FDA to Probe Deaths of Kids on Tamiflu

By ANDREW BRIDGES Associated Press Writer

The Associated Press

WASHINGTON Nov 17, 2005 — Federal health advisers are looking into the deaths of 12 Japanese children who took Tamiflu, part of their annual safety review of the anti-flu medication and seven other drugs.

There are no reports of deaths in the United States or Europe associated with Tamiflu.

"Based on the information we have right now, we cannot say definitively there is a causal relation between the drug and the children's death," Dr. Murray Lumpkin, the deputy commissioner of the U.S. Food and Drug Administration, said Thursday.

The Japanese deaths were detailed in papers released in advance of a Food and Drug Administration advisory committee meeting Friday.

An update by FDA staff also includes reports of 32 "neuropsychiatric events" associated with Tamiflu, all but one experienced by Japanese patients. Those cases included delirium, hallucinations, convulsions and encephalitis.

"Clearly, any time you get a report of a death or a serious occurrence, you want to look into it," Lumpkin said.

The FDA sought and received more information from the Swiss pharmaceutical company Roche Holding AG, which makes Tamiflu, and from Japanese health authorities. It has not issued any warnings or initiated any other action, spokeswoman Susan Bro said.

Lumpkin said "millions and millions" of patients have safely used the drug to treat the flu.

Complicating the issue is that many of the Japanese death and adverse reaction reports list symptoms commonly associated with the flu, he said.

"It is very difficult, when the underlying disease causes what it is being reported, to figure out: Is it the underlying disease? Is it the drug?" said Lumpkin.

A Roche spokesman did not immediately return an e-mail message seeking comment. Roche has supplied the FDA with two additional studies it commissioned that evaluated the safety of Tamiflu in pediatric patients.

Japan's Health Ministry warned last week that Tamiflu may induce "strange behavior" after reporting that two teenage boys died shortly after taking the medicine.