- The US FDA approved the use of Tamiflu for prevention
of seasonal influenza in children ages ONE YEAR to TWELVE YEARS. The FDA
reviewed the deaths of 12 Japanese children who received the drug, yet,
the FDA concludes there is no connection between the drug and the deaths
of the children.
- I believe the FDA is far too hasty in changing the age
requirement of Tamiflu allowing children ages 1 through 12 to take the
drug. There needed to be much more research in the use of Tamiflu for children.
It is not the safe drug that the FDA would have us believe and there is
also a question as to its effacacy.
- TAMIFLU DOES NOT CURE INFLUENZA.
- It does not prevent the onset of flu in some people,
as well. It may shorten the duration of influenza in SOME PEOPLE. Is this
worth the risk...esepcially for our children and infants?IS?
- Patricia Doyle
- From ProMED-mail
- Tamiflu Approved For Prevention Of Influenza
In Children Under Age 12
- U.S. Food and Drug Administration News
- On Wed 21 Dec 2005, the U.S. Food & Drug Administration
(FDA) approved the use of Tamiflu (oseltamivir phosphate) for prevention
(prophylaxis) of seasonal influenza ("flu") in children one to
12 years of age who had close contact with an infected individual. This
is the 1st drug approved for prevention of both influenza A and B [human
influenza virus infection] in pediatric patients.
- Tamiflu is an oral anti-viral drug previously approved
by FDA for both the prevention and treatment of influenza in adolescents,
13 years and older, and in adults. Tamiflu also is approved for treatment
of influenza in pediatric patients older than one year of age.
- A study of the spread of flu in households involving
over 1100 people included 222 children one to 12 years of age. When someone
in the household was diagnosed with seasonal flu, other family members
received either Tamiflu once a day for 10 days or no Tamiflu at all unless
they became ill. The rate of children developing fever and other symptoms
confirmed to be flu was reduced from 17 percent in the group receiving
no preventative treatment to 3 percent in the group that received Tamiflu
as a preventative measure. The benefit in children mirrored the benefit
seen in older individuals in this and earlier studies. The effective use
of Tamiflu to prevent influenza in immunocompromised patients has not been
- In the studies, side effects from Tamiflu, when taken
for prevention, were similar to those from patients who took the drug for
treatment. The most common side effects were nausea, vomiting, headache
and fatigue. Vomiting was reported more frequently in people receiving
the twice daily treatment dose compared to once daily prophylaxis. In the
current study, children reported higher rates of vomiting than adults,
but this was observed to be dose-related. Although no new side effects
occurred in these studies, FDA has requested additional post-market study
data from the drug maker to support the long term safety of the drug.
- A comprehensive review of post-marketing safety reports
for Tamiflu indicated rare reports of severe rash and allergic-type skin
reactions that may be drug-related. As was discussed at the FDA Pediatric
Advisory Committee, on 18 Nov 2005, FDA required that new safety language
regarding serious skin/hypersensitivity reactions be added to the Tamiflu
product label. Patients should be cautioned to stop taking Tamiflu and
contact their health care providers if they develop a severe rash or allergic
- Tamiflu is not a substitute for the [seasonal] flu vaccine.
Patients should continue receiving an annual flu vaccination according
to guidelines on immunization practices.
- Tamiflu is manufactured and distributed by Roche Pharmaceuticals,
Inc. of Nutley, New Jersey.
- [ProMED-mail has no commercial or other association with
- Pharmaceuticals Inc.; the above information is relayed
in the public
- (Media Inquiries; Julie Zawisza, FDA at 301-827-6242:
- Inquiries; 888-INFO-FDA)
- Previously, a U.S. government safety investigation of
the antiviral drug oseltamivir (Tamiflu) reviewed 12 deaths in Japanese
children who had received the drug, but a U.S. Food and Drug Administration
(FDA) advisory panel concluded that the deaths were not related to it (see
ProMED-mail post "Avian influenza, human - East Asia (179): Tamiflu
20051122.3396"). This new U.S. FDA press release further extends approval
of the use of the anti-neuraminidase inhibitor Tamiflu to include prophylactic
treatment of children under 12 years of age known to be exposed to infection
with either A or B type human influenza viruses. However, the increased
frequency of vomiting in treated children indicates a need for careful
control of dosage. - Mod.CP
- Patricia A. Doyle, DVM, PhD- Bus Admin, Tropical Agricultural
- Please visit my "Emerging Diseases" message
- Also my new website:
- Zhan le Devlesa tai sastimasa
- Go with God and in Good Health