November 8, 2012 — In early October, New England Compounding Center (NECC) recalled all lots of all medications due to potential fungal contamination. The Centers for Disease Control (CDC) recommended that anyone who had been exposed to the medications should be vigilant for symptoms of infection for 42 days. The incubation period has passed, but new cases continue to trickle in. This suggests that the fungus, mostly Exserohilum rostratum may take many weeks to infect a patient after it enters their body.
The outbreak of fungal meningitis has claimed 31 lives and sickened 424 people. Most of the people who were injured received epidural steroid injections of methylprednisolone acetate to treat back pain. Others received injections for joint pain. Although the fungus is not contagious and does not usually infect humans, once it enters the human body, it can cause a life-threatening fungal infection.
Health officials have taken action by shutting down NECC and its sister-company, Ameridose LLC, which are owned by the same people and both operate in Massachusetts. Although the Ameridose shutdown was initially a precautionary measure, FDA inspections have found problems with the company’s sterility procedures. Ameridose has recalled all of its medications, though they have not been linked to any illnesses.
Gaping problems with the sterility procedures at NECC have come to light in recent weeks. For example, the Tennessee Department of Health reported that at least 150 people received injections from NECC that were at least 7 weeks old, when the injections are supposed to be used within 24 hours. The products were sold without preservatives or warnings to keep them refrigerated.
The FDA and Massachusetts Board of Pharmacy have found that NECC violated their pharmacy license by mass-producing drugs and selling them across state lines without prescriptions for individual patients.
On July 26, Colorado pharmacy regulators sent a memo to the Massachusetts Board of Pharmacy, complaining that NECC was violating their license in Colorado by mass-producing drugs. James Coffey, director of the Massachusetts Board, failed to take any action on the complaint, just months before the outbreak. Coffee has been fired from his position on the Board.
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