WASHINGTON, Nov. 18 (UPI) -- An FDA advisory panel Friday said that Tamiflu is safe and apparently unrelated to the deaths of 12 Japanese children who took the drug.
The Food and Drug Administration panel did suggest adding warnings about possible serious skin conditions, and said the FDA should review the drug safety profile again in a year. But by a unanimous vote, they said there was no evidence to link the drug to the deaths or to serious psychiatric events in children.
The 12 deaths in the past 13 months included one suicide, four cases of sudden death and four heart attacks. Other deaths involved asphyxiation, pneumonia and acute pancreatitis.
There have also been 32 cases of psychiatric abnormalities, including delusions, hallucinations and delirium, reported in children who had taken Tamiflu. Thirty-one of the cases involving psychiatric episodes occurred in Japan.
Two of the psychiatric cases involved teenagers who jumped from second-floor windows after taking two doses of the drug.
"In many of these cases, a relationship to Tamiflu was difficult to assess because of the use of other medications, presence of other medical conditions, and/or lack of adequate detail. The level of detail in these reports was highly variable and determining the contribution of Tamiflu to the deaths was difficult," an FDA summary said.
Meanwhile:
--China Friday reported two further outbreaks of avian influenza, bringing the monthly total to 15.
The outbreaks, in Shanxi and Xinjiang provinces, were hundreds of miles apart.
--Lingtan, the village where China's fist human bird-flu victim died last week, has been locked down by government authorities, with only local residents permitted to enter or leave.
--Beijing has designated two hospitals in the city to deal with emergency cases of bird flu, Xinhua news agency reported Friday. The "hospitals are to arrange sufficient and competent medical staff and will form a special team to deal with any outbreak of the disease," according to Xinhua.
All of the capital's hospitals have been asked to improve training in prevention and control of avian influenza in humans.
--Sinovac Biotech, a Beijing-based vaccine producer, has announced plans to start mass-producing an avian influenza vaccine. The company was the first to produce a SARS vaccine.
"We have applied for human clinical trials for the vaccine with the Chinese State Food and Drug Administration and the vaccine can be put into production once the clinical trials complete," Yin Weidong, Sinovac Biotech's general manager, told CRI Online.
"We get the virus samples from the lab of the influenza center under the World Health Organization and the research is going on well. If the bird flu virus mutates, we can develop new vaccines in four months."
--Two further reports of epidemics in northern provinces mean that more 25 percent of Vietnamese provinces and cities have now suffered avian-flu outbreaks.
In the last month, 17 of the country's provinces and cities have been affected by avian influenza, from a total of 64.
