November 2007
The Food and Drug Administration (FDA) has recommended that extra label precautions be added to two different prescription flu medications for children. Tamiflu and Relenza may be linked to potential neurological problems that have contributed to the deaths of 25 children worldwide.
Hallucinations and convulsions were the primary side effects identified in the FDA’s assessment. Although all 25 deaths occurred in patients less than 21 years old while taking Tamiflu, Relenza has been has been found to have similar adverse risks. Although the problems have not been directly linked to the drugs, regulators have requested the labeling as a precaution while collecting and evaluating further information.
This news comes as the FDA has also increased scrutiny of asthma drugs for kids. Use of Serevent and Advair has become questionable for children, where negative side effects may differ from the risks already noted in the black box labels accompanying the medications. No label changes have been announced yet, but the agency has disclosed that changes may be coming soon.