A Nashville doctor is being credited for alerting health officials about a rare case of meningitis that has affected Tennessee and four other states.
Dr. April Petit, an infectious disease specialist at Vanderbilt, found the unusual case of meningitis in one of her patients and alerted the State Health Department in Tennessee.
Petit told the New York Times she became alarmed because the case of meningitis was in an otherwise healthy person.
Petit's patient was one of the two people in Tennessee who died from fungal meningitis linked to a certain kind of steroid injection administered to the spine that is used to relieve back pain.
Petit reported her patient became so ill before he died that he could no longer communicate.
A Massachusetts company that produced a medical compound linked to the multi-state outbreak 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.
"Certainly there has to be a question as to why clinics were going through a compounding pharmacy that is not controlled by the FDA, versus purchasing from the major drug companies the medicines - the steroid epidurals - that could be shipped directly to them," Clayton said.
Clayton is not the only attorney who is planning legal action as the number of these rare, non-contagious meningitis cases grow.
Houston attorney Mark Weycer is representing another Tennessee patient who got a spinal injection at the Saint Thomas clinic on Sept. 7. That patient is now at a local hospital in bad shape, he said.
The incubation period for fungal meningitis can be as long as four weeks, and the state health department said Wednesday it is almost certain there will be more people becoming sick who may not be even showing symptoms yet.
FDA officials said they are working with several state health departments and the Massachusetts Board of Pharmacy on this issue. They are still trying to get a handle on the scope of this investigation and exactly what caused the fungal meningitis outbreak.
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