Twenty-four people have died and 317 were sickened in a fungal meningitis outbreak traced to steroids produced at the compounding pharmacy at the New England Compounding Center in Framingham, Mass., a facility licensed by the Massachusetts Board of Registration in Pharmacy Board.
The Massachusetts Department of Public Health Executive Office of Health and Human Services says the outbreak of the non-contagious fungal meningitis originated from a medication produced in non-sterile or unsanitary conditions at the NECC facility.
The U.S. Centers for Disease Control and Prevention in Atlanta confirmed the fungus Exserohilum rostratum was detected in unopened vials of a preservative-free steroid -- methylprednisolone acetate -- produced at NECC.
About 17,000 doses of the steroid were shipped from NECC and an estimated 14,000 were used in treatment to ease back and joint pain. Patients have become ill about one to four weeks following the injection, but health officials said infections, meningitis and stroke appeared to occur within the first 42 days after receiving the injections. The CDC said the risk of serious complications was lower after that time period.
The CDC said the NECC steroid recalled Sept. 26 -- administered to patients on or after May 21 -- was expected to have the highest risk of infection around Nov. 6.
Health departments estimate 97 percent of the approximately 14,000 patients who might have received injections from the three implicated lots of methylprednisolone were contacted for follow-up.
The U.S. Food and Drug Administration advised medical professionals Oct. 4 that all products produced by NECC should be retained, secured and withheld from use. NECC announced a voluntary recall Oct. 6 of all its products currently in circulation that were compounded at and distributed from its Framingham facility.
A complete list of all NECC products subject to this recall can be accessed at: fda.gov/Safety/Recalls/ucm322979.htm.
The CDC said Tennessee was the first state to identify the fungal meningitis and had nine deaths and 70 patients sickened -- followed by five deaths and 80 cases in Michigan; two deaths and 43 cases in Virginia; three deaths and 43 cases in Indiana; one death and 17 cases in Maryland; three deaths and 19 cases in Florida; eight cases in Minnesota; 10 cases in New Hampshire; 11 cases in Ohio; one death and two cases in North Carolina; 18 cases in New Jersey, and one case each in Idaho, New York, Illinois, Texas, Pennsylvania, Georgia and South Carolina.
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