FDA Wants Warning that Tamiflu may Cause Psychotic Reactions
After several cases in which children and teenagers experienced suicidal or psychotic side behavioral side effects after taking Tamiflu (and related drug Relenza), the FDA wants to add a warning label.
By Anastacia Mott Austin
After reports emerged of children exhibiting delirium, suicidal tendencies, and other psychotic side effects after taking the flu drug Tamiflu, the Federal Drug Administration (FDA) this week recommend that a pediatric panel examine the drug and issue an additional package warning. Tamiful is currently made by pharmaceutical company Roche.
The FDA has been reviewing Tamiflu since 2005, after some users, mostly children, reported experiencing hallucinations, delirium, or seizures.
Five deaths in Japan were tied to Tamiflu, after children taking the medicine fell from windows or ran into traffic. The incidents occurred primarily in Japan, where use of Tamiflu is much more widespread than in the United States.
Another related flu drug, Relenza, has also come under scrutiny for similar reactions, though no suicides have been blamed on the drug.
The makers of both drugs claim that the likely cause of psychotic side effects is a genetic mutation of a flu virus, and that it is the virus, not the medication, that is causing the problems.
A statement on the FDA website read, in part, "Although there is still uncertainty about the cause of the reported abnormal behavior in patients, it is prudent [to add a new warning to the label]." The agency plans to continue to monitor the flu drugs, it said.
In March of 2007, the Japanese Ministry of Health asked that restrictions be added to the use of Tamiflu on patients aged 10-19.
Though the FDA does not appear to be suggesting restricting the drug’s use, Roche representative Terry Hurley told reporters, "If the FDA concludes that it is valuable to place additional details on the label with regard to specific adverse event reports, then Roche is open to that consideration. We would also remind patients that reports of neuropsychiatric events are infrequent."
During its review, the FDA examined 596 cases in Japan and 365 cases in the United States of children whose parents reported psychiatric side effects after taking Tamiflu. Common behavioral side effects were violent behavior, head-banging, or an overwhelming "urge to flee," often from a window.
Sales of Tamiflu in Japan have decreased to about half of what they were in 2005, after the adverse reactions were widely reported in the press.
After reports emerged of children exhibiting delirium, suicidal tendencies, and other psychotic side effects after taking the flu drug Tamiflu, the Federal Drug Administration (FDA) this week recommend that a pediatric panel examine the drug and issue an additional package warning. Tamiful is currently made by pharmaceutical company Roche.
The FDA has been reviewing Tamiflu since 2005, after some users, mostly children, reported experiencing hallucinations, delirium, or seizures.
Five deaths in Japan were tied to Tamiflu, after children taking the medicine fell from windows or ran into traffic. The incidents occurred primarily in Japan, where use of Tamiflu is much more widespread than in the United States.
Another related flu drug, Relenza, has also come under scrutiny for similar reactions, though no suicides have been blamed on the drug.
The makers of both drugs claim that the likely cause of psychotic side effects is a genetic mutation of a flu virus, and that it is the virus, not the medication, that is causing the problems.
A statement on the FDA website read, in part, "Although there is still uncertainty about the cause of the reported abnormal behavior in patients, it is prudent [to add a new warning to the label]." The agency plans to continue to monitor the flu drugs, it said.
In March of 2007, the Japanese Ministry of Health asked that restrictions be added to the use of Tamiflu on patients aged 10-19.
Though the FDA does not appear to be suggesting restricting the drug’s use, Roche representative Terry Hurley told reporters, "If the FDA concludes that it is valuable to place additional details on the label with regard to specific adverse event reports, then Roche is open to that consideration. We would also remind patients that reports of neuropsychiatric events are infrequent."
During its review, the FDA examined 596 cases in Japan and 365 cases in the United States of children whose parents reported psychiatric side effects after taking Tamiflu. Common behavioral side effects were violent behavior, head-banging, or an overwhelming "urge to flee," often from a window.
Sales of Tamiflu in Japan have decreased to about half of what they were in 2005, after the adverse reactions were widely reported in the press.
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