Roche’s Tamiflu Gets Stronger Psychiatric Warning
5 CommentsBy Ed Silverman // March 4th, 2008 // 11:24 am
Under pressure from regulators, drug maker Roche has added stronger language to its Tamiflu label, warning of sometimes fatal psychiatric problems seen in a small number of patients, the Associated Press reports.
The drugmaker warned in a letter to docs that cases of delirium and self-injury have been reported among patients taking the prescription flu med. The older label mentioned reports of psychiatric problems, primarily seen among children in Japan. But the new label specifies that those problems sometimes proved to be fatal, which was recommended by an FDA panel at an advisory committee meeting last November. UPDATE: Glaxo also sent a letter concerning its Relenza flu med.
At that meeting, the FDA revealed that nearly 600 cases of psychiatric problems had been reported in Tamiflu patients, with 75 percent of them coming from Japan. At least five children there died after “falling from windows or balconies or running into traffic,” according to FDA.
The new labeling for both meds states that “the contribution of Tamiflu to these events has not been established,” and also stresses that the flu, with or without treatment, can cause behavioral problems ranging from delirium to hallucinations. “Patients with influenza should be closely monitored for signs of abnormal behavior,” the Tamiflu label states. Japan accounts for two-thirds of the $2.4 billion global market for Tamiflu, because doctors there usually prescribe drugs to treat flu symptoms, the AP reminds us.
Callie Roberts
And this product is still on the market? Why? “600 cases of psychiatric problems” for a product that doesn’t even prevent the flu, but purports to reduce the time of discomfort? What a trade-off… hey… I can go back to work 3 days sooner at the risk of psychiatric problems… no problem!
Clo
A personal experience with the side effects from Tamiflu were close to horrific. No warning or caution was provided by the doc even after asked about the safety of this product. Only a slight pause before stating that the drug was usually tolerated well. Huh, are you kidding!
Anna
My husband almost killed himself and his family (including 2 small children) due to the effect of Tamiflu. No previous psych history. Negative flu test but doctor prescribed it anyway. No warning given to us. He ended up in a psych hospital, not given any meds because doctors felt this was due to Tamilfu and just waited for medicine to wash out.
Very traumatic thing that ever happened to us. Life will never be the same after this………….
AA
Anna,
I am so sorry about the nightmare your husband experienced with Tamiflu.
But he is very lucky he wasn’t given more psych meds. Most people in similar situations, particularly people with psych med histories, would have been hit with more psych meds. Complaints about the symptoms being from the Tamiflu would have fallen on deaf ears.
I don’t mean to sound insensitive as I know what your husband has experienced as the result of a prozac induced suicidal ideation. But if someone like me were to report the same symptoms, I greatly fear that I wouldn’t have the same treatment as your husband.
I do feel for what you have been through.
AA
AA
John A. Mattera
Tamiflu is the worst thing that has ever happened to me!
Prescribed for the flu, 4 days later the EMR was called by my girlfriend as I was found laying unconscious on my bedroom floor. I apparantly vomited and deficated and was unresponsive. She called 911 who came to the house, tried to awake me, and based on the report, awoke a person that is NOT ME! They found an aggitated, hallucinating, psych case. No history of violence, psychiatric disorders,seizures, hallucinations etc…..
This needs to be pulled off the market immediately!