UPDATED: Meningitis Outbreak Linked to Framingham Pharmacy
18 of the cases, and two deaths, are in Tennessee where a Nashville clinic received the largest shipment of the steroid suspected in the outbreak. The FDA said the maker of the steroid is in Framingham.
A Framingham pharmacy—New England Compounding Center—is the maker of a steroid containing a fungal form of meningitis that has killed four people across the country, reported CNN.
The strain of the disease, which is not contagious, has made 26 people in five states ill, with Tennessee receiving the largest amount of the steroid.
Last week, the company issued a recall of three lots of the steroid.
According to the Centers for Disease Control and Prevention, the other cases are in Virginia, Maryland, Florida and North Carolina. Virginia and Maryland had one death each.
The Food and Drug Administration identified the maker of the steroid as the New England Compounding Center, a specialty pharmacy in Framingham. Last week, the company issued a recall of three lots of the steroid.
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.”
The Framingham company released this statement:
“New England Compounding Center (NECC) is working closely with the Massachusetts Department of Public Health, the Massachusetts Board of Pharmacy and other regulators to identify the source of infection in patients who received injections of methylprednisolone acetate. Upon notification of incidents of infection, NECC immediately initiated a voluntary recall of this product on Sept. 26. As part of this process, we have voluntarily suspended operations while we assist authorities in their investigation.”
The CDC said these are cases of fungal meningitis, which are not transmittable person to person.
FDA spokeswoman Erica Jefferson e-mailed the Boston Globe 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 Sept. 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”