Tamiflu & Relenza: FDA Experts Recommend New Label Warnings for Children's Flu Medications
According to a safety review by FDA experts, the flu drugs Tamiflu and Relenza should carry a package warning label about possible dangerous psychiatric side effects in children. Tamiflu was approved by the FDA for pediatric use for children under 12 in 2005.
Safety concerns became evident two years ago after Japanese reports of 25 deaths and 32 incidents of psychiatric problems in children after taking Tamiflu. Following reports of children experiencing "neuropsychiatric events," to include delirium, delusions, hallucinations, impulsive behavior and self-injury, new studies of the drug were initiated. Tamiflu is available in pill and syrup form, and is used to treat symptoms of seasonal influenza.
On Tuesday, November 27, 2007, the FDA's Pediatric Advisory Panel will review the data and determine whether to issue new warning labels for Tamiflu and Relenza. According to the FDA documents, the problems usually occur within 24 hours of first taking the medication, and usually among patients younger than 21. FDA documents indicate, "In the remaining reports of delirium with impulsive behavior and self-injury, patients were attempting to flee or escape from windows or balconies and were unsuccessful in their efforts. In addition, there were a few patients who became aggressive or violent and/or performed acts that were injurious to themselves (e.g. banging head against wall) or others (e.g. child tried to strangle mother)."
Although FDA regulators caution that causal link has not been established between Tamiflu and the reported abnormal behavior, they are recommending that U.S. labeling be updated to include, "fatalities have occurred in adult and pediatric patients in Japan, the onset may be abrupt, and fatal events have occurred even while the patient was being monitored."
Relenza is an anti-viral drug that is in the same class as Tamiflu. Studies have revealed 115 cases of psychiatric problems, including 74 cases in patients younger that 21, but no related fatalities have been reported. Relenza is inhaled by mouth and is not easily absorbed. Currently, no label warning of psychiatric side effects is included. The FDA panel will recommend that Relenza's label carry a warning of psychiatric side effects to note that "postmarketing reports of hallucinations, delirium and abnormal behavior have been observed in patients" receiving the drug for influenza treatment.
Experts also noted that Tamiflu and Relenza are used in Japan to both prevent and treat influenza, whereas in the United States the drugs are generally used for shorter periods of time.
For further information about Tamiflu, Relenza, or any other medications prescribed for pediatric use, parents are cautioned to always consult their physicians for safety warnings and recommendations.