Meningitis Death Toll Reaches Five With More NECC Products Due To Be Recalled

(Newsroom America) -- A rare fungal meningitis has now killed five people in the United States but health officials say this type of meningitis is not transmissible from person-to-person and is believed to have come from contaminated steroid injections.

CDC said to date a total of 35 cases in six states have been identified. At least five deaths have been reported with three in Tennessee and one each in Virginia and Maryland.

On September 21, CDC was notified by the Tennessee Department of Health of a patient with the onset of meningitis approximately nineteen days following epidural steroid injection at a Tennessee ambulatory surgical center.

On September 28, investigators identified a case outside of Tennessee, possibly indicating contamination of a widely-distributed medication.

Investigation into the exact source of these infections is ongoing, but all infected patients received preservative-free methylprednisolone acetate from among the three lots voluntarily recalled by the New England Compounding Center (NECC) in Framingham, Massachusetts, on September 25th.

The 23 states that received the recalled medication include California, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Maryland, Michigan, Minnesota, North Carolina, New Hampshire, New Jersey, Nevada, New York, Iowa, Pennsylvania, Rhode Island, South Carolina, Tennessee, Virginia, Texas, and West Virginia.

Infected patients have surfaced about one to four weeks following their injection with a variety of symptoms including fever, new or worsening headache, nausea and symptoms consistent with a stroke.

Medical officer at the Mycotic Diseases Branch at CDC, Dr Benjamin Park, said some of these patients symptoms were very mild in nature.

"Cerebrospinal fluid obtained from these patients has shown findings consistent with meningitis. It is important to note that this type of meningitis is not transmissible from person-to-person.

"CDC and FDA are working closely with state health departments on this challenging investigation. Out of an abundance of caution, CDC and FDA recommend that all health care personnel cease use and remove from their pharmacy inventories any product produced by the New England Compounding Center."

CDC also recommends that clinicians contact all patients who received injections using product from any of the three recalled lots to determine if they are having symptoms.

Ilisa Bernstein from the Office of Compliance at FDA said the product most closely associated with this outbreak of meningitis is preservative-free methylprednisolone acetate, 80 milligrams per ml, an injectable steroid compounded and distributed by NECC.

Ms Bernstein said officials were in the process of further identifying the fungal contaminant.

"Foreign material has also been observed in other vials produced by the company they were collected by FDA during an inspection," she said. Additional microbial testing was under way and three lots of methylprednisolone acetate were recalled.

As of yesterday, New England Compounding Center has voluntarily shut down all operations and expanding its recall to include all methylprednisolone acetate prepared by NECC as well as all other drug products for intrathecal administration prepared by NCEE.

FDA said it would post this expanded recall information on its website as soon as it was available.

Ms Bernstein said NECC has voluntarily ceased distribution of all of its products.

"While these are significant steps towards containing the potentially contaminated drug products out of abundance of caution, FDA is taking the additional step of advising all health care practitioners to not to use any product that originated from New England Compounding Center until the investigation into the source of the outbreak is complete and further information is provided.

"We are urging physicians and other health care practitioners, clinics, and hospitals, to check their drug supply and purchase records to determine if they have purchased products from NECC to immediately discontinue use and isolate those products from their supply," said Ms Bernstein.

Ms Bernstein said given the severity of the illnesses so far, these precautionary measures are warranted to protect the public health.