Japan Today - News - Gov't suspends use of anti-flu drug Tamiflu for teens after abnormal behavior reports
Gov't suspends use of anti-flu drug Tamiflu for teens after abnormal behavior reports
Wednesday, March 21, 2007 at 11:30 EST
TOKYO — The government issued an emergency instruction Wednesday to suspend the use of Tamiflu for teenage patients as another two cases of abnormal behavior by teenagers given the anti-flu drug were reported.
The Health, Labor and Welfare Ministry instructed Tamiflu importer-distributor Chugai Pharmaceutical Co to state in the drug's explanatory note that its use for teenage patients should be refrained in principle. Chugai was also instructed to provide the information to medical institutions using Tamiflu.
The ministry said it has newly received reports that after taking Tamiflu, two 12-year-old boys jumped off the second floor of their houses and broke their legs in February and March, respectively. The ministry did not disclose where the incidents took place.
In February, a 14-year-old boy fell to his death at his condominium in Miyagi Prefecture after apparently taking the drug while a 14-year-old girl died in similar circumstances in Aichi Prefecture.
At a news conference urgently convened Wednesday, Tatsuo Kurokawa, who is in charge of pharmaceutical issues at the ministry's secretariat, said it is necessary to issue an alert although there are no causal relations between Tamiflu and the incidents.
Asked if the instruction came late, Kurokawa, "We've never left the issue needlessly and have done our best at every step of the way while the causal relations remain unclear."
Following the number of cases involving abnormal behavior, Tamiflu has sparked growing concern in Japan, and many have asked that the ministry act quickly.
Chugai Vice President Mikio Ueno, who was also at the conference, said, "We, too, still believe in Tamiflu's benefits."
"On the other hand, it is also true that there are people who have encountered these accidents. We have decided to work with the ministry as a preventive step," he said.
The ministry's latest decision is seen by critics as contradictory — providing an emergency safety information and suspending the prescription of Tamiflu to teens while backing the effectiveness of the drug.
Tamiflu has been reputed for its potency against influenza. Japan has been stocking up the drug for some time.
Following the ministry's instruction, Chugai will revise the drug information sheet on two types of Tamiflu, one in capsules and another in dry-syrup granule form.
The sheet will state that the drug should not be given in principle to teens, excluding those who may suffer serious conditions without it. The drug may be used for patients from infants to nine years old, but the sheet will clearly ask doctors to tell families of the patients that it may cause abnormal behavior.
Within this week, the revised information sheet will be sent to all medical institutions to which Chugai currently delivers Tamiflu.
In the latest cases of Tamiflu-related abnormal behaviors, one took place Feb 8, when a 12-year-old boy dashed outside the house barefoot. His father got a hold of him, but the boy jumped out the window on the second floor, breaking his right knee.
Another case occurred last Monday, when another 12-year-boy suddenly ran upstairs. He was brought back by his mother but went upstairs again before jumping off a balcony, breaking his right heel.
The two boys were both diagnosed with influenza, and exhibited the odd behavior after taking Tamiflu. They are not in a life-threatening condition.
When the two death cases were reported in February, the ministry issued documents to doctors and medical institutions to warn them that the drug may trigger abnormal behavior.
"While teens can be saved by not prescribing the drug, cases of sudden death linked to Tamiflu have also been reported among infants and adults," said Haruhiko Nokiba, who heads a group created last June by families of those who they say died from accidents triggered by abnormal behavior after taking Tamiflu.
The group asked the government in February to acknowledge the causal link between the antiviral drug and abnormal behavior and issue an alert to the people.
"The ministry should totally ban the prescription of the drug except for the elderly who have weak immune systems," Nokiba said.
Roche says no link between Tamiflu, abnmormal acts
Meanwhile, Swiss drugmaker Roche Holding AG said in Geneva on Tuesday there was no established causal link between its antiviral drug Tamiflu and psychiatric symptoms recently reported in Japan and the United States.
Roche said in a statement that its clinical studies have shown similar rates of neurological and psychiatric events between pediatric influenza patients being treated with Tamiflu and those receiving no treatment.
It said "delirium and neuropsychiatric disorders" associated with influenza are "not uncommon" and occur in the United States in approximately four out of every 100,000 influenza patients. It added that the incidence in Japan "is believed even higher."
"Roche is aware that a number of reports have been received in Japan of neuropsychiatric symptoms including delirium, with associated abnormal behavior, and very rare cases of death in patients suffering from influenza who have also been taking the antiviral Tamiflu," it said.
Roche said Tamiflu has been used in over 45 million influenza patients worldwide, and that its "post marketing surveillance has confirmed that rates of neuropsychiatric events in patients taking Tamiflu occurred in around one in 37,000 patients."
It added reports of such events leading to death "are extremely rare, occurring in around one out of every 5 million influenza patients treated."
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