An outbreak of rare fungal meningitis has sickened 35 people six states, including five people who died, health officials say.
The source of the outbreak is still under investigation, but injections of a drug called methylprednisolone acetate have been closely associated with cases. The steroid is used to treat lower back pain; it is injected into the spine.
Most of the cases occured in Tennessee, but cases have also been seen in North Carolina, Florida, Virgina and Maryland.
Patients affected by the outbreak had received steroid drugs produced by the New England Compounding Center in Framingham, Mass.
An investigation of the NECC facility found sealed vials of the drug that were contaminated with fungus. Foreign materials were also found in other vials produced by the company, said Ilisa Bernstein, director of the Office of Compliance at the Food and Drug Administration's Center for Drug Evaluation and Research. Additional testing of drugs produced by the company is underway, Bernstein said.
Three lots of the injectable steroid from NECC have been recalled. These lots were distributed in 23 states.
Out of an abundance of caution, the FDA and Centers for Disease Control and Prevention are urging all healthcare practitioners not to use any products they may have that originated from NECC.
NECC has voluntarily ceased distribution of its products, and shut down all operations.
The type of meningitis seen in the outbreak is not transmissible from person to person, said Dr. Benjamin Park, medical officer at the CDC's National Center for Emerging and Zoonotic Infectious Diseases.
Symptoms of the fungal meningitis take one to four weeks to appear, and include fever, new or worsening headache, and nausea.
Some people may have received injections of the recalled drug in places other than the spine, in which case, they would experience different symptoms, such as swelling or pain at the injection site, Park said.
If patients are identified soon and started on appropriate antifungal therapy, some of the unfortunate consequences of the illness may be avoided, Park said.
Despite the recall and precautions taken, health officials expect to see additional cases as the investigation continues.
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