The Japanese distributor of Tamiflu denied a link between the anti-flu drug and the deaths of six children on Friday following an announcement that the U.S. government is looking into the deaths of 12 Japanese children who took the drug. Chugai Pharmaceutical Co. said that the company has reported to Japan's Health Ministry a total 13 cases of deaths of children aged 15 and under who had used Tamiflu, said company spokesman Yuji Yamashita.
The company ruled that six of the deaths had nothing to do with the drug, based on judgments made by the patients' main doctors, Yamashita said. But for the seven other cases, a link between Tamiflu and deaths could not be ruled out, he said.
The announcement came after the U.S. Food and Drug Administration said Thursday that it will investigate the reports as part of the annual pediatric safety review of the drug. U.S. officials have cautioned they have no evidence to suggest the drug is to blame for the deaths.
Yamashita said that the company has reported to the health ministry at least 21 deaths of people aged 16 and over involving Tamiflu since 2001, when the drug went on sale in Japan.
He said the company has no immediate plans to withdraw Tamiflu. "We are not considering stopping sales at this point," he said. Tamiflu is widely used in Japan. Of 32 million people treated with the drug since its approval in 1999, 24 million were in Japan, according to Roche Holding AG, which makes Tamiflu.
Health authorities urged calm regarding the safety of the drug, which is one of the few drugs believed effective in treating bird flu. Health officials fear bird flu could spark a pandemic should it mutate into a form easily passed from human to human.
"We've asked experts' opinions on all cases but they doubt a causal relation. The Health Ministry does not think there are great concerns as to the safety of Tamiflu. We don't need to be overly concerned," Toshiro Nakagaki, a ministry official in charge of drug safety was quoted as saying by Kyodo News agency, reports the AP. I.L.