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: Combining epilepsy drug, morphine can result in less pain, lower opioid doses

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

Vaccine proves effective against deadly Middle East virus

Sep 15, 2014

(Medical Xpress)—A vaccine developed by an international team of scientists led by the University of Pittsburgh School of Medicine successfully protects mice against a contagious and deadly virus spreading across the Middle ...

New study looks at improving vaccine awareness

Sep 15, 2014

The best medical therapies won't do much good if the public abstains from using them. Resistance to life-saving interventions may have a variety of root causes, particularly if the biotechnology involved is new and poorly ...

High-dose opioid prescribing continues to climb

Sep 12, 2014

High-dose opioid prescribing increased by 23 per cent in Canada between 2006 and 2011, despite clinical guidelines recommending that most patients should avoid high-doses of these drugs, according to new ...

Feds say Bayer colon supplement makes bogus claims

Sep 12, 2014

The United States government accused Bayer of making scientifically unproven statements about the health benefits of a popular probiotic on Friday, claiming the German pharmaceutical giant was in contempt of court.

User comments : 0