Roper St. Francis Healthcare is examining the Food and Drug Administration’s (FDA) expanded list of precautionary medicines coming from the New England Compounding Center (NECC) in Massachusetts, and following guidelines to ensure patient safety. All of the pharmaceutical products that have been sold by NECC are now being recalled, including one that RSFH did purchase called Nalbuphine, (product name Nubain). RSFH is reaching out to patients that received Nalbuphine.
Multistate Meningitis Outbreak Investigation
- Centers for Disease Control and Prevention (CDC), with state and local health departments and the Food and Drug Administration (FDA), are investigating a multistate outbreak of fungal infections among patients who have received a steroid injection with a contaminated product, methylprednisolone acetate, produced by a single compounding pharmacy, New England Compounding Center (NECC).
- The cases of meningitis that have been identified as part of the multistate outbreak investigation were found to be caused by fungi that are common in the environment but rarely cause meningitis. This form of meningitis is not contagious.
- CDC continues to find the fungus Exserohilum in clinical specimens from people with meningitis. At this time, only one clinical specimen has tested positive for the fungus Aspergillus.
- Additionally, one clinical specimen tested positive for Cladosporium, a black mold related to Exserohilum. From the beginning of this investigation, CDC anticipated identifying additional types of fungi; these findings do not change current treatment recommendations.
- CDC and FDA have confirmed the presence of a fungus known as Exserohilum rostratum in unopened medication vials of preservative-free methylprednisolone acetate (80mg/ml) from one of the three implicated lots from NECC (Lot #08102012@51, BUD 2/6/2013). The laboratory confirmation further links steroid injections from these lots from NECC to the multistate outbreak of fungal meningitis and joint infections.
- FDA advises doctors to contact patients who have received an NECC injectable product after May 21, 2012.
About CDC’s Response:
- Through continuous efforts at our state and local public health departments, and utilizing CDC’s Emergency Operations Center to staff a call center to contact patients, 97% of the nearly 14,000 patients have now been contacted.
- The epidural steroid medication associated with this outbreak is not the same as the epidural injections given to pregnant women during childbirth.
- As of October 21 at noon (EST), a total of 282 cases of fungal meningitis, stroke due to presumed fungal meningitis, or other central nervous system-related infection meeting the outbreak, including 23 deaths.
- Additionally, as of October 21, there were 3 persons with reported peripheral joint infections (e.g., knee, hip, shoulder, elbow). No deaths have been associated with peripheral joint infections. These people received an injection from one of the three recalled lots. Laboratory results are not complete at this time, so we cannot be sure if it is a fungal infection.
- A breakdown of the cases by state is available on CDC’s website and is updated daily at 2 p.m. ET
- Florida – 17 cases, including 3 deaths
- Idaho – 1 case
- Illinois – 1 case
- Indiana – 38 cases, including 2 deaths
- Maryland – 16 cases, including 1 death
- Michigan – 53 cases, including 5 deaths
- Minnesota – 7 cases
- New Hampshire – 10 cases
- New Jersey – 16 cases
- New York – 1 case
- North Carolina – 2 cases, including 1 death
- Ohio – 11 cases
- Pennsylvania – 1 case
- Tennessee – 69 cases, including 9 deaths
- Texas – 1 case
- Virginia – 41 cases, including 2 deaths
- People injected in peripheral joint spaces only are not at risk for fungal meningitis, but could be at risk for joint infection.
Messages for Patients:
- Patients who feel ill and are concerned about whether they received a medication produced by NECC should contact their physician to find out if an NECC product was used.
- To date, CDC has not confirmed a link between infections and other recalled NECC products.
- Patients who have had an epidural steroid injection (medication injected into the spine) since May 21, 2012, and have any of the following symptoms, should talk to their doctor as soon as possible.
- Worsening headache
- Sensitivity to light
- Stiff neck
- New weakness or numbness in any part of your body
- Nausea and vomiting
- Slurred speech
- Altered mental status
- Patients who have only had injections in peripheral joint space, such as an ankle, hip, knee, or shoulder since May 21, 2012, are not likely to be at risk for fungal meningitis, but could be at risk for joint infection. Patients who have any of the following symptoms, should talk to their doctor as soon as possible.
- Increased pain, redness, warmth, or swelling in the joint where they received the injection or at the injection site
- Among people with meningitis for whom we have clinical information available, the onset of symptoms is typically between 1 to 4 weeks following injection.
- Nevertheless, fungal infections can be slow to develop and there are reports of longer periods of time between injection and onset of symptoms, so patients and their doctors will need to be vigilant for at least several months following the injection.