Meningitis warning spreads to 23 states as investiagtors focus in on cause: fungal contaminate/foreign material in the contaminated steroid solutions

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Officials said all of those infected received spinal injections of a steroid solution sold by a Massachusetts-based facility

    • Karen McVeigh in New York,     Thursday 4 October 2012 17.11 EDT


Saint Thomas Hospital meningitis

Dr Robert Latham, chief of medicine at Saint Thomas, said a patient died there, bringing the number of deaths in Tennessee to three. Photograph: Mark Humphrey/AP

Health officials investigating a deadly outbreak of a rare fungal meningitis have urged doctors and hospitals across 23 states to contact patients who may have received a contaminated steroid injection in the last three months, in order to check them for symptoms.

The rapidly evolving outbreak has already killed five people and a further 35 are ill in six states, some of them “very seriously”.

Officials, who have focused their investigations on an injection made by the New England Compounding Center (NECC), in Massachusetts, have expanded a recall and warned physicians, hospitals and clinics not use any products which may have come from the company.

When investigators from the Food and Drug Administration inspected NECC’s facility, they found a fungal contaminate in a sealed vial of a steroid, methylprednisolone acetate.

They also found what they described as “foreign material” in another, opened vial. Tests are still being carried out to determine if the contaminant matches that causing the illnesses and to determine the second contaminant.

NECC, which issued a recall of three lots of the steroid last week, has told the Food and Drug Administration that it is expanding its recall. The company is licensed to distribute injections in 50 states.

Officials said all of those infected with fungal meningitis received spinal injections of a steroid solution sold by NEEC.

The outbreak has renewed debate over who should regulate specialty pharmacies which combine, alter active ingredients or both to make custom medications, much like early pharmacists. They are under the control of state pharmacy boards, but critics have pointed to outbreaks of deadly infections linked to compounded pharmacies, as evidence that they need tighter controls by federal agencies.

The New York Times reported a bacterial infection that killed nine people in two hospitals in Birmingham Alabama, in early 2011. Another 10 people were sickened by the Serratia marcescens bacteria, which was in an intravenous nutritional supplement prepared by a local compounding pharmacy.

The FDA said it had issued a warning letter to NEEC in 2006, but it was not about the steroid solution. It did not elaborate.

On Thursday, during a joint press conference by the FDA and the Centers for Disease Control and Prevention (CDC), officials described the type of meningitis as “severe” and said early intervention was important for treatment.

They said they did not know how many patients might be affected. Neither did they know how many doses of injection were in each lot of the steroids already recalled or the volume involved.

Ilisa Bernstein, director of compliance at the FDA’s center for drug evaluation and research, said: “Given the severity of the illness, we believed this precautionary measures are necessary to protect public health.”

Dr Benjamin Park, a medical officer at the CDC, said the number of infected patients is expected to grow, as the three lots of methylprednisolone acetate initially recalled by the company on 26 September were distributed to 75 health care facilities in 23 states.

Park said: “If patents are concerned, they should call to find out if they have received medicine from one of these lots”

Asked if it were possible that the products could be available in more than 23 states, Bernstein said: “There is a risk that’s why we are asking physicians hospitals and clinics not to use their products at all.”

To date, they have no evidence of any ill effects of any other NECC product, according to the CDC.

She said they were working with the company to establish a list of products they manufacture.

Twenty-five of the cases are in Tennessee, where a Nashville clinic received the largest shipment of the steroid, according to officials at the CDC. Four cases have been reported in Virginia, two in Maryland, two in Florida, one in Indiana and one in North Carolina. Three of the deaths were in Tennessee, one in Virginia and one in Maryland.

The type of meningitis involved is not contagious like the more common forms. This type is caused by a fungus often found in leaf mould and which health officials suspect may have been in the steroid.

Early intervention is important in treatment and could improve the outcome in patients, Park said.

“Fungal meningitis is quite a rare infection and physicians may not be suspecting it. The treatment is an anti-fungal medicine given intravenously, so a patient would be admitted to hospital.”

Treatment for the illness could take months. He said the steroid is usually given for back pain and that the patients tended to be older but were otherwise in good health.

What is not clear is whether new infections are occurring. Federal health officials are looking for, and increasingly finding, illnesses that occurred in the past two or three months.

At three clinics in Tennessee, officials are contacting the more than 900 people who received the steroid in the past three months. The incubation period is estimated at anywhere from two to 28 days, so some people may not have fallen ill yet, Tennessee health officials said.

Meningitis is an inflammation of the lining of the brain and spinal cord. Symptoms include severe and worsening headache, nausea, dizziness and fever. Some of the patients also experienced slurred speech, and difficulty walking and urinating, Tennessee health officials said.

“Some are doing well and improving. Some are very ill, very, very seriously ill and may die,” Dr David Reagan, a Tennessee health official, said of the state’s patients.

Investigators also have been looking into the antiseptic and anaesthetic used during the injections. Neither has been ruled out. However, the primary suspicion is on the steroid medication. Steroid shots are common for back pain, often given together with an anaesthetic.

Categories: All Posts, Lethal or Unintended Side Effects, Pharmaceutical - Medical Devices

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