US warning on oseltamivir
Oseltamivir (Tamiflu) should not be administered to children younger than one year, according to a new warning issued by the Food and Drug Administration in the US.
The FDA and Roche Laboratories, manufacturer of Tamiflu, have notified
US health care professionals of safety data that raise concerns about
the use of oseltamivir in young infants. They suggest that clinicians
may be tempted to use the drug off-licence during the influenza season.
Preclinical research has shown that a high dose of oseltamivir results
in drug levels in the brains of juvenile rats approximately 1,500 times
those seen in adult animals. The high exposure, which the FDA suggests
is related to immature blood brain barriers, was associated with deaths
among the seven-day old rats.
Roche and the FDA say they do not know what the clinical significance
of the research may be but stress that oseltamivir should not be prescribed
outside its licensed indications. Tamiflu is not licensed for use in
children under one year in the US or the UK. |
