flu drugs in children

flu drugs in children

FDA Ponders Psychiatric Warning for Common Flu Drugs

An FDA staff report recommends adding label warnings about possible

neuropsychiatric side effects in individuals taking the influenza

drugs oseltamivir (Tamiflu) and zanamivir (Relenza).

The report was prepared for a meeting of the Pediatric Advisory

Committee to take place this week. The FDA found 596 cases of

neuropsychiatric events associated with oseltamivir and 115 with

zanamivir. The cases, mostly in people age 21 or younger and mostly

from Japan, included delirium, hallucinations, and impulsive behavior,

including a desire to jump. Five fatalities were associated with

oseltamivir use while none were associated with zanamvir.

The agency cautioned it could not rule out the possibility that the

behavior was due to the illness rather than the treatment. However,

the reports "raise the question" of whether the events result from the

neuraminidase inhibitor class. It said "it seems prudent" for both

drugs to carry label warnings of hallucinations, delirium, and

abnormal behavior.

Glaxo and Roche, which make the two drugs, said label updates are

unnecessary, because the events could have resulted from flu symptoms.

Link(s):

FDA staff report (Free PDF)

http://www.fda.gov/ohrms/dockets/ac/07/briefing/2007-4325b_02_04_Tamif

lu%20Adverse%20Event%20Review%202007.pdf

Bloomberg News story (Free)

http://www.nytimes.com/2007/11/24/business/24drug.html?ref=business

GlaxoSmithKline response (Free PDF)

http://www.fda.gov/ohrms/dockets/ac/07/briefing/2007-4325b_02_16_Spons

or%20Background%20Package%20GSK.pdf

Hoffman-LaRoche response (Free PDF)