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NUTLEY, N.J., Nov. 18 /PRNewswire/ -- The Pediatric Advisory Committee of
the U.S. Food and Drug Administration (FDA) has confirmed the safety of
Tamiflu (oseltamivir phosphate) in children following a scheduled
comprehensive review of data about the use of Tamiflu in children. According
to Dr. Robert M. Nelson, chairman of the committee, there is "no concern at
all" that Tamiflu played a role in the reported deaths of children with
influenza in Japan. Dr. Nelson is an associate professor in the department of
anesthesia and critical care at The Childrens Hospital of Philadelphia.
The FDA indicated that it intends to continue normal monitoring of the
safety of Tamiflu for use in children, but found no basis for changing the
labeling of the product for neuropsychiatric issues. Roche intends to work
with the FDA to change the drugs labeling based on adverse skin events that
have occurred in a small number of patients, mostly in Japan. The FDA said it
would report back to the committee in two years.
"We welcome the outcome of the FDA advisory committee and look forward to
working with the FDA and other health authorities to extend our knowledge of
the use of Tamiflu and its safety profile. The positive role of Tamiflu
remains unchanged," commented William M. Burns, CEO Roche Pharma Division.
The meeting of the Pediatric Advisory Committee on November 18th was a
scheduled one at which adverse events for eight medicines used in children
were reviewed. Tamiflu was among the drugs reviewed because it was granted
pediatric exclusivity in March 2004. Pediatric exclusivity is granted as an
incentive to industry to study the use of medicines in children.
The committee heard several presentations on Tamiflu including adverse
event reports, a literature review and analysis of clinical trials data.
Facts and Figures
* To date, Tamiflu has been used by about 33 million patients worldwide
* In Japan, 24.5 million patients have used Tamiflu, 11.6 million of whom
were children
* 12 deaths in children aged 1 to 16 years occurred; this number of
reported deaths, placed into the context of overall usage, would be a
rate of 1 death per million patients treated. This is in close
accordance with or lower than published rates of mortality in children
infected with influenza (2 per million pediatric patients)
* Safety reporting is based on clinical trials and routine use from about
33 million patients worldwide; of these, about 13 million were children.
About Tamiflu
Tamiflu, co-developed by Gilead Sciences, Inc., based in Foster City, CA,
is a systemic treatment for the most common strains of influenza (types A and
B). The leading prescription oral antiviral drug, Tamiflu is indicated for
treatment of type A and B influenza in patients one year and older. Tamiflu is
an effective treatment, and can reduce the duration and severity of the flu
when taken within two days of symptom onset. Tamiflu, a neuraminidase
inhibitor, works by attacking the influenza virus and its ability to
replicate, rather than simply addressing influenza symptoms.
Tamiflu is also approved for the prevention of influenza in adults and
adolescents 13 years and older. Clinical trials have shown Tamiflu is
effective in preventing influenza illness when taken once daily for at least
seven days. For the prevention of influenza in those 13 years or older,
Tamiflu is administered following close contact with an infected individual
who demonstrates characteristic symptoms of influenza, and based on knowledge
that influenza is circulating in the area for 10 days, or up to six weeks for
seasonal prophylaxis.
Tamiflu is generally well tolerated. In treatment studies in adults, the
most frequently reported adverse events were mild-to-moderate transient nausea
and vomiting. Other events reported more frequently than with placebo were
bronchitis, insomnia and vertigo. In prophylaxis studies in patients aged 13
and older, adverse events were qualitatively similar to those seen in the
treatment studies despite a longer duration of dosing. Events reported more
frequently in subjects receiving Tamiflu compared to subjects receiving
placebo in prophylaxis studies included nausea, vomiting, diarrhea, abdominal
pain, dizziness, insomnia, headache, vertigo and fatigue.
In pediatric treatment studies, the most frequently reported adverse event
was vomiting. Other events reported more frequently by pediatric patients
treated with Tamiflu included abdominal pain, epistaxis, ear disorder and
conjunctivitis. These events generally occurred once and resolved despite
continued dosing.
Efficacy of Tamiflu in the treatment of subjects with chronic cardiac
disease and/or respiratory disease has not been established.
Tamiflu was approved by the U.S. Food and Drug Administration (FDA) for
the treatment of uncomplicated acute illness due to influenza infection in
adults in October 1999.
The FDA granted marketing approval for the prevention of naturally
occurring influenza A and B in adults and adolescents 13 years and older in
November 2000. The FDA granted marketing approval of the oral suspension for
use in the treatment of influenza A and B in children one year and older in
December 2000. Tamiflu oral suspension is used for pediatric patients one
year and older or adult patients who cannot swallow a capsule. Tamiflu is the
first and only liquid suspension to treat influenza A and B.
Vaccination is considered the first line of defense against influenza.
Tamiflu is available for the treatment of influenza in more than 40
countries worldwide. For more information visit http://www.Tamiflu.com
About Roche -- More Than a Century in the U.S. and the World
Founded in 1896 and headquartered in Basel, Switzerland, Roche is one of
the worlds leading innovation-driven healthcare groups. Its core businesses
are pharmaceuticals and diagnostics. Roche is one of the worlds leaders in
diagnostics, the leading supplier of pharmaceuticals for cancer, as well as a
leader in virology and transplantation. As a supplier of products and
services for the prevention, diagnosis and treatment of disease, the Group
contributes on many fronts to improve peoples health and quality of life.
Roche employs roughly 65,000 people in 150 countries, including approximately
15,000 in the United States.
Roches U.S. operations celebrate their American Centennial in 2005. In
another milestone this year, Roche was named in January to Fortune magazines
list of Best Companies to Work for in America. One of an increasingly rare
breed of major healthcare companies that still bear their original name, Roche
today has more than a dozen U.S. sites located in California, Colorado,
Indiana, New Jersey and South Carolina, as well as in Puerto Rico. Roche has
alliances and research and development agreements with numerous partners,
including majority ownership interests in Genentech and Chugai. Roches
Pharmaceuticals Division offers a portfolio of leading medicines in
therapeutic areas including cancer, HIV/AIDS, hepatitis C, transplantation,
dermatology and influenza. Roches Diagnostics Division supplies a wide array
of innovative testing products and services to researchers, physicians,
patients, hospitals and laboratories world-wide. For further information,
visit the worldwide and U.S. websites (Global: http://www.roche.com and U.S.:
http://www.roche.us).
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