Methylprednisolone Acetate Recall Due to Meningitis Outbreak: 26 Cases, 4 Deaths

[UPDATE 10/8/2012: CDC reports that the meningitis toll has now risen to 100 people ill, with eight deaths.]

[UPDATE 10/5/2012: CDC reports that the meningitis toll has risen to 35 people in six states, with five deaths.]

The Centers for Disease Control and Prevention (CDC) announced yesterday that a non-contagious, fungal form of meningitis has sickened 26 people in five states, killing four. A total of eighteen cases have been reported in Tennessee, three cases in Virginia, two each in Florida and Maryland, and one in North Carolina. Two people have died in Tennessee, one in Virginia, and one in Maryland.

All of those infected had received methylprednisolone acetate injections to the spine. Methylprednisolone acetate is an injectable steroid product used to treat pain and inflammation when oral therapy is not feasible.

FDA officials identified the causative agent to be methylprednisolone acetate 80mg/mL injection, compounded at the New England Compounding Center (NECC). The NECC is conducting a voluntary recall of three lots of the compounded product. The recalled lot numbers are #[email protected], #[email protected], and #[email protected]

Three pain treatment centers in Tennessee received the steroids that were part of the three recalled lots: Specialty Surgery Center in Crossville, Tennessee; the PCA Pain Care Center in Oak Ridge, Tennessee; and the St. Thomas Outpatient Neurosurgery Center in Nashville. In addition, biopsies from two patients were consistent with the aspergillus fungus found in another patient.

Meningitis is a swelling typically caused by an infection of the fluid surrounding the brain and spinal cord that can be caused by bacteria, viruses, parasites or fungus, although meningitis also be caused by injury, cancer or medications. For this type of meningitis, symptoms include worsening to severe headache, nausea, dizziness and fever.

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Should the FDA enforce more strict quality controls and sterility testing for compounded prescriptions?