On Monday, the Food and Drug Administration (FDA) announced that as result of an ongoing investigation of NECC, a possible case of meningitis has been potentially associated with a second steroid (triamcinolone acetonide) produced by NECC and that a NECC drug used in open heart surgery has been associated with a patient who developed a fungal infection.
Since Oct. 4, state health departments, the CDC and the FDA have been investigating a multistate outbreak of fungal infections among patients who received a steroid injection with a potentially contaminated product.
Previously, health officials were focusing on contacting and evaluating those patients who received injections of the steroid methylprednisolone acetate from specific lots that were suspected of being contaminated. In Minnesota, that amounted to about 985 patients associated with 6 Medical Advanced Pain Specialists and Minnesota Surgery Center clinics. Almost all of those patients had been contacted by MDH or MAPS staff by Monday afternoon.
The FDA is now advising health care professionals to follow-up with patients who were administered any injectable medication from or produced by NECC, including an ophthalmic drug that is injectable or used in conjunction with eye surgery, or a cardioplegic solution purchased from or produced by NECC after May 21, 2012. The FDA says health care providers and clinics should inform patients who received the NECC products of the symptoms of possible meningitis infection and tell them to contact their health care provider immediately if they experience any of these symptoms.
MDH Tuesday issued a health alert urging health care providers to follow the updated FDA guidance and to report adverse events or side effects related to the medications to the FDA (www.fda.gov/MedWatch/report.htm ) and to also call MDH at 651-201-5414.
It is not known at this time how many patients in Minnesota are affected.
Staff from MDH were calling the 129 clinics Tuesday to make sure they have seen the FDA alerts and are following up with their patients. The clinics were identified based on information provided by NECC and the FDA.