Feds checking post-vaccine seizures in young kids

Jan 20, 2011 By MIKE STOBBE , AP Medical Writer

(AP) -- Government officials are investigating an apparent increase in fever-related seizures in young children after they got a flu shot.

The U.S. on Thursday said there have been 36 confirmed reports of seizures this flu season in children ages 6 months through 2 years. The seizures occurred within one day after they were vaccinated with Fluzone, the only flu shot recommended in the United States for infants and very . Ten of the children were hospitalized, but all recovered.

The FDA said it is investigating to see if there is any connection between the and the seizures, or if something else caused the convulsions. The agency said recommendations for using the vaccine have not changed, nor has there been any change in guidance.

In the U.S., vaccination is recommended for everyone except infants under 6 months.

The vaccine's manufacturer, Sanofi Pasteur, issued a statement emphasizing that no clear link has been established between the flu shot and the seizures and that the cases may be coincidental.

Thursday's announcement comes at a time when the FDA has been working on disclosing more information about potential safety problems with drugs and devices after they've been approved.

The government uses a national reporting system to monitor possible side effects following vaccination. Doctors, nurses, parents and vaccine manufacturers all can file reports.

"It's meant to cast a wide net" to look for problems, but is only regarded as preliminary information that must be checked out, said Shelly Burgess, an FDA spokeswoman.

FDA officials said they've been paying special attention to seizure reports because of an unexplained higher rate of fevers and seizures in young children in Australia and New Zealand who got a specific flu vaccine earlier this year.

In August, a U.S. vaccines advisory panel said doctors should avoid using that vaccine, made by CSL Biotherapies, in children ages 6 months through 8 years.

It's possible the Australia cases sparked increased reports this fall, said Dr. Andrea Sutherland, an official in the FDA's Center for Biologics Evaluation and Research.

The fever-related seizures - called febrile seizures - are convulsions brought on by a fever in infants or small children. A child often loses consciousness and shakes. Most seizures last a minute or two, and often children quickly recover.

Such may occur with any common childhood illnesses that may cause fever, such as ear infections, colds, influenza and other viral infections.

Explore further: Feds vows to publicize vaccine injury help program

More information: FDA notice: http://tinyurl.com/FDAnotice

not rated yet
add to favorites email to friend print save as pdf

Related Stories

Mother's flu shot protects newborns

Sep 17, 2008

Newborns can be protected from seasonal flu when their mothers are vaccinated during pregnancy, according to a study led by researchers at the Johns Hopkins Bloomberg School of Public Health. The researchers observed a 63 ...

Recommended for you

US approves new, hard-to-abuse hydrocodone pill (Update)

Nov 20, 2014

U.S. government health regulators on Thursday approved the first hard-to-abuse version of the painkiller hydrocodone, offering an alternative to a similar medication that has been widely criticized for lacking ...

Soaring generic drug prices draw Senate scrutiny

Nov 20, 2014

Some low-cost generic drugs that have helped restrain health care costs for decades are seeing unexpected price spikes of up to 8,000 percent, prompting a backlash from patients, pharmacists and now Washington ...

Only half of patients take their medications as prescribed

Nov 20, 2014

The cost of patients not taking their medications as prescribed can be substantial in terms of their health. Although a large amount of research evidence has tried to address this problem, there are no well-established ...

User comments : 0

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.