US and European regulators are examining the deaths of 12 Japanese children who took Roche Holding AG's Tamiflu influenza medicine, in a review of the drug being stockpiled worldwide for a potential bird-flu epidemic.
Four of the fatalities were due to ''sudden death, an unusual phenomenon in otherwise healthy" people 16 and under, the US Food and Drug Administration said in a report posted yesterday on its website.
The connection to Tamiflu has not been proved and may be coincidental, said Susan Bro, an FDA spokeswoman. Other causes included suicide and pneumonia.
''You always keep a careful eye on things like this, but you also need to consider the evidence," said T. Grant Phillips, a doctor at Washington Hospital in Washington, Pa., in a telephone interview. Phillips, who published a 2003 article on Tamiflu, said he has no connection to Roche.
''Bad things can happen to people that have nothing to do with a drug," Phillips said.
An FDA advisory panel will review Tamiflu risks today at a routine meeting under a law requiring monitoring of drugs that have been tested in children to win a certain type of regulatory approval. Demand for Tamiflu has surged with the threat of a global epidemic of the avian influenza that has killed at least 67 people in Asia since 2004.
The European Medicines Agency also said yesterday it decided to ask Roche for ''a cumulative safety review of all available data on serious psychiatric disorders, including all case reports with a fatal outcome where Tamiflu was involved."
About 11.6 million children in Japan have taken Tamiflu, said David Reddy, head of Roche's virology unit, on a conference call yesterday.
''This equates to a death rate of about one in a million," Reddy said. ''These deaths are not new and have occurred over the last several years."
No deaths in children have been reported in the United States, and 89 deaths occurred worldwide in all age groups, Reddy said.