Rare Meningitis Outbreak Linked to Steroid Injections

A steroid meningitis outbreak in 10 US states that prompted a recall on September 26, 2012 by the manufacturer, the New England Compounding Center has infected about 469 patients and killed 33 as of November 18, 2012 . The Tennessee meningitis outbreak has seen more cases than other states, with about 1,000 people exposed to the steroid. As of October 17, 2012, as many as 14,000 people had potentially received contaminated steroid injections from the company.

Patients are injected in their spines with the steroid, Methylprednisolone Acetate (PF), a preservative-free steroid used to treat pain and inflammation. Methylprednisolone Acetate is also known by the brand names A-methaPred, Depo-Medrol, Medrol, Medrol Dosepak, Meprolone Unipak, and Solu-Medrol.

The start date in which recalled lots of steroid injections may have been used is May 21, 2012, which means that thousands more patients may be at risk. However, no more new exposures are likely, according to MedPage Today. But the incubation period of the fungus involved is not known, and officials expect to identify new cases for the next several weeks.

The Centers for Disease Control has posted on its website a list of 76 medical facilities that received the contaminated steroid injections from the New England Compounding Center (NECC). And the CDC has posted a map of healthcare facilities that received lots of the recalled compound.

Tennessee Meningitis Outbreak

In Tennessee, the first state to report the outbreak, 61 cases to date have been identified. Although 1,000 people in the state have been exposed to the steroid, Tennessee health official said that only about 5 percent of those injected with the drug have developed the typical symptoms of the fungal infection. There have been 8 reported deaths in Tennessee related to the contaminated steroid injections.

Meningitis Symptoms

Unlike other forms of meningitis, the fungal type is not spread from person to person. However, it does affect the spine and membrane surrounding the brain.

Early symptoms of fungal meningitis are new or worsening headache, fever, dizziness, nausea and slurred speech, and new neurological deficit consistent with deep brain stroke. The inflammatory disease can later cause permanent neurological damage and death. Patients are told symptoms can occur up to a month after their spinal injections.

Compounding Centers/Pharmacies and Possible Contamination

Compounding pharmacies custom-mix solutions, creams and other medications in doses or in forms that aren't generally commercially available.

The New England Compounding Center (NECC), a compounding pharmacy in Framingham, Mass, said the recall--involving three lots of the injected steroid-- is a cautionary move to prevent any risk of contamination and that there is no indication of any other products being contaminated.

However, the NECC settled a lawsuit alleging it produced a tainted injection that killed a man—from a different form of meningitis--in 2004, according to the Boston Herald (Oct 10, 2012). The 83-year-old man died about 18 months after receiving a shot produced by the Framingham pharmacy.

The state is now looking into whether or not NECC was in violation of its license.

Meanwhile, Ameridose LLC, another drug company based in Westborough, Mass with the same owners, has temporarily stopped its compounding and manufacturing operations--as a precautionary measure only--while regulators inspect its facilities. Earlier this year Ameridose was accused by a business customer of failing to separate sterile and non-sterile products in its warehouse.

The FDA has never reviewed compounded drugs for safety and effectiveness. Due to this outbreak, lawmakers are calling to strengthen the agency' oversight over the drugs. Rare Meningitis Outbreak Steroid Injection lawsuits are expected to follow.

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Last updated on May-12-14