Roche's Tamiflu to Add Warning on Psychiatric Risks

[Jcrowley]

Tamiflu takers: Watch out for bizarre behavior
Strange side effects reported overseas spur FDA to review labeling
Updated: 2:55 p.m. CT Nov 13, 2006

Doctors and parents should watch for signs of bizarre behavior in children treated with the flu drug Tamiflu, federal health officials suggested Monday in citing an increasing number of such cases from overseas.

Food and Drug Administration officials still don’t know if the more than 100 new cases, including three deaths from falls, are linked to the drug or to the flu virus — or a combination of both. Most of the reported cases involved children.

Still, FDA staff suggested updating Tamiflu’s label to recommend that all patients, especially children, be closely monitored while on the drug. They also acknowledged that stopping treatment with Tamiflu could actually harm influenza patients if the virus is the cause of delirium, hallucinations and other abnormal behavior, such as aggression and suicidal thoughts.

http://www.msnbc.msn.com/id/15701254/

Roche's Tamiflu to Add Warning on Psychiatric Risks (Update1)

By Catherine Larkin

Nov. 13 (Bloomberg) -- Roche Holding AG's Tamiflu flu treatment must carry information warning of potential risks of psychiatric side effects, U.S. regulators said.

The Food and Drug Administration approved a labeling revision to include information on those risks after reports of self-injury and mutilation among Japanese patients using the drug, the agency said today in an e-mailed statement. Most of these side effects were reported in children.

http://www.bloomberg.com/apps/news?pid=20601087&sid=aLUqmToDWYS8&refer=home

[niyad]

1. how much is rummy making from this, as a stockholder?

[Jcrowley]

3. Last I heard

Rumsfeld served as Gilead (Research)'s chairman from 1997 until he joined the Bush administration in 2001, and he still holds a Gilead stake valued at between $5 million and $25 million, according to federal financial disclosures filed by Rumsfeld.

The forms don't reveal the exact number of shares Rumsfeld owns, but in the past six months fears of a pandemic and the ensuing scramble for Tamiflu have sent Gilead's stock from $35 to $47. That's made the Pentagon chief, already one of the wealthiest members of the Bush cabinet, at least $1 million richer.

Rumsfeld isn't the only political heavyweight benefiting from demand for Tamiflu, which is manufactured and marketed by Swiss pharma giant Roche. (Gilead receives a royalty from Roche equaling about 10% of sales.) Former Secretary of State George Shultz, who is on Gilead's board, has sold more than $7 million worth of Gilead since the beginning of 2005.

http://money.cnn.com/2005/10/31/news/newsmakers/fortune_rumsfeld/

In April 2005, Roche reported its first quarter sales of Tamiflu quadrupled to $330 million.

[Horse with no Name]

2. I won't take any anti-flu preparations

I don't advocate others to do as I do, however, I had extrapyramidal symptoms after taking amantadine. I wouldn't give them to any member of my family except under the direst of circumstances.
It is a HORRIBLE feeling--I didn't realize it was the medication causing the problems, I thought it was the flu making me feel so bad.
My physician was a close personal friend and I saw his wife at the grocery store one evening after I started taking the medication.
She is also a nurse.
She called him IMMEDIATELY and we went to his office for him to give me medication to reverse the side effects of the medication.