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| Tamiflu
kills 12 children, Causes hallucinations and
mental illness -- FDA investigates |
The Coming Engineered
Genocide
User ID: 15807
11/17/2005
3:03
pm EST |
Tamiflu kills 12 children, Causes
hallucinations and mental illness -- FDA
investigates
By Lisa
Richwine
WASHINGTON (Reuters) - U.S.
regulators are studying the deaths of 12 children
in Japan who took Roche AG´s flu-fighting drug
Tamiflu, officials said on Thursday, but they said
it was difficult to tell whether the drug played a
role in any of the cases.
The U.S. Food and
Drug Administration said it was "concerning" that
32 psychiatric events, such as hallucinations and
abnormal behavior, also had been reported in
children who took Tamiflu, which is in high demand
because it is considered to be one of the best
defenses against avian flu in people.
All
but one of the psychiatric problems also were
reported in Japan, the FDA said.
The agency
will ask for input on the cases from an advisory
panel of outside experts at a public meeting on
Friday. Officials said the review was part of the
routine monitoring of the safety of medicines used
by children.
In a separate summary posted
on the FDA Web site, Roche said: "There is no
increase in deaths and neuropsychiatric events in
patients on Tamiflu versus influenza patients in
general."
Roche shares fell 2.7 percent in
Swiss trading. Shares of Gilead Sciences Inc.,
which invented the drug and receives royalties on
Tamiflu sales, were down 1.6 percent in afternoon
Nasdaq trade.
Interest in Tamiflu has risen
as experts around the world warn of the
possibility for an H5N1 bird flu pandemic in
people. Several countries are stockpiling Tamiflu,
which may be able to lessen
symptoms.
Earlier this week Roche reported
two possible suicides of Japanese youth who took
Tamiflu but said there was no clear evidence the
drug contributed.
"Tamiflu is recognized as
causing psychological disturbance, and therefore
the apparent suicidal behavior of these two
teenagers has been linked to taking Tamiflu,"
analysts at Morgan Stanley Equity Research said in
a statement.
The FDA said the 12 deaths it
was reviewing included one suicide, four cases of
sudden death and four cases of cardiac arrest.
There also were single cases of pneumonia,
asphyxiation and acute pancreatitis.
"The
level of detail in these reports was highly
variable and determining the contribution of
Tamiflu to the deaths was difficult," the FDA
summary said.
"At this point in time, we
cannot make an association between Tamiflu and the
deaths of these children," said Dr. Murray
Lumpkin, FDA deputy commissioner for international
and special programs. He said no similar cases
have been seen in the United States.
"But
we thought it was very important to talk about
these publicly with our advisory committee,"
Lumpkin said.
The "most alarming"
psychiatric events included two cases in which a
12-year-old and a 13-year-old jumped out of the
second-floor windows of their homes after
receiving two doses of Tamiflu, the FDA summary
said.
Warnings about possible skin
reactions may need to updated on the Tamiflu
label, the FDA said. Twelve cases have been
reported, including one of a severe skin problem
known as Steven-Johnsons syndrome that was
reported in a 3-year-old.
The agency said
it had requested more information from Roche and
Japanese regulatory authorities and had received
preliminary responses.
"We ... conclude
that there is virtually no chance of the FDA
making any significant changes to the labeling of
Tamiflu as a result of these observations," the
Morgan Stanley team said.
Roche will
present data from three drug databases and a study
of Tamiflu use in young children at the advisory
panel meeting, company spokesman Al Wasilewski
said.
"Over the past six years, Tamiflu has
been used widely and has set a consistent safety
record in both the United States and Japan," he
said. |
Anonymous Coward
User
ID: 10413
11/17/2005
3:06 pm EST |
Re: Tamiflu kills 12 children, Causes
hallucinations and mental illness -- FDA
investigates
Japan had two
deaths, one in Feb 2004 and one later. Both took
tamiful and then killed themselves.
Japans
tamiflu states that possible side effects are
halluncinations.
FDA is always quite a few
steps behind...
Remember Viagra, and the
high heart attaack rate?
FDA is a pharma
favourites lap dog. |
Anonymous Coward
User
ID: 11275
11/17/2005
3:08 pm EST |
Re: Tamiflu kills 12 children, Causes
hallucinations and mental illness -- FDA
investigates
Earlier this week
Roche reported two possible suicides of Japanese
youth who took Tamiflu but said there was no clear
evidence the drug contributed.
"Tamiflu is
recognized as causing psychological disturbance,
and therefore the apparent suicidal behavior of
these two teenagers has been linked to taking
Tamiflu," analysts at Morgan Stanley Equity
Research said in a statement.
The FDA said
the 12 deaths it was reviewing included one
suicide, four cases of sudden death and four cases
of cardiac arrest. There also were single cases of
pneumonia, asphyxiation and acute
pancreatitis. |
petron
User ID:
4617
11/17/2005
3:24 pm EST |
Re: Tamiflu kills 12 children, Causes
hallucinations and mental illness -- FDA
investigates
Looks like Brian
predicted this on the
14th
http://briansprediction.com/pri/nov2005.htm
Is
this guy for real or what? |
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