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FDA Review Recommends Warnings on Kids' Flu Drugs

Reports of neurological problems in children taking the
flu drugs Tamiflu and Relenza mean the medicines
need a warning label on their packaging, according to a
U.S. Food and Drug Administration safety review
released Friday.

According to the Associated Press, the safety review
follows 25 deaths among Tamiflu users under the age
of 21, most of them occurring in Japan. In five cases,
children fell from windows or balconies or ran into traffic,
the AP said.

The FDA began its review in 2005 after receiving reports
of children experiencing hallucinations, convulsions and
other neurological problems while on Tamiflu.

Data from the review will be considered by a special
panel of outside experts that will meet on Tuesday to
mull the agency's proposed label changes. The FDA is
not required to follow the advice of its advisory panels,
but usually does.

According to the AP, there have so far been no child
deaths linked to Relenza, but regulators say some
children taking the drug have shown similar neurological
symptoms.

Neurological side effects may come from a rare strain of
the flu, or a rare genetic reaction to the flu drugs,
according to the FDA.
Relenza's current label makes no mention of
neurological problems. Tamiflu's labeling currently
mentions the potential for self-injury or delirium, but
does not say these incidents could prove fatal. The
proposed labeling change would add that warning to
Tamiflu, the AP said.

In a statement, Tamiflu's maker, Swiss-based Roche,
said there's no hard evidence linking the drug to
neurological trouble, which the company says can also
be caused by the flu. However, referring to a proposed
label change, Roche said it is "open to that
consideration." Copyright © 2007 ScoutNews LLC. All
rights reserved.

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