Study Shows Physician Judgment is Important in Reducing Rate of RSV-Related Hospitalizations Among High-Risk Infants
HONOLULU, May 05, 2008 /PRNewswire/ -- MedImmune announced today that the company presented results from a retrospective chart review that evaluated the use of Synagis(R) (palivizumab) as a preventive measure against respiratory syncytial virus (RSV) disease in high-risk infants. RSV is a leading cause of viral respiratory infection among preterm infants.
Approximately 4,000 medical records from premature infants born at 32-to-35 weeks gestational age were reviewed. Fifty percent of those infants received Synagis. RSV prophylaxis was requested, but not administered in about one quarter of these infants. This group was found to have an RSV hospitalization rate of 8.3 percent, which was almost three times the rate of RSV hospitalization among those infants whose physicians did not request RSV prophylaxis (2.9 percent).
"These data support our position that pediatricians should have the final say in the diagnosis and care of their high-risk patients," said Jessie Groothuis, M.D., lead author of the study and MedImmune vice president, medical and scientific affairs, infectious disease. "Our findings indicate that after nearly 10 years of use of Synagis, the clinical judgment and experience of physicians serve to identify infants at high risk of RSV hospitalization, and should be relied upon to ensure patients get proper care."
This retrospective chart review, conducted in 10 geographic regions across the United States, included 376 physicians from 2005 to 2006. Data were presented at a poster session at the Pediatric Academic Societies (PAS) Annual Meeting being held this week in Honolulu, HI.
Synagis (palivizumab) is indicated for the prevention of serious lung infections caused by respiratory syncytial virus (RSV) in children at high risk of RSV disease. Synagis is given as a shot, usually in the thigh muscle, each month during the RSV season. The first dose of Synagis should be given before RSV season begins. Children who develop an RSV infection while receiving Synagis should continue the monthly dosing schedule throughout the season. Synagis has been used in more than one million children in the U.S. since its introduction in 1998.
Very rare cases (<1 per 100,000 patients) of severe allergic reactions such as anaphylaxis and rare (<1 per 1,000 patients) hypersensitivity reactions have been reported with Synagis. These rare reactions may occur when any dose of Synagis is given, not just the first one. Also, rare but serious side effects can occur, which may lead to unusual bruising and/or groups of pinpoint red spots found on the skin.
Other side effects with Synagis may include upper respiratory tract infection, ear infection, fever, and runny nose. In children born with heart problems, Synagis was associated with reports of low blood oxygen levels and abnormal heart rhythms. Synagis should not be used in patients with a history of a severe prior reaction to Synagis or its components. Side effects, such as, skin reactions around the area where the shot was given (like redness, swelling, warmth, or discomfort) can also occur.
Please see complete prescribing information at www.synagis.com.
MedImmune strives to provide better medicines to patients, new medical options for physicians and rewarding careers to employees. Dedicated to advancing science and medicine to help people live better lives, the company is focused on infection, oncology, respiratory disease and inflammation, cardiovascular/gastrointestinal disease, and neuroscience. With approximately 3,000 employees worldwide and headquarters in Maryland, MedImmune is wholly owned by AstraZeneca plc . For more information, visit MedImmune's website at www.medimmune.com.
CONTACT: Tor Constantino, +1-301-398-8501, or Investors, Peter Vozzo,+1-301-398-4358, both of MedImmune
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Posted: May 2008