November 18, 2012 – This fall’s nationwide fungal meningitis outbreak was rare and unprecedented, both because the illnesses were caused by tainted shots of steroid pain relievers, as well as the fact that the fungus involved is not known for making people sick. To date, contaminated vials of methylprednisolone acetate processed by the New England Compounding Center (NECC) in Framingham, Mass. have sickened nearly 500 people and caused 33 deaths in 23 states around the country. This article provides a brief chronological overview of the events surrounding the outbreak.
Compounding Pharmacy Recall Update 8/12/13: Texas-based compounding pharmacy Specialty Compounding, LLC, has issued a nationwide recall for all lots of medications it has processed since May 9. To date, at least 15 people have been diagnosed with a rare bacterial infection after being administered injections of calcium gluconate at a pair of Texas hospitals. In response to this and a number of other recent compounding pharmacy recalls, the FDA is asking Congress for increased oversight and authority over these operations.
Fungal Meningitis Update 1/30/13: This week, a federal judge ruled that assets of the company at the center of last year’s unprecedented fungal meningitis outbreak will be frozen indefinitely. An emergency injunction was placed on the New England Compounding Center (NECC) after the owners were accused of funneling more than $21 million out of the company’s assets before filing for bankruptcy in December.
Fungal Meningitis Outbreak Timeline
- Early September 2012 – The first patients to be positively identified with a rare variety of fungal meningitis arrive at hospitals around the country. A clinician in Tennessee, Dr. April Pettit, is the first to realize that the illnesses represent the beginning of a nationwide health epidemic after finding fungus in one of her patient’s spinal fluid.
- September 18 – Pettit contacts the Tennessee Department of Health in an attempt to determine if other patients have recently been diagnosed with fungal meningitis. Her efforts set the response in motion after she notes that her patient had recently received an epidural steroid injection.
- September 20 – The Tennessee Department of Health contacts the Centers for Disease Control and Prevention (CDC) to report the cases of fungal meningitis. Officials from the state health department inform the CDC that one patient had been injected with a steroid pain reliever at the Saint Thomas Outpatient Center the previous month. Although this is the first case of fungal meningitis reported to the CDC, the center suggests that Tennessee health officials visit Saint Thomas. The clinic voluntarily closes the same day, and has not reopened since.
- September 21 – The likely source of the outbreak is narrowed down to contaminated vials of methylprednisolone acetate processed by the New England Compounding Center (NECC) in Framingham, Mass., environmental contamination, or mishandling of equipment.
- September 24 – A number of other fungal meningitis cases are reported in Tennessee, prompting state officials to contact the Massachusetts Department of Health in order to obtain information about NECC.
- September 25 – Officials from the U.S. Food & Drug Administration (FDA) become involved in the investigation.
- September 26 – In response to these developments, NECC recalls three lots (approximately 17,000 vials) of methylprednisolone acetate. According to the company, the tainted steroids may have been injected into as many as 1,400 patients beginning as early as May 21. Since September 26 marks the last day patients could have received steroid injections from NECC, it becomes day one of the 42-day risk period the CDC began talking about. The same day, the Massachusetts Department of Public Health begins investigating NECC’s plant in Framingham.
- October 6 – At least 64 cases of fungal meningitis have been reported nationwide. NECC makes the decision to recall all products processed by the company in 2012, and to shut down operations until the FDA completes its investigation into the source of the outbreak.
- October 24 – Massachusetts health officials find dirty floors and a leaky boiler at the NECC plant. Floor mats in sterile drug-mixing areas were “visibly soiled with assorted debris,” and a leak from a nearby boiler created an “environment susceptible to contaminant growth,” according to the report.
- November 16 – In all, 480 people in 19 states are diagnosed with fungal meningitis, 33 of whom eventually died because of their illness. Curiously, methylprednisolone acetate from NECC was sent to four states where no cases of meningitis were reported, and no cases or complaints have been found in Massachusetts, the only state where NECC has a license.