November 8, 2012 — Shortly after all medicines from New England Compounding Center (NECC) were recalled in early October due to potential fungal contamination, the Centers for Disease Control (CDC) warned that fungal meningitis may have a 42-day incubation period. This time period has passed, but new cases are still being reported, suggesting that this particular strain of fungus (mostly Exserohilum rostratum) may have a longer incubation period than expected.
As of today, the CDC has reported that 31 people have died and 424 people have been infected after being treated with a medication from NECC. Most of the injuries involve people who were given epidural steroid injections directly into their central nervous system, which makes it very easy for organisms to invade the body.
NECC and its sister company, Ameridose LLC, have ceased operations and recalled all medications. Ameridose has laid off about 650 workers and 140 marketing personnel at an affiliated company. Although the company expected the shut-down to be temporary, the closure was extended after the FDA found problems with the company’s sterility procedures.
NECC is accused of inadequate sterility testing on its injectable medications, particularly methylprednisolone acetate, which is used to treat back pain. The Tennessee Health Department announced that at least 150 people received tainted products that were more than 7 weeks old, when the products are supposed to be used within 24 hours. The products are sold without preservatives, which makes sterility, testing, refrigeration, and prompt use essential to prevent an infection.
According to officials at the U.S. Food and Drug Administration and the Massachusetts Board of Pharmacy, NECC violated its license by mass-producing drugs without prescriptions for individual patients, and then selling them across state lines.
The director of the Massachusetts Board of Pharmacy, James Coffey, has also been fired for failing to disclose a complaint against NECC. The complaint, dated July 26, was sent to the Board by Colorado pharmacy regulators just months before the outbreak. The officials warned that NECC was mass-producing drugs without specific patient prescriptions, in violation of their licenses in Colorado and Massachusetts. Coffee failed to take any action on the complaint.