colectomy by 41% compared to patients treated with placebo.”

Previous research has shown that infliximab therapy induced clinical remission and bowel healing for colitis patients. This new research provides more information and options for patients struggling with this difficult disease, explained Sandborn.

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FDA approves Perrigo’s laxative generic

BY Michael Johnsen

ALLEGAN, Mich. Perrigo on Tuesday announced that it has received final approval from the Food and Drug Administration for its abbreviated new drug application for over-the-counter polyethylene glycol 3350, powder for solution, a generic equivalent to Schering-Plough’s MiraLAX laxative.

Perrigo said it would begin shipping immediately.

Estimated brand sales MiraLAX for the 12 months ended Aug. 28 were $200 million, Perrigo stated.

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