The Food and Drug Administration has released lists of providers that may have received the tainted steroid that has led to the outbreak of fungal meningitis.
The FDA last week advised healthcare providers to follow up with patients who were administered any New England Compounding Center injectable product on or after May 21, including an ophthalmic drug that is injectable or used in conjunction with eye surgery, or a cardioplegic solution purchased from or produced by NECC.
This week, the FDA has made available two lists of customers that received products shipped on or after May 21 from the NECC facility. The first list (www.fda.gov/downloads/Drugs/DrugSafety/FungalMeningitis/UCM325467.pdf) includes customer names and addresses, organized by state. The second list (www.fda.gov/downloads/Drugs/DrugSafety/FungalMeningitis/UCM325466.pdf) contains the same basic information as the first, but is organized alphabetically by customer name and also includes the specific products shipped, the quantities of product shipped and the shipping date.
The lists were prepared based on information provided by NECC, and the FDA stated it cannot vouch for the completeness or accuracy of the lists. The lists were reposted Oct. 23 after the FDA had taken them down to address reports of discrepancies.
The FDA and Centers for Disease Control and Prevention 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. The laboratory confirmation further links steroid injections from these lots to the multistate outbreak of fungal meningitis and joint infections. Testing continues on the two other implicated lots of methylprednisolone acetate and other NECC injectables continues.
The CDC and state health departments estimate that approximately 14,000 patients may have received injections with medication from three implicated lots of methylprednisolone. Nearly 97% of these patients have been contacted for further follow-up. As of Oct. 24, the CDC had received reports of 317 cases of infection and 24 deaths in 17 states due to the outbreak (www.cdc.gov/hai/outbreaks/meningitis-map.html).
The FDA has produced a patient notification letter template (www.fda.gov/downloads/Drugs/DrugSafety/UCM324538.pdf) for healthcare professionals notifying patients who were administered one of the recalled products from NECC.
The FDA last week advised healthcare providers to follow up with patients who were administered any New England Compounding Center injectable product on or after May 21, including an ophthalmic drug that is injectable or used in conjunction with eye surgery, or a cardioplegic solution purchased from or produced by NECC.
This week, the FDA has made available two lists of customers that received products shipped on or after May 21 from the NECC facility. The first list (www.fda.gov/downloads/Drugs/DrugSafety/FungalMeningitis/UCM325467.pdf) includes customer names and addresses, organized by state. The second list (www.fda.gov/downloads/Drugs/DrugSafety/FungalMeningitis/UCM325466.pdf) contains the same basic information as the first, but is organized alphabetically by customer name and also includes the specific products shipped, the quantities of product shipped and the shipping date.
The lists were prepared based on information provided by NECC, and the FDA stated it cannot vouch for the completeness or accuracy of the lists. The lists were reposted Oct. 23 after the FDA had taken them down to address reports of discrepancies.
The FDA and Centers for Disease Control and Prevention 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. The laboratory confirmation further links steroid injections from these lots to the multistate outbreak of fungal meningitis and joint infections. Testing continues on the two other implicated lots of methylprednisolone acetate and other NECC injectables continues.
The CDC and state health departments estimate that approximately 14,000 patients may have received injections with medication from three implicated lots of methylprednisolone. Nearly 97% of these patients have been contacted for further follow-up. As of Oct. 24, the CDC had received reports of 317 cases of infection and 24 deaths in 17 states due to the outbreak (www.cdc.gov/hai/outbreaks/meningitis-map.html).
The FDA has produced a patient notification letter template (www.fda.gov/downloads/Drugs/DrugSafety/UCM324538.pdf) for healthcare professionals notifying patients who were administered one of the recalled products from NECC.
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