Federal health officials are reporting the death toll from an outbreak of a rare fungal meningitis has risen to 15. The Centers for Disease Control and Prevention says the outbreak has now sickened 197 people in a 13 states.
The latest state reporting cases is Illinois. Others include Florida, Idaho, Indiana, Maryland, Michigan, Minnesota, New Jersey, North Carolina, Ohio, Tennessee, Texas and Virginia.
The outbreak has been linked to steroid shots used for back pain made by the New England Compounding Center, a specialty pharmacy in Framingham, Mass. The medication has been recalled, along with all other products manufactured by the company.
NECC was founded in 1998 by Barry Cadden and Gregory Conigliaro as a compounding pharmacy, a laboratory that custom-mixes solution, creams and other medicines in dosages and forms that often are unavailable from pharmaceutical companies.
State officials have inspected NECC at various times, most recently last March, following a complaint about the potency of a product used in eye surgery. The results of that inspection have not been released, and state officials said the complaint appears unrelated to the meningitis outbreak.
However, NECC was licensed only to fill individual patients’ prescriptions, state officials said. Authorities said it may have been operating beyond its legal boundaries by shipping products for broad use around the country. Compounding pharmacies are more lightly regulated than pharmaceutical makers, and their products are not subject to Food and Drug Administration approval.
“The New England Compounding Center was masquerading as a compounding pharmacy so it could escape federal regulation when it was actually operating as a drug manufacturer,” said Rep. Edward Markey, D-Mass., who sits on the Energy and Commerce Committee, which has jurisdiction over the FDA.