FDA Panel to review Relenza and Tamiflu side effects
According to reports received by the FDA, Relenza and Tamiflu side effects could be responsible for neuropsychiatric problems, such as delirium, delusions, hallucinations, impulsive behavior and self-injury. After identifying a significant number of episodes among users which resulted in serious injury or death, the regulators will convene a panel of outside experts this week to review possible label changes which may be needed for the flu drugs.
Tamiflu and Relenza are approved for treatment of influenza, or the flu. Tamiflu (oseltamivir) is delivered as a pill or syrup and Relenza (zanamivir) is inhaled. Since 1999, about 4 million courses of Relenza have been given and approximately 48 million people worldwide have taken Tamiflu, including 21 million children.
At least 25 deaths have been reported among users of Tamiflu, some of them involving children falling out windows or running into traffic as a result of delusions and hallucinations. The reported problems generally occur within 24 hours of first taking the drugs While most of the reported occurrences involve those under 21 years old, there have also been three reports of suicide death among adults taking Tamiflu.
The FDA indicated that they recently performed a safety review of Tamiflu and Relenza to examine the neuropsychiatric side effects. The review found nearly 600 neuropsychiatric events among users of Tamiflu and about 115 events associated with Relenza. The majority of the reports of side effects associated with both drugs came from Japan, where the drugs are typically taken for several weeks since it is approved not only to treat the flu, but also to prevent it. In the United States, children typically only take the drugs for five days or less.
The FDA’s Pediatric Advisory Committee is scheduled to meet this week on Tuesday to comment on possible label changes proposed by the FDA, which discuss the risk of neuropsychiatric side effects. Although the FDA is not required to follow the recommendations of their advisory panels, they usually do.
Concerns about Tamiflu side effects surfaced two years ago following reports of deaths and psychiatric problems among children in Japan. A similar advisory panel meeting was held by the FDA at that time, and experts were unable to find a direct connection between the drugs and the deaths. However, the warning label for Tamifly was updated to add caution and urge close monitoring for abnormal behaviors.
The drug manufacturers stress that there has been no established causal link between the flu drugs and the abnormal behaviors identified. The drug companies indicate that the problems could possibly be associated with the underlying influenza or could be caused by a rare genetic reaction to the drug. However, experts have suggested that based on the available data, the proposed warnings are appropriate and necessary.
The product liability lawyers at Saiontz & Kirk, P.A. are closely monitoring the FDA’s investigation into Relenza and Tamiflu side effects. If you, a friend or family member suffered serious physical injury or death as a result of abnormal behavior, hallucinations, delusions, or self-inflicted injury after taking Tamiflu or Relenza, request a free consultation.
