Pharmacy suspends operations after meningitis outbreak

Posted: Published on October 4th, 2012

This post was added by Dr P. Richardson

NASHVILLE, TN (WSMV) -

A Massachusetts company that produced a medical compound linked to a multi-state outbreak of a rare form of meningitis has suspended operations, according to a statement from the company.

The New England Compounding Center, of Waverly, MA, released a statement Wednesday about the outbreak:

"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."

There have been 18 cases reported in Tennessee and two deaths, in addition to at least eight cases and two deaths in four other states.

The company sent shipments of methylprednisolone acetate, a lumbar epidural steroid medicine, to Saint Thomas Outpatient Neurosurgery Center in Nashville, Specialty Surgery Center in Crossville and PCA Pain Care Center in Oak Ridge.

The Channel 4 I-Team has learned compounding pharmacies, such as this Massachusetts company, that make these type of drug mixtures are not regulated by the Food and Drug Administration.

Compounding pharmacies don't make drugs. Instead, they take medication and put it into different doses and mixtures, but those drug mixtures don't go through the federal government's approval process.

The FDA sent a warning letter to the New England Compounding Center in 2006. It says, in part: "The drugs that pharmacists compound are not FDA-approved and lack an FDA finding of safety and efficacy. However, FDA has long recognized the important public health function served by traditional pharmacy compounding."

Daniel Clayton is representing two Nashville families who said their loved ones became seriously ill after getting a spinal epidural from the Saint Thomas Outpatient Neurosurgery Center.

Original post:
Pharmacy suspends operations after meningitis outbreak

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