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TDH Update on Outbreak of Infections Associated with Epidural Steroid Injections

Thursday, October 04, 2012 | 10:46am

NASHVILLE – Tennessee Health Commissioner John Dreyzehner, MD, MPH, has provided an update on the investigation of infections associated with epidural steroid injections. His statements from today’s conference call are included below.

TDH will provide new information on this investigation to media in a press briefing on Friday, Oct. 5, at 11 a.m. Central time. Members of the media are invited to attend the Oct. 5 news conference at the TDH Central Office in the Cordell Hull Building at 425 5th Avenue North in Nashville. Media members wishing to attend in person must be in place by 10:45 a.m., and should arrive earlier at the Cordell Hull Building with photo identification to be checked in by security. Media members may also participate in the news conference via telephone by calling 1-888-757-2790, passcode 781337.

Statement by Commissioner Dreyzehner October 4, 2012:

Good afternoon and thank you for your continuing coverage of this important public health concern.

We begin by again extending our sympathy to the patients and their loved ones affected by this situation. While we are working with a lot of numbers, records and pieces of information, those all connect to very real people who are experiencing a very traumatic experience, and those impacted are in our thoughts and prayers.

We want to again thank everyone in the health and medical communities at the local, state and national levels who have worked so cooperatively throughout this outbreak. The commitment to patients and collaborative efforts to share information have been remarkable. We are appreciative of their efforts as we all work to assure that all patients at risk for infection are evaluated promptly.

We are grateful to the numerous media organizations who have provided information in Tennessee and nationally. Your reporting of evolving issues has been very helpful in reaching a broad audience.

I recognize many of you were probably involved with the CDC/FDA joint press conference conducted earlier, so I will try to avoid covering the same information and focus on information pertaining to Tennessee.   

• Seven new cases in Tennessee have been identified in the last 24 hours, bringing the total number to 25 in our state. Unfortunately, there is one additional death, as reported in the CDC briefing earlier, bringing our total to three patients who have died. Additional potential cases are currently being evaluated, and we expect that to be the norm for some time. 

• As before we believe this to be fungal in nature. Aspergillus fumigatus has been isolated from one patient and we are awaiting results of tests on additional samples and further information from the CDC and FDA.

• The FDA has now confirmed that a sealed vial of methylprednisolone acetate was opened, viewed under a microscope by an FDA laboratory and a fungal contaminant was identified by microscopic examination. We understand further testing is ongoing. 

Methylprednisolone acetate from New England Compounding Center, or NECC, continues to be the primary material of concern, although we continue to evaluate all possible factors. As you know, 23 states have been confirmed by the FDA as recipients of these materials. We applaud the actions today of the CDC to advise ceasing use of all materials compounded and distributed by NECC. We are in the process of alerting our provider community via our Tennessee Health Alert Network and will recommend following this advice out of an abundance of caution. We have no evidence to date implicating any other NECC products in the outbreak. We will continue to be alert for any such development.

Any patients who are concerned can contact their physician to see if they could have received material from any one of the three recalled lots. To our best knowledge all such patients in Tennessee have been contacted. Any patient with a change of symptoms who received an epidural steroid injection, no matter how mild the symptoms are, should seek evaluation immediately.

Because this is an evolving situation with large amounts of data and materials being continuously reviewed, the investigation process demands great attention to detail. We will continue to be as transparent as possible, providing as much information as we can, and we will continue to keep the media and the public informed through this and other mechanisms as long as there is a need. 

We are not aware of any ongoing exposure in Tennessee to any of the potentially contaminated methylprednisolone acetate from New England Compounding Center. That product was withdrawn from use at all three facilities here who received it, and we are relying on our partners with the CDC and FDA to assist in this area in other states.

We would like to again emphasize this outbreak has no relationship to other cases of bacterial or viral meningitis recently occurring in Tennessee or elsewhere. The meningitis in this outbreak is neither bacterial nor viral and it is not transmitted person to person. 

Tomorrow we will hold a press briefing and conference call at 11 a.m. Central time, using the same number. We encourage you to listen in and to continue to monitor information supplied by our partners with the CDC and FDA.

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