Retrospective Chart Review in 10 Geographic Regions throughout the United
States Presented at Pediatric Academic Societies (PAS) Annual Meeting
HONOLULU, May 5 /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
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 (LSE: AZN.L, NYSE: AZN). 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