The U.S. Food and Drug Administration (FDA) has raised concerns regarding the safety of using the flu medication Tamiflu in children.
In a memorandum released on November 17, 2005, the agency reported 12 cases of pediatric deaths occurring over the past 13 months.
The FDA memorandum referenced 75 cases that raised concerns about the use of Tamiflu in children.
Among the 12 reported deaths, there were four cases of sudden death, one case of neurological disorder, and several others that experienced respiratory and cardiac arrest.
Additionally, there were 32 other cases of neurological disorders, including instances of hallucinations.
The report indicated that there is not enough detailed information to evaluate the causes of these illnesses; however, the occurrences are highly unusual, warranting further investigation.
To date, Tamiflu remains the most critical antiviral medication in the fight against avian influenza and the risk of an outbreak.
Roche is ramping up production of Tamiflu to 300 million doses per day to meet global demand.
Avian influenza poses serious and unusual risks to young patients, with a higher mortality rate among children compared to adults.
Roche has stated that the rates of death and psychiatric disorders do not differ between those using Tamiflu and individuals affected by the flu.
