
FDA presses flu shot makers to add seizure warning for young children
The FDA has asked six influenza vaccine manufacturers to add a label warning about a small increased risk of febrile seizures within the first day after vaccination in children aged 6 months through 4 years, based on two postmarketing studies. Estimated rates are about 21 seizures per million quadrivalent doses and 44 per million for the older trivalent ones. Companies have 30 days to respond or propose changes. The move comes as the CDC has revised childhood flu vaccination recommendations amid broader vaccine-safety scrutiny.

