The Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) have confirmed the presence of a fungus known as Exserohilum rostratumin unopened medication vials of preservative-free methylprednisolone acetate (80mg/ml) from one of the three lots from New England Compounding Center (NECC) (Lot #08102012@51, BUD 2/6/2013), which were implicated in the fungal meningitis outbreak. 

The fungi is exactly the same as the one implicated in the fungal meningitis outbreak which has led to 254 cases of fungal meningitis and 20 deaths from the fungal infections, according to Reuters.

The FDA says "The laboratory confirmation further links steroid injections from these lots from NECC to the multistate outbreak of fungal meningitis and joint infections.  Testing on the other two implicated lots of methylprednisolone acetate and other NECC injectables continues."

CDC and state health departments estimate that about 14,000 patients may have received tainted steroid injections from three tainted lots of methylprednisolone, which is intended to ease back pain, and nearly 97% of these patients have been contacted for further follow-up, the FDA says.

The food and drug regulator says it advises that clinicians should report any suspected adverse events following use of these tainted steroid products to FDA's MedWatch program at 1-800-332-1088 or www.fda.gov/medwatch.

The FDA has been criticized for its inaction prior to the fungal meningitis outbreak. But the agency says that it does not have the authority to intervene the drug compounding business.  Unlike drug companies, drugs prepared by "pharmacies" or compounding centers and used by doctors are not subject to strict regulation by the FDA.  

By the FDA definition, anything that is intended to diagnose, prevent or treat any disease should be viewed as a drug and is subject to the regulation by the FDA.  In the case of the fungal meningitis outbreak, the steroids were used by physicians to treat pain and because of this, these steroid injections are clearly drugs by the FDA definition and the FDA should have the authority to safeguard the manufacturing and use of these steroid shots.

Steroids can compromise a patient's immunity and put the patient in a defenseless position, which is one of the reasons that patients who were exposed to the fungi were more likely than other patients to suffer fungal infections.

Health observers expected more deaths from the fungal infections and they warmed that the potential risk can linger for months or even years if not decades. (David Liu)