A Framingham compounding pharmacy has been identified by state and federal health officials as the source of a medication being investigated as a possible cause of an unusual fungal meningitis outbreak that has sickened 26 patients in five states who received steroid injections. Four of the patients have died.
The pharmacy, New England Compounding Center, recalled three lots of methylprednisolone on Sept. 26, according to the US Food and Drug Administration.
Eighteen of the meningitis cases have been reported in Tennessee, and cases also have been reported in Virginia, Maryland, Florida, North Carolina. A Nashville outpatient neurosurgery clinic closed last month after patients got sick after receiving steroid injections in their backs for pain.
Here is a statement released Wednesday night by the Massachusetts health department regarding the investigation:
“The Massachusetts Department of Public Health is collaborating with the CDC, FDA, and other state public health officials to identify the cause of an outbreak of more than 25 suspected cases of aspergillus (fungal) meningitis under investigation in Florida, Maryland, North Carolina, Tennessee and Virginia. The cause for this cluster of cases is not yet known. There are four products common to all of these cases. One medication, Methylprednisolone Acetate, a steroid, was prepared at the New England Compounding Center, Inc (NECC), a pharmacy in Framingham, Massachusetts. It has been recalled and quarantined as a precaution. NECC is voluntarily recalling all similar medications. In addition, at the request of DPH, NECC has agreed to voluntarily surrender their license to operate until this investigation is complete. The form of fungal meningitis in these patients is not transmitted from person to person. There are no known cases in the Commonwealth.”
FDA spokeswoman Erica Jefferson e-mailed the following statement:
“FDA is working with CDC, several state health departments and the Massachusetts Board of Pharmacy on this issue and is still investigating the scope and cause of the outbreak of fungal meningitis.
“What I can say is that on September 26, New England Compounding Center (NECC) conducted a voluntary recall of 3 lots of Methylprednisolone (PF) 80mg/ml Injection produced at NECC. The lot numbers of this product are:
--Methylprednisolone Acetate (PF) 80 mg/ml Injection, Lot #05212012@68, Beyond Use Date (BUD) 11/17/2012
--Methylprednisolone Acetate (PF) 80 mg/ml Injection, Lot #06292012@26, BUD 12/26/2012
--Methylprednisolone Acetate (PF) 80 mg/ml Injection, Lot #08102012@51, BUD 2/6/2013”
New England Compounding Center did not answer its phone tonight.