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Outbreak of Fungal Meningitis in Contaminated Injections

The New England Compounding Center (NECC) recalled all products it produces on October 6, 2012 after an earlier September recall is being investigated by Congress.


What happened?

In September 2012 NECC, located in Framingham, Massachusetts, recalled three lots of preservative-free injectable betamethsone (methylprednisolone acetate) and cardioplegia solutions after 2 of these batches were found to be contaminated with bacteria and fungal meningitis. Testing is still being done on the third recalled lot to ensure that no other contamination is involved.

Two patients cases have been released to the public thus far. The first patient, who is being tested for the possibility of meningitis, has had an injection of the NECC product triamcinolone acetonide (a steroid injection usually given at soft tissue areas). The second patient was a heart transplant patient that was given the NECC product cardioplegic solution during open heart surgery. Cardioplegic solutions stop muscle function in order to prevent heart injury during surgery. Investigations started after patients may have been infected by contaminated NECC products, however rigorous testing by the FDA and CDC is still occurring. Meningitis that has been identified, although without any infected patients, has been found in methylprednisolone acetate.

Until mid-October, no patients had any adverse reaction to any NECC ophthalmic injection that is used for eye surgery, but all concerns are not off the table as the FDA still believes that because of their worries about NECC’s sterilization process. When the FDA’s concerns were raised and further investigations were begun, NECC decided to additionally recall all products it produces.

Part of the FDA’s investigation is the NECC’s clean room, which is a room dedicated to control contamination and sterility. As a result of this concern, the FDA and CDC have decided to further their investigation and testing in order to ensure that other contamination does not pose a threat. As of November, the CDC hasn’t received intel insinuating that any NECC product except those under investigation (the three batches of preservative-free methylprednisolone acetate) are contaminated.


Those affected

NECC logo used on all of its products.

Patients can ensure their safety by checking labels of injections for the NECC logo.

The FDA is advising patients and physicians of the risks associated with bacterial meningitis, as well as controlling the suspected lots. Those who received an injection, including ophthalmic injections, or cardioplegic solutions after May 21, 2012 that have been produced by NECC should receive urgent medical care and testing. A full list of recalled products can be found here.

Fungal meningitis is very serious in nature as it causes inflammation of brain lining and inflammation of the spinal cord. Signs and symptoms of a meningitis infection include sudden fever, headaches and stiff neck, combined with nausea, vomiting, sensitivity to light and abnormal confusion. If the conditions worsen, it can cause seizures and comatose states. These symptoms can appear suddenly or spread throughout several days, developing 3 days to a week after exposure to the bacteria.

The contaminations is to have caused around 440 people to fall ill, and caused 32 deaths.


What is being done?

Congressional hearings by the House Energy and Commerce Committees are taking place to decide whether the meningitis outbreak could have been prevented considering the fact that products were found to be shipped without verifying sterility.

The NECC has had previous complications with the FDA dating back to 1999, and included five patients becoming sick with what seemed like meningitis-like symptoms in 2002. Two of those five patients were hospitalized and were found to have used the same medications under fire in the outbreak today. A letter from the FDA was submitted to the NECC to implement changes but no follow up was ever recorded.

For more information and FAQs from the FDA, please click here.