In Japan, they call it “Tamiflu Suicide.” And it refers to more than 50 instances in which people, including more than a dozen youngsters, died after taking the flu pill. Some were last seen on high-rise balconies. For several months, Japan’s Health Ministry echoed the manufacturer about the lack of a causal link, after a survey of 2,800 patients didn’t suggest a relationship.

Now, health officials want Roche’s Chugai Pharmaceutical unit to send “emergency safety information” to doctors and hospitals stating Tamiflu shouldn’t be given to teenagers. “Despite uncertainty regarding any causal relationship, there are reports of abnormalities appearing in adolescent patients older than 10 after taking the drug,” says the ministry, which continues to hold out hope that Tamiflu will guard against bird flu.

The move comes after Rokuro Hama, who heads the Japan Institute of Pharmacovigilance, began receiving notice for examining the health ministry data. He says the ratio of people displaying abnormal behavior is “four times greater” after immediately taking the pill, but this wasn’t publicly reported. He was recently quoted in the Japanese press saying that “no children exhibited abnormal behavior if they only had the flu,” and tells Pharmalot the Japanese media has “gradually noticed my evidence-based opinion.”

Last November, the FDA required Tamiflu labeling to mention abnormal behavior, citing the Japanese reports, but both the agency and Roche say the episodes may have been sparked by severe cases of the flu. Roche continues to say that cases of “neuropsychiatric symptoms, including delirium,” are “very rare,” Japanese officials see “no causal relationship,” and separate studies in the US and Japan have shown similar rates of psychiatric disturbances in kids with the flu being treated with Tamiflu compared with those not on the pill.

What else constitutes abnormal behavior? How about a health ministry that fails to be more vigilant about investigating a public health threat? Tamiflu may or may not be effective against a deadly strain of bird flu, but a closer examination of its effects on people is ovderdue.

Kyodo News;
PharmaTimes;
Bloomberg News;
Kyodo News last month after fresh suicide reports;
International Society of Drug Bulletins alert about Tamiflu;
Rokuro Hama’s analysis;
FDA safety alert last November;
Roche ‘Dear Doctor’ letter last November;
USA Today story last November about FDA move.[tags]Bird Flu, Chugai, Roche, Tamiflu[/tags]