FDA Suggests ‘Precautionary Wording’ for Flu Drugs

Reports of strange behavior in people taking anti-flu drugs have long been a concern in Japan. Now those concerns seem to be spreading to the U.S.

In this memo, posted online today, an FDA review team recommends adding “precautionary wording” to the labels of Roche’s Tamiflu and GlaxoSmithKline’s Relenza to alert doctors and patients to case reports of hallucinations and strange behavior in people taking the drugs.

Most of the reports come from Japan (see this post), where the drugs are used more often than they are here. The events seem more common in children and adolescents than adults.

The agency memo says it’s unclear whether the drug is causing these events, or whether they are the result of the flu or other factors. A pediatric advisory committee of outside experts will meet next week to discuss the subject. Glaxo and Roche say the evidence doesn’t warrant revising the drugs’ labels, Dow Jones Newswires reports.