This photo shows shows vials of the injectable steroid product made by New England Compounding Center implicated in a fungal meningitis outbreak.(Photo: AP)
NASHVILLE -- Gender and age as well as frequency and timing of
injections have been shown to be key risk factors for people developing
fungal meningitis after they were treated with potentially moldy
medicine, state health officials said in a paper published Tuesday.
at greatest risk included women at least 60 years old, those who
received multiple epidural injections and those treated with vials of
medicine more than 50 days old from one lot of recalled steroids,
Tennessee health officials said.
Those and other details about the
outbreak are contained in an article published on the New England
Journal of Medicine's website. It was based on an analysis of 817
patients who received the injections, mostly for back pain, at Saint
Thomas Outpatient Neurosurgery Center between July 1 and Sept. 20.
that period, the clinic administered 1,663 vials of methylprednisolone
acetate produced by New England Compounding Center of Framingham, Mass.
Authorities believe the steroid was contaminated with different types of
fungi that have sickened more than 400.
Those who had four
injections were three times more likely to get sick than those who had
one, the team of Tennessee state health officials reported. Women were
twice as likely to get sick, as were those older than 60, they said. And
those who received medicine that was more than 50 days old also were at
NECC's methylprednisolone acetate was
preservative-free, and "the level of contamination in the vials may have
increased over time," the report noted.
The compounding pharmacy has closed and recalled all of its products.
FDA files warning
report came a day after federal officials warned a Franklin,
Tenn.-based company about claims that its light therapy product cures or
treats various health problems, including meningitis.
Food and Drug Administration sent a warning letter Monday to The Avalon
Effect Inc., telling the company to stop marketing an unapproved medical
device called the Quantum Series Personal Wellness Pack.
letter contends the company's website claims the product can cure and/or
treat symptoms of fungal meningitis, concussions and Lyme disease,
among other conditions. That violates federal law because Avalon does
not have approval to market the device or an exemption to investigate it
for safety and effectiveness, the FDA said.
The device, the
Quantum Series Personal Wellness Pack, also is misbranded because the
company did not notify the FDA of plans to introduce it to the
marketplace, the letter said.
It's the second time the FDA said it
has warned Avalon, which has its offices on Mallory Lane in Cool
Springs. The agency notified the company of possible marketing
violations in August. Avalon said then that it did not intend for any of
its products to be used to treat, cure, mitigate, prevent or diagnose
any medical condition.
But the FDA said a follow-up review of the
company's website and related links showed Avalon was still making those
claims, prompting the second warning.
Avalon founder Tinka Smith and Chief Executive Officer Michael Haarlander disputed that in a statement issued Tuesday.
simply have no intention to market a device in that manner," they said.
"We are working with the FDA with full cooperation to clarify this
matter. The FDA is essential to our success. We are committed to the
long-term health of our company, our product and our clients."
Duane Marsteller, The Tennessean