Is the Flu Drug Safe for Kids?
Listen up, parents: The flu medication Tamiflu could cause erratic behavior in children, like delirium, self-injuries, and hallucinations. That's the warning the Food and Drug Administration is now requiring on the Tamiflu product label. The agency made the decision earlier this week after reviewing reports of more than 100 adverse events linked to the use of Tamiflu, most of them occurring in children. One patient was a 14-year-old boy from Japan who fell to his death after climbing on his condominium balcony railing.
"At this point, we can't definitively say whether these cases were caused by Tamiflu, the influenza virus, or a combination of both," says Debbie Birnkrant, director of antiviral products at the FDA. "The flu can also cause the same psychological symptoms, so it's difficult to tease out." Still, she cautions parents to monitor their children taking Tamiflu closely for signs of behavioral changes.
Terry Hurley, spokesperson for Tamiflu manufacturer Hoffman-La Roche, says, "Parents should know that reports are rare based on usage." In fact, the vast majority of the problems were reported from surveillance of the drug in Japan, not the United States. That could be because of the more common use of the drug in Japan, according to Birnkrant. Japanese doctors wrote about 9 million prescriptions for Tamiflu in 2005 compared with 1.7 million prescriptions for Americans. Hurley stresses that the benefits of the drug still outweigh the risks.
When taken within the first day or two of flu symptoms, Tamiflu reduces their severity and cuts their duration by about a day. (Flu typically resolves within seven days when running its natural course.) Approved for children over age 1, it can also be used as a prophylactic to prevent the flu in someone who has been exposed. An inhalable flu drug, Relenza, can be used in children over 5, but it carries a small risk of wheezing and other breathing problems. Neither of the drugs, though, has been shown to prevent serious flu-related complications like pneumonia.
Pediatricians, by and large, prefer vaccinating against the flu to prevent it from occurring in the first place. "I rarely prescribe flu drugs," says Henry Bernstein, a professor of pediatrics at Dartmouth Medical School who serves on the American Academy of Pediatrics' infectious disease committee. Given the new warning on Tamiflu's label, he says he'll advise parents to stop the drug immediately if their child starts to exhibit strange behavior.
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