Tamiflu And Relenza Treat Flu, But Might Make You Crazy

This week, an FDA advisory panel will review a recommendation to put a warning on flu drugs Tamiflu and Relenza that says there have been “psychiatric events observed in some patients.” The companies who make the drugs have both responded that they’ve found no causal link between their drugs and “psychiatric events.”

Even the FDA has mixed feelings about it, which it may resolve this week.

The FDA staff said the evidence is “conflicting” as to whether the events are medication-related, a manifestation of disease or a combination of the two.

Tamiflu has been more widely used in Japan than in the United States, and there is some evidence that the Japanese are more vigilant about reporting side effects, the FDA has said.

FDA staff based its recommendations on a review of nearly 600 cases of neuropsychiatric events reported by patients on Tamiflu and 115 cases of such events by patients taking Relenza.

Tamiflu already has a warning label that says patients should be closely monitored “for abnormal behavior such as delirium or self-injury,” which the FDA placed on it after a report two years ago that 12 Japanese children who were taking Tamiflu died. Relenza is currently free from any psychiatric warning.

The new Tamiflu warning would state: “”In some cases, these behaviors resulted in serious injuries, including death, in adult and pediatric patients.”

For Relenza, the proposed warning would caution that “reports of hallucinations, delirium and abnormal behavior” have been observed in some patients.

“FDA staff urge psych warnings for two flu drugs” [Reuters]
(Photo: Getty)

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  1. Omi says:

    I might be picking one of these up soon. I, uh, am pretty sure I got the flu.

  2. swalve says:

    I seem to remember reading (when this story came out last time) that Influenza itself has a similar rate of incidents. Or was it the population at large?

    That’s the double-edged sword of side effect reporting. People are hyper vigilant about blaming the drug, and they can’t reliably know whether “the chills” is from the drug or the illness.

  3. Dancing Milkcarton says:

    Until then we’ll just file flu shots next to every other damn thing in the world – the ‘we don’t know shit, yet, but hopefully science will catch up’ file.

  4. timmus says:

    A Glaxo spokeswoman said a review of premarketing and post-approval trial data showed no worrying safety signals on patients taking Relenza.

    The media should not be in the habit of allowing manufacturers to whitewash their products. If they want to, they can do this on their own websites. The newspaper’s crime page certainly doesn’t allow the latest burglary suspect to make a public statement.

  5. Candyman says:

    @timmus: But they should be in the habit of bashing them without even giving them the opportunity to respond? That’s not journalism, it’s propaganda. Believe the company spokesman or don’t, but it’s entirely appropriate for the media to get their comment, and would be unprofessional NOT to. And, BTW, the media uses statements from criminal suspects or their spokesperson ALL THE TIME. Maybe not a simple burgler perhaps, but that’s lack of interest, not because it’s something they “shouldn’t” do.

  6. no.no.notorious says:

    once again, thanks getty!

  7. RvLeshrac says:

    @swalve:

    The flu in-and-of-itself doesn’t, but a high fever can make you extremely crazy. The one time I had a severe flu case and hit 110F, I seem to recall the walls moving like conveyor belts and riding on the back of a multicolored dinosaur.

    That’s not to excuse the drugs if this turns out to be true, mind, but random people reporting side-effects in a random fashion does not a scientific study make.

    @bitfactory:

    That sounds a lot like anti-science talk. You’re not going to start saying off-putting things about the moon landing, are you?

  8. flairness says:

    Funny coincidence. My friend’s name is Tami and she is batshit crazy.

  9. lincolnparadox says:

    You should only ask for Tamiflu if you can’t beat a flu. Tamiflu is for life-threatening illness, not a week of the sniffles.

    @RvLeshrac: Dude, if you had a 110F fever, even for a short time, you’d have brain damage. Hyperpyrexia is anything over 107F, and that is ice-bath and praying to G-d “bad.”

  10. mexifelio says:

    Does Tamiflu come in an Aquadot gelcap?

  11. swalve says:

    @bitfactory: These aren’t flu shots.

  12. ex_ea_slave says:

    [www.theonion.com]

    Reminds me of a story the Onion did on a mormon teen who took one too many Benadryl.