Multistate steroid injection outbreak update, CDC and FDA release organism identifications

Penicillium
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New information has been released concerning the multistate investigation of Suspscted infections following steroid injections by both the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) Thursday.

To date, the investigation into suspected skin infections from injectable steroid compounded at the Main Street Family Pharmacy in Newbern, Tennessee shows the number of cases now stand at 26 reported from four states. This is up one case from the previous update.

The four states reporting cases include Arkansas, Florida, Illinois, and North Carolina.

However, MSFP records indicate that MPA products were distributed to facilities in 17 states since December 1, 2012 including: Alabama, Arkansas, California, Florida, Illinois, Kansas, Kentucky, Louisiana, Montana, Mississippi, New Mexico, New York, North Carolina, Oklahoma, South Carolina, Tennessee, and Texas.

In addition, the FDA is now reporting it's finding on cultures of bacterial and fungal growth in samples from two unopened vials of preservative-free (PF) methylprednisolone acetate (MPA) 80 mg/mL, 10mL vials. Growth was seen in two separate lots.

Based on preliminary microbial identification, the first lot of preservative-free (PF) methylprednisolone acetate (MPA) 80 mg/mL, 10mL vials, 011413dan, revealed a variety of fungal and bacterial growth to include Bacillus pumilus, Bacillus cereus/thuringiensis/mycoides, Roseomonas gilardii, Acinetobacter ursingii, Alternaria sp.and Cladosporium sp.

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Cultures on the second lot under investigation, 010913dan, revealed Bacillus licheniformis, Penicillium sp.

The investigation continues as additional samples are being evaluated.

Since the investigation began in early June, federal health officials knew of reports of skin and soft tissue infections related to the tainted steroid injection. Now they have some data as to the etiology of some of the infections.

The CDC reports, of the 26 cases meeting the CDC's case definition, "A person who developed a suspected infection associated with injection of a product, labeled as sterile, that was distributed by the Main Street Family Pharmacy (Newbern, TN) since December 1, 2012", four cases have bacteria/fungi detected from the wound cultures.

Two patients had the bacterium, Enterobacter cloacae and Klebsiella pneumoniae, one had mixed bacterial culture not otherwise identified, and one had fungus highly suggestive of an Aspergillus sp., with confirmation pending.

However, it is unclear if these infections were due to the steroid injection or other factors.

In an email statement earlier this week, a spokesman for Main Street Family Pharmacy said, "Main Street Family Pharmacy is aware of the FDA's recent findings. Since this matter surfaced, the pharmacy has done everything in its power to ensure that all potentially affected compounded medicines are recalled and no longer used by consumers or health care providers. In addition to the recall, our efforts have also included comprehensive, aggressive outreach to everyone who could be affected. We continue to fully cooperate with the state boards of health and pharmacies, the FDA and CDC to protect patients and resolve any lingering concerns."

On May 28, Main Street Family Pharmacy announced a voluntary nationwide recall of all lots of all sterile products compounded by the pharmacy.

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