Two Deaths Prompt FDA Meningitis Alert on Cochlear Implants

ROCKVILLE, Md., Oct. 11 -- The FDA has alerted physicians to the need for children with cochlear implants to be fully immunized against bacterial meningitis, citing two recent deaths that might have been prevented.

In a public health notice, the FDA said there was an increased life-threatening risk of bacterial meningitis in cochlear implant recipients caused by Streptococcus pneumoniae, particularly those children with implants that have a positioner.

Only one cochlear implant has a position and that device was withdrawn from the market in July 2002.

The FDA said the two deaths -- in children ages nine and 11 -- both occurred in the past year in children who were not fully immunized and had been implanted with a cochlear implant with a positioner.

"At least one of these children had meningitis caused by a serotype of Streptococcus pneumoniae that may have been prevented by proper vaccinations," the FDA said.

The FDA said that results of a recent survey revealed that only 29% of parents or guardians of children younger than two with cochlear implant knew whether their children were properly vaccinated. The survey, by John Niparko, M.D., of Johns Hopkins, found that vaccination status was also unknown for 43% of implant patients older than two.

The FDA said physicians should follow CDC recommendations regarding vaccinations for cochlear implant patients, which is the same vaccination schedule as that recommended for other high-risk patients.

The FDA also recommended that cochlear implant recipients, their families, teachers, and daycare providers be briefed on the signs of meningitis in order to ensure early detection and treatment.

Early signs of meningitis may include high fever, headache, stiff neck, nausea, or vomiting, discomfort looking into bright lights, sleepiness, or confusion. Some patients have ear pain or ear infection. Very young children may be sleepy, cranky, or eat less.

Finally, the FDA recommended that physicians:

• Diagnose and treat otitis media promptly. In some of the meningitis cases reported to FDA, cochlear implant recipients had signs of middle ear infection prior to surgery or before the meningitis developed. For this reason, according to American Academy of Pediatrics clinical practice guidelines, clinicians should diagnose and treat otitis media promptly in patients with cochlear implants. They should also consider antibiotic therapy more readily in these patients than others.
• Consider prophylactic antibiotics. Healthcare providers should consider prophylactic antibiotic treatment perioperatively in children receiving cochlear implants.