Tamiflu

November 13, 2006 --The Food and Drug Administration (FDA) and Roche Pharmaceuticals sent out a letter to healthcare professionals informing them of the potential of side effects associated with Tamiflu.

The FDA's Pediatric Advisory Committee had been monitoring adverse events in Roche's Tamiflu since November 2005. Tamiflu, also known as oseltamivir, is the only treatment available for avian flu. 

The letter is a result of postmarketing reports, mostly from Japan , of self-injury and delirium with the use of Tamiflu in patients with influenza. The FDA warns that people with the flu, particularly children, may be at an increased risk of self-injury and confusion shortly after taking Tamiflu and should be closely monitored for signs of unusual behavior. A healthcare professional should be contacted immediately if the patient taking Tamiflu shows any signs of unusual behavior.

The 12 deaths reported in Japan were among children between the ages of 1 and 9.  Four of the cases were unusual sudden deaths, 2 were teenage suicides and 1 involved a young boy whose hallucinations caused him to run out of his house and into traffic.  Six of the cases occurred in children who were reported to be healthy before getting the flu. 

Additionally, there have been 32 reports of neuropsychiatric events including delirium, abnormal behavior and hallucination.  Thirty one of these reports occurred in Japan .  There have also been reports of serious skin reactions in Japan as well as in other countries.

Up until now, the FDA had maintained that there was no evidence that the deaths were caused by Tamiflu. Roche, the manufacturer of Tamiflu, had also been defending its treatment.  According to the company, only one in a million children who have used Tamiflu have died.  Roche says that of the 32 million people worldwide who have used Tamiflu, 89 died and 130 experienced neuropsychiatric side effects. 

Tamiflu was approved in 1999 in the United States and in 2000 in Japan.