Meningitis outbreak: Report shows who's most at risk

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.

Those 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.

During 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 higher risk.

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

The 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.

The U.S. 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.

The 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.

"We 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