US Rush Approves Tamiflu
For Children Under 12

From Patricia Doyle, PhD

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.
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 established.
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 symptoms.
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 Roche
Pharmaceuticals Inc.; the above information is relayed in the public
(Media Inquiries; Julie Zawisza, FDA at 301-827-6242: Consumer
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 Economics
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