Health Canada looking at Tamiflu data after reports of deaths in Japan

Health Canada looking at Tamiflu data after reports of deaths in Japan

Canadian Press

Friday, November 18, 2005
TORONTO (CP) - Health Canada said it is going over the safety data for the flu drug oseltamivir or Tamiflu after reports have come to light of a number of deaths in children in Japan who took the drug.

A spokesman said such a study is always undertaken when there are reports of potential adverse reactions to a drug. "It's being looked at," Jirina Vlk said from Ottawa. "It would be stretching it to say we're ordering a review."

Health Canada's U.S. counterpart, the Food And Drug Administration, said Thursday it was also studying the deaths of 12 Japanese children who'd taken the drug. And the regulator termed "concerning" reports of 32 psychiatric events among children who took Tamiflu.

But the U.S. agency said it was difficult to tell whether use of Tamiflu played a role in any of these events.

The FDA said all but one of the psychiatric events were reported in Japan, the one market to date where Tamiflu has been widely used during flu season.

The drug's maker, Hoffman-La Roche of Switzerland, said in a statement the rate of these events in people who took the drug was not higher than in the population at large.

Vlk said a rapid analysis of 73 Tamiflu-related adverse drug reactions reported to Health Canada showed seven people taking the drug died. None were children. Most if not all were elderly and four of the seven had other illnesses.

Vlk said most of the adverse reactions were mild symptoms such as nausea, a known side-effect of the drug.

"The evidence we have so far does not allow a clear causal link to be established," she said. "We're going to take a closer look to see if a true signal is present."

Tamiflu was first brought to market in 1999. Roche says 33 million patients in roughly 80 countries have used the drug since then.
© The Canadian Press 2005
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