TAMIFLU TAPPOI 12 LASTA?

[Bb]

Lähettäjä: Soijuv Lähetetty: 18.11.2005 15:28

12 japanilaista lasta on kuollut käytettyään lintuinfluenssalääkettä
(Tamiflu). Valmistajan (Roche) mukaan suoraa yhteyttä lääkkeen
ja kuolemien välille ei voida osoittaa, mutta sitä ei voida myöskään
poissulkea. FDA aikoo tutkia Tamiflun ja 7 muun influenssalääkkeen
turvallisuutta:


FDA to Probe Deaths of Kids on Tamiflu
Thu Nov 17, 3:12 PM

WASHINGTON - The deaths of 12 Japanese children who had
taken Tamiflu is to be discussed on Friday by a U.S.
government committee conducting a routine annual review of
the safety of the anti-flu medication and seven other drugs.

The deaths are detailed in a Tamiflu pediatric safety update
released in advance of the meeting. There have been no
reports of deaths in the United States.

The update also includes reports of 32 "neuropsychiatric
events," 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," said Dr. Murray
Lumpkin, the deputy commissioner of the U.S. Food and Drug
Administration. "Going into the discussion tomorrow, 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."

The FDA sought and received more information from the Swiss
pharmaceutical company Roche and Japanese health authorities
about the deaths in advance of Friday's meeting, but has not
initiated any action, spokeswoman Susan Bro said.

Complicating the issue is that many of the death and adverse
reaction reports list symptoms commonly associated with the
flu, Lumpkin 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, adding
that "millions and millions" of patients have safely used
the drug to treat the flu.

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 can
induce "strange behavior" after reporting that two teen boys
died shortly after taking the medicine.
"Roche has carefully reviewed these events and has concluded
that a causal link cannot be established," the company said
in a statement released on Monday.

However, the Japanese distributor of the Roche-patented drug
told health officials it could not rule out a link between
Tamiflu and the deaths. Tamiflu is extensively used to treat
children in Japan, according to the FDA.

The U.S. labeling for Tamiflu lists nausea and vomiting as
its most serious side effects. It labeling in Japan includes
any adverse effects that have been reported - including
impaired consciousness, abnormal behavior and hallucinations
- regardless of whether they can be attributed to the drug,
according to Roche.

Tamiflu is one of the few drugs believed effective in
treating bird flu, which health officials fear could spark a
pandemic should it mutate into a form easily passed from
human to human.